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There is a scene in The Hunt for Red October where Captain Marko Ramius, wonderfully played by the late, great Sean Connery, says of an impending nuclear standoff: “We are once again playing our dangerous game, a game of chess against our old one Opponent – The American Navy. “We were reminded of that scene this week when the US Food and Drug Administration (FDA) issued warning letters to companies selling over-the-counter (OTC) pain relief drugs containing CBD. Affair between federal regulators and part of the hemp community as the legal boundaries of this mature industry are rigorously scrutinized. As in the movie, much is at stake. Unlike Hollywood, the FDA doesn’t see this as a game.
While the 2018 Farm Bill legalized the production of hemp at the federal level, hemp products intended for human or animal consumption are still subject to the Food, Drugs and Cosmetics Act (FDCA) and FDA and federal trade regulations Commission Act (FTCA) and Federal Trade Commission (FTC) regulations. Products containing CBD – including foods, tinctures, and oils – have been on the crosshairs of the FDA and FTC since April 2019 when these agencies issued three companies warning letters to three companies that use their CBD products to treat and cure a variety of diseases and conditions Market diseases. We discussed these letters in a previous blog post where we summarized key federal laws governing the labeling and advertising of CBD products and provided a list of marketing activities for CBD companies. Perhaps the biggest “not” is this – do not claim that a CBD product “can prevent, treat or cure a disease”. Such marketing results in a product being considered a “drug” under the FTCA and a CBD product without FDA approval cannot be marketed as a drug.
As of April 2019, some companies have continued to make improper health claims about their CBD products, and the FDA and FTC have issued dozens of similar warning letters, largely based on such improper claims that we discussed in the previous blog posts (here and here) . And the FDA is showing no signs of slowing down.
On March 22, 2021, the FDA issued two warning letters (available here and here) to companies that the FDA claimed were “illegal”[ly] Marketing … unapproved drugs that are labeled as containing CBD. “These companies were marketing OTC pain relievers that listed CBD as an inactive ingredient. The FDA determined that these listings were misnomer – “[a]Although CBD is listed as an inactive ingredient, the product labeling clearly depicts CBD as an active ingredient that is part of a medicinal product that is said to have pharmacological activity or other direct effects on the diagnosis, cure, alleviation, treatment or prevention of disease or structure or affect function of the body[.]The FDA also noted that CBD cannot be listed as an “inactive” ingredient for several reasons, including the fact that it “has known pharmacological activity with proven risks”.
There are some key takeaways from the FDA’s recent action:
- If anyone hoped that with the advent of the Biden government, the FDA would simply stop enforcing federal hemp policy, that hope should be dashed. Although President Joe Biden has not yet appointed a standing FDA commissioner – Dr. Janet Woodcock has been acting commissioner since January 20th – this latest development is a clear indication that the agency does not intend to stop overseeing the industry and CBD companies specifically.
- The game of cat and mouse continues. First, CBD companies marketed products by making health claims about the benefits of CBD. The FDA and the FTC intervened. Now, CBD companies are marketing products by making health claims but listing CBD as an inactive ingredient (wink). The FDA intervenes again. Make sure this pattern repeats itself as some CBD companies are testing the limits of FDA regulations and, perhaps more importantly, enforcement options.
- The warning letters also listed the robust FDA inspections sparked by these companies’ improper health claims and marketing, as well as the list of violations the FDA found during those inspections, including non-compliance by the current good manufacturing processes Companies. This portion of the letters serves as an important reminder that inadmissible health claims appear to be the focus of the FDA, but often serve as the tip of the spear. Just because the FDA initially considers a company’s health claims does not mean that the scope of the FDA investigation will be limited to that claim.