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HBW18 March 2019 • No. 12hbw.pharmaintelligence.informa.com

I N S I G H T

HEALTHBEAUTYWELLNESS

F R O M T H E E D I T O R S O F : Rose SheetPharma intelligence

Pink SheetPharma intelligence

WELLNESS

Targeted Omega-3 Supplementation Could Save Up To €64.5bn In Health Care Costs, FSE Claims, p.15

HEALTH

France’s Prime Minister Wades Into Liberalisation Debate, Claiming Online Restrictions Have Gone ‘Too Far’, p. 4

BEAUTY

FDA Determined To Update Cosmetics Regs After Claire’s Refuses To Recall Asbestos-Tainted Makeup, p. 9

Australian Industry Welcomes Possible Oral Contraceptive SwitchDAVID RIDLEY [email protected]

T he Australian Self Medication Industry (ASMI) has welcomed moves to increase access to oral

contraceptives in the country, after the opposition Labor Party announced it would revisit the issue if elected to parlia-ment this year.

Last week, the Australian Labor Party pledged that if voted into government in the upcoming federal elections it would ask the country’s Therapeutic Goods Ad-ministration (TGA) to advise on options to “reduce barriers to improve access to the contraceptive pill.”

Responding to the announcement, the ASMI said that it “very much welcomed and encouraged” the pledge, arguing that reducing barriers to the contraceptive pill

would result in greater choice for women and help more Australians to practice self-care with confidence.

“Increasing access to medicines, where safe and appropriate, will lead to greater choice for consumers and sub-stantial benefits throughout the coun-try,” it added.

The ASMI pointed out that it had “long been advocating for a progressive switch agenda” in Australia, and that oral contraceptives had been identi-fied as possible contender for down-scheduling by the country’s recently established ‘multi-stakeholder working group’ on prescription-to-OTC medicine reclassification, which includes the as-sociation as a member.

APPENDIX M CONSULTATIONAs part of its switch campaign, the ASMI has successfully campaigned for the ad-dition of an ‘Appendix M’ to the country’s primary medicines legislation, the Poi-sons Standard.

According to the ASMI, this reform will help expedite switches by introduc-ing additional controls for medicines rescheduled from ‘Schedule 4’ (prescrip-tion-only) to ‘Schedule 3’ (non-prescrip-tion, pharmacist-only) status.

The TGA is now consulting on proposed criteria for Appendix M, which include:● A requirement that pharmacists give

specific advice relating to resched-uled medicines as a condition of their purchase;

● That pharmacists should have spe-cific training relating to such advice, as well as on how to assess the suit-ability of individual patients for these medicines;

● Limitations on the duration of use and quantity and/or frequency of supply of rescheduled medicines;

● The need for prior formal diagnosis or periodic review of the condition requiring the medicine by a medical practitioner.Based on consultation responses –

which can be submitted through the TGA’s website before 1 April – a final position pa-per will be developed by the agency and published by mid-2019. (See also: TGA Schedule M Consultation).

The ASMI said that it hoped the creation of Appendix M would foster a regulatory environment that encouraged more re-scheduling applications and increased access to medicines for Australians, where safe and appropriate.

Published online 11 March 2019

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@HBWInsightHBW-Insight

COVER / Australian Industry Welcomes Possible Oral Contraceptive Switch

Health 4 France’s Prime Minister Wades Into Liberalisation Debate,

Claiming Online Restrictions Have Gone ‘Too Far’

5 OTC Marketing Awards 2019 Winners Announced – GSK Company Of The Year, Pfizer’s Viagra Best Brand

6 FDA $6.1Bn Budget Proposal Includes $28M From OTC Monograph User Fees

7 Abortion Pills Offered Nonprescription By E-Commerce Firms FDA Warned

Beauty 9 FDA Determined To Update Cosmetics Regs After Claire’s

Refuses To Recall Asbestos-Tainted Makeup

10 Rep. Pallone’s Discussion Draft For Cosmetics Reform Closely Mirrors Reintroduced Feinstein/Collins Bill

11 House Committee Hearing Shows How Talc/Asbestos Concerns Could Be Impetus For Cosmetics Reform

12 California In Upgrade Mode, Now Exploring Safer Consumer Products 2.0

13 Beiersdorf’s Three Pillars Of Success Amid Digital Disruptor ‘Turmoil’

Wellness 15 Targeted Omega-3 Supplementation Could Save

€64.5bn In Health Care Costs, FSE Claims

16 CBD Oral Sprays For Pain, Sleep, Weight Recalled On Microbial Contamination

18 Poor Results For Supplementation To Curb Depression In First-Of-Kind Study

19 FTC’s Prevagen Complaint Revived: Court Says ‘Deceptive’ Ad Allegation Plausible

21 Boots’ Symptoms Claim For Dual Defence Not A Prevention Pitch – UK Regulator

22 Prop 65 ‘Responsibility’ Proposal Stirs Retailers For Manufacturers’ Guarantees

22 18 12

GNC, Vitamin Shoppe Not On Same Page In Solving Similar Growth Challengeshttps://bit.ly/2Hw5UGt

Common thread between the manufacturers and retail chain operators offering their own and other brands extends to relatively recent executive suite shakeups following extended stretches of declining sales growth. GNC reported nearly $70m net income for 2018 after two years of net losses and Vitamin Shoppe trimmed its loss by more than $200m from 2017 to $12.1m.

British Sport Supps Firm Busted For Supplying Deadly DNP, Fake Viagra Seizedhttps://bit.ly/2u82DFm

Two drug busts in the UK: the director of a British supplements firm is given a nine-month custodial sentence after illegally selling DNP and 60,640 doses of unlicensed medicines are seized, including tramadol and fake Viagra.

Wellness Industry News: Acting FDA Commissioner Named, Thorne Test Line Grows, Nitrosigine In Revel Energy, Morehttps://bit.ly/2JeJtrT

NCI’s Sharpless named acting FDA head; Mannatech trims loss as costs grow; Nilo drinks to avoiding hangovers; Daoust leads Soylent Nutrition development, innovation; Viactim in taller, narrower package; Revel Energy made with Nitrosigine; and Thorne has at-home tests for additional concerns.

exclusive online content


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H E A LT H ( O T C D R U G S )

France’s Prime Minister Wades Into Liberalisation Debate, Claiming Online Restrictions Have Gone ‘Too Far’DAVID RIDLEY [email protected]

T he French Prime Minister, Edouard Philippe, has come out in support of online sales of OTC medicines,

as the country’s competition authority prepares to wind up its investigation into France’s medicines distribution system.

Speaking at the competition author-ity’s 10th anniversary celebrations, Philippe – who represents in parliament the conservative Les Republicains party – suggested that current regulations re-garding online sales of OTC medicines needed to be relaxed.

“I am, like many I believe, concerned to ensure the safety of the drug supply chain,” Philippe commented. “It is there-fore an area in which it is legitimate to set strict rules.”

“At the same time,” he continued, “we have probably gone too far in this area and the conditions of online sales of medicines in our country appear too restrictive.”

Currently, French pharmacists can only sell OTC medicines online if they own and operate a bricks-and-mortar pharmacy and have a website registered with the country’s medicines agency.

This puts them at a disadvantage in relation to European ‘pure play’ pharma-cies like DocMorris, which can sell into the country from abroad, and which are, according to a 2016 ruling by the Eu-ropean Court of Justice, not subject to these local rules.

Philippe questioned whether the prohibition on French pharmacies co-operating to sell drugs online was justi-fied and argued for the benefits of online competition in making drug pricing more transparent and fairer for consumers.

CONSULTATION NEARING ITS END The Prime Minister’s intervention comes as the French competition authority pre-pares to publish the results of its investiga-tion into the country’s medicines distribu-tion system.

In the first installment of what it called a “vast” public consultation, the compe-tition authority asked key stakeholders

in the system – including pharmacists, wholesalers and ‘para-pharmacy’ retailers such as supermarkets – whether:● OTC medicines should be sold outside

pharmacies;● A pharmacist would still need to be

present if such medicines were sold out-side pharmacies;

● Such reforms would introduce a risk to public health.In its rationale for the consultation,

the competition authority argued that France’s healthcare sector needed to “evolve” in response to new competitive and economic challenges and major tech-nological developments.

Reforms to the way that the sector was regulated would enable it respond to what it said was a “triple challenge”:● To satisfy consumer demand for quality

healthcare;

● To continue to offer a high level of pro-tection of public health;

● To enable national players in this sec-tor to seize the economic opportunities offered by the European Union’s (EU) single market.At present, French bricks-and-mortar

pharmacies were too often at a disadvan-tage compared to their foreign counter-parts, the authority pointed out.

This was especially the case with regard to the online sale of OTC medicines, it ar-gued, where the French market leader was currently a Belgian company.

Furthermore, due to restrictive regula-tions on the advertising of OTCs, the au-thority noted that pharmacies struggled to compete effectively with large- and medi-um-sized retail outlets and para-pharma-cies. Wholesalers also faced difficulties that were symptomatic of the sector’s “com-petitive sluggishness,” the authority con-tinued, particularly when it came to prices.

Without countervailing purchasing power, the authority said that wholesalers were struggling to impose themselves in relation to pharmaceutical manufacturers, especially with regards to non-reimburs-able OTC medicines.

SELF-MEDICATION INDUSTRY CRITICAL The country’s self-medication industry, however, remains opposed to breaking up the monopoly that French bricks-and-mortar pharmacies still hold over the sale of OTC medicines. (Also see “Afipa Remains Steadfast In Defense Of French Pharmacy Monopoly “ - HBW Insight, 20 Dec, 2018.)

Afipa – France’s self-medication indus-try association – said that it had respond-ed to the consultation by reiterating its commitment to the “high quality and safe” distribution of OTC products through tra-ditional pharmacies.

“A secure framework for the distribution of OTC medicines can only be achieved by dispensing medicines within pharmacies and by pharmacists,” Afipa insisted.


“I am, like many I believe, concerned to ensure the safety of the drug supply chain ... At the same time,

we have probably gone too far in this area and

the conditions of online sales of medicines in

our country appear too restrictive.” - France’s

Prime Minister, Edouard Philippe




OTC Marketing Awards 2019 Winners Announced – GSK Company Of The Year, Pfizer’s Viagra Best BrandTOM GALLEN [email protected]

GlaxoSmithKline PLC rose to the top in a highly-competitive field to be named Company of the Year

at the OTC Marketing Awards 2019.At a Gala Dinner & Awards Presentation

held in London on March 7 to celebrate the best of the British OTC industry, GSK was the night’s biggest winner, nabbing top honors in three categories

Following closely were Pfizer Inc., HRA Pharma SA, and The Mentholatum Com-pany, with two Awards each.

GSK’s collaborative work was cited by the judging panel drawn from multiple and independent retailers who voted the firm OTC Company of the Year.

“GSK has consistently delivered growth through a collaborative ap-proach in its business development for its OTC brands,” said one judge. “The company works with us on category

plans to help deliver an unbiased strat-egy for mutual growth.”

