supplement industry and regulations

8/13/2019 Supplement Industry and Regulations

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Supplement Industry and Regulations

KIN 380 Malin Lecture 14 1


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What are dietary supplements?

Powdered Protein?Testosterone?Nutra-sweet?

EPO?Androstenedione?

Human Growth Hormone?Calcium?

Vitamin C?Jellybeans?



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Supplements are NOT

Drugs alter physiologicaland biological processes.According to the 1985Federal Food, Drug, andCosmetic Act, a drug isintended for diagnosis,cure, mitigation, treatmentor prevention of diseaseand articles (other thanfood) intended to affectthe structure or functionof the body. Before adrug can be sold in the US

it must undergo clinicalstudies to determine itsefficacy, safety, possibleinteractions with other drugs, and appropriatedosage. Drugs must beapproved by the FDA.

A food additive is anysubstance added tofood. Legally, they are"any substance of whichthe intended use resultsor may reasonably beexpected to result-directly or indirectly-inits becoming acomponent or otherwiseaffecting thecharacteristics of anyfood." This includes any

substance used inproduction, processing,treatment, packaging,transportation or storageof food. Food additivesmust be approved by theFDA.

DrugsDrugsFood AdditivesFood AdditivesFoodsFoods"Food" means a raw,cooked, or processededible substance, ice,beverage, or ingredientused or intended for useor for sale in whole or inpart for humanconsumption, or

chewing gum. Foodsmust be handled andlabeled in accordancewith laws of the FDA.



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How are Supplements defined?

Supplement s are products that supplies a componentmissing in diet.

Since 1994 the Diet Supplement Health & Education Act ( DSHEA), definition is:

1. A product (not tobacco) intended to supplementthe diet that contains: a vitamin, a mineral, a dietarysubstance to increase total daily intake, aconcentrate, a metabolite, a constituent, an extract,

a combination of the above.2. Intended for ingestion in pill, capsule, tablet or liquid form.



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DSHEA: Dietary Supplement Health &

Education Act Love it or hate it KNOW IT!

Passed originally in Congress in 1994 Revised in 1999 Places the burden of proof on the FDA to

ensure product safety.

Created limits on what claims could be madeabout dietary supplements.



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WHY DSHEA EXISTS If you were Congress, would you regulate

dietary supplements like: Food?

Drugs? Some sort of in between natural

consumable substance?

How much money are we talking about?



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In 2007, sales of dietary supplements reached approximately$25 billion dollars and 68% of Americans reported that theyhad taken one or more dietary supplements in the past year.



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People generally take


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Marketing a new drug requires a complex seriesof testing in both animals and humans todetermine:

1. safety2. effectiveness3. possible interactions with other substance4. appropriate dosages

Takes millions of dollars and years of research to

bring a new drug (or food additive ) to market.For example, Prozac, Viagra, Olestra, NutraSweet



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Who is responsible for supplement safety/efficacy?

The FDA (Food and Drug Administration) overseessafety, manufacturing and product information(such as claims) in package inserts, on the label, or in accompanying literature.

FTC (Federal Trade Commission) overseesadvertising (TV, newspaper, magazine, internet?)

The Dietary Supplement Health and Education Act

(DSHEA ) of 1994 specifies powers that the FDAhas to regulate the sale of dietary supplements.



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OPTIONAL: structure/function claims

CAN make general claims about a nutrient or other compound in terms of a non-specific effect onhealth and well-being :

maintains bone health;

supports the immune systemRequires label to say : This statement has notbeen evaluated by the FDA. This product is notintended to prevent, treat, cure or mitigate disease

Manufacturers (CRN) have lobbied hard to softenthe FDA position on health claims with some success.



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Manufacturers can make 3 claims about their products:

Show a link between a food or substance and adisease or health-related condition. FDA authorizes

these claims based on a review of the evidence.Example, calcium lowers the risk of osteoporosis.

