Rebuke: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

PRESS RELEASE

WASHINGTON–(BUSINESS WIRE)–In response to an alert from the U.S. Food and Drug Administration (FDA), “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” and a news release, “FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns,” published online Nov. 25, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement and functional food industry, issued the following statement.

Statement by Steve Mister, president & CEO, CRN:

“Yesterday evening, FDA unnecessarily alarmed consumers with a headline-grabbing announcement on the potential health risks of CBD-containing products consumed by over 20 million Americans without any plan to address it. Meanwhile it abdicates its regulatory oversight for the subset of these products that do pose risks to consumers because they are poorly made, improperly labeled or illegally deliver THC. FDA’s inaction for the past year has facilitated an unregulated marketplace—which is bad for consumers and bad for business. It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements.

FDA’s announcement raises legitimate questions about the safety of CBD, questions that CRN and its members take very seriously. But the agency’s actions to date have not advanced that cause:

• FDA invokes potential adverse effects from CBD, but does not distinguish between the high doses delivered in the approved prescription drug, and supplement levels. It is worth noting the CBD prescription drug Epidiolex uses daily doses that could be as high as 1,500 mg; many supplement products in the market provide suggested daily doses of 50 mg/day or less. As with most substances, the dose makes the poison, and publicly-available data, including a report from the World Health Organization indicates CBD is generally well tolerated and has a good safety profile.
• FDA’s announcement acknowledges the presence of CBD-containing products that are in serious violation of general dietary supplement regulations—products that include appreciable levels of the psychoactive compound THC; ones whose CBD content does not come close to matching the labeled amounts; and still others that contain unsafe levels of pesticides, heavy metals or other contaminants. Third-party analyses by watchdog groups confirm these concerns. FDA has the authority to mandate recalls, to begin seizures of potentially harmful products, and to issue injunctions, but instead, the agency is choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode.
• FDA has the opportunity to receive meaningful safety data in the context of new dietary ingredient notifications and GRAS submissions from responsible companies in the industry. Yet while FDA broadly declares CBD to be an illegal ingredient—despite the express statutory discretion to change that status—the agency declines the opportunity to create incentives for that research or to give this data assurances of confidentiality that drug submissions are accorded. FDA continues to call on industry to produce safety research for the public docket but to dismiss NDI notifications and GRAS declarations for CBD.
• The agency has repeatedly said CBD must be treated like any other ingredient, but it has refused to do just that. While FDA spins its own warning to consumers as prudent and taken out of an abundance of caution, it ignores products marketed as food, dietary supplements, and cosmetics that disregard basic requirements for all of these regulatory categories and create their own safety risks.

It is not too late for FDA to do the right thing: it should explicitly open the dietary supplement lane to CBD and be the ‘cop on the beat’ enforcing the whole range of dietary supplement laws and regulations against those products.

The FDA’s continued failure to take this action, while raising consumer alarm over the entire market, requires that Congress get involved to direct the regulator to open the supplement lane to CBD and to police these products with the ample enforcement tools at its disposal.

Responsible companies marketing CBD in dietary supplements already comply with the law— which means that they hold data justifying their own evaluations that their products are safe, that they follow good manufacturing practices, that they register their facilities, and that they have a serious adverse event reporting system in place. These responsible companies have been unfairly maligned by FDA’s overbroad warnings on safety, and ironically, are actually deterred from sharing the safety data they have with the agency.

In the absence of an effective regulator, consumers can turn to organizations such as the Council for Responsible Nutrition to help them distinguish responsible supplement companies from those who may or may not be. CRN is proud of its members—both pure play CBD manufacturers and legacy manufacturers of other supplements who have added CBD to their product lines—and holds them out to the public as companies who can be trusted to make consumer safety a top priority. CRN recommends that consumers interested in CBD talk with their doctor or other healthcare practitioner about the potential benefits and safety concerns. If CBD is a smart choice for their wellness needs, consumers should choose a responsible CBD company with which to partner on their health.”

Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn.

Contact:

Holly Vogtman, 202-204-7665