The FDA is relaxing its stance on CBD supplements, but due to select exceptions and what the agency is referring to as “enforcement discretion,” some companies continue to receive warning letters.
According to FDA commissioner Scott Gottlieb (who happens to be serving his last week as a government employee), there is one condition to the approval of CBD supplement sales, but this condition can cover a very broad spectrum of products and companies. “We’re using enforcement discretion right now,” said Gottlieb during a hearing before a subcommittee of the U.S. Senate Committee on Appropriations. “I will take enforcement action against CBD products that are on the market if manufacturers are making ‘over-the-line’ claims.”
Let’s consider what it means to make an “over-the-line” claim in this industry. Example: a company claiming that CBD can cure cancer or prevent Alzheimer’s would fall into this category, because it could mislead patients and cause them to abandon otherwise effective treatment, possibly putting them in life-threatening situations.
Gottlieb pointed out that the FDA has “a very high-level working group staffed by some of the most creative policy-makers to try to think through alternatives, including potential legislative alternatives.” Amy Abernethy, MD, PhD, and Principle Deputy Commissioner of Food and Drugs who previously worked as chief medical officer of Flatiron Health, oversees the working group.
The FDA is Already Sending Out Warning Letters
So far, three companies have received warning letters from the FDA this year for making uncorroborated claims about their products – PotNetwork Holdings in Florida, Nutra Pure in Washington state, and Advanced Spine and Pain in New Jersey. According to the FDA and the Federal Trade Commission, the companies in question were “making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites.”
Additionally, Gottlieb expressed concern regarding the recent revelation that major U.S. pharmacies, such as CVS and Walgreens, will begin selling CBD products in the near future (check back with us for an updated report on that as well). He mentioned on Twitter that “the agency will be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.”
Keep in mind that these warning letters are nothing new and the FDA has been orbiting this issue for many years now. However, they’ve been under pressure to create regulatory framework for the distribution of CBD products, so it’s to be expected that more companies will continue receiving letters of this nature.
FDA CBD Regulations: Takeaway
Basically, if you’re selling a CBD product – especially a supplement – make sure you’re not making any promises that you can’t back up 100 percent. If the medical claim hasn’t been studied and approved by the FDA then it’s an illegal claim to make. While it may seem like a bit of government overreach, it ultimately boils down the safety of patients/consumers, who rely on the company to keep things honest and on the level. It does complicate things for many businesses though, considering that the FDA has not completed very much research in this field.