Consumer interest and public health groups are urging federal agencies to proceed with caution on regulating cannabidiol (CBD) in dietary supplements and food.
Consumer Reports, the Center for Science in the Public Interest, the Public Health Institute and the Consumer Federation of America recently sent a letter to Congress urging it “to reject any attempts to force federal regulators to immediately legalize” CBD.
The groups assert that Congress should not “place undue political pressure” on the U.S. Food and Drug Administration’s (FDA) process in regulating CBD. Rather, the letter says, Congress should provide the FDA with the resources and authority it needs to do so, noting that the FDA’s priorities have temporarily shifted because of COVID-19.
“Forcing the FDA into rushed decisions and to prematurely implement major regulatory changes would result in an unsafe CBD market and distract the FDA from its current pandemic response and recovery efforts,” the letter says.
The groups say much is still unknown about CBD, especially on vulnerable populations, such as children.
Because CBD was the subject of a new drug application, it is currently illegal to include in other products under the Federal Food, Drug and Cosmetic Act (FD&C Act). CBD could be included in products if the FDA waived that provision of the FD&C Act for the cannabinoid, but only after a lengthy process.
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“As a practical matter, development of such a waiver would require the FDA to develop a concrete, public-facing program to address each category of cannabis product within its jurisdiction, to take steps to specifically mitigate their risks, and to enforce standards that, over time, bring conflicting state and local programs into alignment with applicable federal laws supporting consumer health and safety,” the letter says. “Any bill or legislative language that would short-circuit this process by pressuring the agency to rapidly issue an enforcement discretion policy is ill-advised.”
Suggested Improvements
In their letter, the organizations suggest numerous improvements Congress can help make within the FDA.
For regulating food, those include:
Encouraging the FDA to request scientific evidence that CBD is safe for uses in food at particular doses.
Updating the FDA’s procedures used to determine whether new food additives are toxic or unsafe before granting pre-market approval.
Closing a loophole regarding the FDA’s “generally recognized as safe” (GRAS) designation, which the letter says many companies have used to market CBD.
The FDA’s process of regulating supplements is even more complex than for food, as numerous loopholes exist in the industry, leading some—including the authors of the letter—to dub it the “Wild West.”
The groups had more than a dozen requests for updating the dietary supplement approval process, including:
Strengthening the FDA’s safety standards and recall authority regarding dangerous supplements.
Granting the FDA authority to recall supplements with drug contaminants.
Spreading enforcement powers to also include state Attorneys General and citizen suits.
Additionally, the letter says the FDA needs more funding overall for proper oversight. The organizations urge Congress to provide dedicated funding for the FDA to take action against CBD products that pose the greatest health risks. Those include:
Products making health claims.
Products that appeal to children and youth.
Products with high doses of CBD or tetrahydrocannabinol (THC), or those that have mislabeled concentrations of cannabinoids.
Products that are contaminated with things like dangerous mold, pathogens, high levels of pesticide residues and more.
“Congress should give the FDA the support it needs to do its job, and fix the many serious shortcomings in its existing authorities. These shortcomings pose a safety risk to consumers of CBD and other products that cannot be ignored,” the letter says. “We urge Congress not to erode—but instead to strengthen—the position of the FDA to address these issues in foods and supplements and protect health, as its mission requires.”
The full letter can be found on the Center for Science in the Public Interest’s website.
