Marijuana

2022, The Year Of CBD Warning Letters From The FDA

These letters continue to stress the need for Congress to enact legislation that will force the FDA to finally establish a regulatory pathway to govern CBD products intended for human and animal consumption.

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Legal Marijuana Concept

Last week, the Food and Drug Administration (the FDA or the Agency), issued a new round of warning letters to five companies selling cannabidiol (CBD)-infused products.

 

These recent enforcement actions continue to show a growing level of scrutiny against CBD companies. This year alone, the FDA has released thirty-three warning letters to CBD companies, which represents a 371+% increase from last year, with only seven letters issued.

As I have explained before, these letters are a valuable tool for any CBD company. They reveal the types of statements that make the FDA tick, which offers CBD businesses the chance to adjust their marketing practices to reduce the risk of enforcement actions but also shield themselves from more significant headaches, such as facing product seizures, criminal charges, and major fines and penalties, to name a few.

So here are five pearls of wisdom we can extract from these new letters:

1. Medical claims are no longer the sole triggers for warning letters.

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In its letter addressed to 11-11-11 Brands, the FDA signaled it takes issue with a new category of products: CBD-infused caffeinated beverages. The FDA seems concerned with evidence that suggests CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects.

While this issue may signal a potential shift in the FDA’s existing enforcement focus, it does not give the industry carte blanche to start making unapproved medical claims. In fact, the other four companies that fell under the FDA’s scrutiny this month got into trouble for marketing their products as intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals.

2. The Agency continues to strongly oppose the sale and marketing of three categories of products: Delta-8 tetrahydrocannabinol (THC) products, CBD pet products, and CBD OTC drugs.

  • Delta-8 THC products: It is clear from reading these recently-issued letters that the FDA continues to treat Delta-8 THC products, particularly food products, as serious threats to public health. As it did in a consumer update originally published in September 2021, the Agency reiterated its main concerns with the substance, namely that:
    • Delta-8 THC products have yet to be evaluated and approved by the FDA for safety.
    • Delta-THC products have been reported as causing serious health issues, including vomiting, hallucinations, trouble standing, and loss of consciousness, often requiring hospitalization of children.
    • Delta-8 THC products contain enhanced psychoactive and intoxicating effects compared to levels naturally occurring in the hemp plant, making it difficult for consumers to reliably gauge a safe level of consumption.
    • Delta-8 THC products often contain harmful chemicals due to the manufacturing of these products being vastly unregulated.
    • Delta-8 THC products are not suited for children and pets.
  •  CBD pet products: Roughly 40% of CBD warning letters issued this year involved CBD-infused pet products. The Agency seems to have little tolerance for these products which are often marketed as cures for our fury friends’ joint pain and anxiety (e., unapproved medical claims). So, CBD companies selling these products, should remain vigilant when drafting their marketing materials.
  • CBD over-the-counter (OTC) products: The FDA deems OTC drug products infused with CBD as “unapproved new drugs.” As the Agency previously explained, these products violate the Food, Drug and Cosmetic Act (the FDCA) because CBD has yet to be reviewed and approved as an active or inactive OTC ingredient by the Agency.

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Although CBD companies manufacturing, selling, and marketing CBD-infused OTC drug products should be able to mitigate the risk of enforcement actions by refraining from making any medical claims (expressed or implied) about their products, they should understand the heightened level of risk associated with engaging with this particular category of products, especially when combining CBD with a sunscreen product.

3. The FDA takes strong issue with CBD- and Delta-8-THC-infused foods that appeal to children. The companies subject to this round of enforcement all sold CBD- and Delta-8-THC-infused conventional foods, including products in forms that would be attractive to children, such as candies, gummies, and lollipops. This potential confusion is of great concern to the FDA as it fears children are at risk of unintentionally consuming CBD and of being victim of serious health issues, as demonstrated in the 2021 adverse event reports involving Delta-8 THC products.

4. The FDA expects companies to list CBD as an ingredient. In a few letters, the FDA expressly stated that it collected and analyzed samples of the products under investigation to test their CBD content and called these companies on their failure to list the substance as an ingredient on their labels. This is a reminder that even if the Agency deems the sale and marketing of these products unlawful under federal law, it nonetheless expects companies to comply with existing regulations, including listing all product ingredients on the label—Especially when dealing with food products that may easily be confused with conventional foods and result in consumers unwittingly ingesting CBD.

5. The FDA treats all cannabinoid-infused products as unlawful. Per usual, the FDA framed this latest of round of warning letters as enforcement actions against companies illegally selling products containing “CBD.” Yet, two of these letters, the Naturally Infused LLC and Newhere INC dba CBDFX letters, contain references to Delta-9 THC, cannabinol (CBN)- and cannabigerol (CBG)-infused products. Although the Agency does not directly address the legality of these cannabinoids (a missed opportunity if you ask me), its references to these substances seems to indicate that the Agency treats them as if they were CBD. This means that companies selling products infused with cannabinoids other than CBD should be wary of FDA scrutiny and refrain from making egregious medical claims about the therapeutic values of their products.

The safety concerns raised by the Agency in this latest round of warning letters suggest that it intends to make the sale and marketing of CBD products an enforcement priority. But more importantly, these letters continue to stress the need for Congress to enact legislation that will force the FDA to finally establish a regulatory pathway to govern CBD products intended for human and animal consumption. Ironically, by delaying its rulemaking process and by failing to implement meaningful reforms surrounding products infused with hemp-derived cannabinoids, the FDA has created the very problem it is pointing to in these letters.

nathalie bougenies headshotNathalie Bougenies focuses her practice on health and wellness, in addition to corporate transactions and regulatory compliance. For the past four years, Nathalie has helped clients navigate the complex regulatory landscape of hemp products intended for human consumption and advises domestic and international clients on the sale, distribution, marketing, labeling, and importation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s “Marketplace.” She also authors a weekly column for “Above the Law” that features content on cannabis policy and regulation. For four consecutive years, Nathalie has been named Rising Star by Super Lawyers.

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