Bipartisan Legislation Proposed To Authorize CBD Dietary Supplements And Food Additives – Cannabis & Hemp – United States – Mondaq News Alerts

08 October 2021

Beveridge & Diamond

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On May 19, 2021, Senators Rand Paul (R-KY), Ron Wyden (D-OR),and Jeff Merkley (D-OR) introduced the Hemp Access and ConsumerSafety Act of 2021 (SB 1698), which would address long-standingregulatory uncertainty facing products that contain hemp-derivedcannabidiol (CBD) by authorizing use of CBD in dietary supplementsand food. Specifically, the Act would amend the Federal Food, Drugand Cosmetic Act (FFDCA) so that "hemp, hemp-derivedcannabidiol, or a substance containing any other ingredient derivedfrom hemp" are no longer prohibited as dietary supplements orfood additives. The Act would still require manufacturers to complywith all existing federal regulations for products that contain CBDand ensure that these products are properly labeled.

Despite the ubiquity of CBD products on the market, the Food andDrug Administration (FDA) continues to maintain that productscontaining CBD cannot be sold as dietary supplements, foods, and/orbeverages under the FFDCA. Dietary supplements are products takenby mouth that contain a "dietary ingredient," such asvitamins, minerals, or botanicals, intended to supplement the diet.FDA's position relies on the fact that CBD is already anapproved drug product active ingredient, which makes it ineligiblefor dietary supplement or food additive status under the FFDCA,unless exempted by FDA. To date, FDA has approved one cannabis-derived and threecannabis-related drug products, but refused to issue anexemption to allow use of CBD in dietary supplements or food.

Passage of the Hemp Access and Consumer Safety Act of 2021 couldhelp provide much-needed clarity to the CBD market, which has beensubject to a number of FDA enforcement actions in recent years. FDAhas sent warning letters to companies selling CBD products marketedas dietary supplements, including CBD drops, CBD gummies and vapes, and water and sprays. Similarly, companies sellingfood products, such as lollipops and teas, with CBD as an added ingredient, havereceived warning letters from FDA deeming these productsadulterated within the meaning of section 402(a)(2)(C)(i) of theFFDCA.

The global CBD market is currently valued at somewhere between 1 and 2 billion USD withcurrent projections for 2025 between 5 and 20 billion USD. While projections forhow much this market will increase over the next decade vary, mostagree that there will be substantial growth in the years tocome.

Originally published July 9, 2021

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