review of the recent fda letters to cbd companies

Review of the Recent FDA Letters to CBD Companies Page 1

Review of the Recent FDA Letters to CBD Companies

In February, 2015, FDA issued 11 warning letters to the companies listed below for a host of health claims made on product labels and websites, and on Facebook Comments. Products sold by these companies claim to cure, mitigate, treat, or prevent things like bone fractures, cancer, viral tonsillitis, viral hepatitis, herpes, common cold, influenza, measles, mumps, chicken pox and more, in humans or animals. Several of the companies sell several products claiming to contain Cannabidiol (CBD), and market the products for a host of conditions, including cancer, neuroinflammation, schizophrenia, anxiety, and more. A search of all the letters and statements from FDA for the words controlled, CSA, or illegal return a result of zero. Takeaways: it appears FDA agrees with those of us that have known it for years: Cannabidiol in hemp is not a Controlled Substance. Period. Otherwise, FDA would be talking RICO organization with multiple underlying felonies against the Officers of the business. FDA didnt include the test results in the letters, but instead released them to the public as a warning, which is unprecedented. Drugs, botanicals, and supplements are routinely the subject of sensationalistic reporting as to lack of stated potency, it happened recently with ginseng, Echinacea, St. John's Wort, and ginkgo biloba. Its ironic that FDA claim no medicine in a product, but nevertheless assert it violates law by being a medicine. Its clear FDA are monitoring Facebook posts. Even pet products are subject to the same laws as human foods or medicines. Companies and Caregivers that make Cannabinoid products, take notice: this is what FDA enforcement looks like. Step One. No more of that DEA Swat Team BS. Although FDA does use their SWAT, they start with a nasty letter, see below. As for the health claims which are the reason for these letters, weve been down this road already with dietary supplements in the 80s and 90s. This exact same kind of enforcement happened back then on Echinacea health claims, and the like. FDA was ruthless in enforcing no information on health benefits in the store. Therefore, the industry got DSHEA 1994 to protect them. We need our version of DSHEA for Cannabinoids, or we will all be at risk except Big Pharma. To prevent this type of enforcement, one routinely sees the standard FDA disclaimer on websites: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

Remember: one can not market unapproved drugs for the diagnosis, cure, mitigation, treatment, or prevention of diseases in either humans or animals.

http://www.pharmpro.com/news/2015/02/ny-ag-expands-herbal-supplements-investigation


Food and Drug Administration February 3-26, 2015

FDA Warning Letters

Letter

Date Company

Issuing

Office Subject

Close Out

Date

February

26, 2015 Hemp Oil Care

Center for

Drug

Evaluation

and

Research

Unapproved New Drug/Misbranded Not Issued *

February

26, 2015

NanoBiotech

Pharma

Center for

Food

Safety and

Applied

Nutrition

New Drugs/Dietary Supplements/Food

Labeling/Misbranded Not Issued *

February

26, 2015

CBD Life

Holdings LLC dba

Ultra CBD

Center for

Food

Safety and

Applied

Nutrition



February

26, 2015

Twin Falls Bio

Tech, LLC

Center for

Food

Safety and

Applied

Nutrition



February

26, 2015

Modern Herb

Shop

Center for

Drug

Evaluation

and

Research


February

26, 2015 cancerherbtea.com

Center for

Food

Safety and

Applied

Nutrition



February

26, 2015

Infiniti Creations

Inc

Center for

Drug

Evaluation

and

Research


February Purecbd.net Center for Unapproved New Drug/Misbranded Not Issued *

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Letter

Date Company

Issuing

Office Subject

Close Out

Date

26, 2015 Drug

Evaluation

and

Research

February

26, 2015

Nutreglo

Products, Inc.

Center for

Food

Safety and

Applied

Nutrition



February

24, 2015

Canna Companion

LLC

Center for

Veterinary

Medicine

Unapproved New Animal

Drug/Adultered/Misbranded/Misleading Not Issued *

February

24, 2015 Canna Pet LLC

Center for

Veterinary

Medicine

Unapproved New Animal

Drug/Adultered/Misbranded/Misleading Not Issued *

Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#recent AHPA.org

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Warning Letters and Test Results

In late February 2015, FDA issued several warning letters to firms that market unapproved drugs for the diagnosis, cure, mitigation, treatment, or prevention of diseases. Some of these firms claim that their products contain cannabidiol (CBD). FDA has tested those products and, in some of them, did not detect any CBD. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease, and often they do not even contain the ingredients found on the label. Consumers should beware purchasing and using any such products.

