Four dietary supplement trade groups on Tuesday urged Congress to pass legislation clarifying hemp-derived CBD is a lawful dietary ingredient if the supplement meets established product safety and quality criteria.
Lawmakers also were asked to devote sufficient resources to shield consumers from unsafe CBD products.
While FDA has been examining the potential for a rulemaking that would authorize CBD to be added to food and marketed as a dietary supplement, agency officials have stressed such a process could take several years to complete.
Industry representatives have expressed fears that a lack of federal oversight could endanger the health of the public and continue to foster an environment of uncertainty, stymieing investments and innovation.
The U.S. market is already inundated with CBD products and a patchwork of state testing and labeling laws governing them.
Since at least 2015, FDA has asserted CBD can’t be marketed in a dietary supplement under federal law because, in short, the compound was first studied as a pharmaceutical drug. Last year, the agency approved the first CBD medicine, Epidiolex, to treat seizures associated with two severe forms of epilepsy.
Despite the drug-related exclusion above, the Federal Food, Drug & Cosmetic Act (FD&C Act) grants the head of the U.S. Department of Health and Human Services (HHS) discretion to authorize CBD to be marketed in supplements.
In the Oct. 8 letter to Congress, the trade associations noted any CBD products subject to such a “limited waiver” would need to meet the definition of hemp in the 2018 Farm Bill and comply with applicable requirements of the FD&C Act and FDA’s regulations related to dietary supplements, including requirements for new dietary ingredients.
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