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Be Conservative with CBD Claims or Risk Getting A Warning Letter from the FDA

Written by Derek Johnson

Cannabidiol (CBD) is so popular that it can practically sell itself. That said, any establishment in the business of selling CBD still needs a comprehensive strategy for promoting their products, one that is not only effective but is also within the bounds of the law. Since the 2018 Farm Bill legalized hemp and its derivatives, including CBD, many businesses have had problems with legal issues surrounding the advertisement of their products and have received warning letters from the Food and Drug Administration (FDA). Fortunately, there are ways for businesses to help ensure their marketing activities stay within the law and regulations outlined by the FDA.

A large number of the letters issued over the past few years were sent to businesses that made illegal claims that their CBD products could be used to “prevent, diagnose, mitigate, treat or cure various diseases.” Doing so is in direct violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). If a company wishes to make such claims, its product “must be approved by the FDA or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review, before they can be legally marketed as drugs”. And CBD is not under OTC review. A company may also receive a warning letter if they sell an unapproved OTC drug that has CBD listed as an inactive ingredient.

This prohibition on advertising CBD as medicine not only applies to products intended for human use but those for animal consumption as well. Additionally, CBD is not approved as a food additive nor is it approved as a dietary supplement.

When a company receives a warning letter, it has 15 working days to respond to the FDA demonstrating that the legal issue has been dealt with or respond with an argument as to why its product does not violate the law.

The FDA is keeping a close watch on CBD products and is currently developing comprehensive regulations and guidelines for its production, marketing, and sale. CBD companies must closely follow FDA developments to stay on the right side of the law. Therefore, businesses should retain legal counsel to make sure their actions are in full compliance with the FDA. Doing so will save time, money, and effort, and help ensure these businesses have a bright future in the evolving CBD market.

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About the author

Derek Johnson