GSK won praise from a second judge for its hands-on approach. “Always ready to offer category support to ensure we are carrying the best ranges to suit our cus-tomers’ needs, GSK also helps to ensure we can feature and promote the compa-ny’s portfolio to the best of our ability and ensure the best sales revenues possible.”

Alongside Company of the Year, a fur-ther 18 Awards were handed out on the night, for excellence across a wide range of disciplines including innovation, packag-ing, social media and brand revitalization.

Pfizer enjoyed a particularly good eve-ning, picking up the Awards for Brand of the Year and Launch of the Year for its erectile-dysfunction treatment Vi-agra Connect, which was switched from prescription-to-OTC status in December 2017. (Also see “Pfizer celebrates UK Viagra switch” - HBW Insight, 15 Dec, 2017.)

OTC Marketing Awards 2019 Winners

AWARD CATEGORY WINNER

OTC Company of the Year GlaxoSmithKline

OTC Brand of the Year Viagra Connect, Pfizer

OTC Launch of the Year Viagra Connect, Pfizer

OTC Brand Revitalisation of the Year Nurses, GlaxoSmithKline

Best Big Budget OTC Marketing Campaign Hedrin, Thornton & Ross. Agency - Tony & Lesley Keen PR

Best Small Budget OTC Marketing CampaignZovirax Cold Sore Cream, GlaxoSmithKline. Agencies - HRG, Mediacom, Saatchi & Saatchi

Best OTC Audio-Visual Advertising EllaOne, HRA Pharma. Agencies - Dirt And Glory Media, Havas London, UM

Best OTC Social Media Campaign Sudocrem, Facebook Live, Teva UK. Agency - Orbital Media

Best OTC Digital or Mobile Marketing Campaign Deep Heat & Deep Freeze, Mentholatum. Agencies - 1DA, the7stars

Most Innovative New OTC Product Clearblue Connected Ovulation Test, Swiss Precision Diagnostics

Best OTC Consumer Advertising In The Press or Out-of-HomeDeep Heat & Deep Freeze, Mentholatum. Agencies - 1DA, the7stars. Tony & Lesley Keen PR

Best OTC Public Relations Campaign for a Medicine EllaOne, HRA Pharma. Agency - Dirt And Glory Media

Best OTC Public Relations Campaign for a Non-Medicine Superdrug, Superdrug. Agency - Well Hello

Best New OTC Packaging Design Seven Seas Perfect 7 Renewal, Procter & Gamble. Agency - Trident

Best OTC Trade Advertising & Support Package Strefen, Reckitt Benckiser. Agency - Verve

Best OTC Pharmacy Training Maloff Protect, Glenmark. Agency - CIG Healthcare Partnership

Best OTC Pharmacy Salesforce Ceuta Healthcare

Best OTC Performer Outside Pharmacy Calpol, Johnson & Johnson

Best OTC Multiple Retailer of the Year Tesco

A total of 19 Awards were handed out on the night





FDA $6.1Bn Budget Proposal Includes $28M From OTC Monograph User FeesMALCOLM SPICER [email protected]

T he $6.1bn for FDA’s fiscal year 2020 funding the Trump adminis-tration requests includes $28m in

OTC monograph user fees that would be established in legislation to overhaul the agency’s system that allows marketing of the vast majority of nonprescription drugs available.

The budget request the White House published on March 11 proposes a $643m increase in FDA’s total FY 2020 funding, with $281m of the increase from FY 2019 in user fees and $362m from the agency’s budget authority, according to a briefing document for Department of Health and Human Services agencies.

The White House’s FY 2019 budget proposal for FDA included a $22m OTC monograph user fee program. However, legislation to authorize a user fee pro-gram in addition to requiring changes to significantly streamline FDA’s system for adding or eliminating ingredients or indications in the OTC monograph was not by passed by Congress during the previous session and the agency has not imposed the fees.

As FDA officials, drug industry stake-holders and consumer health advocates have told members of Congress, the HHS briefing document describes why OTC monograph reform, including user fees, is needed. Around one third of the mono-graphs, which list ingredients allowed as treatments for certain indications, are not yet final.

“The current monograph system has not kept up in product innovation, leav-ing a framework that does not well serve consumers or industry. FDA still has not been able to complete many mono-graphs begun decades ago. Nor has it been able to make timely monograph modifications to account for evolving science and emerging safety issues, or to accommodate product innovation or marketing changes,” the budget briefing document states.

STREAMLINING AND INCENTIVIZINGThe primary cause of the backlog is that any proposed change to a monograph must be adopted through a notice-and-comment rulemaking, processes that often have remained open more than 10 years. Another cause is that firms are hesitant to invest in studies needed to show an ingredient is gen-erally regarded as safe and effective for its indication because when a proposal is approved, any firm registered with FDA to manufacture drugs also can make the new product, but without in-vesting in research.

In addition to giving FDA authority to make monograph changes as adminis-trative decisions, bills introduced in the House and Senate included language allowing periods of market exclusivity for firms that submit some proposals for changes approved by the agency. Allowing market exclusivity, HHS’ brief-ing document says, “removes barriers to innovation.”

The House has passed three bills with monograph reform language – once in a standalone bill and twice, includ-ing in January at the start of the current session, as a provision on legislation to reauthorize public health security and all-hazards preparedness and response programs. In the Senate, a monograph reform bill did not move out of commit-tee during the previous session and the chamber’s public health security and all-hazards preparedness and response pro-grams bill did not include monograph reform language.

The bills would grant exclusivity for an approved monograph request when a sponsor conducts human data stud-ies FDA deems essential, plus either the product contains an active ingredient not previously allowed by tentative or final monograph or notice of proposed rulemaking; or the sponsor seeks a

VIAGRA CONNECT DRIVES GROWTHJudges praised Viagra Connect for draw-ing consumers into pharmacy and “driv-ing genuine category growth.”

“Viagra Connect is the stand-out product in the OTC market,” comment-ed one judge. “It has been a long time since I can recall a launch quite like it, creating a real buzz in the industry and among consumers. Training levels, marketing materials and support were second-to-none.”

While Viagra Connect was commended for opening up a new category, Swiss Pre-cision Diagnostics’ Clearblue Connected Ovulation Test won acclaim for its cutting-edge technology, helping the brand pick up the Award for Most Innovative New OTC Product.

“Swiss Precision Diagnostics has crafted a highly engaging and benefi-cial testing system based on core prin-ciples of hormone tracking and mobile device connectivity,” said one judge from the Expert Judging Panel of con-sumer health specialists. “The Clearblue Connected Ovulation Test System is an impressive blend of sound science and precision tech.”

Another brand rewarded for shaking up the OTC market was HRA Pharma’s EllaOne, which took the Award for Best OTC Audio-Visual Advertising. HRA – which also won Best Public Relations Campaign for a Non-Medicine – was ap-plauded by judges for its well thought through campaign.

“Based on a single great insight – ‘It’s my morning after’ – the EllaOne cam-paign inspired women to be strong and to make their own decision based on their own needs,” noted one judge. “The results are as strong as the characters in the stories.”

Another said, “An extremely well planned and executed campaign for Ella-One that used social media to effectively target a specific audience.”

Check out the full list of Winners in the table on page 5. For more coverage of the 2019 OTC Marketing Awards visit: https://pharmaintelligence.informa.com/events/awards/otc-marketing-awards-2019



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new dosage format; or the sponsor seeks a new label indica-tion. Each bill passed by the House included a provision for 18-month market exclusivity, while the Senate bill called for a two-year exclusivity period.

The Senate bill stalled after Sen. Richard Burr, R-NC, who was the only Health, Education, Labor and Pensions Committee to vote against it, placed a hold on it. Burr had stated concerns about FDA’s accounting for user fees and could frame his objection as objection to creating a user fee program for monograph ingredi-ents. (Also see “’Lame Duck’ Congress Has High Stakes For Pharma Companies” - HBW Insight, 29 Nov, 2018.)

Monograph reform, a proposal that FDA and industry stake-holders began developing in 2017, remains a topic in the current session of Congress because the proposal was not added to 2018 legislation recognized as its strongest chance for passing, the bill reauthorizing FDA’s drug user fee programs Congress passed. (Also see “House Maintains Momentum For OTC Monograph Re-form, Senate Regard TBD” - HBW Insight, 9 Jan, 2019.)

The Consumer Healthcare Products Association sees the White House request for OTC monograph user fees as an encourage-ment for Congress to pass the legislation.

“It’s a clear sign that they remain committed to modernization efforts and are making accommodations for the bill becoming law. We remain optimistic that OTC monograph reform will cross the finish line in this Congress. It’s our sincere hope that this signal of support from the administration will prompt Senate consider-ation,” the trade group said in a statement.


$1.4B For Food SafetyThe White House proposal also includes an $67m increase from FY 2019 to $1.4bn for the agency’s food safety pro-grams in the Center for Food Safety and Applied Nutrition and for Office of Regulatory Affairs field activities.

All of the increase would come from authorized spending as the total food safety user fees would be unchanged at $44m.

Additionally, the administration for the second consecu-tive year proposes legislation to allow FDA to increase the funding cap for its export certification user fee from $175 per certification to $600 for an estimated total of nearly $9m. FDA’s Center for Food Safety and Applied Nutrition issues export certificates to firms shipping dietary supple-ments and other products under the center’s oversight to foreign countries, some of which require that imported products come with a certificate of FDA’s regulation.

Abortion Pills Offered Nonprescription By E-Commerce Firms FDA Warned MALCOLM SPICER [email protected]

T he list of unapproved Rx drugs FDA has found available on-line without prescriptions has extended to the ingredient in the RU-486 abortion pill, according to agency warning

letters to two businesses operating numerous websites.One active ingredient in unapproved drugs sold by the two e-

commerce operations, identified by FDA as Rabold and AidAc-cess.org, is mifepristone, which also is known as RU-486 when linked to the only drug with the ingredient approved for an indi-cation of medical termination of early pregnancy, Danco Labora-tories LLC’s Mifeprex. The firms’ websites offer sales of products without requiring customers to submit prescriptions, though the sites also include statements recommending exams by physicians.

Both firms also offer a combination pack of mifeprist and miso-prostol tablets. Rablon, which is linked to 87 websites, markets its as “Abortion Pill Pack … medicinal treatment” for “females having urge for discontinuing with their pregnancy” while AidAccess.org’s website says its pack is “indicated for early medical abortion for up to 9 weeks,” according to author of the warnings, the Office of Compliance in FDA’s Center for Drug Evaluation and Research.

According to FDA’s approved drugs database, misoprostol, available in a brand and generic equivalents, is indicated for re-ducing the risk of nonsteroidal anti-inflammatory drugs–induced gastric ulcers in patients at high risk of complications from gastric ulcer. Labeling for products containing the ingredient includes

the warning: “ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE.”

FIRMS FLOUT REMS FDA also stated that the firms are distributing misbranded prod-ucts because they aren’t labeled with “adequate warnings against use ... where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application.”

The agency further explained in the warnings that sales of unap-proved drugs labeled as containing mifepristone are “particularly concerning because FDA-approved mifepristone indicated for medical termination of early pregnancy” is available in the US only

Websites listed in an FDA warning letter include displays for an “abortion pills pack.”



