Bill Would Allow Hemp-Derived CBD In Supplements, Food

Senators Ron Wyden and Jeff Merkley (D-OR) and Senator Rand Paul (R-KY) introduced bipartisan legislation on May 19 that would protect public health by providing legal clarity in the hemp and hemp-derived cannabidiol (CBD) product marketplace. The Hemp Access and Consumer Safety Act of 2021 would amend the Federal Food, Drug, and Cosmetic Act (FD&CA) by establishing exceptions to certain statutory restrictions that have prevented the U.S. Food and Drug Administration (FDA) from setting clear regulatory frameworks for hemp and hemp-derived CBD that would assure consumer access. The legislation would subject foods and dietary supplements containing these ingredients to all of the protections afforded by FDA’s current food and dietary supplement regulatory frameworks.

A growing number of Americans view hemp and hemp-derived CBD as useful for improving health and wellbeing, driving high consumer demand and a proliferation of hemp and CBD-containing products on the marketplace. While the 2018 Farm Bill changed the law to allow hemp farming, there has remained regulatory uncertainty about the inclusion of hemp and hemp-derived CBD in foods and dietary supplements.

Currently, the Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food, or beverage from entering the market if it has been studied or approved as a drug. The FDA has the authority to exempt items from this prohibition, but has yet to exempt hemp-derived CBD despite Congressional action to legalize its production and sale.
The legislation introduced today would allow hemp, hemp-derived CBD, and other ingredients derived from hemp to be legally marketed in foods and dietary supplements, and it would thus require such products to comply with all of the statutes and regulations that apply to other foods and dietary supplements. Establishment of these legal pathways will also provide much needed certainty to hemp farmers.

The bill would also specifically authorize FDA to establish labeling and packaging requirements for dietary supplements and foods that contain hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp.

A summary of the bill can be found at https://www.wyden.senate.gov.

Groups in the hemp and consumer industries have shared their support for the bill.

Michael McGuffin, president, American Herbal Products Association: “Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated. AHPA supports this legislation since it would clarify the lawful pathways for bringing such products to market.”

Jonathan Miller, general counsel, U.S. Hemp Roundtable: “The Hemp Access and Consumer Safety Act is a huge win for American consumers, farmers, and the hemp industry as a whole. Consumers will benefit from knowing that CBD products must be manufactured according to FDA-approved CBD processes. Struggling American farmers will benefit from a stabilized marketplace. It also will stimulate innovation and job creation in the hemp industry. The U.S. Hemp Roundtable is deeply grateful to Senator Ron Wyden for crafting this smart, sensible, and critical legislation, and to Senator Rand Paul and Senator Jeff Merkley for serving as the original co-sponsors.”

Eric Steenstra, executive director, Vote Hemp: “It is critical that FDA begin regulating CBD products to ensure that consumers are protected and top quality compliant producers are the only ones on store shelves. Hemp-derived CBD should be regulated the same as all other food and dietary supplements and we thank Senator Wyden, Senator Paul, and Senator Merkley for their leadership and support.”

Patrick Atagi, board chair, National Industrial Hemp Council: “Last year, nearly $15 billion in economic benefits were left out of the economy because CBD wasn’t regulated appropriately. If the FDA can’t act, Congress should fulfill its oversight role and pass this legislation. NIHC supports Senators Wyden, Paul, and Merkley’s recognition of hemp and CBD as an ingredient in both food and supplements, and we applaud their legislative approach to ensure that it’s regulated accordingly. This bill will deliver safe products to the marketplace and create a hemp economy that works for everyone.”

Jen Daulby, senior vice president, Government Affairs, Consumer Brands Association: “The Consumer Brands Association commends Senators Wyden, Paul and Merkley for shining a spotlight on a product that has been a catalyst for a conflicting patchwork of state laws and regulations. Consumer Brands has long advocated for a national regulatory framework for CBD that empowers FDA to establish smart, consistent regulations and gives them the resources they need. Today’s action is a first step in delivering these much-needed regulations for American consumers.”

Scott Melville, president & CEO, Consumer Healthcare Products Association: “We strongly commend Senators Wyden, Paul and Merkley for their bipartisan bill which will provide a pathway for CBD to be legally marketed as a dietary supplement. A lawful regulatory pathway will provide long-term certainty in the hemp-derived CBD market and protect consumers from potentially unsafe products.”