Dietary Supplement News

FDA concludes that CBD needs its own Regulatory Pathway separate from Dietary Supplements and Food

The FDA has decided that a new regulatory pathway for CBD balances individuals' desire to access CBD products with the oversight needed to manage risks.

Edited for content by Mark Zuleger-Thyss

According to Janet Woodcock, MD, principal deputy commissioner at the U.S. Food and Drug Administration (FDA), the Agency has concluded that “a new regulatory pathway for CBD is needed ….” This new pathway would balance individuals' desire for access to CBD products with the regulatory oversight needed to manage risks.

This stance means that FDA does not believe existing regulatory frameworks for foods and supplements are appropriate for cannabidiol (CBD). FDA also denied three citizen petitions that have asked the Agency to conduct rule making that would allow CBD to be marketed as a dietary supplement.

The FDA cites concerns about the safety of long-term CBD use on liver function and the male reproductive system. There also is a need for the FDA to provide additional safeguards such as CBD content limits and minimum purchase age to mitigate the risk of ingestion by children.

The FDA's authorities claim they provide limited tools for managing many risks associated with CBD products. “Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.”

Legislation designed to revise the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exempt CBD and other hemp products from the drug preclusion clause may no longer be possible based on these new recommendations. However, the Agency has long rejected CBD as a dietary ingredient because, under existing regulation, it falls under drug preclusion.

The FDA did not claim that CBD products sold in the market should be removed or that CBD products are dangerous. However, they acknowledge that there is room for CBD products in the marketplace.

The industry is staunchly expressing its disappointment in FDA's decision, taking issue with its claims of inadequate safety and robustness of the current frameworks to regulate CBD.

Contrary to the FDA's continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. For example, CBD products have been sold at retail for nearly a decade with no significant safety issues.

No level of safety evidence will be good enough for FDA. However, during the past four years, the FDA has repeatedly disregarded evidence demonstrating safety relevant to CBD at the levels commonly used in supplements. 

After more than a decade of promises, hearings, data sharing, market proliferation, and states filling the regulatory vacuum, the FDA claims it cannot do what Congress authorized: regulate dietary supplements under the law.

Advocates Question the Logic of the FDA's Arguments

For example, if the question of CBD's legality as a dietary ingredient hinge on the drug preclusion clause, then why is safety a factor in its consideration? Without drug preclusion, CBD should be able to go through the NDIN process like any other novel dietary ingredient.

Nothing is stopping FDA from using its rule making authority for CBD, apart from FDA itself. Instead, FDA suggests Congress must address this issue when FDA has had the power to address it all along.

The fear for the industry is that devising an alternative regulatory pathway for CBD and other cannabinoids would give FDA new and far-reaching authority.

Reading between the lines of the FDA's statement, the Agency is saying that it prefers to defy and attack The Dietary Supplement Health and Education Act of 1994 (DSHEA) and develop different regulatory paths for ingredients at its discretion.

The Drug Preclusion Rule

In 1994, the U.S. Congress passed the landmark Dietary Supplement Health and Education Act (DSHEA) that amended the FD&C Act and created dietary supplements as a unique regulated product category.

When enacting DSHEA, Congress recognized the need to balance drug interests with this new regulatory category where ingredients from both types could overlap.

FDA needed a fix to ensure supplements would not limit drug research and prevent unscrupulous companies from using the supplement category to bypass the drug approval process. This provision is called “drug preclusion.”

This provision is summarized here:

A substance that was first approved as a drug or was the subject of substantial public clinical drug studies before being marketed as a dietary supplement. And food cannot be used in nutritional supplements unless the FDA issues a regulation allowing its use.

Original Article found in Nutritional Outlook:

FDA concludes that CBD needs its own regulatory pathway separate from dietary supplements and food 

© 2023, Sebastian Krawiec 

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