Hemp-based CBD can be legally marketed in conventional food and dietary supplements, according to the legislation that was unveiled in the U.S. House of Representatives. The bill was introduced by Collin Peterson (D-MN), the Chairman of the House Agriculture Committee, in a simple, three-page bill that would explicitly include hemp-derived CBD in the definition of a dietary supplement.
The bill would also create an exception for cannabidiol to a “prohibited act” in Section 301 of the Federal Food, Drug & Cosmetic Act (FDCA), which bars the introduction of compounds that were earlier studied as a pharmaceutical drug into interstate commerce of a food.
The U.S. Food and Drug Administration has continuously cited that it is due to the FDCA they are not declaring hemp-derived CBD as a legal dietary ingredient, and therefore, has done little to create a reformed regulatory framework for CBD based products.
The agency has been issuing warning letters to companies that market their CBD products with high medicinal claims, however, there hasn’t been much work when it comes to regulating the CBD market.
The new bill introduced by Peterson would also require the Agriculture Secretary, other relevant state and federal agencies to complete research on the market and evaluate regulatory barriers for producers who are operating under the legal domestic hemp production program in USDA’s regulations.
FDA’s Stance on CBD Dietary Supplements
The FDA has continuously reiterated since 2015 in written statements, speeches and warning letters that Cannabidiol was initially authorized for investigation as a new drug and as a subject for substantial clinical investigations by GW Pharmaceuticals plc. According to the agency, CBD cannot be added to conventional food or marketed in dietary supplements.
Despite numerous public statements and warning letters, CBD flourished in the U.S. market with a solid presence virtually from restaurants to grocery stores, gas stations, and online websites.
FDA’s public stance about CBD that it cannot be added or sold in dietary supplements has not been adjudicated in the courts or incorporated in a formal regulation. The FDA might tangle with marketers with collectively hundreds of millions of dollars in the judiciary if the agency moves ahead to shut down the industry.
Nonetheless, if HB 5587 is passed into law, it could potentially avoid the clash between industry regulators and businesses over CBD’s legality status. But it’s doubtful that the members of Congress would intervene with the FDA, which has continually raised concerns about public health safety and mentioned unanswered questions about the safety of CBD.
The FDA has been in the process of exploring whether it should create a regulatory framework and pathway for CBD in dietary supplements and conventional food, but it has not begun a formal rulemaking process.
Geoff Whaling, Chairman of a nonprofit organization, National Hemp Association, said that since the FDA might take a good two to three years to produce a substantial regulatory pathway, it’s good that someone from the Congress is trying to speed up the process. But Congress has many unattended queries and issues that need to be addressed instead of CBD, which should be ideally left with the FDA.
Tami Wahl, a strategic policy advisor said that it seems like both parties, Congress and the FDA, were waiting for someone else to make the first move.
Mike Greene, a seasoned lobbyist and a consultant with the Greene GR Strategies who previously worked as a senior vice president for government relations with the Council for Responsible Nutrition (CRN) said that it’s Congress’ responsibility and job to guide agencies about what to do, how to do it when to do it and to be as transparent and clear as possible to ensure the agencies fully understand it.
Greene said that he and Wahl worked with Collin Peterson, the Chairman of the House Agriculture Committee to introduce the legislation. Greene also expressed hope that the House Committee on Energy and Commerce, the agency that oversees the FDA, would consider the legislation in 2020 during a hearing.
He further added that they aim for the bill to be considered and that Peterson would get a chance to maybe explain or testify as to why he introduced the bill in the first place.
President of the advocacy group, Eric Steenstra, expressed support for the bill put forward by Peterson, saying that it would help provide more clarity to the CBD marketplace and ensure that CBD products are sold and marketed nationwide.
Steenstra said they urge Congress to pass the legislation quickly and the FDA to regulate CBD the same way as other supplements under the existing guidelines and regulations.