On November 22, 2019, FDA’s Center for Drug Evaluation and Research (CDER) sent a warning letter to Bella Rose Labs in Brooklyn, New York. The letter advised the company, after examining the company website, the company would be in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) if the products were introduced into interstate commerce. FDA asserted that the website claims show that the products are unapproved drugs in violation of the act. FDA also asserted that the website claims constituted misbranding. The introduction of these products violates the FD&C Act.
CBD products are a booming industry. The federal hemp law has opened some doors to the manufacture of CBD products. Manufacturers and distributors need to understand when and how FDA can close those doors. Experienced FDA healthcare lawyers can explain the applicable laws and regulations. We help companies assess compliance issues to help reduce risk of FDA warning letters and enforcement.
Dietary Supplement Labeling
The FDA warning letter stated that the company intended to market as dietary supplements two products that contain CBD – Bella Rose Hemp Oil and Yummy Bears Gummies – because the products included the words “Dietary Supplement” on the product labels.
The letter continued by saying “Your products cannot be dietary supplements” because though they do not meet the Act’s definition. Specifically, FDA has determined that, based on the current evidence and the various sections of the FD&C Act, CBD products are excluded from the Act’s definition of dietary supplements. Those sections provide that if an item like CBD is an “active ingredient” in a drug product that has been approved under section 505 of the FD&C Act or has been “authorized for investigation as a new drug for which substantial clinical investigations” have been started and if the investigations have been made public, then the product falls outside the Act’s dietary supplement definition.
The only exception generally allowed to the 505 section requirements is if the substance was “marketed” as a dietary supplement or “as a conventional food” before the new investigations were approved. However, FDA has determined that this exception does not apply for CBD. So far, FDA does not know of any evidence that would change its conclusion that CBD products do not qualify as dietary supplements under the Act – though the respondent, Bella Rose Labs, was welcome to present relevant evidence.
Unapproved New Drugs
FDA review of the company website further determined that the website claims for company products show those products are drugs since the products “are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.”
So far, with limited exceptions, the claims by CBD companies that CBD products have medical benefits have been found to violate the FD&C Act for this very reason – that the claims of medical benefits make the products new drugs. Any company making, marketing, or selling CBD products should understand that FDA warning letters may already be in the mail. Medical claims for CBD, so far, have not met with FDA approval – with rare exceptions.
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To introduce or deliver “new drugs” into interstate commerce requires FDA pre-approval. This pre-approval requires a thorough scientific review to certify that the new drugs are indeed safe and effective. FDA added there are no approved FDA-applications for the products listed.
Some of the medicinal claims FDA found on the company website include the following medical claims for the products – Bella Rose hemp oil, CBD hemp facial moisturizer, CBD isolate, CBD topical, Disposable vape Cartridge CBD hemp, and Yummy Bears Gummies:
- “The fact that Bella Rose CBD oil is THC-free & non-psychoactive makes it an appealing option for patients looking for relief from inflammation, pain, anxiety, psychosis, seizures, neurodegenerative diseases, spasm . . .”
- “Scientific and clinical research . . . underscores CBD’s potential as a treatment for a wide range of conditions, including arthritis, diabetes, alcoholism, MS, chronic pain, schizophrenia, PTSD, depression, antibiotic-resistant infections . . .”
- “CBD has demonstrable neuroprotective and neurogenic effects, and its anti-cancer properties are currently being investigated at several academic research centers in the United States and elsewhere.”
- “Diabetes and chronic pain are public health nightmares for which CBD may play especially important therapeutic roles. Our group owns pertinent patents in this regard, and these conditions comprise enormous markets.”
These statements are all targets for FDA officials because of claims the CBD products have medicinal value.
FDA found that the products listed on the website are also misbranded within section 502(f)(1) of the FD&C Act, because the labeling does not include adequate directions for how to use the products. “Adequate directions” is a term of art which means that the layperson who uses the products should understand how to use the products safely and for the purposes for which it is intended.
FDA found that the directions were not adequate because the products were being offered for conditions which “were not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.” For these reasons, adequate directions cannot be written that a layperson could follow while ensuring that the usage would be safe for the intended purpose.
