FDA Issues Warning Letters Over CBD Claims

The Food and Drug Administration announced today that they have issued warning letters to four cannabidiol companies — including the popular Stanley Brothers — over the health claims the companies were making about their products.

The Stanley Brothers Social Enterprises LLC found themselves alongside three other companies who were issued warnings on Oct. 31 around claims made on more than 25 different products, and thanks to Dr. Sanjay Gupta, the Stanley Brothers are definitely the biggest names of the bunch.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” said FDA Commissioner Scott Gottlieb, M.D. said in a statement on the letters being distributed. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products.”

Gottlieb stressed the importance of caregivers and patients getting the right information and said that cannabis companies should go through the formal drug approval process. “We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market,” he said.

This move from the FDA is not unexpected. The FDA has issued similar letters of warning to CBD companies last year, and Gottlieb hinted in a Congressional hearing earlier this month that he was considering whether or not the FDA had a responsibility to step in and stop these false health claims.

In the letter, reported on first early today by Marijuana Moment, the FDA told Joel Stanley that the claims made by Stanley Brothers Social Enterprises put them in violation of the Federal Food, Drug, and Cosmetic Act. This is because the Stanley Brothers said that their products were intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because the products are intended to affect the structure or any function of the body.

The FDA also took issue with the fact that the Stanley Brothers attempted to label a cannabidiol product as a dietary supplement, which the FDA said “is not the case for CBD.”

According to the letter, Stanley Brothers’ had testimonials on their website that made claims such as: “A patient of mine uses this for Cancer and it gives lots better relief than prescription drugs!” and “My dear ex mother in law has been diagnosed with late stage pancreatic cancer. This is the only thing that gives her relief.”

The next strike against Stanley Brothers was that they provided condition-specific dosing regimes on the company’s cancer dosing guidelines, including recommending 50 mg of CBD twice daily for adult cancer patients and 25 mg of CBD twice daily for child cancer patients.

The FDA letter also revealed that the department monitored the company’s social media posts for misleading claims. In one post from June 28 last year, when the mother of an autistic 17-year-old asked where to get a recommendation so she could purchase products from the CW Hemp Line, CW replied she wouldn’t need to worry about the doctor and provided a link to where she could make the purchase.

Frank Robison, a senior associate working on hemp and CBD law at Vicente Sederberg LLC, said that it doesn’t matter whether or not CBD is harmful to those who are taking it.

“Drug approval requires an extensive process involving collecting clinical and non-clinical data regarding its proposed use and submitting it for review,” said Robison, in an email to Cannabis Now. “While we personally agree CBD is benign, at worst, and, in fact, beneficial on many important levels, benign substances are treated no differently than any other substance when it comes to making medical or therapeutic claims. This would include a substances as simple as vitamins or eucalyptus or mint leaves for tea.”

The Stanleys have 15 working days to fix the problems and then must inform the FDA’s Director of Pharmaceutical Quality Operations of the specific steps they have taken to correct the violations. They also must include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

In a cannabis world scared of handcuffs, many had always wondered how these kinds of claims have lasted this long.

Longtime cannabis researcher Dr. Amanda Reiman said there have been rules in place about the standard of evidence needed to make a medical claim, such as the claims made by these CBD companies, for years.

“These standards are important, especially given the U.S.’s history of ‘snake oil’ medicines,” Dr. Reiman said.

“Now that cannabis is moving into a regulated framework, these same rules apply and cannabis companies should not contribute to the doubts about cannabis as medicine by making unsubstantiated medical claims,” said Dr. Reiman. “It hurts the validity of the entire industry.”

Reiman went on to emphasize that, until cannabis is moved out of Schedule I and allowed to enjoy the same medical development pathway as other medications, “the FDA is holding the industry to a standard it is not able to meet because of the FDA’s own rules on what constitutes a medicine and what path must be taken to advertise it as such.”

Morgan Fox of the Marijuana Policy Project says the FDA action just further proves the complexity of the developing cannabis industry.

“People trying to get into the marijuana industry should consult independent legal counsel at every stage of the process, and maybe get a second opinion as well,” said Fox. “If something seems too good to be true, it probably is. Failing to fully explore all the legal ramifications of selling a cannabinoid product puts them at serious risk.”

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