The links to the Warning Letters and the test results for the CBD-related products are below:

Canna Companion,

LLC

Canna Companion Capsule Size: 4

WA cannaforpets.com 0.1% 0.1% CBDA: 0.3%

THCA: 0.9%

Canna-Pet, LLC CBD Wedges - Canna-

Biscuits for Dogs

WA canna-pet.com negative for cannabinoids

Canna-Pet, LLC Canna-Pet for Cats WA canna-pet.com 0.5%

Canna-Pet, LLC Canna-Pet MaxCBD Capsules for Dogs

WA canna-pet.com 2.6% 0.1% CBC: 0.1%

CBD Life

Holdings LLC dba Ultra CBD

UltraCBD* AZ ultracbd.com negative for cannabinoids

CBD Life

Holdings LLC dba Ultra CBD

UltraCBD* AZ ultracbd.com 0.02% ID

only

CBDA:

0.02%

Hemp Oil Care Hemp Pure Vape E-

Drops: Peached

CA hempoilcare.com negative for cannabinoids

Hemp Oil Care Cibaderm Hemp Salve CA hempoilcare.com CBDA:

0.2%

Hemp Oil Care Cibdex Hemp CBD CA hempoilcare.com 0.3%

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435671.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435671.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435671.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435662.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435662.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435662.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435778.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htm


Complex Drops - Peppermint

Hemp Oil Care Cibdex Hemp CBD

Complex Drops - Unflavored

CA hempoilcare.com 0.3%

Hemp Oil Care Cibdex Hemp CBD

Complex Drops - Vanilla

CA hempoilcare.com 0.3%

Hemp Oil Care Hemp Honey 21%

Cannabidiol Oil


Hemp Oil Care Hemp Honey CBD

Vape Oil - Blueberries & Cream


Natural Organic

Solutions

CBD Oil Extract

Capsules (500mg - 10 Capsules)

WA purecbd.net negative for cannabinoids

Natural Organic

Solutions

Real CBD Extract -

CBD (Cannabidiol) Cannabis Extract

Capsules (1500mg - 30 Capsules)

WA purecbd.net 0.5% 0.20% CBDA:

0.1% THCA:

0.03% CBN: ID only

Natural Organic

Solutions

21% CBD Hemp Oil

Treatment

WA purecbd.net negative for cannabinoids

Natural Organic Solutions

26% CBD Hemp Oil Treatment

WA purecbd.net 0.14% 0.45% CBDA: 0.05%

CBN: ID only

Twin Falls Bio Tech, LLC

Arisi-Tol SC arisitol.com 0.2%

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436066.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435777.htmhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435777.htm


*Multiple samples tested

Abbreviations: 9-tetrahydrocannabinol (9-THC), Tetrahydrocannabinol (THC), Cannabidiol

(CBD), Cannabinol (CBN), Cannabidiolic Acid (CBDA), Tetrahydrocannabinolic acid (THCA), Cannabichromene (CBC)

Public Health Focus Expanded Access (Compassionate Use) Page Last Updated: 03/03/2015

Source: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm

http://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/default.htmhttp://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm


Canna Companion LLC 2/24/15

Department of Health and Human Services Public Health Service Food and Drug Administration

February 24, 2015

WARNING LETTER VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED Canna Companion, LLC Sarah Brandon, DVM Greg Copas, DVM 928 Merea Lane Sultan, WA 98294 Dear Drs. Brandon and Copas, This letter concerns the marketing of the product Canna Companion by your firm Canna Companion, LLC. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.cannaforpets.com, where you promote and sell the product. We have determined that your product is a drug as defined by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)(1)(B)], as the product is intended for use in the mitigation, treatment, or prevention of disease in animals. As discussed below, this product is an unapproved new animal drug and your marketing of it violates the FD&C Act. Unapproved New Animal Drug

