The FDA and Hemp-Derived CBD: The Hemp Access and Consumer Safety Act Explained

A group of legislators have reintroduced a bipartisan bill aimed at ensuring cannabidiol (CBD) is adequately regulated in the United States. The Hemp Access and Consumer Safety Act is designed to push the Food and Drug Administration (FDA) to take decisive steps to control the use of hemp-derived CBD in foods, beverages, and dietary supplements.

The U.S. Congress had previously passed the Farm Bill that legalized the cultivation and sale of hemp and hemp products in 2018. However, five years later, the FDA still hasn’t developed a framework for its regulation.

Hemp and the 2018 Farm Bill

The 2018 Bill removed hemp from the list of controlled commodities, allowing it to be legally produced and sold in the State. It also categorized the substance as covered under crop insurance, and the Federal Crop Insurance Corporation board was given the responsibility to develop hemp policies.

According to the legislation, hemp refers to the cannabis plant and ” any part of the plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” Also, the bill outlines that plans should be developed to regulate the substance. The existing uncertainty on the marketing of hemp products has affected the production and consumption of CBD.

The Hemp Access and Consumer Safety Act

This recent legislation is an update in the federal laws and ensures the FDA regulates hemp-derived CBD products under the federal Food, Drug, and Cosmetic Act (FD&C Act). It was introduced on July 20, by Rep. Earl Blumenauer (D), Sen. Ron Wyden (D) and Jeff Merkley (D) from Oregon, and Sen. Rand Paul (R) from Kentucky. These bipartisan legislators described the bill in a joint statement as “an action that is essential to protecting consumer safety and treating hemp producers fairly.”

Wyden explained that “Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back.” He further stated that “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”

Paul, who was formerly an ophthalmologist for over 15 years, also said that “Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement. The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants.”

The proposed bill is supported by key hemp and CBD industries like the Wine and Spirits Wholesalers Association (WSWA), the Hemp Roundtable, Hemp Industries Association (HIA), National Hemp Growers Association, Realm of Caring, U.S. Hemp Authority (USHA), National Industrial Hemp Council and the Veterinary Cannabis Society.

Jonathan Miller, the general counsel of the Hemp Roundtable, expressed his optimism as regards the act. He said it would provide the “much-needed pathway for FDA to establish a clear and consistent framework for the production, marketing, and sale of hemp-derived CBD to ensure consumer safety while fostering a thriving, regulated market.”

The Regulatory Role of the FDA

The FDA is ladened with the responsibility to protect public health by ensuring effective pathways to manage the manufacture and commerce of certain commodities. The legalization of cannabis and cannabis-derived products like CBD, alongside the increasing public interest in the substance, necessitates the need to monitor its consumption. Cannabis and its derived products should be subject to the same guidelines and requirements put in place for other FDA-controlled goods.

What Is Expected

It is expected that the FDA creates pathways to make sure hemp-derived products are lawfully introduced as food, beverages, or dietary supplements. In light of this expectation, bipartisan leaders of high-ranking House and Senate Committees are out to obtain vital information from experts on the matter using a Request for Information (RFI). The effort is led by the chairs and top members of the House Energy & Commerce Committee, and the Senate Health, Education, Labor, and Pensions (HELP) Committee to discuss these FDA-CBD-related issues.

The Request for Information

The RFI posed some questions to the FDA on July 27, 2023. Seeking clarity on the current market dynamics, it asks, “What does the current market for CBD products look like? Please describe the types and forms of products available, manufacturing practices within the industry, market supply chain, how products are marketed and sold, the types of cannabinoids used in products, the marketed effects of CBD products, and the range of CBD doses currently found in the market.”

As regards possible pathways for regulations, it asks, “Please comment on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products. If existing regulatory pathways are sufficient for regulating CBD products, please explain how these existing pathways can be used to address the concerns raised by FDA, as appropriate.”

It also asks questions like “What is currently known about the safety and risk-benefit profile of CBD and other hemp-derived cannabinoids? What safety and toxicity data are available to support this knowledge? Please include in your answer any relevant information about safety with regard to specific populations, such as children and pregnant individuals.” And, “How should a new framework for CBD products balance consumer safety with consumer access?”

The RFI included a total of 29 questions and was signed by Bernie Sanders, Bill Cassidy, Cathy McMorris Rodgers, and Frank Pallone. Responses are to be submitted by August 18, 2023.