On April 2, 2019, the U.S. Food and Drug Administration issued a public hearing notice and a press release from the Commissioner to announce FDA’s interest in hearing from cannabis-industry stakeholders on the “safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” The hearing is set for May 31, 2019.
While FDA and Congress are moving forward on a number of fronts on issues related to cannabis and related products, including the passage of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), which approved the broad-based cultivation of hemp (formerly a Controlled Substance) and allows the transfer of hemp-derived products across states lines, companies producing and marketing cannabidiol (CBD) products must still toe the line regarding representations regarding CBD products and unauthorized medical claims. It remains against the law to place food or beverages containing CBD or THC into interstate commerce or to market them as dietary supplements, primarily (but not solely) because both CBD and THC are either active ingredients in approved drugs (Epidiolex – a CBD based oral solution used in the treatment of severe forms of epilepsy) or in drugs that are currently under study in an Investigative New Drug Application.
Under the current rules, it remains unlawful to market any food or dietary supplements containing CBD, let alone make specific claims regarding CBDs effectiveness in treating diseases such as cancer or Alzheimer’s. In fact, several companies have recently received joint warning letters from FDA and the Federal Trade Commission (FTC), which oversees instances of unsubstantiated advertising claims related to medical efficacy, that are alleged to have made unfounded and unproven medical claims about the CBD-related products that they offer for sale. These products included food, supplements, oils and salves. The FDA and FTC have requested responses from the companies receiving warning letters stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.
The federal legalization of hemp production did not alter in any way, shape or form the “old” restrictions around the sale and marketing of CBD or THC products. Unless and until Congress and FDA change the laws and enact new rules – hence the May 31 hearing and the creation of a corresponding FDA “working group” to study the issues – the regulatory scheme remains the same and FDA will take action against companies that market such products and make claims as to their efficacy in the treatment of disease. Producers and sellers of CBD products should not interpret the legalization of hemp as a signal that FDA is ready to pull back from oversight or enforcement of existing regulation of non-hemp products. Per FDA Commissioner Scott Gotlieb, “We’ll continue to use our authorities to take action against companies illegally selling these types of products when they are putting consumers at risk.”
The FisherBroyles Pharmacy and Health Care Law team is pleased to keep you updated on events of interest to those in the healthcare and pharmaceutical industries. Questions regarding the subject matter of this alert may be directed to any of the following attorneys:
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