While prescription drugs that have been approved by FDA and include FDA-approved labeling are exempt from the adequate directions requirements, the products Bella Rose Labs are offering are not exempt because there is not an effective FDA-approved application for the covered products. Therefore, introducing the listed products into interstate commerce would constitute a violation of the “misbranded drugs” sections of the FD&C Act.
301 (ll) and Adulterated Foods
FDA also expressed concern in the warning letter that Bella Rose Labs may desire to promote one of its products, Yummy Bears Gummies, as a “conventional food since it states on the website that is product is “fruity,” “yummy,” and “delicious.” FDA states that promoting this product as a conventional food is prohibited under the Act if the food is introduced or delivered into interstate commerce – and if the approved drug is added to the conventional food or substantial clinical investigations have been started and made public.
FDA asserts the adulterated food prohibition set forth in section 301 (II) applies. While FDA recognizes that an exception may apply if the substance/CBD was marketed in food before the “drug was approved or before the substantial clinical investigations involving the drug had been institute,” FDA has not approved this exception for CBD. FDA further states that the agency does not have any evidence that would change this finding that an exception applies, though Bella Rose Labs could present evidence.
FDA also states that the FD&C Act includes the term “food additive” which refers to “any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.” Based on FDA analysis, “CBD in conventional food products does not satisfy the criteria for GRAS status under 21 CFR 170.30.”
FDA requires that food additives have premarket approval. That approval must be founded on data that confirms the food additives are safe. Food additives are deemed unsafe under the FD&C Act if the food additives are not “approved for their intended use.” If the food additive is deemed unsafe, then the food is considered “adulterated.” Adulterated food cannot be introduced into interstate commerce because of concerns about the additives’ safety.
There are food safety concerns regarding CBD. These include concerns about:
- Liver injury due to CBD
- Possible dangerous interactions with other drugs
- Animal studies that show “CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males.”
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FDA does not have knowledge of any other food additive exceptions so that CBD could be used as a conventional food ingredient
The FD&C Act excludes the following substances from the definition of “prior additive:”
- pesticide chemical residues in or on a raw agricultural commodity or processed food
- pesticide chemicals
- color additives
- substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act)
- new animal drugs
- dietary ingredients in or intended for use in a dietary supplement.
The warning letter concludes that:
- CBD when added to a conventional food is a “food additive” and subject to FD&C Act rules
- Food additives are not safe unless approved by FDA “for its intended use prior to marketing,”
- CBD has not been approved in any conventional food
- Unsafe additives to food cause the food to be “adulterated”
- Adulterated food cannot be entered into interstate commerce
FDA requirements for responding to a warning letter
FDA’s warning letter indicates that there may be other violations related to the marketing of the CBD products as well. Bella Rose Labs must make its own investigation in determining what other violations exist and the causes for those violations. Makers of CBD products are required to comply with all FDA regulations.
The FDA warning letter directs Bella Rose Labs to promptly correct the cited violations. If the maker of these CBD products does not comply with FDA’s warning letter, the manufacturer could be subject to further legal action including “without limitation, seizure and injunction.”
The warning letter directs Bella Rose Labs to:
- Inform FDA in writing, within 15 days from the time the respondents receive the warning letter, the specific steps the company has taken to come into compliance with the FD&C Act.
- Provide how the CBD product maker will prevent future violations from occurring.
- Provide the reasoning and supporting information in support of these information requirements.
- If a delay beyond 15 days is required, provide reasons why and the time frame for coming into compliance.
Despite the explosion of CBD businesses, any company that manufactures, sells, and distributes CBD products needs to understand that FDA regulations do cover CBD products that qualify as dietary supplements, new drugs, conventional foods, food additives, and other categories. FDA warning letters may be sent if FDA review of company websites finds that CBD products meet a covered FDA category and the company is not complying with applicable FDA regulations. FDA warning letters for CBD products generally question whether the medical claims are valid, whether the products should be new drugs which require scientific review, and whether the products are adulterated or misbranded.
Contact Cohen Healthcare Law Group, PC for legal counsel on healthcare transactions, regulatory compliance, and FDA and FTC law. Our experienced healthcare & FDA attorneys advise healthcare companies and healthcare providers ranging from medical centers, to integrative and functional medicine practices, cosmetics and supplement companies, and medical device manufacturers.