Disease claims(needs FDA

approval)

Can make general claims about a nutrient or other compound in terms of a non-specific effect onhealth and well-being. Example, calcium buildsstrong bones. Manufacturers may base claims ontheir review of the literature. These claims do notneed FDA authorization but must include Thisstatement has not been evaluated by the Food andDrug Administration. This product is not intendedto diagnose, treat, cure, or prevent any disease.

Structure function claims

Describes the level of a nutrient in a food or dietary

supplement. For example, a supplement containingat least 200 milligrams of calcium per serving couldcarry the claim "high in calcium."

Nutrientcontent claims



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NO DISEASE CLAIMS but statements of nutritionalsupport and Structure/Function Claims are allowed.

4 general categories of S-F claims:1. Nutrient deficiency disease - but must alsodisclose its prevalence

2. Role of a nutrient / ingredient in affecting astructure or function

3. Describes the documented mechanism by which anutrient or dietary ingredient acts to maintain abodily structure/function

4. General well-being



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UNACCEPTABLE: DISEASE (DRUG)ACCEPTABLE: STRUCTURE FUNCTION

UNACCEPTABLE: Protects against heart diseaseHelps maintain cardiovascular function

UNACCEPTABLE: Lowers cholesterol levelPromotes healthy cholesterol level

UNACCEPTABLE: Reduces pain of arthritisPromotes healthy joints

UNACCEPTABLE: Prevents urinary tract infectionsPromotes urinary tract health


Examples of unacceptable/acceptable claims


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18KIN380 Malin Lecture 14

SummaryDifference between a supplement and a drug...

- Why do we care?Testing and marketing by the FDA is different for supplements compared to drugs (and food& foodadditives).DSHEA (act signed by Clinton in 1994): basicallyallows supplement manufacturers to market moreproducts as supplements and to provide moreinformation to the consumer about the supplementsbenefits.

- In the eyes of the consumer, it weakened theenforcement ability of the FDA.


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Because of the DSHEA...- supplement labels are more consumer friendly- But are supplements still safe?- Supplements used to regulated as food additives but

getting FDA approval for new food additives takes yearsof research...$$$Food additive does not apply to supplements... They arenot subject to the same pre-market safety assessment.With the DSHEA, FDA regulation went from evaluatingpre-market safety to policing the industry. This means thatthe FDA evaluates adverse event reports and then makesdecisions about whether or not to categorize supplementsas adulterated (impure or questionable).


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Consumer Savvy

Because the DSHEA requires less pre-market review for dietary supplementsmaking an informed decision as aconsumer is important. Look for unbiased information and

evaluate studies as we have practiced inclass.

Also look to see if the findings of a studyhave been re-produced...


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Tips for developing sport supplement savvy Be suspicious of a single substance that claims to

do multiple things build muscle, increasestrength, burn fat and increase stamina...etc

Be wary if companies tell you that you dont have

to eat properly when taking the supplement. Natural doesnt equal safe Be critical of the studies that the manufacturer

cites as proof of safety/efficacy (mistrust the

information if you cant find the reference!) Use common sense, if the claim appears too

good to be true, it probably is.


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Good + Cheap = Not fastGood + Fast = Not cheapFast + Cheap = Not good

Fast

Cheap Good

The R&D Conundrum

Is it better to be FIRST?Is it better to be BEST?

The bottom line

KIN 380 Malin Lecture 14

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In the supplement industry , enough research is...

Enough to convince enough consumers to buy theproduct that $$ from sales greatly exceeds thecosts of manufacture, distribution and advertising.

$$$$ in >>> $ outTo do more violates the interests of employees,shareholders and, in terms of price, consumers.Doing more than the minimum research needed

to maximize sales is not only unnecessary buteven incompatible with the interests of thecompany.



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Summary questions

What is the difference between a food, foodadditive, drug and supplement?

What are the 4 roles the FDA play indrug regulation?

Name the 3 types of claims that manufacturerscan make. Dene them. Which one does theFDA have to approve?

supplement industry and regulations

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