April 2, 2019
Editor's note: This story was updated April 3 with comments from one of the companies that received a warning letter.
Three companies marketing CBD (cannabidiol) in their products have landed on the radar of U.S. regulators.
In letters dated March 28, government officials alleged the companies made claims about their products’ ability to treat cancer and other serious diseases without adequate evidence and drug approval from FDA.
Among some of the claims targeted by FDA and FTC officials:
“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
“CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.”
“For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
“I believe these are egregious, over-the-line claims, and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” Scott Gottlieb, M.D., the outgoing commissioner of FDA, said Tuesday in a statement. “The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today.”
The letters advised the companies that their products are unapproved new and misbranded drugs. FTC, which regulates advertising claims, also raised concerns that their statements are not adequately supported with "competent and reliable scientific evidence."
Commenting on the alleged violations of the Federal Food, Drug & Cosmetic Act, the letters instructed the companies to promptly come into compliance with the law and cautioned, "Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction."
FDA and FTC officials addressed the letters to Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc.
A spokesperson for Nutra Pure said the company has removed the sentences that triggered FDA’s concerns.
“In our case, the FDA raised concerns about a few sentences from some of our internal pages that were deeper analyses of published independent studies,” the spokesperson said in an email. “These weren't from customer-facing marketing pages, so we kept the citations to the NIH, JAMA, and similar clinical studies on those pages, but removed the commentary and quotes from the studies.”
In the warning letter to Nutra Pure, the agency reiterated its long-held position that CBD is excluded from the definition of a dietary supplement. According to FDA, Nutra Pure’s website, www.cbdpure.com, markets “Hemp Oil” and “CBD Softgels” as dietary supplements.
FDA also referenced claims on the company’s website that it said established the use of the products as drugs. For instance, the warning letter quoted a statement on a webpage titled “CBD: Alzheimer’s” that asserted, “Science also shows that CBD has anti-emetic, anti-convulsive, anti-inflammatory and analgesic properties. Because all of these come into play with Alzheimer’s, particularly brain inflammation, CBD is a viable option for minimizing these effects within the brain.”
Although Nutra Pure takes “full responsibility for the challenged language,” the claims were not part of e-commerce pages or marketing materials distributed to the company’s broader base of customers, the spokesperson said in the email.
“With many CBD-related related companies making over-the-top health claims or neglecting to cite the actual published research on CBD and its limitations, we welcome more regulatory oversight and review in this fast-growing CBD market,” the email added.
Relievus and PotNetwork Holdings Inc. did not immediately respond to INSIDER’s requests for comment.
FDA has asserted CBD can’t be added to food or sold in dietary supplements, but hundreds of hemp-based CBD products are nonetheless being marketed today in the United States. Last week on Capitol Hill, Gottlieb told lawmakers his agency is using its “enforcement discretion” to target products containing CBD. For example, he cited claims to cure cancer or prevent Alzheimer’s disease.
“Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk,” Gottlieb said Tuesday in his statement. “These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. Additionally, because they are not evaluated by the FDA, there may be other ingredients that are not disclosed, which may be harmful.”
Since 2015, FDA has sent warning letters to marketers of CBD—largely over claims that their products treat diseases. Some of the letters also noted amounts of CBD declared on the labels were inconsistent with testing results.
At the same time FDA is exercising its “enforcement discretion" when it comes to CBD products, the agency is examining possible regulatory pathways that would allow the compound to be lawfully sold in a conventional food or supplement. FDA on Tuesday announced a public hearing on May 31 to explore the above issues.
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