FDA Warns Fifteen Companies, Including One in Colorado, About CBD Claims

The Food and Drug Administration flexed its regulatory muscle on Monday, November 25, sending warning letters to fifteen American CBD companies that might be getting too bold. One is a Colorado outfit: Infinite CBD in Lakewood.

While FDA employees acknowledge that their agency doesn't have the resources to shut down a thriving CBD market, it can slow things down by sending such letters. The warnings issued yesterday cautioned the companies that they are "illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act," according to the FDA.

These violations typically stem from claims made by the companies on their packaging or in advertisements.

"The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act," the warning continued. "Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement."

Cannabidol, or CBD, is a non-intoxicating cannabinoid derived from marijuana or industrial hemp, which was legalized federally at the end of last year. However, hemp's legalization didn't extend to CBD meant for human consumption (topicals, lotions and non-consumables are legal), because of its connection to marijuana. Despite the federal prohibition, hemp-derived CBD oils, vaporizer products, edibles and more consumable products are sold around the country at retail outlets and online, and the majority of them receive little regulatory oversight.

The FDA is currently collecting consumer and stakeholder feedback regarding future CBD regulations, and will hold a public hearing on the topic later this year.

To remind the industry that CBD still isn't legal, the FDA sends these warnings to high-profile or reckless companies from time to time, according to the agency, but will typically hold off on legal enforcement action if the companies change their claims or marketing to comply with FDA standards.

“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,” says FDA deputy commissioner Dr. Amy Abernethy in a statement about the warning letters.

"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," she continues. "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.”

In a response to Westword's inquiry about the FDA warning, Infinite CBD called the FDA's actions "frustrating," but adds it will work with the agency to correct and possible mistake.

"Receiving a warning letter from the FDA on Monday was very frustrating to us as a company. However, the FDA’s top priority is to provide safe CBD products to the market. This priority is something that we can agree on. Please rest assured that We are working with our legal team to resolve the concerns within the FDA Warning letter and we will make sure that the content and products that we continue to produce are of quality standards that Infinite CBD stands behind," the company says in a statement.

Infinite CBD is not the first Colorado company to hear from the FDA. The founders of Charlotte’s Web Holdings Inc., creators of the Charlotte's Web strain and CW Hemp products, received a similar warning letter from the FDA in 2017. Yesterday, the same day the FDA announced its new round of warnings, BizWest reported that Charlotte's Web Holdings had raised over $66 million in a public stock offering.

Update: This story was updated on November 27 to include Infinite CBD's response to the FDA warning.