AidAccess.org

AidAccess.org

AidAccess.org

AidAccess.org



under a Risk Evaluation and Mitigation Strategy program. FDA’s REMS program for Mifeprex, which was approved in 2000, restricts dispensing to clinics, medical offices and hospitals by or under the supervision of a certified prescriber. For certification. prescribers must have ability to assess the duration of a patient’s the pregnan-cy accurately; diagnose ectopic pregnancies; and provide surgical intervention in cases of incomplete abortion or severe bleeding, or to make arrangements for others to provide the care.

Health care providers certified under the mifepristone REMS also must be able to ensure that patients have access to medical facilities for emergency care and must agree to other responsi-bilities including reviewing and signing a patient agreement form with patients and providing each with a copy of the form and the medication guide for the drug.

Additionally, the REMS program contains other requirements for distributors including following processes and procedures for storage, handling, shipping, tracking package serial numbers, proof of delivery and controlled returns of Mifeprex.

“The REMS program reflects [FDA’s] conclusion that certain dis-tribution restrictions are necessary to ensure the safe use of the drug. The distribution of unapproved mifepristone for medical termination of early pregnancy sidesteps these risk mitigation re-quirements and can put the safety of patients in jeopardy,” said an FDA representative in a statement to HBW Insight..

Additionally, a boxed warning that FDA requires for Mifeprex labeling is not on packaging for the mifepristone products Rablon and AidAccess.org are selling. “The online sale of unapproved mifepristone for medical termination of early pregnancy is also concerning” the boxed warning on Mifeprex indicates mifepris-tone “carries a risk of serious or even life-threatening adverse effects, including serious and sometimes fatal infections and prolonged heavy bleeding, which may be a sign of incomplete abortion or other complications,” the agency rep said.

E-COMMERCE FRAUGHT WITH PHARMA PERILFDA submitted the warnings to the e-commerce businesses, which are not identified with address in the letters, on March 8 and published the documents on March 12.

The agency’s representative noted FDA’s enforcement against e-commerce and other businesses distributing unapproved drugs in the US includes a February warning to a company identi-fied as CanaRx about facilitating distribution of unapproved new drugs and misbranded drugs to US consumers through contracts

with public and private sector employers. Additionally, in October 2018 FDA announced warning letters to online businesses oper-ating a total of 465 websites selling unapproved Rx drugs for in-dications including breast cancer, viral infections such as chicken pox, and pain relief. FDA sent the warnings as part of the Interpol’s annual Operation Pangea XI to combat the sale and distribution of illegal and potentially counterfeit medical products sold online.

The latest warnings to online sellers continue FDA’s crackdown on businesses flouting FDA regulations for drug approvals and distribution. “Unapproved new drugs do not have the same as-surance of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” the agency rep stated.

Emergency contraceptive drugs formulated with levongesterol are approved for Rx and OTC sales in the US, but mifepristone is available only by prescription. Its approval by FDA came in a pro-cess fraught with opposition from anti-abortion groups, which have continued pushing in states to restrict its use more narrowly than the agency approved. (Also see “Off-Label Is Off The Docket: Supreme Court Leaves RU-486 Flexibility Intact” - Pink Sheet, 15 Dec, 2014.)

While emergency contraceptives are widely available OTC, the products reached nonprescription approval only after another FDA evaluation of a new drug application staunchly opposed by anti-abortion groups, with support from some lawmakers. The products’ initial nonprescription sales were limited to distribution by pharmacist to consumers age 19 and older before a federal judge, in multiple rulings on women’s health advocates’ litigation against FDA, struck down the agency’s attempts to restrict access to the products. (Also see “Court Ruling Compels Emergency Con-traceptives Over The Counter” - Pink Sheet, 8 Apr, 2013.)

An NDA for an OTC switch of a daily oral contraceptive is being considered by HRA Pharma SA, which expects in April to com-plete an actual use trial it began a year ago using progestin-only oral contraceptives with norgestrel 0.075 mg, which currently is not available in the US in a single-ingredient oral contraceptive. Rx oral contraceptives currently approved and available in the US that contain norgestrel, a progestational compound, also con-tain the estrogenic compound ethinyl estradiol. (Also see “Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study” - HBW Insight, 21 Jun, 2018.)


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B E A U T Y ( C O S M E T I C S )

FDA Determined To Update Cosmetics Regs After Claire’s Refuses To Recall Asbestos-Tainted Makeup RYAN NELSON [email protected]

FDA says samples of three Claire’s makeup products tested positive for asbestos contamination following reports to that effect in 2017.

The agency is holding the case up as a vivid example of why cos-metics regulations must be updated to ensure consumer safety.

In a March 5 safety alert, FDA advises consumers to stop us-ing Claire’s Eye Shadows, Compact Powder and Contour Palette, which it says may contain asbestos fibers, based on testing per-formed on FDA’s behalf by the Occupational Safety and Health Administration and AMA Analytical Services, Inc.

Claire’s, which touts itself as a trusted source of jewelry and accessories, stylish cosmetics and ear-piercing services, first came under fire in December 2017 when a Rhode Island mom and law clerk had a number of the specialty retailer’s cosmetics analyzed by an independent lab, which found traces of asbes-tos in all of them.

Claire’s responded by pulling products in question from its store shelves “out of an abundance of caution,” while noting that its own testing through an unnamed accredited laboratory had cleared the products as asbestos-free. (Also see “‘Asbestos-Free’ A Relative Term? SAI Testing Expert On Cosmetic Talc Challenges” - HBW In-sight, 19 Mar, 2018.)

The specialty retailer, which emerged from Chapter 11 bank-ruptcy in October 2018, continues to maintain that its products are safe and for that reason has not elevated its response to a for-mal voluntary recall. The company tweeted March 6, “There is no evidence that any products sold by Claire’s are unsafe.”

Claire’s continues, “The recent test results the FDA have shared with us show significant errors. Specifically, the FDA test reports have mischaracterized fibers in the products as asbestos, in direct contradiction to established [Environmental Protection Agency] and [United States Pharmacopeia] criterion for classifying asbes-tos fibers.”

The retailer says its efforts to discuss the issues with FDA met with resistance from the agency, which “insisted” on moving for-ward with the safety alert.

According to FDA Commissioner Scott Gottlieb, Claire’s re-fused to comply with the agency’s request for a recall. He notes in a statement that FDA does not have the authority to mandate such action.

That’s just one point of weakness in the current regulatory framework for cosmetics, which FDA characterizes as “outdated,” having gone virtually unchanged for more than 80 years.

“These findings serve as an important reminder that under our current authority, the FDA has only limited tools to ensure the safety of cosmetics products,” says Gottlieb, who announced the same day that he’ll be leaving the agency in about a month to spend more time with his family in Connecticut. (Also see “With High Profile At FDA, Gottlieb Headed Ambitious Consumer Health Initiatives” - HBW Insight, 5 Mar, 2019.)

FDA CALLS FOR VOLUNTARY INDUSTRY EFFORTS Before he exits, Gottlieb is setting the stage for increased FDA col-laborations with cosmetics industry stakeholders in the interest of improving safety within the confines of existing law.

FDA is urging companies to participate in the Voluntary Cos-metic Registration Program and says it will continue evaluating concerns about ingredients and take measures as needed to re-strict or prohibit use.

Specifically regarding talc, which is known to exist in close prox-imity to asbestos at mining sites around the world, FDA says it has formed an interagency working group to draft talc testing stan-dards and soon will be working with cosmetics manufacturers to get a better sense of how they source and vet the quality of talc used in their products.

“We also want to know how many cosmetics products contain talc and whether manufacturers have received adverse event re-ports associated with talc-containing products,” Gottlieb says.

He notes that adverse event reporting is not required of cos-metics companies under the Federal Food, Drug and Cosmetics Act at present, but it’s an important part of responsible marketing and product safety oversight, according to the Commissioner.

Gottlieb goes on to outline elements that FDA believes should be included in a modernized cosmetics oversight system, namely “appropriate frameworks for registration and listing of products and their ingredients, good manufacturing practice regulations, company reporting of adverse events, access to records (includ-ing consumer complaints) during routine or for-cause inspec-tions, mandatory recalls, disclosure of known cosmetic allergens on a product’s label, and ingredient review.”

The Personal Care Products Safety Act, reintroduced March 7 by Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine, covers most of those points, as does a discussion draft released two days earlier by House Energy and Commerce Committee Chair Frank Pallone, D-N.J. (Also see “Rep. Pallone’s Discussion Draft For Cos-metics Reform Closely Mirrors Reintroduced Feinstein/Collins Bill” - HBW Insight, 8 Mar, 2019.)

The PCPSA has the championship of NGOs and is supported to an uncertain extent by leading cosmetics firms and the Personal Care Products Council, while the Independent Cosmetic Manufacturers and Distributors trade group, which represents primarily small busi-nesses, has been staunchly opposed, favoring more modestly scaled reforms. (Also see “ICMAD Responds To Senate Proposal: Cosmetics Should Not Be Regulated Like Foods” - HBW Insight, 23 Mar, 2018.)

The Environmental Working Group’s Scott Faber, senior vice president for government affairs, states in a release, “I urge con-sumers to heed the FDA’s alert and avoid these [Claire’s] products, and I hope members of Congress finally recognize the current sys-tem that has allowed the cosmetics industry to operate beyond the reach of FDA’s authority must end.”






Rep. Pallone’s Discussion Draft For Cosmetics Reform Closely Mirrors Reintroduced Feinstein/Collins BillRYAN NELSON [email protected]

Federal lawmakers are hitting the ground running with proposals for cosmetics regulatory reform in the

116th Congress.Sens. Dianne Feinstein, D-Calif., and

Susan Collins, R-Maine, reintroduced the Personal Care Products Safety Act March 7, just two days after House Energy and Commerce Chairman Frank Pallone, D-N.J., announced that he’d begun circulat-ing a bipartisan discussion draft bill to up-date cosmetics oversight.

Like the PCPSA, the discussion draft from Pallone and Rep. John Shim-kus, R-Ill. – tentatively called the Cosmetic Safety Enhancement Act of 2019 – would require companies to register facilities with FDA and provide the agency with in-gredient statements for all cosmetic prod-ucts sold in the US.

Under both the House and Senate pro-posals, responsible persons would be expected to put in writing that marketed cosmetics have been assessed for safety.

The bills also would require firms to re-port serious adverse events to FDA within designated timeframes and submit an-nual reports of all adverse events received for products they market.

Further, companies would be required to comply with good manufacturing prac-tices developed via FDA rulemaking. Cur-rently, FDA has provided the cosmetics industry only with GMPs draft guidance.

FDA would be granted mandatory recall authority and vastly improved access to company records under both the House Energy and Commerce discussion draft and the PCPSA.

Additionally, both proposals would require FDA to target at least five cos-metic ingredients or non-functional constituents for safety review on an annual basis, starting with a list that in-cludes preservatives diazolidinyl urea, propyl paraben and quaternium-15, along with methylene glycol/formalde-hyde, which has raised concerns as used in heated hair-smoothing treatments. (Also see “FDA Warns Brazilian Blowout-

Like Brand For Undeclared Formaldehyde Risks” - HBW Insight, 23 Sep, 2015.)