Statements on your website and product labeling that establish these intended uses of your product include, but are not limited to, the following: From the home page, www.cannaforpets.com:

Under the heading Heres how Canna Companion may help your dog or cat: o Reduce cancer-associated symptoms o Aid in decreasing severity of dementia o Reduce bronchial spasms in asthmatics

CBD Antibacterial . . . Inhibits cancer cell growth . . . Reduces blood sugar levels Reduces inflammation, Reduces risk of artery blockage, . . . Slows bacterial growth, . . . Treats psoriasis

Under the heading Scientific: o CBD . . . Antidiabetic, . . . Antimicrobial, Antineoplastic, Anti-proliferative, Antipsoriatic, Antipsychotic. . . . (http://www.cannaforpets.com/scientific). Further, claims made on your Facebook page, https://www.facebook.com/pages/Canna-Companion-LLC/277998209043875, which also has a link to your website at http://www.cannaforpets.com/ where products can be purchased directly, provide additional evidence that your product is intended for use as a drug:


Posts by your company on your Facebook page include the following:

On November 21, 2014: Good news about our Texas friend, Cyndi Shes a 14 yr lab who has spinal arthritis & a type of cancer called adenocarcinoma. Miss Cyndi is responding well to her Canna C. . . .

On November 19, 2014: Morgaine, one of our lymphoma patients is responding very positively to the extra strength capsules.

The above referenced products are only intended to be a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only intended to be a sampling of statements that demonstrate the intended uses of your product. Because your product is intended to mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)]. Further, this product is a new animal drug, as defined by section 201(v) of the FD&C Act [21 U.S.C. 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. 360b, 360ccc, and 360ccc-1]. Your product is not approved or listed by the FDA, and therefore the product is considered unsafe under section 512(a) of the FD&C Act [21 U.S.C. 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. 351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. 331(a)]. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your written response should be sent to Mr. Dillard Woody, Supervisory Consumer Safety Officer, U.S. Food and Drug Administration, 7519 Standish Place, Rm 107, Rockville, MD 20855. If you have any questions about this letter, please contact Mr. Woody at 240-276-9237 or by e-mail at [email protected]. Sincerely, /S/ Mr. Eric Nelson Director, Division of Compliance Center for Veterinary Medicine U.S. Food and Drug Administration


Canna Pet LLC 2/24/15


February 24, 2015

WARNING LETTER

VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED Daniel K. Goldfarb, President Canna-Pet, LLC 10115 Greenwood Ave., N., #191 Seattle, Washington 98133-9197 Dear Mr. Goldfarb,

This letter concerns the marketing of the products Canna-Pet for Cats, Canna-Pet for Dogs, Canna-Pet MaxCBD Capsules, and Canna-Biscuits for Dogs, by your firm Canna-Pet, LLC. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the Internet address www.canna-pet.com, where you promote and sell the products. We have determined that your products are drugs as defined by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)(1)(B)], as the products are intended for use in the mitigation, treatment, or prevention of disease in animals. As discussed below, the products are unapproved new animal drugs and your marketing of them violates the FD&C Act. Unapproved New Animal Drugs Statements on your website and product labeling that establish these intended uses of your products include, but are not limited to, the following: From the home page, www.canna-pet.com:

FAQs about Canna-Pet: We find medical benefits, behavioral benefits, prolonged life, reduced stress, and improved quality of life with our pets. (http://canna-pet.com/how-to-use/faqs/).

Medical Benefits: We Recommend Canna-Pet as a daily food additive for all pets, but especially for those with arthritis, allergies, anxiety or behavior issues, compromised immune systems, diabetes, digestive issues, nausea, chronic pain, cancer, seizures, and those receiving palliative care. (http://canna-pet.com/how-it-works/the-basics/).

Health Benefits of Cannabidiol (CBD) Canna-Pet: Antitumor, Antiepileptic, Anticancer, Anti-inflammatory, Bone stimulant, Analgesic, Anti-depressant, Antibacterial, Antipsoriatic, Antidiabetic, . . . Anti-nausea, Anti-anxiety, . . . Antipsychotic, . . . Immunosuppressive. (http://canna-pet.com/how-it-works/phytochemistry-active-compounds/).


