CBD's uncharted regulatory territory requires precedent-setting solution

MARCH 9, 2021 — SPECIAL: UNLOCKED MEMBER CONTENT

Bipartisan support growing for CBD legislation, CRN says

A recent HBW Insight article pushed back against the Natural Products Association's (NPA) assertion that legislation specifically making hemp­-derived cannabinoids lawful for use in supplements would signal to critics of the industry that Congress should propose other changes to DSHEA.

Hemp-derived cannabinoids' existing uses in the U.S. are without regulatory precedent, making a precedent-setting solution necessary for their lawful use as dietary ingredients, CRN's Steve Mister explained in the article, available to HBW Insights subscribers here. Mister emphasized bipartisan support of HR 841 that would exempt CBD from FDA's drug preclusion that currently prevents it from being lawfully sold as a dietary ingredient.

Mister further pointed out that NPA's proposal that Congress should instruct FDA to first determine a safe daily limit for cannabinoid use is a far more threatening precedent for U.S. supplement marketers.

"FDA doesn't get to decide in advance of a product coming to market what is safe level of use. That's one of the fundamental tenets of DSHEA," Mister explained. "If it's an herbal extract and it meets the definition of an herb, the burden is on FDA to show that it's not safe."

Additionally, it's not their safety profile that makes cannabinoids unlawful for use in supplements. "If this were any other ingredient that wasn't caught up in the drug preclusion language, the ingredient would come to market," Mister stated.

HR 841 is in the early phase of discussion and potential revision by Energy and Commerce members. Making cannabinoids lawful as a dietary ingredient under FDA regulations could pass Congress on its own or as part of broader legislation, Mister noted. Subscribers to HBW Insight can read more here. Contact CRN's Gretchen Powers for more information.




“FDA doesn't get to decide in advance of a product coming to market what is safe level of use. That's one of the fundamental tenets of DSHEA.”

Steve Mister CRN President & CEO in HBW Insight