The draft CSEA proposes lead acetate as the fifth ingredient for first-round re-view at FDA, similar to previous versions of the PCPSA.

However, the reintroduced PCPSA replac-es lead acetate with diethyl phthalate, likely because the former’s use in hair-coloring treatments has been largely phased out due to regulatory and consumer pressures.

Unlike a discussion draft released by the Senate Health, Education, Labor and Pensions Committee in early 2018, nei-ther the proposed PCPSA nor CSEA in-cludes provisions for accredited external bodies, such as the Cosmetic Ingredient Review, to have a role in FDA’s ingredient review process, though the agency likely

would consider CIR findings in its assess-ment work along with other available data. (Also see “Cosmetic Ingredient Review Program Will Get ‘Fresh Look’ In 2018 – PCPC” - HBW Insight, 1 Mar, 2018.)

HOUSE BILL’S PREEMPTION SECTION LEFT BLANK FOR NOW Federal preemption of state and local cos-metics laws is likely to be a major point of debate among cosmetics stakeholders in the 116th Congress, as it has been in previ-ous meetings.

The Personal Care Products Council continues to express support for cosmet-ics regulatory modernization, but pre-emption appears at the top of the trade organization’s list of guiding principles for reform legislation, so its backing may hinge on getting that piece right.

Specifically, the group seeks pre-emption of state and local laws “for all cosmetic ingredients based on human health concerns if FDA has reviewed the ingredient’s safety or has been present-ed with a safety review of the ingredi-ent by the Cosmetic Ingredient Review Expert Panel (CIR) and, after a period for FDA review, has not rejected the CIR safety finding.”

The PCPSA includes preemption terms along those lines. However, it’s not clear whether the provisions would cover – or if PCPC has in mind – labeling mandates at state or local levels in the way of ingre-dient warnings based on safety concerns, such as California’s Proposition 65 as it ap-plies to cosmetics.

New York is considering similar “right to know” labeling requirements for per-sonal care and other consumer prod-ucts. (Also see “California Dreamin’: New York Exploring Prop 65-Like Program For Hazardous Chemical Labeling” - HBW In-sight, 14 Feb, 2019.)

Robust preemption would halt if not void the growing patchwork of state and local laws across the US that represent in-creasing burdens and costs for cosmetics companies.

The Personal Care Products Council seeks preemption of state and

local laws “for all cosmetic ingredients based on

human health concerns if FDA has reviewed

the ingredient’s safety or has been presented with a safety review of the ingredient by the Cosmetic Ingredient

Review Expert Panel and, after a period for FDA review, has not rejected the CIR safety finding.”




The Independent Cosmetic Manu-facturers and Distributors trade group, which advocates largely on behalf of small and medium-sized entities, has made it clear that it won’t entertain proposals for large-scale regulatory re-forms without strong preemption lan-guage in place.

Pallone and Shimkus’ discussion draft includes preemption, but its scope and terms are not defined as of yet. That lan-guage is “to be supplied,” potentially rep-resenting opportunity for industry to firm up or expand provisions in the PCPSA.

In his March 5 statement, Pallone says the proposed CSEA would close gaps in FDA’s authority that currently challenge its ability to regulate the cosmetics mar-ket effectively.

“Examples like Claire’s refusal to volun-tarily recall their asbestos-tainted prod-ucts demonstrates the need to modernize the current regulatory framework for cos-metic and personal-care products to en-sure that FDA can act to protect consum-ers when industry fails to do so,” he says. (Also see “FDA Determined To Update Cos-metics Regs After Claire’s Refuses To Recall Asbestos-Tainted Makeup “ - HBW Insight, 7 Mar, 2019.)

In the 115th Congress, proposed cos-metics reform bills in the House received little to no serious attention, seen by some as excessively industry-friendly in one case and overly oppressive in the other. (Also see “116th Congress Could Test Cos-metic Industry’s Commitment To Reg Re-form, Preemption Viability “ - HBW Insight, 19 Nov, 2018.)

Pallone’s ascension to the Energy and Commerce chair in late 2018 all but as-sured that cosmetics issues would be a higher priority for the Democrat-led House in the new session. In addition to asbestos-contamination issues, the con-gressman has raised concerns about the inadequacy of FDA’s inspection program for imported cosmetics, among other ar-eas where the agency’s resources are seen as sorely lacking.

Like the PCPSA, the proposed CSEA would provide FDA initially with $20.6m in new cosmetics funding through industry registration fees, which would be levied on companies on a sliding scale based on their annual revenues.


House Committee Hearing Shows How Talc/Asbestos Concerns Could Be Impetus For Cosmetics ReformRYAN NELSON [email protected]

Concerns about talc-containing products were the basis for a March 12 hearing convened by a

House Oversight and Reform subcommit-tee, but the larger discussion pertained to the regulatory framework for cosmetics and FDA’s authorities – or lack thereof – under current law.

In its inaugural hearing, the Subcom-mittee on Economic and Consumer Policy – “created to focus attention on pock-etbook issues that matter the most to Americans,” according to Chairman Raja Krishnamoorthi, D-Ill. – heard from three witnesses on the subject of carcinogens in consumer products.

Krishnamoorthi pointed to allega-tions of Johnson & Johnson’s knowing use of talc in Johnson’s Baby Powder de-spite evidence of asbestos contamina-tion risks, and FDA’s March 5 safety alert to consumers confirming reports of as-bestos in makeup sold in Claire’s stores. (Also see “FDA Determined To Update Cosmetics Regs After Claire’s Refuses To Recall Asbestos-Tainted Makeup “ - HBW Insight, 7 Mar, 2019.)

The witness panel did not include J&J or other industry representatives, though the former provided a statement to the committee in advance of the hearing de-fending the safety of its talcum powders, and the Personal Care Products Council expressed an interest through Ranking Member Michael Cloud, R-Texas, in work-ing with the committee to modernize cos-metics oversight.

Anne McTiernan, an epidemiologist at Fred Hutchinson Cancer Research Center in Seattle, Wash., was on hand to provide an overview of available science linking talcum powder use to increased ovarian cancer risks.

According to McTiernan, the 38 epide-miology studies she reviewed – which spanned 40 years and included more than 14,000 women with ovarian cancer – showed a 22% to 31% increased cancer

risk among women who had used talcum powders for genital dusting, compared with women who did not report such use.

“Women need to know about the risks of using talcum powder products in the genital areas, and all consumers need to be warned about the contents of these products, including asbestos in fibrous talcs, so that they can make informed de-cisions about use,” McTiernan said.

The physician has said as much on be-half of plaintiffs in ongoing multi-district litigation against J&J.

The Environmental Working Group’s Scott Faber, vice president of government affairs, also testified before the Democrat-led committee, noting that more than 2,000 talc-containing personal-care prod-ucts are known to the NGO, including more than 1,000 loose or pressed powder cosmetics.

“Unfortunately, cosmetics purchased at stores like Claire’s and Justice are not the only products that are likely to contain asbestos. There is always some risk that products produced with talc will contain this dangerous carcinogen,” Faber said.

He added, “Companies have known of this risk since at least the 1950s.”

ASBESTOS IN TALC ISN’T WHOLE STORY Faber quickly expanded to the cosmetics marketplace as a whole.

“Asbestos is not the only contaminant or chemical of concern in personal-care products,” he said. “Since 2009, cosmetics manufacturers themselves have reported using 88 chemicals linked to cancer, birth defects or reproductive harm in both men and women.”

Faber likely was referencing data com-piled under California’s Safe Cosmetics Act, which since 2007 has required com-panies to report their use of state-listed chemicals of concern, many of which list-ings industry maintains are not scientifi-cally based.





From EWG’s standpoint, such figures underscore the need for a stronger FDA with increased oversight of the cosmetics sector, in-cluding systematic ingredient review. Newly proposed legislation in Congress would provide FDA with the authority and resources needed to achieve those ends, Faber said. (Also see “Rep. Pallone’s Discussion Draft For Cosmetics Reform Closely Mirrors Reintro-duced Feinstein/Collins Bill” - HBW Insight, 8 Mar, 2019.)

Rep. Gerald Connolly, D-Va., identified himself as a possible ally for EWG and like-minded stakeholders.

“When we mindlessly deregulate or don’t regulate to protect the public, this is what can happen. I hope that we will all remem-ber that, and frankly I hope this hearing will lead to some legis-lative direction that empowers FDA, especially in the cosmetics field,” he said.

Congresswoman Rashida Tlaib, D-Mich., suggested that the asbestos-tainted cosmetics situation calls for more urgent action ahead of legislative measures.

“I really want to put these products on my congressional web-site … and provide this information to young girls and try to in-crease education – because I can’t wait for this legislation to pass for people to stop dying,” Tlaib said.

Like others on the committee, she offered her condolences to Marvin Salter, who provided testimony on the experience of his mother, Jacqueline Fox, an ovarian cancer casualty who attributed

her illness to decades-long use of J&J talcum powders. (Also see “J&J Wins Reversal Of $72M Talc Verdict, Signaling Whole New Ball-game” - HBW Insight, 18 Oct, 2017.)

Committee members pressed Faber for a viable solution to the talc problem.

The EWGer responded, “If I were in your shoes or in [FDA] Com-missioner Gottlieb’s shoes I wouldn’t wait another day to require a warning on all these products. FDA has twice refused to do so after receiving citizen petitions,” Faber noted. (Also see “FDA Re-search Seeks Better Understanding Of Talc’s Potential Cancer Link” - HBW Insight, 15 Feb, 2017.)

He continued, “That would be the first step and the easiest step we could take to protect consumers. The next step would be to better understand whether it’s even possible to produce these products without containing asbestos – and if not, then there are plenty of alternatives available, including alternatives made with cornstarch.”

Committee Chair Krishnamoorthi said he’d stay top of the issue. “Today’s hearing was just our first step in protecting consumers

from potentially hazardous or carcinogenic products,” he said. The hearing also was a reminder of changed dynamics in the

Democrat-controlled House, promising new challenges for indus-try as cosmetics reform talks proceed.


California In Upgrade Mode, Now Exploring Safer Consumer Products 2.0LAUREN NARDELLA [email protected]

A proposed bill in the California Senate could shift the center of gravity in the state’s Safer Consumer Products program, allowing the Department of Toxic Substances Control to

bypass the current company-led alternatives analysis process and proceed directly to regulation.

Introduced in February by Sen. Benjamin Allen, D-Los Angeles,, SB 392 is being championed by NGOs as the fix the SCP regulation needs to realize its full potential.

The bill came days after after DTSC proposed nail products con-taining toluene as its next Priority Product. (Also see “California DTSC Selects Toluene In Nail Care For Potential Phase-Out” - HBW Insight, 25 Feb, 2019.)

A rulemaking process now is underway that could take up to a year, according to DTSC. Once the selection is finalized, manufactures and other responsible entities will have 60 days to notify the agency of their use of toluene in nail-care prod-ucts and 180 days to submit a preliminary alternatives analy-sis report.

The objective of AAs is to determine whether safer chemical op-tions are available as replacements or how otherwise to reduce exposure to flagged chemicals of concern.

