On July 22, 2019, the Food and Drug Administration (“FDA”) released its fourth warning letter for cannabidiol (“CBD”) related products since the enactment of the 2018 Federal Farm Bill in December. Though not a formal action or rule-making by the FDA, understanding FDA warning letters is crucial guidance for processors and retailers that are selling hemp and hemp-derived cannabis products commercially in an emerging industry where the legal guidance is rapidly changing.
In the warning letter to Curaleaf, Inc., the FDA scrutinized Curaleaf’s CBD Lotion, CBD Pain Relief Patch, and numerous versions of its CBD Tincture, CBD Disposable Vape Pen, and Bido CBD for Pets and how these products are both marketed and communicated to consumers on Curaleaf’s website, social media pages (i.e. Facebook, Twitter, etc.) and labels. Consistent with prior FDA guidance and warning letters to other cannabis product companies, the FDA determined, in part, that Curaleaf’s products sold in interstate commerce are unlawful unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (the “FDCA”).
Unapproved New Human Drugs. First, the FDA concluded that Curaleaf’s CBD Lotion, CBD Pain-Relief Patch, CBD Tincture, and CBD Disposable Vape Pen, are unapproved new drugs (which may not be sold without FDA approval) because (1) “they are intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure function or any function of the body,” and (2) they are not generally recognized as safe and effective for their intended use.
What does this mean for processors and retailers of hemp and hemp-derived products? The FDA is not primarily concerned with the ingredients of the products themselves, but instead, focused on the intended purpose of each product. For example, among many others, the FDA identifies the following claims that Curaleaf makes about the intended purpose of its products to its consumers on its website and social media accounts:
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“[S]oothing tincture for chronic pain.”
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“How to Use CBD Oil for Anxiety”
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“CBD has also been shown to be effective in treating Parkinson’s disease.”
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“CBD has been linked to the effective treatment of Alzheimer’s disease...”
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“CBD was effective in killing human breast cancer cells.”
Unapproved New Animal Drugs. The FDA also determined that Curaleaf’s Bido CBD for Pets is an unapproved new animal drug because the products “are intended for use in the mitigation, treatment, or prevention of diseases in animals.” The FDA arrived at this conclusion by reviewing Curaleaf’s claims about Bido CBD for Pets intended purposes. For example, among many others, Curaleaf claimed that Bido CBD for Pets “decrease[s] compulsive behavior like biting, scratching, chewing, whining, eliminating, and other symptoms of dog separation anxiety.” Based on its review of these claims, the FDA concluded that these products are unsafe and adulterated; because to be legally marketed to consumers, Curaleaf must have an approved or conditionally approved new drug application or be indexed under the FDCA.
Misbranded. The FDA also determined that Curaleaf’s products were misbranded because their labels did not adequately bear directions for their use. Under the FDCA, products must bear “adequate directions for use” which requires each product to bear directions for which a layperson can understand how to use the product and the purposes for which it is intended. Conditions such as cancer, Alzheimer’s, anxiety, depression, chronic pain, etc., are not amenable conditions capable of self-diagnosis and cannot be treated by laypersons who are not trained medical professionals.
The FDA further determined that Curaleaf unlawfully and incorrectly marketed its products as dietary supplements. For example, the label on Curaleaf’s CBD Lotion and CBD Pain-Relief Patch indicated that they are to be applied transdermally to the body and its CBD Vapes are for inhalation. This is the first time that the FDA has addressed transdermal patches in its review of consumer products containing CBD. However, the FDA’s position is consistent with other transdermally applied products. Under the FDCA, a dietary supplement is a product which is solely “intended for ingestion.” As such, products which are not solely intended for ingestion (e.g. topical use or ingestion and topical use) are not dietary supplements and thus, cannot be marketed as a dietary supplement.
Whether your product is ingestible, topical or both, it is important to note that simply not marketing the product as a dietary supplement and instead as a cosmetic or otherwise does not eliminate the risk of scrutiny by the FDA. Since the enactment of the 2018 Federal Farm Bill, the FDA has been steadfast in its conclusion that products containing CBD are excluded from the meaning of dietary supplements because CBD is an active ingredient in an FDA approved drug, Epidiolex, and CBD was not marketed as a dietary supplement or food prior to the new drug investigation.
What are the takeways from this FDA warning letter? First, this summary only addresses a few of the many determinations made in this warning letter and the many other warning letters by the FDA over the years with respect to cannabis and cannabis-derived products. Second, this warning letter is the first since the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds held on May 31, 2019, indicating that the FDA maintains its consistent position on cannabis and cannabis-derived products containing CBD. Third, while these warning letters are not formal or final action, they are an example of the FDA applying facts (consumer products and information) to the FDCA, which is law. Finally, understanding FDA, FTC and various other federal and state laws and navigating how these laws apply to the hemp industry is crucially important to operating in this industry. Businesses and entrepreneurs should seek legal advice before marketing products and actively review how and what products they market to consumers.
