“FDA is late to the table on cannabis”: CSPI urges agency to act on regulating CBD

18 Jul 2019 --- The US Food and Drug Administration (FDA) needs to assert a more active role in regulating consumer health and safety with regard to cannabis use. This is according to comments filed by the Center for Science in the Public Interest (CSPI) to the agency. The consumer group notes that the decriminalization and legalization of cannabis occurring at the state level is producing a legal patchwork with inadequate policies and funding to protect consumers. Cannabinoids (CBD) and the risks they may pose are also poorly understood.

Despite patchy regulatory assertions, cannabis-derived products – most of which contain CBD – are found today in hundreds of supplements, foods and other products. Players from a range of backgrounds have been attracted to the platform, spanning food and beverage, pharmaceutical, personal care and even biotech. 

Now, the FDA is already late to the table and should try to figure out a plan and come up to speed, Laura MacCleery, Policy Director at CSPI, tells NutritionInsight.The FDA is already late to the table and should try to figure out a plan and come up to speed, says CSPI.

“We ask the FDA to take charge of cannabis products in the food space and to evaluate them for safety, applying the federal standard, and to create a long-term process for aligning state medical systems with the federal drug approval process over time,” she adds.

“This exploding marketplace for consumer goods is well out in front of federal law, which – despite its myriad of flaws – historically provides the most robust assurance of safety and quality in food and drugs,” notes MacCleery’s statement.

Her statement further describes that decriminalization addresses a host of problematic aspects of prohibition, including long-standing patterns of racial discrimination in the prosecution of marijuana-related criminal offenses. But current state legalization approaches, combined with lack of clarity over the federal role, fail to provide appropriate levels of consumer protections.

“It is critical that FDA assert its authority on behalf of consumers to ensure that products are safe, accurately labeled, and free of adulterants and contaminants, and that consumers are aware of relevant risks. To do so will require that the agency articulate a long-term program to gradually align the state laws that legalize these products with applicable federal health and safety protections, as we [CSPI] propose,” urges MacCleery.

In addition, the statement recommends that the FDA should take enforcement action on products that pose the greatest public health risks, including:

• Products that make health claims, especially for serious or life-threatening diseases, those with serious side effects, or that pose a hazard to vulnerable populations, including children and pregnant women.
• Products that appeal to children and youth.
• Products containing high doses of either CBD or THC, products with higher concentrations than labeled, CBD products not labeled for THC content but that contain THC; and products found to be mislabeled or contaminated.

CSPI’s comments outline a “comprehensive, multi-step plan for the FDA and Congress to, over time, align state and federal law, better protect children and vulnerable groups, and improve the safety and quality of cannabis products that may be sold.”

Where does the FDA stand on cannabis?
The FDA has made it clear that its stance on CBD is cautionary, but despite this, action has been slow.

In April, the agency said that it continued 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.” 

The FDA issued a set of warning letters – in conjunction with the Federal Trade Commission (FTC) – to companies reportedly doing so. The claims in question included CBD products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder and other serious diseases. The three companies were Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc, who advertise a range of supplements they say contain CBD, such as “Hemp Oil,” “CBD Softgels,” “Liquid Gold Gummies” and “CBD Oil.”

The agency also held a long-overdue public consultation on CBD on May 31. “While we have seen an explosion of interest in products containing cannabidiol (CBD), there is still much that we don’t know,” said Dr. Ned Sharpless, acting US Food and Drug Administration (FDA) Commissioner, at the May 31 hearing.

The consultation reportedly lasted over ten hours, and ended without reaching a consensus. However, one thing was agreed on: action needs to be taken – soon. But it is likely that this hearing will be just one in a lengthy process. This is undoubtedly infuriating for an industry that is ready to capitalize on this compound brimming with potential.

Aside from the hearing and cautionary letters, the agency also said that it would form a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. In addition, updates would be made to the FDA webpage with answers to frequently asked questions on this topic. 

A detailed article on the current CBD market opportunities for suppliers and ingredients companies will appear in the July/August issue of The World of Food Ingredients. 

By Laxmi Haigh