Ultimately, DTSC concludes the SCP process with a regulatory response in the interest of public health and maximal use of ac-ceptable and feasible alternatives of least concern.

Under SB 392, DTSC could rely on publicly available alternatives information, potentially cutting industry users out of the process altogether, and skip straight to its regulatory response.

The bill indicates that this could occur only after public notice and consultation, but it’s not entirely clear when those steps would take place or how feedback the agency obtains could im-pact proceedings.

DTSC’s publicly available information sources could include peer-reviewed scientific literature or analyses issued by a govern-ment agency or “credible institution with relevant expertise.”




The Natural Resources Defense Council is excited about the proposed changes. In a Feb. 21 blog post, senior attorney Avinash Kar says the SCP program has been unable to deliver on its vast potential, with just a handful of product-chemical combinations addressed over the program’s 10-year-history.

Part of the problem, according to Kar, is the program’s reli-ance on company-driven alternatives analyses started from near scratch “even when information on alternatives is available from reliable sources.”

He notes, “When such information is available, SB 392 creates a fast-track option that allows the agency to move faster. … [This] is important for allowing the program to address more of the huge universe of products and chemicals on the market in a timely manner.”

Kar suggests that industry, particularly smaller players, could benefit from being spared the expense and trouble of conducting AAs themselves.

However, the SCP program could become more invasive under the proposed bill, requiring manufacturers to provide DTSC with requested data within designated timeframes, potentially includ-ing ingredient concentrations, functional uses and national or state product sales data.

SB 392 also would amend the SCP regulation to specify that regulations proceeding from AA findings can not be contested in DTSC’s informal dispute resolution forum if the agency already provided notice and opportunity for comment on the regulation prior to its adoption.

In addition, SB 392 would set clearer timelines for the depart-ment’s prioritization process and expand DTSC’s Candidate Chemicals list to include fragrance allergens required to be la-beled in the EU, American Conference of Governmental Industrial Hygienists-identified asthmagens, California Environmental Con-taminant Biomonitoring Program-designated chemicals, and the

Office of Environmental Health Hazard Assessment’s list of endo-crine disrupting chemicals.

The proposed reforms track closely with recommendations set forth in an October 2018 report from the Oakland, Calif.-based Public Health Institute, “California’s Green Chemistry Initiative at Age 10: An Evaluation of Its Progress and Promise.”

SB 392 has been referred to the Senate Judiciary and Environ-mental Quality committees. The latter, which sponsor Allen chairs, is slated to consider the proposal at its April 3 meeting, according to information online.

Also on the table in California are proposed bills to strengthen the state’s Safe Cosmetics Program by requiring greater transpar-ency around fragrance ingredients and constituents in person-al-care products and empowering investigations into “harmful cosmetics” identified via company notifications to the California Department of Public Health. (Also see “California Lawmaker Wants To Beef Up Safe Cosmetics Program” - HBW Insight, 22 Feb, 2019.)


“SB 392 creates a fast-track option that allows the agency to move faster. [This] is important for allowing the program to address more of the huge universe of products and chemicals on the market in a timely manner.” – NRDC senior attorney Avinash Kar

Beiersdorf’s Three Pillars Of Success Amid Digital Disruptor ‘Turmoil’DAVID RIDLEY [email protected]

Innovation, renewed investments in digital and a focus on emerging markets will enable German skin-care specialist Bei-ersdorf AG to drive growth against a backdrop of “profound

transformation” in the global consumer goods industry, says new Chief Executive Officer Stefan De Loecker.

In a call with analysts to discuss the firm’s financial results for the year ended Dec. 31, 2018, De Loecker, who assumed the company’s helm at he start of 2019, outlined the new three-pillar strategy Beiersdorf is implementing in the face of “turmoil” in the consumer goods industry, particularly health and beauty.

The growth of digital and consumer demand for more person-alised products has shaken up the industry, he said. In the new cli-mate, Beiersdorf’s mass-market skin-care business – which gener-ated over three-quarters of the company’s turnover last year (see Figure 1), led by its Nivea brand – is under threat.

De Loecker pointed to competition from agile, web-based start-ups as a particular concern. With the rise of e-commerce, such companies are able to bypass traditional supply chain chal-lenges and put highly personalised products directly in consum-ers’ hands.

According to De Loecker, small disruptive brands now account for around 40% of the European skin-care mass market.

Despite these challenges, Beiersdorf’s growth prospects are “second-to-none,” but Beiersdorf must act quickly and decisively so as not to fall behind, the CEO said.

Beiersdorf’s newly unveiled growth strategy focuses on acceler-ating the firm’s presence in “white spot” growth markets, such as India and China, strengthening its skin-care portfolio with a focus on value-added products, and ramping up digitalization to better connect with consumers.





PILLAR 1: LOOK BEYOND EUROPE Explaining the strategy’s first pillar, De Loecker said Beiersdorf needs to look be-yond Europe, which contributed about half of the firm’s fiscal 2018 Consumer turnover (see Figure 2).

While Latin America, Africa and the Near East are growth engines for Beiers-dorf, De Loecker said the firm remains under-represented in Asia, where the biggest growth potential exists for its Consumer business.

India, which has become one of Bei-ersdorf ’s most successful emerging markets, provides a model the com-

pany aims to replicate, De Loecker said. Since 2011, the company has multiplied sevenfold its turnover in the country, rising to No. 2 in the deodorant and body-care categories and becoming the market leader in the country’s e-commerce channel.

Beiersdorf’s flagship skin-care brand, Nivea, is key to winning in India, De Loeck-er said. “It’s a brand people desire,” he add-ed, “but are unable to use regularly.”

Making the brand relevant by offering a tailored product portfolio supported by locally relevant marketing, he said, would help get Nivea products into the hands of those potential consumers.

To that end, the firm recently launched a new face-cleansing product incorporat-ing “local insights” for an enhanced propo-sition.

“I think it’s very clear that in a market like India, the potential to [grow] is still un-limited,” De Loecker said.

China is another emerging market with significant potential for Beiersdorf. De Loecker acknowledged that Beiers-dorf has had mixed success in the coun-try to date.

The company’s La Prairie line of luxury skin-care products is faring well with consumers in China and other markets around the globe, with sales soaring al-most 39% for the year.

On the other hand, the firm’s premium Slek hair-care products have failed to meet expectations in China since being acquired from C-Bons Hair Care in 2007.

After taking a related impairment charge of €16m last year, Beiersdorf con-tinues to have the brand under strategic review to determine the most promis-ing investment opportunities to fuel its growth, according to De Loecker.

Beiersdorf also will be expanding its R&D capability in China with a new skin-care innovation center, he said.

Further, the firm recently appointed Asim Naseer chief marketing officer for consumer brands. Formerly in charge of skin care marketing for Procter & Gamble Co.’s Singapore business, Naseer will be a “real asset” in providing insight into Asian markets, De Loecker said.

“We can win, and we can make a differ-ence [in China],” he concluded.

PILLAR 2: PRIORITIZE MARGIN-ENHANCING PRODUCTS Turning to the second pillar of the firm’s growth strategy, De Loecker said Bei-ersdorf’s future depends on propelling growth not only in its core portfolio, but also in added-value segments like natu-ral cosmetics.

“We have a number of extremely strong iconic brands covering the major seg-ments of the skin-care market: mass mar-ket, derma-cosmetic, luxury skin-care, healthcare.” He added, “However, many opportunities are created outside these core segments.”

Going forward, De Loecker said that the firm would focus on delivering more new

Figure 1: Beiersdorf's Business Units By 2018 Sales

Consumer 81.47%

Tesa 18.53%

Based on Beiersdorf's 2018 sales, which totaled €7.23bn (Source - Beiersdorf)

Figure 2: Beiersdorf's Consumer Business By RegionGlobal

Europe 49.92%

Americas 17.83%

Africa/Asia/Australia 32.26%

Europe

Western Europe 79.93%

Eastern Europe 20.07%

Americas

North America 26.51%

Latin America 73.49%

Based on 2018 total Consumer sales of €5.89bn (Source - Beiersdorf)

Figure 2: Beiersdorf's Consumer Business By RegionGlobal

Europe 49.92%

Americas 17.83%

Africa/Asia/Australia 32.26%

Europe

Western Europe 79.93%

Eastern Europe 20.07%

Americas

North America 26.51%

Latin America 73.49%

Based on 2018 total Consumer sales of €5.89bn (Source - Beiersdorf)



products with science- and technology-driven benefits.

De Loecker was particularly excited about a new innovation from Eucerin that he predicted will be a blockbuster success for the company.

Designed to address what the exec identified as one of the most challenging skin concerns in the world today, hyper-pigmentation, the 2019 launch contains a patent-protected ingredient, Thiamidol, which is clinically proven to reduce mela-nin production and give skin a more even complexion, according to De Loecker.

“Obviously, many products already exist addressing this issue,” he noted, “but ef-fectiveness remains a challenge. Our R&D team has worked for over 10 years to find a more effective solution to this problem.”

PILLAR 3: STEP-UP DIGITAL CAPABILITY The last pillar of Beiersdorf’s growth strat-egy – investment in digital – is critical for the firm to be able to engage meaningfully with today’s consumers, De Loecker said.

He noted that digitalization offers Bei-ersforf a way to “connect with consumers throughout the consumer journey” and said the company must step up its capa-bilities in this dimension substantially to continue to compete effectively.

“We believe that this is a major challenge for us, that we need to accelerate and in-vest more in order to be able to increase our abilities,” De Loecker said. Specifically,

Beiersdorf intends to more than double its investment in digital communications and e-commerce over the next five years.


Beiersdorf Grows SteadilySales at Beiersdorf’s Consumer division – excluding the impact of currency fluctua-tions – grew by 5% to €5.9bn ($6.67bn) in 2018.

A double-digit sales increase in emerging markets and good performances in its Western European and North American businesses had been behind the single-digit rise in Consumer turnover, the firm said.

Looking at the company’s performance by market segment, Beiersdorf pointed out that its luxury skin-care brand La Prairie had performed “outstandingly”, help-ing its ‘selective cosmetics’ business achieve a 38.5% sales boost in the 12 months.

Good performances from Nivea in Germany, India, Saudi Arabia and Mexico boost-ed sales in Beiersdorf’s ‘mass-market’ skin-care business by 2.8%, it continued, with Nivea Body, Nivea Shower and Nivea Sun also representing “key growth drivers” during the year.

Sales at Beiersdorf’s ‘derma’ business increased by 5.9%, thanks, the company said, to an “especially large” contribution from its Aquaphor brand and from Eucerin in the body, face and sun categories.

On a more negative note, turnover fell by 1.8% at Beiersdorf’s ‘healthcare’ business, which houses its Hansaplast and Elastoplast brands. The firm attributed this decline to problems in Austria’s sports bandages category and an economic crisis in Argentina.

Consumer contributed 81% to Beiersdorf’s total sales in 2018, which grew by 5.4% to €7.23bn. The remainder of Beiersdorf’s turnover came from its adhesives division, Tesa.