Canna-Pet MaxCBD Capsules

For pets with extreme issues, who require larger doses of CBD. Most commonly these are pets suffering from seizures, although we often see pets with cancers and aggressive tumors, severe chronic pain, and in end-of-life care using our MaxCBD products. (https://canna-pet.com/how-it-works/our-products/).

The above referenced products are only intended to be a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only intended to be a sampling of statements that demonstrate the intended uses of your product. Because your product is intended to mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)]. Further, this product is a new animal drug, as defined by section 201(v) of the FD&C Act [21 U.S.C. 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. 360b, 360ccc, and 360ccc-1]. Your product is not approved or listed by the FDA, and therefore the product is considered unsafe under section 512(a) of the FD&C Act [21 U.S.C. 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. 351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. 331(a)]. [TESTING RESULTS (if included in the letter)] You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your written response should be sent to Mr. Dillard Woody, Supervisory Consumer Safety Officer, U.S. Food and Drug Administration, 7519 Standish Place, Rm 107, Rockville, MD 20855. If you have any questions about this letter, please contact Mr. Woody at 240-276-9237 or by e-mail at [email protected]. Sincerely, /S/ Mr. Eric Nelson Director, Division of Compliance Center for Veterinary Medicine U.S. Food and Drug Administration


CBD Life Holdings LLC dba Ultra CBD 2/26/15


College Park, MD 20740 FEB 26, 2015

WARNING LETTER VIA EXPRESS MAIL

Mohit Asnani CBD Life Holdings LLC dba Ultra CBD 10435 N. Scottsdale Rd Scottsdale AZ 85253

Re: 445847 Dear Mohit Asnani, This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.ultracbd.com in November 2014 and has determined that you take orders there for the product Ultra CBD. FDA also reviewed literature that accompanies the sale and shipment of your product Ultra CBD and has determined that your website and the literature promote Ultra CBD for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)]. The therapeutic claims on your website and in promotional literature establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDAs home page atwww.fda.gov.

Examples of some of the website claims that provide evidence that your product is intended for use as a drug include: Under the heading, Research:

[S]tudies have found CBD to possess the following medical properties: Antipsychotic combats psychosis disorderscombats neurodegenerative disorders Anti-tumoral combats tumor and cancer cells combatsdepression disorders

Moreover, when scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the products intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of publications that are used to market your product for disease treatment and prevention on your website and are thus evidence of your products intended use as a drug:

The Inhibitory Effects of Cannabidiol on Systemic Malignant Tumors

Cannabidiol inhibits lung cancer cell invasion and metastasis via intercellular adhesion molecule-1

Cannabidiol Induces Programmed Cell Death in Breast Cancer Cells by Coordinating the Cross-talk between Apoptosis and Autophagy

http://www.fda.gov/


Pathways mediating the effects of cannabidiol on the reduction of breast cancer cell proliferation, invasion, and metastasis

Examples of claims from the literature that accompanies the sale and shipment of your Ultra CBD that provide evidence that your product is intended for use as a drug include:

Treats rheumatoid arthritis

CBD Promotes Cell Death in Breast Cancer Cells

CBDAntibacterial Inhibits Cancer Cell GrowthReduces risk of artery blockage Further, claims made on your Facebook page https://www.facebook.com/ultracannabidiol, which includes a link to your website at http://www.ultracbd.com where products can be purchased directly, provide additional evidence that your products are intended for use as drugs: Posts by your company on your Facebook page include the following:

On October 26, 2014: CBD Protective Against Ebola Virus Cannabinoids are emerging as a new class of drugs that treat infections of bacteria, fungi and virus

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a new drug under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also section 301(d) of the Act [21 U.S.C. 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Additionally, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, Ultra CBD is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. 331(a)]. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will make the correction. If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee (HFS-608). If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972. Sincerely, /S/ William A. Correll Director Office of Compliance Center for Food Safety and Applied Nutrition


