On Tuesday, the FDA and FTC issued another joint Warning Letter to a company for selling and marketing “unapproved new drugs” containing CBD in violation of federal law. Not surprisingly, the letter cites numerous disease claims included in the marketing of these products (e.g., statements related to the treatment of Parkinson’s and Alzheimer’s Disease, depression, anxiety, PTSD, cancer, diabetes, ADHD, pain/inflammation, etc.).
Consistent with any prior Warning Letters issued by the FDA/FTC for similar violations, the agencies explain in the letter that introducing or delivering such “unapproved new drugs” into interstate commerce violates the Food, Drug & Cosmetic Act (“FD&C Act”). 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) 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.”
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 the most recent letter, the FDA and FTC emphasize their concern with marketing such products for use in infants and children. As evidenced by the citations in the letter, this company had included express representations on its website as to the products’ efficacy in children (e.g., “Children can use high amounts of CBD safely and without any risk.”)
Notably, nearly all of the claims cited are referenced as being located on product website pages or social media forums. 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 or hemp 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.
If you are unsure whether any statements in your product labeling or website content violates any of the above rules, 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.