Targeted Omega-3 Supplementation Could Save €64.5bn In Health Care Costs, FSE ClaimsDAVID RIDLEY [email protected]

Food Supplements Europe (FSE) has published a position pa-per arguing that targeted supplementation in key areas of public health could save tens of billions in healthcare costs

across Europe over a five-year period.Omega-3, calcium, phytosterols and vitamins D and B9 (fo-

lic acid) should be a focus for targeted supplementation in the short term, FSE argued, as adequate levels were either difficult to achieve through normal diets or in higher doses could prevent potentially costly chronic diseases.

“In an ideal world, all nutritional requirements for health would be met by an adequate and varied diet,” FSE explained. “But, mil-lions of Europeans are not achieving dietary reference values (DRVs), let alone the levels required for optimal nutritional status and health.”

While a “full spectrum of micronutrients and fatty acids” was necessary for people to achieve their DRVs, FSE insisted that tar-

geted supplementation in groups at risk of chronic disease would help policy makers achieve significant cost savings for over-stretched healthcare budgets.

To evidence this claim, FSE commissioned three ‘case stud-ies’ to show the cost-savings of targeted supplementation with omega-3, phytosterols and a combination of calcium and vita-min D respectively.

In the first case study, FSE claimed to have found that 1g of omega-3 taken daily as a dietary supplement could lead to a 4.9% reduction in the relative risk of cardiovascular disease (CVD) events, resulting in a potential healthcare cost saving of €64.5bn ($73bn) over a five-year period.

“Studies reveal that fish oil supplementation reduces all-cause mortality and sudden death,” FSE explained. “A review of the evi-dence suggested that 24% of adults aged over 55 years are ex-pected to have a CVD-attributed hospital event in the next five

� W E L L N E S S �




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years at a cost of €34,637 per event.” Targeted supplementation with omega-3 could reduce the risk of CVD events in such groups by 4.9%, which FSE calculated would realise a €2.29 cost benefit for every €1 spent on these supplements.

In a second case-study, FSE explained that a 1.7g supplement of phytosterols – cholesterol-busting plant sterols and stanols – per day could save €26.5bn over a five-year period.

“Raised serum low-density lipoprotein (LDL) cholesterol is a risk factor for CVD, affecting 31 million European adults aged 55 years or above,” FSE pointed out. “For every 1mmol/L reduction in LDL-cholesterol, the relative risk of a cardiovascular event is reduced by 26.6%, irrespective of whether this is achieved by diet or medication.”

Targeted supplementation with phytosterols could reduce the risk of CVD events in at-risk groups by 2.3%, FSE argued, delivering a €4.37 saving on avoidable heart health costs for every €1 spent on these supplements.

In the final case study, FSE reported that daily supplementation with 1000mg calcium and 15µg vitamin D could achieve an over-all five-year saving of €19.8bn.

“Osteoporosis is a huge health burden affecting over 27.8 mil-lion older adults, most of these women,” FSE noted. “The cost of treating osteoporosis-attributed bone fractures is over €26.4 billion per year in Europe, a cost which is expected to grow as populations age.”

Targeted calcium and vitamin D supplementation could reduce bone fracture incidents by 15%, FSE maintained, and deliver a €3.47 cost saving for each €1 spent on supplements.

EUROPEANS FAILING TO REACH DRVS Vitamin D was one of many essential vitamins and minerals for which consumers were failing to meet DRVs in many European countries, FSE insisted.

Fewer than one in 10 Belgians, for example, consumed the recommended amount of fruit or vegetables, FSE pointed out. “This pattern is seen across the European Union,” it added. “De-spite clear guidance on DRVs, dietary surveys reveal time and

again that specific nutrients pose a concern.” A review of 21 Eu-ropean countries found that not one had met more than 40% of DRVs for macro or micronutrients, FES continued. This meant mil-lions of Europeans were failing to achieve DRVs, it explained, let alone the intakes required for optimal nutritional status.

Optimal nutritional status, FSE said, went beyond deficiency and provided a “nutritional platform for optimal health and func-tion,” as well as generally lowering the risk of chronic diseases.

TIME TO ACT While scientific studies and economic analyses had shown target-ed supplementation to be an effective way of bridging the gap between deficiency and optimal intake, as well as a means of sav-ing costs for over-stretched healthcare budgets, FSE asserted that European policy makers now needed to take this advice forward in practice.

“Business as usual in nutrition is not working,” it insisted. “De-spite the best efforts of health educators, significant groups in the populations are either at risk of deficiency or failing to achieve op-timal nutrient intakes.”

“This is having an impact on health outcomes, particularly for vulnerable groups of people, and those experiencing social de-privation who tend to have less healthy diets,” FSE continued.

“Targeted use of food supplements is a cost-effective way to bridge the gap between dietary recommendations and current intakes,” it added. “The benefits of supplementation can help to save lives and significantly reduce healthcare costs.”

“The scientific evidence is in place,” FSE concluded. “All that is now needed to leverage these benefits is the will of policy leaders to integrate this into policy.”


CBD Oral Sprays For Pain, Sleep, Weight Recalled On Microbial ContaminationMALCOLM SPICER [email protected]

FDA allows using cannabis- and hemp-derived ingredients in food and dietary supplements even

though it does not consider the substanc-es compliant as dietary ingredients, but it formally noted the recall of cannabidiol-containing oral sprays due to microbial contamination.

In other recent wellness market recall announcements, the first report of salmo-nella contamination for a kratom supple-

ment in nearly nine months prompted Sunstone Organics LLC on March 1 to recall one lot each of its white vein and maeng da types of the herb.

FDA’s Feb. 27 update to its recall da-tabase included a class II recall by Nu-trafuels Inc. more than 1,500 of its CTFO Oral Spray with pure CBD hemp oil isolate dietary supplements for sleep support, weight loss and pain relief in 1-ounc (30 ml) containers. The Coco-

nut Creek, Fla., firm started the recall on Jan. 11 after a consignee conducted third-party testing showing microbial contamination in the products.

According to Nutrafuels information provided on the recall, aspergillus was found in the sleep supplement; entero-bacteriaceae in the weight loss spray; and total aerobic bacteria in the pain relief product. Launched in 2010, Nu-traFuels manufactures, distributes and

@HBWInsight




markets oral spray nutritional dietary products.

FDA assigns a class II designation to re-calls of violative products that may cause temporary or medically reversible adverse health consequences but have remote probability of serious consequences.

Although FDA does not consider hemp and cannabis constituent ingredients to be dietary ingredients eligible for use in food and supplement products, the US market is teeming with those types of products containing hemp or cannabidiol. FDA regulations prohibit using in supple-ments ingredients contained in approved drug products or that are being studied in pharmaceutical tests – CBD is active ingredient in an FDA-approved drug and it and tetrahydrocannabinol (THC), the psychoactive compound in cannabis, are subjects of clinical investigations.

However, FDA targets its enforcement in the hemp- and CBD-containing supple-ment space to firms that sell products la-beled or promoted with drug claims.

FDA said in December that it would consider changing its hemp and can-nabis polices. Commissioner Scott Gott-lieb told House appropriators on Feb. 27 that he would appoint a working group to consider FDA’s options for allowing hemp- or cannabis-derived ingredients in nutritional products following a public meeting the agency will conduct in April for comments on lawful pathways for marketing products containing cannabis or cannabis-derived compounds and on making the pathways more predictable and efficient.

Hemp, CBD and THC are among the more than 80 active chemicals in marijua-na. Neither hemp nor CBD causes intoxi-cation or euphoria associated with THC.

In another recall included in FDA’s most recent database update, a Tubby Todd Bath Co. shea butter made by Mariposa Labs LLC and classified by FDA as an OTC drug was recalled after testing prompted by a consumer complaint found the prod-uct out of specification for mold (see table linked below for more recent health and wellness recalls).

CAPSULE, POWDER KRATOM RECALLEDSunstone Organics is recalling one lot each of its namesake brand white vein and maeng da kratom in 25-, 50- and 100-g packages 20-, 60- and 150-count cap-sule containers. The products, which are not labeled with an expiration date, have been found potentially contaminated with salmonella, but the firm said it had not received any reports of adverse events related to the recalled lots, which were distributed to retail outlets in California, Nebraska, Oregon and Washington.

Sunstone Organics is notifying its dis-tributors and customers by visiting retail outlets on its distribution routes, phone calls to outlets it cannot visit, letters to all outlets and with a sign posted in all out-lets notifying consumers. The product is used as a tea or supplement and is pack-aged in craft-paper, stand-up pouches in both capsule and powder forms.

Salmonella contamination plagued the US kratom market in the first half of 2018, a period also marked by FDA targeting the herb as unsafe for use in food and supple-ments. In July, the agency said consumers using the botanical in supplements or oth-er products “may be placing themselves at a significant risk of being exposed to” salmonella after it ended an investiga-tion of a “large outbreak of salmonellosis”

linked to kratom. (Also see “Salmonella In Kratom, Like Use Of The Herb, Exceeds FDA Expectations” - HBW Insight, 2 Jul, 2018.)

FDA previously had completed an evaluation of two compounds in kratom – mitragynine and 7-hydroxymitragy-nine – that the Drug Enforcement Ad-ministration has proposed to schedule as controlled substances and had reported that its testing of the chemical structures of the 25 most prevalent compounds in the herb found that all share the most structural similarities with controlled opioid analgesics, such as morphine de-rivatives. DEA has yet to decide whether to schedule kratom.

The kratom industry, however, contests FDA’s findings and contends that the bo-tanical is a safe dietary ingredient that has been used in other parts of the word for centuries and was prevalent in the US before the October 1994 grandfather date for an ingredient to be eligible for use in supplements without first being notified to the agency with proof of reasonable ex-pectation of safety for its intended use.


More information on these and other recent health, beauty and wellness recalls is available online at https://bit.ly/2FbrRsQ

The Weight, Sleep and Pain varieties of Nutrafuels’ CTFO Oral Sprays with pure hemp oil isolate are on recall due to microbial contamination.

One lot each of Sunstone Organics’ white vein and maeng da kratom are being recalled due to potential salmonella contamination.


https://bit.ly/2FbrRsQ



Poor Results For Supplementation To Curb Depression In First-Of-Kind Study EILEEN FRANCIS [email protected]

Supplementation with omega-3s, folic acid and other nutri-ents did not reduce major depressive disorder in overweight subjects with a history of depression, according to a study

that adds to a body of evidence suggesting that adding vitamins, minerals or supplements to diets may not be helpful for people with depression.

The study published in the Journal of the American Medical As-sociation was the first randomized controlled trial to evaluate the effectiveness of two nutritional strategies and their combination in preventing depression in a high-risk group of overweight subjects.

It showed that multi-nutrient supplements containing ome-ga-3 polyunsaturated fatty acids, vitamin D, folic acid and sele-nium “neither reduced depressive symptoms, anxiety symptoms, nor improved health utility measures. In fact, they appeared to result in slightly poorer depressive and anxiety symptoms scores compared with placebo,” said the authors, led by Mariska Bot of Amsterdam University Medical Center. “

The study tested for the cumulative one-year onset of major de-pressive disorder (MDD) among 1,025 overweight subjects with a body mass index between 25-40 who had experience MDD but had not had symptoms in the previous six months. Researchers assigned 257 subjects to placebo without food-related behavioral activation therapy, and 256 in each of the placebo with therapy, supplements without therapy and supplements with therapy groups.