Hemp Oil Care 2/26/15


February 26, 2015

WARNING LETTER VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED Tigran Lalayan Hemp Oil Care 5511 Virginia Ave Los Angeles, CA 90038 Dear Tigran Lalayan:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.hempoilcare.com[1] in November 2014 and has determined that you take orders for several products that you claim contain cannabidiol (CBD), including but not limited to Cibdex Hemp CBD Complex Drops, Cibaderm Hemp Salve, Dixie Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey 21% Cannabidiol Oil, Hemp Honey CBD Vape Oil, and Hemp Pure Vape E-Drops, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)], because the products are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Examples of claims observed on your website https://www.hempoilcare.com that establish the intended use of your products include, but may not be limited to: On the CBD oil Pure Vape E-Drops 50mG product webpage, https://www.hempoilcare.com/product/cbd-oil-pure-vape-drops/: A literature review from 2009 recapped CBDs documented capabilities as an . . . antipsychotic . . . vasorelaxant (lower blood pressure), antispasmodic, anti-ischemic, anti-cancer agent . . . antibacterial agent, anti-diabetic . . . On the Hemp oil Dixie Botanicals Dew Drops product webpage, https://www.hempoilcare.com/product/hemp-oil-dixie-botanicals-dew-drops-100mg/: EXPLORING SEVEN HEALTH BENEFITS OF CANNABIDIOL (CBD) . . . antipsychotic, anti-depressant . . . analgesic for rheumatoid arthritis . . . stimulating new bone growth and strengthening bones affected by osteoporosis . . . vasorelaxant for glaucoma . . . atheroscloerosis [sic], anti-ischemic (prevents plaque buildup in arteries) On the CBD Oil webpage, https://www.hempoilcare.com/cbd-oil/: Under the heading, Study: Cannabinoids Could Play A Role In Pancreatic Cancer Treatment:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htm#_ftn1


[A study] suggests that cannabinoids could help treat pancreatic adenocarcinoma one of the most aggressive forms of cancer. [T]he administration of cannabinoids seemed to induce cancer cell apoptosis . . .. Under the heading, CBD May Help Reduce Psychotic Symptoms of Schizophrenia: CBD has shown promise in preventing cancer from cigarette smoke, reducing heart damage from chemotherapy . . .. [Researchers] compared benefits of CBD and amisulpride, a potent antipsychotic, in 42 acute schizophrenia patients . . . . The researchers found that cannabidiol and amisulpride were both safe and effective but they declared CBD superior . . . . It is clear from the claims above that your marketed products Cibdex Hemp CBD Complex Drops, Cibaderm Hemp Salve, Dixie Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey 21% Cannabidiol Oil, Hemp Honey CBD Vape Oil, and Hemp Pure Vape E-Drops are drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Your marketed products Cibdex Hemp CBD Complex Drops, Cibaderm Hemp Salve, Dixie Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey 21% Cannabidiol Oil, Hemp Honey CBD Vape Oil, and Hemp Pure Vape E-Drops are also new drugs under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also section 301(d) of the Act [21 U.S.C. 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Additionally, your marketed products Cibdex Hemp CBD Complex Drops, Cibaderm Hemp Salve, Dixie Botanicals Dew Drops Hemp Oil Supplement, Hemp Honey 21% Cannabidiol Oil, Hemp Honey CBD Vape Oil, and Hemp Pure Vape E-Drops are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], because the labeling for these products fails to bear adequate directions for use. Adequate directions for use means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR 201.5]. Your marketed products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR 201.100(c)(2) and 201.115]. Because the above-mentioned products lack FDA-approved applications, they are not exempt under 21 CFR 201.100(c)(2) and 201.115. For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. 331(a)]. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the


recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to: U.S. Food and Drug Administration CDER/OC/OUDLC 10903 New Hampshire Avenue, WO51 Silver Spring, MD 20993-0002 [email protected] Sincerely, /s/ Cynthia Schnedar, J.D. Director Office of Compliance Center for Drug Evaluation and Research [1] FDA notes that http://www.cbdactive.com also redirects to https://www.hempoilcare.com/ when purchasing CBD oil products.

mailto:[email protected]:[email protected]://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436069.htm#_ftnref1


Purecbd.net 2/26/15


February 26, 2015

WARNING LETTER VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED Natural Organic Solutions Attn: Joe Cain 1001 Cooper Point Rd. SW Ste.140 #149 Olympia, WA 98502

