FDA warning about unsubstantiated CBD claims

FDA warning about unsubstantiated CBD claims

At the pace of growth the CBD industry is currently undergoing – forecasts estimate the industry will reach $22 billion by 2022 – you can certainly expect a few regulatory hiccups along the way. On April 2, the FDA and FTC issued warning letters to three supplement companies1 about unsubstantiated health claims made by the companies on their websites and in other promotional materials. The letters cite “unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”

The landmark Agriculture Improvement Act of 2018, also known as the 2018 Farm Bill, a mere five months old at the time of this writing, created a new category of cannabis and extremely low-THC cannabis extracts. Designated as “hemp”, the new category includes all cannabis strains and cannabis extracts containing less than 0.3 percent THC.  The Farm Bill’s historic accomplishment is also due, in no small measure, to the fact that it removed hemp from the controlled substances list.

However, the 2018 Farm Bill explicitly retains the FDA’s authority to regulate hemp under both the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Under these directives, the FDA is obligated to enforce existing regulations.

Specifically, the FDA warning letter emphasizes the following two regulations:

  • Where marketing claims for cannabis-derived or hemp-derived products include therapeutic benefits those benefits must be expressly approved for such use by the FDA.
  • Food to which CBD or THC has been added cannot be marketed as a dietary supplement.

The FTC echoes these sentiments, as reported in Market Watch2, which reports that the director of the FTC’s Advertising Practices Division, Mary Engle claims that the FTC was “always concerned about advertising claims affecting consumers’ health or safety, and is particularly concerned about products purporting to treat serious diseases such as Alzheimer’s and cancer. Regardless of the type of product, marketers must have solid science to back up their claims that a product can improve people’s health. Under FTC law, CBD products are no different.”

Certain unresolved health and safety issues also underscore the need for caution, according to the FDA commissioner. One such issue is a known potential for liver damage resulting from consumption of therapeutic doses of CBD. This adverse effect has been reported in association with an FDA-approved CBD drug for seizure disorders. Additionally, a wide range of CBD-enhanced products and CBD delivery forms creates the potential for unintended excessive exposure and/or cumulative adverse effects of CBD through consumers accessing multiple types of products concurrently.

FDA warning about unsubstantiated CBD claims 

A Regulatory Balancing Act

Another piece of the puzzle facing the FDA as it seeks to regulate hemp and CBD products stems from the fact that both CBD and THC are active ingredients in several drug products currently on the market. Moreover, these drugs were approved prior to the 2018 Farm Bill. Thus, the FDA is tasked with balancing the competing interests of pharmaceutical companies on one hand, and food and nutritional supplement manufacturers on the other.

The agency is concerned that, with hemp no longer a controlled substance, the increased availability of CBD and other hemp-derived products may disincentivize drug developers or that it could lead patients to use CBD inappropriately or as a substitute for medical care.

 

Public Input

To address these concerns and to help ensure fair and appropriate policy development going forward, the FDA will be holding a public hearing3 on May 31st   at which all interested parties will be invited to submit public comment on safety issues surrounding CBD. In particular, the agency will be seeking input about what levels of CBD and other cannabis-derived products lead to safety concerns, the relative safety considerations and levels for each delivery methods, and any potential interactions of CBD and other cannabis-derived products with drugs or other substances.

One of the goals of the hearing will be to find ways to help companies that market CBD avoid warnings and/or punitive actions by establishing acceptable rules for marketing that are more “predictable and efficient.”

Following the hearing the FDA will form an internal working group to continue the conversation started at the May31st meeting and to facilitate procedures for enacting legal and/or regulatory changes deemed necessary to accomplish agreed upon goals. Additionally, the FDA has committed itself to keeping the public informed with up-to-date information on this rapidly developing topic by maintaining timely updates on its website.

As a CBD industry pioneer, you can help shape public policy. The May 31st public hearing announcement can be found here4. Those who wish to attend in person, make a presentation, or provide oral comments must register by May 10th. A webcast will also be available to registrants.

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References:

  1. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-steps-advance-agencys-continued-evaluation
  2. https://www.marketwatch.com/story/government-warns-companies-to-stop-making-unsubstantiated-claims-about-cbd-2019-04-04?mod=mw_theo_homepage
  3. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/scientific-data-and-information-about-products-cont aining-cannabis-or-cannabis-derived-compounds
  4. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/scientific-data-and-information-about-products-containing-cannabis-or-cannabis-derived-compounds