The study was conducted between July 2015 and October 2017 with subjects recruited from Germany, the Netherlands, Spain and the UK. Subjects were given either daily doses of placebo or the multi-nutrient combo, which included 1,412 mg omega-3 fatty acids, 30 µg selenium, 400 µg folic acid and 20 µg vitamin D3 plus 100 mg calcium. They were assessed through neuropsychiatric in-terviews at three, six and 12 months. Among 779 participants who completed the trial over a one-year period, 105 (10%) developed MDD: 25 (9.7%) in the placebo without therapy group; 26 (10.2%) in the placebo with therapy, 32 (12.5%) in the supplement without therapy and 22 (8.6%) in the supplement without therapy group.

“None of the treatment strategies affected MDD onset,” which was the primary outcome, the researchers said. The odds ratio for supplements ability to prevent MDD onset was 1.06; for therapy 0.93 and for their combination, 0.93.

Treatment strategies also showed a slightly negative impact on secondary outcomes of depression severity and anxiety severity. Assessing patient health questionnaires determining severity of depression or anxiety symptoms on a scale with higher values in-dicating higher severity, the unadjusted, 12-month patient health questionnaire score for placebo was 4.1 versus 4.9 for supplements.

FOOD BEHAVIORAL THERAPY STUDIES NEEDEDThe researchers note that few experimental studies have directly evaluated the effect of changing diet, food-related behavior, or nutrients in preventing MDD.

Despite containing a large sample and selection of people with elevated depression symptoms, the onset of MDD was lower than expected, which “reduced the statistical power to detect a statisti-cally significant effect,” the researchers cautioned. “However, be-cause placebo outperformed supplements for some secondary outcomes, it is unlikely that inclusion of an adequately powered sample would favor supplements for the prevention of depression.”

Despite “substantial” evidence of observational studies linking lower nutrient levels to higher depressive symptoms, the findings, like a number of earlier RCTs on supplementation and depression, do not support the use of supplements as interventions for de-pression, the researchers concluded.

A review of nine RCTs the Journal of Affective Disorders published in 2016 found no support that vitamin D could prevent depression in older adults, the researchers add. The add a 2008 study on ome-ga-3 PUFAs published in the British Journal of Nutrition showed no favorable effect of the substances on depressive symptoms. Similar studies on folic acid combined with B6 and B12 and on selenium also did not demonstrate a preventative effect on depression.

However, several studies have shown a benefit from food behav-ioral therapy in preventing depression. Recent RCTs have found that dietary improvement strategies reduced symptoms in depressed

Despite “substantial” evidence of observational studies linking lower nutrient levels to higher depressive symptoms, the findings, like a number of earlier RCTs on supplementation and depression, do not support the use of supplements as interventions for depression, the researchers concluded.




adults relative to control conditions, but too few RCTs have tested dietary strategies to prevent depression, the researchers note.

“With sufficient dose and a higher-risk sample, food-related be-havioral activation therapy might prevent depression, although this requires further study,” Bot and her colleagues wrote.

Funding for the study was provided by grants from the Euro-pean Union and the UK National Institute for Health Research.

Results from research on omega-3s efficacy have been mixed, with some studies finding a mild benefit to mood or depres-sion. A meta-analysis at the University of Amsterdam found

that supplementation with omega-3 fatty acids could assist in the development of a personalized treatment plan to prevent MDD, although researchers saw the biggest benefit in pairing the supplements with anti-depressants.

FDA has warned firms for claims that products labeled as vita-mins, minerals or supplements could treat depression. In 2017, Total Body Nutrition LLC received a warning letter for claiming that children taking an omega-3 product could experience “less likelihood of depression and reduced risk of ADHD.”


FTC’s Prevagen Complaint Revived: Court Says ‘Deceptive’ Ad Allegation PlausibleEILEEN FRANCIS [email protected]

A federal appeals court did not rebuke a standard the Fed-eral Trade Commission imposes for substantiating health claims, as the dietary supplement industry hoped, in a

ruling on a complaint alleging misleading memory claims for the Prevagen cognitive health supplement.

FTC can proceed with litigation against Quincy Bioscience LLC after the US Court of Appeals for the Second Circuit vacated a dis-trict court decision dismissing the commission’s complaint.

“The FTC and New York have made plausible allegations that Quincy’s marketing campaign for Prevagen contained decep-tive representations and the district court erred in dismissing the complaint in its entirety and refusing to exercise supplemental ju-risdiction over New York’s claims,” said Second Circuit judges in a Feb. 21 summary order.

In considering whether to dismiss the district court decision, the circuit court determined whether the complaint would allow a court to “draw the reasonable inference that the defendant is li-able for the misconduct alleged,” which is deceptive advertising under the FTC Act.

Returning the complaint to the US District Court for the South-ern District of New York, the circuit determined FTC made a rea-sonable argument that Quincy’s representations about Prevagen are contradicted by the results of the firm’s clinical trial and are materially deceptive in violation of FTC regulations and New York business law.

As an example, the court noted FTC’s complaint quotes Quincy’s broad claim that in its clinical study, “Prevagen improved memory for most subjects within 90 days.” Yet, the study failed to show a statistically significant improvement in the treatment group over the placebo group in any of nine computerized cognitive tasks, the court noted.

“Taking these allegations as true, not only has the FTC ad-equately alleged that that Quincy’s study undermines its rep-resentations that ‘the majority of people’ experience cogni-tive improvement from taking Prevagen, but the FTC has also stated a claim that Quincy’s representations that this cognitive improvement is clinically supported are deceptive,” the Sec-ond Circuit said.

Additionally, FTC plausibly alleged that Quincy’s representa-tions about Prevagen’s active ingredient entering the brain are false. FTC argued Quincy’s safety studies “show that apoaequorin is rapidly digested in the stomach and broken down into amino acids and small peptides like any other dietary protein.”

The decision is the latest twist in a legal battle that started when FTC and the New York attorney general jointly filed a complaint alleging Quincy, a subsidiary of Madison, Wis.-based Quincy Bio-sciences Holding Co. Inc., preyed on elderly consumers in ads for its product, which included claims its product – containing active ingredient apoaequorin derived from jelly fish – “improves memory.” (Also see “New York AG And FTC Target Prevagen Memory Claims” - HBW Insight, 10 Jan, 2017.)

In September 2017, Quincy’s request to dismiss the complaint was granted by the district court, which said in order to allege a violation of the FTC Act, the commission must demonstrate a claim is likely to mislead consumers acting reasonably under the circumstances. A district judge said FTC would have supported its complaint if it could show a double-blinded, placebo-controlled study Quincy used to back the claims was erroneous, which it

FTC alleges Quincy Biosciences preyed on elderly consumers in ads for Prevagen including claims the product – containing active ingredient apoaequorin derived from jelly fish – “improves memory.”





could not do. (Also see “Prevagen Study Data Withstand False Ad Complaint By FTC, New York AG” - HBW Insight, 5 Oct, 2017.)

FTC and New York officials filed an ap-peal of the decision in March 2018, argu-ing the district court judge made “serious and fundamental errors.”

Quincy urged the appeals court to re-affirm the district court decision in a May 2018 brief. The firm said it relied on FTC guidance for supplement marketing claims and backed its claims with a dou-ble-blinded, placebo-controlled human study and other evidence.

The court also noted that on Feb. 20, Quincy filed for a motion for recusal of a circuit judge with a potential conflict with a Public Citizen amicus curiae brief. The court stuck the consumer advocacy group’s brief from its review, but it denied the motion for recusal.

‘CARVING UP DATA’ SHOWS ‘FALSE POSITIVES’ – FTCFTC and New York officials stated in their appeal that while the trial Quincy relied on showed no effect across the study population as a whole, the firm later broke down the data into subgroups and analyzed each separately, finding two “subgroups showed statistically sig-nificant differences on isolated cogni-tive task outcomes.”

However, “the vast majority of out-comes for these and other subgroups analyzed after the original study results showed no significant differences” and “the selective post hoc subgroup re-sults did not provide reliable scientific evidence for Quincy’s advertising claims about Prevagen,” the federal and state officials argued.

“To the contrary, carving up the data into small, after-the-fact subgroups in-creased the probability that seemingly ‘statistically significant’ differences were actually false positives caused by chance alone,” they added.

In a March 2018 amicus curiae brief, ad-vocacy group Truth In Advertising Inc. also was critical of the more than 30 post hoc analyses Quincy conducted on its study results, a practice TINA called “data dredg-ing” to manipulate findings.

Through post hoc analyses, Quincy researchers showed “statistically sig-nificant improvement” on two overlap-

ping subgroups to try to support their memory claims. However, post hoc analyses “are not study results upon which marketing claims can be based because they are likely to be specious,” TINA argued.

“Armed with these unreliable and limit-ed data, Quincy mounted a full-throttled marketing campaign with claims that ‘a landmark double-blind and placebo-controlled trial demonstrated Prevagen improved short-term memory, learning and delayed recall over 90 days,’” but “Quincy’s marketing never informs con-sumers of the severe limitations of its findings,” TINA stated.

TINA said the district court “made its own appraisal of the factual allegations, picking and choosing for itself which facts to believe.”

INDUSTRY-FTC STANDARD BATTLE CONTINUES Industry groups submitted amicus briefs in support of Quincy, and supplement industry stakeholders long have com-plained that FTC is demanding clinical tri-als equivalent to tests conducted for drug ingredients by imposing RCTs to support health claims made in ads for vitamins, minerals and supplements. (Also see “FTC Leaves Supplement Industry Still Wait-ing For Shift Away From RCT Standard For Claims” - HBW Insight, 6 Jul, 2016.)

In their June 2018 amicus brief support-ing Quincy, the Council for Responsible Nutrition and the Consumer Healthcare Products Association argued that vacating the district court decision and allowing the complaint to proceed could result in a “wholesale change in the governing sub-stantiation standard.” (Also see “Imposing RCTs For Supplement Claims Would Cause ‘Wholesale Change’ In Regulation – CRN, CHPA” - HBW Insight, 13 Jun, 2018.)

CRN and CHPA said the complaint is “premised on a novel legal standard that is

irreconcilable with the governing statute, as well as FTC and FDA guidance for more than 20 years.”

They said the two federal agencies al-leged, even though Quincy relied on a randomized controlled trial, that Preva-gen’s supplement claims were unsubstan-tiated, because the trial lacked positive re-sults from primary end points. “This legal standard is fundamentally flawed because dietary supplements are not drugs and drug-level RCTs are not required under the law at all,” CRN and CHPA stated.

The trade groups argued the district court “properly recognized that the gov-ernment’s attempt to use litigation to im-pose a novel, heightened substantiation standard on a dietary supplement fails to state a viable legal claim.”

