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FDA Warning Letters and Guidance for FDCA Compliance


This article is the first in a series that focuses on various aspects of FDCA compliance for individuals and businesses that sell hemp derived products. 

The 2018 Farm Bill legalized the cultivation of hemp and manufacture and sale of hemp derivatives, such as CBD and delta-8 THC (for the moment), at the federal level.  The Farm Bill defines hemp generally as cannabis sativa L with a delta-9 THC concentration of less than 0.3% on a dry weight basis.  The cultivation and distribution of raw hemp flower is regulated by the USDA.  The FDA ostensibly regulates the manufacture and sale hemp products through the Food Drug and Cosmetic Act (FDCA), however, since the Farm Bill went into effect in 2019, the FDA has failed to promulgate regulations.  The absence of regulations means individuals and businesses that sell hemp derived products are essentially foreclosed from selling and marketing  these products in interstate commerce.  It also makes retailers that rely heavily on online sales and/or social media marketing particularly vulnerable, because these platforms easily reach consumer that are out of state. 

To avoid violating the FDCA, it is important to understand both the scope of the regulations and how it is enforced by regulators. The FDCA regulates the sale and marketing of drugs, cosmetics, dietary supplements, foods, and beverages. The FDA enforces the FDCA via the issuance of  Warning Letters, which are intended to promote voluntary compliance with the FDCA and to establish prior notice in the event the FDA initiates an enforcement action. Warning Letters are issued for FDCA violations that the FDA considers to be of “regulatory significance”  and which may lead to enforcement action if not promptly corrected. 

This article focuses on how the FDCA is applied to the sale and marketing of “drugs”. The FDCA defines the term “drug” as (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).  See 21 U.S.C. 321(g)(1). The definition of the term “drug” is particularly amorphous and is applied very broadly by FDA regulators.  

FDA Warning Letters often cite three FDCA violations related to “drugs”: (1) hemp derived products are “unapproved new drugs” because they are intended “for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”; (2) hemp derived products are “misbranded drugs” because the products are offered for a condition that is not amenable to self-diagnosis and treatment by individuals that are not medical practitioners; and (3) hemp derived products cannot be sold as non-prescription drugs because CBD is an active ingredient is not “generally recognized as safe and effective (GRASE)”. Below are several examples of specific language cited as a drug-related violation of the FDCA:

(a) “Fighting opioid addiction with whole spectrum hemp extract CBD Oil is scientifically proven to block the rewards of opioids.”

(b) “CBD reduces need for opioid use in pain treatment.”

(c) “Delta-8 consumers report many of the same effects as THC…and relief from some symptoms such as pain…delta-8 can help with insomnia.”

(d) “Our Organic Diaper Cream contains our natural organic Whole Spectrum Hemp Extract and just 7 other natural ingredients. In contrast, the leading diaper rash cream is 57% petroleum!”

(e) “Delta-8 THC Syrup…is ideal for anybody experiencing a sleeping disorder or other ailments looking to be relieved.” 

(f) “Cinnamon powder contains many antioxidants that may help reduce oxidative stress due to high blood glucose, improve insulin sensitivity, lower blood sugar levels, and prevent complications.” 

(g) “According to studies, CBD oil can help weaken habitual triggers and breaks the addictive association with time, allowing smokers to quit.” 

(h) “Anti-Inflammatory Effects…Most cannabis plants produce low concentration of THCV. Certain strains can offer higher concentrations, your best bet may be from the entourage effect associated with our full spectrum-CBD products.” 

The examples above demonstrate that it is crucial to carefully curate the language used to describe hemp derived products on labels, websites and social media platforms to avoid violating the FDCA. While examples (a), (b) and (c) make affirmative claims using words like “CBD oil…is proven”, “CBD reduces” and “consumers report”; the language in the remaining examples is not as straightforward.  Example (d) does contain any affirmative or conclusory language and only tangentially mentions a “disease” – diaper rash. Examples (e), (f), (g) and (h) all use qualifying language: “Delta-8 THC Syrup…is ideal for…”; “cinnamon powder contains many antioxidants that may help reduce…”; “according to studies CBD oil can…”; “THCV may” have anti-Inflammatory effects.  It could easily be argued that terms like “ideal, may and can” are not affirmative claims about the products intended use.

Warning Letters provide an opportunity to correct violations and are not immediately punitive, however, these letters should still be taken very seriously.  Failure to correct the cited violations could result in significant civil fines, the seizure of products or an injunction preventing the sale of specific products.  Retailers that receive Warning Letters bear responsibility for investigating and “determining the causes of any violations and preventing the recurrence or the occurrence of other violations.”  Retailers are also required to respond to the Warning Letter within 15 business days of receipt. The response must lay out the specific steps they have taken to correct the violations and explain how each of these steps will prevent the recurrence of a violation and include documentation of all corrections. 

If you receive a Warning Letter you should strongly consider contacting an experienced firm like Kinner & McGowan to investigate the violations and prepare your response to the FDA.  


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