Despite the impending Thanksgiving holiday, the U.S. Food and Drug Administration (“FDA”) kept plenty busy this week in keeping the hemp industry on its toes issuing: (a) yet another round of a whopping fifteen (15) warning letters to companies purportedly marketing “unapproved new drugs” containing hemp-derived cannabidiol (“CBD”) in violation of FDA regulations; and (b) a long-awaited update concerning FDA’s perspective on cannabis-derived compounds, including products containing hemp-derived CBD.
In sum, the warning letters should not come as a surprise, as FDA continues to target impermissible disease claims, but FDA’s newest “update” serves to compel the hemp industry to action in a variety of ways, namely, in seeking legislative and regulatory clarity and in compiling and producing additional data in support of its products.
I. Yet Another Round of Warning Letters
Since 2015, accounting for this week’s 15 warning letters, FDA has collectively issued nearly 70 warning letters to manufacturers of hemp-derived CBD products. Not surprisingly, these newest FDA warning letters cite numerous disease claims included in the marketing of these products for human and animal use (e.g., statements related to treatment of Parkinson’s and Alzheimer’s Disease, Schizophrenia, Autism, depression, stress/anxiety, PTSD, cancer, diabetes, ADHD, chronic pain/inflammation, etc.).[GG1]
Consistent with any prior warning letters issued by the FDA for similar violations (as well as those issued by FDA’s sister agency, the Federal Trade Commission (“FTC”)), FDA explains in its letters that introducing or delivering such “unapproved new drugs” into interstate commerce violates the Food, Drug & Cosmetic Act (“FD&C Act”), in FDA’s eyes. Of course, it is well-established that when a manufacturer or distributor of consumable products represents to the public that the product (regardless of ingredients, such as CBD, calcium or vitamin C) is intended to be used in the treatment, prevention, cure, mitigation or diagnosis of disease, these statements will establish the product’s “intended use” as a “drug.” For this reason, FDA’s targeting of companies who purportedly continue to make these claims should come as no surprise.
Accordingly, if that product has not been pre-approved by FDA as a “new drug,” the product is then considered an “unapproved new drug” distributed in violation of federal law.
In five of the most recent letters, the FDA and FTC emphasized their concerns with marketing such products for use in infants and children. As evidenced by the citations in the letters, these companies had included express representations on their website as to the products’ efficacy in children suffering from seizures and Autism, while another company recommended parents give CBD “as a treat to your kid[.]” (These concerns follow an October 2019 warning letter concerning the blatant statement, “Children can use high amounts of CBD safely and without any risk.”)[HM2]
Notably, nearly all of the claims cited are referenced as being located on product website pages and social media forums, however the FDA and FTC have also reviewed published customer testimonials. As FDA views a firm’s website, social media content, marketing materials, flyers, etc., collectively as the “labeling” of the products, manufacturers and distributors of products regulated by FDA must understand that federal regulations governing the labeling of these products cannot be avoided by placing statements on the website or social media only (i.e., without making claims on the physical product label).
Nothing in this letter should be construed as the FDA saying anything “new” about CBD products to the hemp industry. As we have known since the birth of the industry, and well before that, marketing a product that has not been approved by the FDA with any disease claims (express or implied) means the product is an “unapproved new drug” under the law. This is true regardless of the presence of CBD or any other ingredient(s). Making any disease claims about non-FDA-approved products subjects you to the possibility of FDA/FTC determining that your products are “unapproved new drugs” distributed in violation of the FD&C Act.
In addition to the possibility of facing consequences enforced by FDA/FTC, another legitimate concern is the potential for becoming the target of plaintiffs’ lawsuits under state consumer protection statutes. FDA and FTC certainly have the power and ability to enforce “unapproved drug” violations, but consumers also have the power to bring lawsuits based on products marketed with “drug” claims under consumer protection laws.
If you are marketing hemp-derived products: (1) as potentially treating diseases or health conditions; (2) as potentially mitigating the symptoms associated with diseases or health conditions, even without references to specific diseases; or (3) with any other statement that may be construed as an implied “disease” claim about your products, you run the risk of FDA/FTC intervention and/or being the subject of a civil lawsuit.
II. FDA Shines New Spotlight on Safety of CBD
In May 2019, FDA convened a public hearing, soliciting public input concerning cannabis-derived compounds in light of the 2018 Farm Bill with respect to hemp, along with other policy shifts concerning cannabis generally. In the months since, FDA had promised an “update” later in 2019 concerning its evaluation of CBD and other cannabis-derived compounds; it seems FDA also took this holiday week as the opportunity to publish such an “update.”
Corresponding with the freshly published warning letters, FDA is now also citing a new concern
over the safety of CBD. Citing data made available through pharmaceutical trials, FDA notes the potential of several potential conditions, side effects and other related concerns. Certainly, it is important to contextualize FDA’s concerns, as such are rooted on limited data, much of which is conducted through pharmaceutical research of high potencies/dosages, which do not perhaps compare to many product types widespread in the hemp industry. At the same time, FDA’s publications of its concerns present an opportunity for the hemp industry and public to collaboratively compile and present data which satisfies FDA’s solicitation for such data and positively supports the conclusion that hemp-derived CBD products are safe.
If you are unsure whether any statements in your product labeling or website content violates any of the above rules or have questions concerning FDA’s recent statements on hemp-derived CBD products, please contact us. We can assist you in determining how these agencies will likely interpret any statements made about your products. We can also review your materials for general regulatory compliance issues to ensure the labeling and marketing complies with all applicable laws.
by Hoban Law Team