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FDA Warns 'CBD Has The Potential To Harm You'

Ben Yakas

Published Dec 2, 2019

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Ben Yakas

Published Dec 2, 2019

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Right before Thanksgiving break, the Food and Drug Administration (FDA) issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. They also updated their own guidelines for consumers outlining safety concerns about CBD products, based on what they say is a lack of scientific information currently available supporting the safety of CBD in food: "CBD has the potential to harm you, and harm can happen even before you become aware of it."

Despite the fact that CBD is legal on a federal level, the FDA made a ruling last December saying that it is "unlawful to add CBD to food or drink," which influenced policy on local levels around the country. This led to the Department of Health and Mental Hygiene in NYC announcing that it would begin ordering all restaurants and bars in the city to stop selling CBD-infused products—that CBD edibles ban went into effect in the city as of this summer.

CBD is one of more than 80 naturally occurring active compounds found in cannabis plants. But it lacks the psychoactive tetrahydrocannabinol, a.k.a. THC, the compound which gives weed its extra oomph. Since it doesn't get you high, the applications for CBD are seemingly limitless. Last year, the increasing popularity of CBD led to numerous local restaurants and bars embracing the trend and incorporating CBD products into their food and drinks. That included by Chloe, the fast-casual vegan restaurant and sweets purveyor, which launched its own CBD-infused product line of sugary confections (which has since ended), and Adriaen Block, a full-on CBD-focused cocktail bar and restaurant in Astoria. Bubby's also offered CBD sugar for your coffee.

Among the 15 companies who received warning letters recently was Bella Rose Labs, which operates out of Brooklyn.

The FDA said in its release that it is working to further clarify its regulatory approach for products containing cannabis and cannabis-derived compounds like CBD.

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

The FDA noted that there has been little testing of CBD so far outside of Epidiolex, a specific CBD drug that has been approved to be used for seizures. The FDA's revised Consumer Update contains a lot of speculative caveats about CBD's possible negative effects, including "potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood." They say that studies in animals have shown that CBD can "interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males." They add that questions also remain about "cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women."

Some say that the FDA has been too cautious in their approach toward CBD, and has engaged in scaremongering. Anecdotally, people claim it can help with a wide variety of maladies, from insomnia and anxiety to Crohn's disease and fibromyalgia. CBD has become the ultimate nexus point between the wellness industry, the burgeoning legal marijuana industry, and the alternative medicine community. And despite the edible crackdowns, local businesses have found loopholes so they wouldn't have to stop selling the product, like offering individual CBD products on the side for customers to mix into their drinks on their own. And it hasn't stopped companies like Mondelez, multinational snack conglomerate, from considering CBD Oreos.

Dr. Orrin Devinsky, director of the NYU Comprehensive Epilepsy Center, has been closely studying CBD for the last five years, and his research led to the seizure medication being approved. He told Gothamist that it's wise to be skeptical about CBD hype, but he has found that "there is a lot of additional data from animal studies and small human studies to suggest that CBD may have benefits for a variety of other disorders, from anxiety to autism to sleep induction for people who have insomnia, to sleep disorders and inflammatory disorders, so it has a very wide range of potential uses." You can read more about Devinsky's thoughts on CBD here.

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Ben Yakas

Ben Yakas is a former Gothamist reporter.

Gothamist is funded by sponsors and member donations

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