Mike Montemarano, Associate Editor 05.19.21
For years, the cannabis industry has advocated for a legal pathway to market for the hemp-derived compound Cannabidiol (CBD) to be used in foods and supplements, under the same regulatory status as any other food and supplement ingredient in the purview of the U.S. Food and Drug Administration (FDA)’s enforcement authority. Today, Senators Ron Wyden, Jeff Merkley (both D-OR) and Rand Paul (R-KY) introduced a bill called the Hemp Access and Consumer Safety Act of 2021.
The bill, if passed, would amend the federal Food, Drug, and Cosmetic Act (FD&CA) by establishing exceptions to current restrictions that have prevented hemp and hemp-derived CBD from falling under FDA’s regulatory enforcement authority as food and supplement ingredients. Currently, the regulatory framework surrounding the FD&CA prevents FDA from setting clear regulatory frameworks for hemp and hemp-derived CBD when used as food and supplement ingredients. Importantly, 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.
The CBD industry saw massive growth following the passage of the 2018 Farm Bill, which changed the law to allow for hemp farming but did not specify whether hemp or hemp-derived CBD could be included in foods and dietary supplements. Proponents have long stated that the legal inclusion of non-intoxicating hemp compounds into foods and supplements was the intent of Congress when the 2018 bill was passed – since then, there has been regulatory uncertainty regarding the status of CBD products on the market today.
By the legislation allowing for hemp, hemp-derived CBD, and other hemp ingredients to be legally marketed in foods and supplements, it would require that such products comply with all of the statutes and regulations that apply to other foods and dietary supplements. These legal pathways would also provide assurances to hemp farmers and others involved in the industrial hemp supply chain regarding the commercial viability of hemp products. Furthermore, the legislation also has provisions enabling FDA to set labeling and packaging requirements for products containing CBD or any other hemp-derived ingredient.
“Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated,” Michael McGuffin, president of the American Herbal Products Association (AHPA), a trade organization representing dietary supplements, said. “AHPA supports this legislation since it would clarify the lawful pathways for bringing such products to market.”
The Natural Products Association (NPA) another trade group representing the dietary supplements industry, reports that following lobbying efforts to include food products in the legislation (beyond just CBD supplements), the organization holds the position that the legislation is insufficient without the establishment of a safe level of daily consumption for CBD.
“Setting a safe level of daily exposure remains the number one issue when it comes to regulating CBD products,” Daniel Fabricant, PhD, president and CEO of NPA, said. “It’s Congress’ job to keep the FDA accountable, but this is like slapping a band-aid on a bullet wound. Setting a safe level of daily consumption will not only keep the FDA accountable, but also set an important precedent that will pave the way for future cannabinoids and hemp constituents in foods and dietary supplements.”
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
The bill, if passed, would amend the federal Food, Drug, and Cosmetic Act (FD&CA) by establishing exceptions to current restrictions that have prevented hemp and hemp-derived CBD from falling under FDA’s regulatory enforcement authority as food and supplement ingredients. Currently, the regulatory framework surrounding the FD&CA prevents FDA from setting clear regulatory frameworks for hemp and hemp-derived CBD when used as food and supplement ingredients. Importantly, 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.
The CBD industry saw massive growth following the passage of the 2018 Farm Bill, which changed the law to allow for hemp farming but did not specify whether hemp or hemp-derived CBD could be included in foods and dietary supplements. Proponents have long stated that the legal inclusion of non-intoxicating hemp compounds into foods and supplements was the intent of Congress when the 2018 bill was passed – since then, there has been regulatory uncertainty regarding the status of CBD products on the market today.
By the legislation allowing for hemp, hemp-derived CBD, and other hemp ingredients to be legally marketed in foods and supplements, it would require that such products comply with all of the statutes and regulations that apply to other foods and dietary supplements. These legal pathways would also provide assurances to hemp farmers and others involved in the industrial hemp supply chain regarding the commercial viability of hemp products. Furthermore, the legislation also has provisions enabling FDA to set labeling and packaging requirements for products containing CBD or any other hemp-derived ingredient.
“Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated,” Michael McGuffin, president of the American Herbal Products Association (AHPA), a trade organization representing dietary supplements, said. “AHPA supports this legislation since it would clarify the lawful pathways for bringing such products to market.”
The Natural Products Association (NPA) another trade group representing the dietary supplements industry, reports that following lobbying efforts to include food products in the legislation (beyond just CBD supplements), the organization holds the position that the legislation is insufficient without the establishment of a safe level of daily consumption for CBD.
“Setting a safe level of daily exposure remains the number one issue when it comes to regulating CBD products,” Daniel Fabricant, PhD, president and CEO of NPA, said. “It’s Congress’ job to keep the FDA accountable, but this is like slapping a band-aid on a bullet wound. Setting a safe level of daily consumption will not only keep the FDA accountable, but also set an important precedent that will pave the way for future cannabinoids and hemp constituents in foods and dietary supplements.”
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