Commission officials acknowledge that no FTC rule specifically requires clinical trials for supplement ad claims substantiation, but the agency it ex-pects supplements’ health and struc-ture/function claims to have support from tests similar to those FDA requires for drug ingredients. While a VMS health or structure/function claim doesn’t need support from research the size and scope of studies looking at the safe-ty and efficacy of a drug ingredient pro-posed for a certain indication, ad claims still need competent and reliable scien-tific evidence as support, and random-ized controlled trials are the method FTC accepts. (Also see “Clinical Trials For Supplement Claims Not An FTC Rule, But A Standard” - HBW Insight, 24 Aug, 2018.)

Additionally, FTC has prioritized en-forcement against unsubstantiated cogni-tive claims for VMS products. Its Prevagen complaint was not its first targeting a firm promoting a product for brain health. (Also see “Prevagen Study Data Withstand False Ad Complaint By FTC, New York AG” - HBW Insight, 5 Oct, 2017.)


“Carving up the data into small, after-the-fact subgroups increased the probability that seemingly ‘statistically significant’ differences were actually false positives caused by chance alone.” – FTC, New York AG motion



Boots’ Symptoms Claim For Dual Defence Not A Prevention Pitch – UK RegulatorEILEEN FRANCIS [email protected]

A Boots UK Ltd. Dual Defence ad claim to shorten cold and flu symptoms likely would not deceive consumers to ex-pect the nasal spray to prevent infection, says UK’s adver-

tising regulator in the latest review of whether consumer health products’ symptom claims imply prevention.

The formula containing carragelose, made from red seaweed, designed to shorten the duration and severity of cold- and flu-like symptoms was promoted in a Boots poster ad featuring images of people wearing space suits, a woman blowing her nose and text stating, “STOP COLD + FLU like symptoms.” Smaller text in the ad stated, “helps shorten the duration and severity of cold & flu like symptoms,” according to the Advertising Standards Authority’s Dec. 6 report.

Carragelose is approved for use nasal sprays in the UK, other European countries, Asian markets and Australia. It also is widely used in the food industry and in the US has generally regarded as safe status, but it is not approved by FDA as an ingredient for therapeutic treatments.

Five complaints challenged whether the ad was misleading in implying the product could prevent or treat cold and flu in-fections.

Boots, part of Walgreens Boots Alliance Inc., argued the ad, dis-played on London subway trains between November 2017 and December 2018, made it clear that when the product is used at the first sign of a cold, it can help stop cold-and flu-like symptoms, and consumers would understand that, to stop or shorten symp-toms, a virus already must have begun.

Boots also said claims in the ad were assessed by Nottinghamshire Trading Standards, the British city’s regulatory body that protects consumers from unfair trading practices. The agency determined the claims in the ad would not mislead consumers, the retailer said.

ASA acknowledged the headline claim, “Use at 1st signs to help STOP COLD + FLU like symptoms” was in larger text surrounded by a yellow border, but other text in the ad “was still sufficiently

prominent to contextualize” the headline’s message. Text immedi-ately below the headline stating “Helps shorten the duration and severity” of symptoms “clearly explained that the function of the product was not for prevention of colds and flu but for the treat-ment of symptoms after their onset,” ASA said.

“Because we considered that consumers would understand from the ad that the product could only shorten the duration and severity of cold- and flu-like symptoms rather than prevent the in-fection or the symptoms before they started, we concluded the ad was not misleading,” according to the report.

DIFFERENTIATING SYMPTOMS A COMMON CLAIM PROBLEMASA assessed evidence submitted by Boots for the same product in 2015 when it upheld complaints and advised the firm to dis-continue the claim the nasal spray is “clinically proven to defend against cold and flu.” However, it also said Boot could continue us-ing claims the spray is capable of reducing the duration and sever-ity of cold- and flu-like symptoms.

In the US, Council of Better Business Bureaus advertising watch-dog National Advertising Division also has found that consumer health product marketers take cold and flu symptom claims too far. In 2016, ProPhase Labs Inc. was advised to alter a claim its zinc-based Cold-EEZE homeopathic products reduce the duration of a cold “nearly half” because studies supporting claims found duration reduced by 42%.

In an earlier challenge ProPhase made, though, NAD said Ma-trixx Initiatives Inc. supported using “pre-cold” claims that set its zinc-containing Zicam homeopathic cold remedy apart in the market. The CBBB’s appeals panel in 2013 upheld a NAD decision deeming “pre-cold” not misleading. In its challenge, ProPhase ar-gued the statements make an unsubstantiated prophylactic or preventive claim.

NAD also has parsed whether symptom claims put a drug product outside the indications allowed under an FDA OTC monograph. In August 2018, NAD said Aubio Life Sciences LLC’s Aubio Cold Sore treatment claims weren’t within FDA’s monographs for the product’s active ingredients, lidocaine 0.5% available under the external anal-gesic drug products tentative final monograph and allantoin 0.5% in the skin protectant final monograph. NAD review the claims on a challenge by GlaxoSmithKline PLC’s consumer business, which markets the only OTC cold sore treatment available through FDA pre-market approval, Abreva (docosanol 10%) cold sore cream.

GSK also was the challenger in a NAD review earlier in 2018 of Carma Laboratories Inc.’s ad claims for Carmex Cold Sore Treat-ment. NAD attorneys in May said product performance claims based on indications “referenced in an FDA monograph or pro-posed rule should mirror the language in the monograph or pro-posed rule and not extend beyond” listed indications.


Boots says its poster ad made clear that when Dual Defence is used at the first sign of a cold, it can help stop cold-and flu-like symptoms and consumers would understand that, to stop or shorten symptoms, a virus already must have begun.





Prop 65 ‘Responsibility’ Proposal Stirs Retailers For Manufacturers’ GuaranteesEILEEN FRANCIS [email protected]

Retailers in California have “awakened” to the state’s Prop 65 and are taking drastic actions including seeking

unrealistic compliance guarantees from manufacturers and marketers, says Clif Bar & Co.Chief Counsel Amy Norris.

Retailers were stirred by a proposed “Responsibility to Warn” Prop 65 amend-ment intended to minimize the impact of warning requirements on them by clarifying that manufacturers and oth-ers in the supply chain bear primary re-sponsibility for compliance, Norris said during a Feb. 27 Food & Drug Law Insti-tute webinar.

“At the end of the day, we have a variety of different demands from our retailers and we are left trying to figure out how we respond to them,” she said.

“If a retailer says, ‘please guarantee to me that all of your products are in com-pliance with Prop 65,’ we’re left wonder-ing, ‘how does one do that when you have 900 different chemicals [targeted in the regulation] and however many products you have to have in your product lineup?’”

Under Prop 65, consumer goods mar-keted in California that expose users to any of more than 850 chemicals listed by the Office of Environmental Health Hazard Assessment as carcinogens or reproductive toxins must furnish “clear and reasonable” warnings to inform con-sumer choice, or else face possible private enforcement actions. If companies can demonstrate their products expose users to Prop 65 chemicals at levels below state-established safe harbor levels – No Signifi-cant Risk Levels (NSRL) for carcinogens or Maximum Allowable Dose Levels (MADL) for repro-toxins – they are exempt from warning requirements.

OEHHA in in November proposed the amendment that would minimize the impact of warning requirements on retailers. Retailers still assume some re-sponsibility, including an obligation to make sure consumers are warned about potential exposures if they are made

aware of an issue with a product they sell, in which case they must post warn-ings in store with shelf tags, in catalogs and/or online.

‘NO EASY FIXES’Norris said Clif Bar has developed a standard response to retailers’ re-quests. The firm shares with them the “the breadth of Prop 65 requirements and then provide them some informa-tion of what we do ourselves to ensure Prop 65 compliance.”

She said an appropriate response would be “to the best of our knowl-edge, we have no reason to believe [certain products] don’t comply.” She

suggests other companies selling food or supplements follow Clif Bar’s lead in pursuing their own due diligence on product ingredients to estimate where problems may arise.

“If you are selling a product with a vari-ety of different ingredients, especially ag-ricultural components, there is lots of in-formation and data out here to determine which agricultural components have the propensity for up-taking various heavy metals from the soil or which components might have a history of contamination with a particular chemical.”

Norris also recommends manufactur-ers work with ingredient suppliers so they understand their Prop 65 obliga-

“If you are selling a product with a variety of different ingredients, especially agricultural components, there is lots of information and data out here to determine which agricultural components have the propensity for up-taking various heavy metals from the soil or which components might have a history of contamination with a particular chemical.” – Amy Norris, Clif Bar & Co.


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tions, to identify where problems might surface and what to do in response.

“There aren’t any easy fixes I’m aware of, but it is worth tak-ing the time to do the homework and understand where your exposures are so you are not caught surprised down the road,” she said.

SOME RETAILERS ‘OVERREACTING’The proposed amendment has made many retailers that knew little about the law “quite nervous” and most are taking measures to make sure products they offer are in compliance with the law, Norris said.

She noted some retailers are enrolling in database services to stay on top of Prop 65-related information for consumer products marketed in the state.

The website for one service, UL-WERCSmart, which has cus-tomers including Walmart, Costco and Safeway, says users col-lect, manage and evaluate manufacturer product data in order to “maintain compliant and safe store environments.”

Other retailers, however, are “overreacting,” says Norris.A number of retail companies have designed testing programs

they make mandatory for manufacturers. Those programs, if ap-plied across the board, “could create for manufacturers of prod-ucts a variety of different potential exposures,” to meet various retailer thresholds, Norris said.

“We don’t know how that information would be protected, who that information gets shared with, what would happen to that in-formation in the event of later litigation,” she added.

Several large retailers have created a “restricted substances” list for products containing ingredients on Prop 65, Norris said.

The restricted substances list sometimes features safe harbor limits set by the retailer, which are not consistently aligned with Prop 65 safe harbor limits.

Retailers commonly ask manufacturers for express indem-nity to protect them in Prop 65 litigation linked to a manufac-

turer’s failure to warn about a certain ingredient in a product. Others have taken the drastic step of suspending sales in Cali-fornia until they are assured their responsibilities under the law, Norris noted.

COMPREHENSIVE SAMPLING REQUESTEDShe added the complicated standards, tests and safe harbors placed on manufacturers are made more challenging by another amendment to Prop 65 proposed in October which would require a change in manufacturers’ product sampling to demonstrate the levels of a substance multiplied by 1,000 is “less than no observ-able effect level” identified in the law.

As Prop 65 does not specify procedures for sampling for a listed chemical, companies often take samples from multiple facilities to find the average amount.

OEHHA is critical of cross-sampling, noting it sometimes re-sults in samples from different states or countries, and propos-es in the amendment to restrict sampling in a way that some stakeholders say would essentially force a company wanting to make an MADL defense take multiple samples from each fa-cility that manufactures their product. (Also see “Prop 65 Label-ing Exemption Degree Of Difficulty Higher In Proposed Amend-ment” - HBW Insight, 1 Mar, 2019.)

Retailers are essentially asking manufacturers for a “guar-antee” on their products that would force them to test every product formula in every facility for every Prop 65-listed chemi-cal, said Norris.

“It’s virtually impossible to test for all of them. Assuming posi-tive intent on the part of retailers, I think many of them just don’t understand the enormity of what they are asking when they ask us to please guarantee all your products are in compliance with Prop 65 because I don’t think they understand the number of chemicals or the way testing works or the way courts have looked at compliance.”





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