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Springtime Is Warming Up For Regulating CBD

May 16, 2019 10:13 am
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Last week, Hemp Business Journal Founder Sean Murphy spoke at a Congressional briefing before the Dietary Supplement Caucus. Presenting market data and analysis, he discussed the state of the hemp and cannabidiol (CBD) markets as well as regulatory challenges facing the industry, including how the Food and Drug Administration (FDA) may ultimately regulate the use of hemp-derived CBD.

Lawmakers are focusing on the FDA’s regulating hemp-derived CBD based on the 2018 Farm Bill, which removed hemp and CBD from the federal list of controlled substances.

During his testimony to Congress in March, outgoing FDA commissioner Scott Gottlieb said that the agency is practicing “enforcement discretion” with regard to CBD products, and that they will only take action against companies that are making “over-the-line claims.”

5-15-19-cbd-supplements-1.jpg

However, shortly before Murphy’s briefing, sources told the Hemp Business Journal that enforcement discretion was not the FDA’s expressed position, which is formally posted on its website.

A statement issued by Gottlieb following the Farm Bill’s passage lends some insight into the FDA’s current approach to CBD. In it, Gottlieb notes that it is illegal under the Federal Food, Drug, and Cosmetic Act to introduce food containing CBD or to market CBD products “as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”

CBD is used as an active ingredient in an FDA-approved drug, Epidiolex, which was the subject of substantial clinical investigations.

Though CBD may have some pharmaceutical applications, the hemp industry at large has asserted that the intent of the Farm Bill is to regulate hemp and its derivates like any other agricultural crop. In the case of hemp-derived CBD, that would mean regulating it as a dietary supplement as defined by the Dietary Supplement Health and Education Act of 1994 (DSHEA). By so regulating CBD, licensed producers and mass-market retailers would have more assurance (and less risk) to sell ingestible, hemp-derived CBD products on their shelves.

Under DSHEA, dietary supplements are generally regarded as food products. Whereas supplements are not required to undergo the extensive FDA approval process, supplement manufacturers are required to provide the agency with reasonable evidence and expectations of their safety.

On May 31, 2019, the FDA will hold its first public hearing on CBD, to allow stakeholders in the market to express their concerns and provide guidance on how to regulate the substance.

Image sourced from Pixabay


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