1675 Mottman Rd. SW Tumwater, WA 98512 Dear Joe Cain: This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the internet address www.purecbd.net and your Etsy.com marketplace store at the internet address www.etsy.com/shop/PureCBD in February 2015, and has determined that you take orders for several products claiming to contain cannabidiol (CBD), such as (but not limited to), CBD Hemp Oil Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti Anxiety Formula, and High CBD Healing Salve. FDA also reviewed literature which accompanies the sale and shipment of your products. Based on our review, we have determined that your websites and accompanying literature promote these products for conditions that cause them to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As explained further below, the introduction or delivering these products for introduction into interstate commerce for such uses violates the Act. Examples of claims observed in the accompanying literature titled, Real CBD Cannabis Extracts, that establish the intended use of your products include, but may not be limited to, the following: It has shown great promise in treating the most aggressive forms of Cancer, MS . . . Resistent [sic] Bacteria . . . and so many other conditions. CBD acts in some experimental models as an anti-inflammatory . . . and antipsychotic agent, and is therefore a potential medicine for the treatment of Neuroinflammation . . . and Schizophrenia, respectively. Examples of claims observed on your website www.purecbd.net that establish the intended use of your products include, but may not be limited to, the following: On the webpage titled, About:


Our oil is making a difference in the lives of our patients . . . Cancer is going into remission. People are recovering from serious disease. On the webpage titled, Reviews:

CBD hemp oil critical for cancer treatment Stage 4 Metastatic Breast Cancer Patient has symptom relief Examples of claims observed on your www.etsy.com/shop/PureCBD marketplace store website that establish the intended use of your products include, but may not be limited to, the following: On the webpage titled 30 Capsules CBD Hemp CBD Extract Capsules Anti Anxiety Formula: CBD Extract Capsules Anti Anxiety Formula This formula has been specifically designed to prevent Panic/Anxiety Attacks from occurring. The medicine eliminates many of the peaks and valleys that are normally responsible for causing a panic attack. On the webpage titled, 4 Ounces High CBD Healing Salve for Wounds, Blemishes and Cancers: High CBD Healing Salve for Wounds, Blemishes and Cancers In the pictures above you can see the amazing results. The patient presented with third degree burns. Infection was present. Within 48 hours significant healing has occurred with no sign of infection. We have treated thousands of patients and have seen this medicine work! On the webpage titled, 60 Grams of 26% CBD Hemp Oil Treatment:

We have treated hundreds of patients using this methodology. There is no stronger treatment available. Here are a just a few studies using hemp oil to treat various acute disease. Cancer . . . http://www.ncbi.nlm.nih.gov/pubmed/?term=cbd+cancer MS . . . http://www.ncbi.nlm.nih.gov/pubmed/?term=cbd+ms Alzheimers . . . http://www.ncbi.nlm.nih.gov/pubmed/?term=cbd+Alzheimers It is clear from the claims above that your products, CBD Hemp Oil Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti Anxiety Formula and High CBD Healing Salve, are drugs under section 201(g)(1)(B) of the Act. Moreover, your products CBD Hemp Oil Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti Anxiety Formula and High CBD Healing Salve are also new drugs under section 201(p) of the Act [21 U.S.C. 321(p)], because they are not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also section 301(d) of the Act [21 U.S.C. 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, your products CBD Hemp Oil Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti Anxiety Formula and High CBD Healing Salve are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] in that their labeling fails to bear adequate


directions for use. Adequate directions for use means directions under which a layperson can use a drug safely and for the purposes for which it is intended [21 CFR 201.5]. Your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR 201.100(c)(2) and 201.115]. Because CBD Hemp Oil Treatment, Hemp CBD (Cannabidiol) Extract Capsules, CBD Extract Capsules Anti Anxiety Formula and High CBD Healing Salve lack FDA-approved applications, they are not exempt under 21 CFR 201.100(c)(2) and 201.115. For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. 331(a)]. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to: U.S. Food and Drug Administration CDER/OC/OUDLC 10903 New Hampshire Avenue, WO51 Silver Spring, MD 20993-0002 [email protected] Sincerely, /s/ Cynthia Schnedar, J.D. Director Office of Compliance Center for Drug Evaluation and Research

mailto:[email protected]


Twin Falls Bio Tech, LLC 2/26/15


College Park, MD 20740 FEB 26, 2015

WARNING LETTER VIA EXPRESS MAIL

David Mouser, CEO Twin Falls Bio Tech, LLC 18 Margarita Court Hilton Head Island, SC 29926

Re: 444405 Dear Mr. David Mouser: This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address www.arisitol.com in November 2014 and has determined that you take orders there for the product Arisi-Tol, which you also refer to as ArisiTol, Arisitol and Arisi-tol. FDA also reviewed literature that accompanies the sale and shipment of your product and has determined that your website and the literature promote Arisi-Tol for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)]. The therapeutic claims on your website and in promotional literature establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introduction or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and FDA regulations through links on FDAs home page at www.fda.gov. Examples of some of the claims observed in the literature titled Read Before Taking that accompanies the sale and shipment of Arisi-Tol and provide evidence that your product is intended for use as a drug include:

Case studies have shown it even reduces or inhibits cancer cell growth in six cancers with breast cancer leading the list.

Over 2/3rds of the 300 individuals, suffering from many forms of Arthritis, tested our formula and reported it worked!

I developed walking pneumonia. A cough developed effecting [sic] my bronchial tubes, they became sore and inflamed.So, instead of taking cough syrup with codeine, I chewed up three Arisi-tol tablets. In less than an hour, no more burning or inflammation! The inflammation never returned as I continued taking three tablets a day.

[T]he knowledge CBD inhibits growth of cancer cells, is why I continue to take one tablet of Arisitol daily.

If you suffer from Arthritis...try chewing up some Arisi-Tol. Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:

http://www.fda.gov/


On the webpage titled, United Patients Group Explains Top 5 Cannabinoids that Help Medical Cannabis Patients Heal:

Cannibidiol (CBD) [sic]: CBD helps with cancer, multiple sclerosisdiabetes, arthritis, dystonia, Chrohns [sic] disease

On the webpage titled, CEO Editorial: Looking for Natural Alternatives and Dealing with Aging, Memory Loss, Arthritis and Pain Management:

If you or someone you know is looking for a safer alternative treatment option for MS, RA, OA,ArisiTol is made just for you.

On the webpage titled, ArisiTol Order Now for Inflammation and Pain Relief:

Arthritis, Arthritis Pain, RA, Rheumatoid Arthritis, Severe ArthritisCancer, Cancer Cure, Cancer Remedies...MS Multiple SclerosisTheilers murine encephalomyelitis virus, Theilers murine encephalomyelitis virus-induced demyelinating diseaseparkinsons [sic]

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a new drug under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also section 301(d) of the Act [21 U.S.C. 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, Arisi-Tol is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. 331(a)]. The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. Please notify this office in writing within 15 working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which each such item will be corrected. If you need additional information or have questions concerning any products distributed through your website, please contact the FDA You may respond in writing to to Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, Attention: Mabel Lee (HFS-608, 2C-047). If you have any questions concerning this letter, please contact Ms. Lee at 240-402-0972. Sincerely, /S/ William A. Correll Director Office of Compliance Center for Food Safety and Applied Nutrition


2015 v1.0 Written by Richard Rose Disclaimer These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. Information is provided for informational purposes only and is not meant to substitute for the advice provided by your own attorney or doctor. We are providing this on an as is basis and make no representations or warranties of any kind with respect to it. No one will be liable for damages arising out of or in connection with the use of this information. This is a comprehensive limitation of liability that applies to all damages of any kind, including (without limitation) compensatory, direct, indirect or consequential damages, loss of data, income or profit, loss of or damage to property and claims of third parties. I am not a lawyer, a doctor, or a scientist.

Trademarks remain the property of their respective owners.

This work is licensed under the Creative Commons Attribution 4.0 International License. You are free to: Share copy and redistribute the material in any medium or format Adapt remix, transform, and build upon the material for any purpose, even commercially. Under the following terms: Attribution You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. No additional restrictions You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits. Notices: You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation. No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

Credit: Medicinal Hemp Association.

http://creativecommons.org/licenses/by/4.0/http://www.the-mha.org/

review of the recent fda letters to cbd companies

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