Mike Montemarano, Associate Editor 02.08.21
Representatives Kurt Schrader (D-OR) and Morgan Griffith (R-VA) re-introduced bipartisan legislation to the 117th Congress which would provide legal clarity in the regulatory status of cannabidiol (CBD) products. Re-introduced as the Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2021, the bill directs the U.S. Food and Drug Administration (FDA) to use its authority and resources to set a clear regulatory framework for hemp and hemp-derived CBD, which proponents say will serve to protect both consumers and companies by ensuring product safety and consistency of quality.
While the 2018 Farm Bill legalized the farming of hemp, regulatory uncertainty does not make the legal status of CBD-containing products which are marketed as foods or dietary supplements known. Because CBD cannot be legally sold as a dietary supplement ingredient, the FDA does not conduct any oversight activity on the CBD products currently being sold. For over two years since the farm bill’s passage, the CBD industry has pushed for the FDA to take swift action to impose legal and regulatory requirements that exist for other supplements, however, the agency has identified a number of quality and safety concerns and lack of long-term clinical substantiation that it states need to be addressed before it will authorize CBD as a dietary supplement ingredient. CBD proponents argue that the agency has used its statutory discretion to authorize the use of other new dietary ingredients in the past, such as red yeast rice, and that this precedent should be applied to CBD.
The new HR bill would require FDA to set a clear pathway to allow hemp and hemp-derived CBD to be sold legally as dietary supplements, so long as manufacturers comply with new dietary ingredient requirements and other Food and Drug Act policies pertaining to dietary supplements. A legal pathway to market would put in place necessary safeguards to protect consumers, and provide certainty to hemp farmers regarding the legal status of their products.
“There remains an absence of substantive progress on FDA’s reported attention to creating a lawful pathway for CBD, and a similar lack of clarification from the agency that simple hemp products, such as tinctures and extracts, should be regulated the same as other herbal supplements,” Michael McGuffin, president of the American Herbal Products Association, said. “This legislation will fill those gaps, and we see it as important for ensuring that consumers will be able to find hemp and CBD products that are clearly subject to FDA’s enforcement of the robust regulations that apply to all other herbal supplements. The bill is also aligned with the position AHPA first adopted almost two years ago to recommend that manufacturers and marketers of hemp and CBD dietary supplements comply with all of the federal regulations that apply to such operations for other supplement products.”
Spokespersons for the Council for Responsible Nutrition shared similar sentiments in their response to the bill’s re-introduction.
“This critical bi-partisan legislation will promote a safer and stronger dietary supplement marketplace, as it will direct FDA to provide a legal pathway to market for dietary supplements containing hemp-derived cannabidiol (CBD), while still assuring FDA’s stringent requirements for manufacturing, labeling, and marketing of other dietary supplements apply to these new ingredients,” Julia Gustafson, vice president of government relations for CRN, said. “Due to continued FDA inaction, more consumers are at risk every day of unsafe or illegal products that are poorly manufactured, incorrectly labeled, or illegally deliver THC or other adulterants. Concurrently, responsible CBD companies that adhere to federal regulations and produce and market safe and beneficial CBD dietary supplements are forced to share the shelf with disreputable companies that compromise public safety for profit.”
A coalition of 18 trade associations representing the dietary supplements, hemp farming, and consumer health products industries have publicly declared support for the bill, including the U.S. Hemp Roundtable, the American Herbal Products Association, Alliance for Natural Health, Citizens for United Health, Consumer Healthcare Products Association, Council for Responsible Nutrition, Hemp Alliance of Tennessee, Hemp Industries Association, Midwest Hemp Council, National Cannabis Industry Association, National Association of State Departments of Agriculture, National Grocers Association, Texas Hemp Coalition, United Natural Products Alliance, U.S. Hemp Authority, U.S. Hemp Building Association, Wisconsin Hemp Alliance, and We Are For Better Alternatives.
While the 2018 Farm Bill legalized the farming of hemp, regulatory uncertainty does not make the legal status of CBD-containing products which are marketed as foods or dietary supplements known. Because CBD cannot be legally sold as a dietary supplement ingredient, the FDA does not conduct any oversight activity on the CBD products currently being sold. For over two years since the farm bill’s passage, the CBD industry has pushed for the FDA to take swift action to impose legal and regulatory requirements that exist for other supplements, however, the agency has identified a number of quality and safety concerns and lack of long-term clinical substantiation that it states need to be addressed before it will authorize CBD as a dietary supplement ingredient. CBD proponents argue that the agency has used its statutory discretion to authorize the use of other new dietary ingredients in the past, such as red yeast rice, and that this precedent should be applied to CBD.
The new HR bill would require FDA to set a clear pathway to allow hemp and hemp-derived CBD to be sold legally as dietary supplements, so long as manufacturers comply with new dietary ingredient requirements and other Food and Drug Act policies pertaining to dietary supplements. A legal pathway to market would put in place necessary safeguards to protect consumers, and provide certainty to hemp farmers regarding the legal status of their products.
“There remains an absence of substantive progress on FDA’s reported attention to creating a lawful pathway for CBD, and a similar lack of clarification from the agency that simple hemp products, such as tinctures and extracts, should be regulated the same as other herbal supplements,” Michael McGuffin, president of the American Herbal Products Association, said. “This legislation will fill those gaps, and we see it as important for ensuring that consumers will be able to find hemp and CBD products that are clearly subject to FDA’s enforcement of the robust regulations that apply to all other herbal supplements. The bill is also aligned with the position AHPA first adopted almost two years ago to recommend that manufacturers and marketers of hemp and CBD dietary supplements comply with all of the federal regulations that apply to such operations for other supplement products.”
Spokespersons for the Council for Responsible Nutrition shared similar sentiments in their response to the bill’s re-introduction.
“This critical bi-partisan legislation will promote a safer and stronger dietary supplement marketplace, as it will direct FDA to provide a legal pathway to market for dietary supplements containing hemp-derived cannabidiol (CBD), while still assuring FDA’s stringent requirements for manufacturing, labeling, and marketing of other dietary supplements apply to these new ingredients,” Julia Gustafson, vice president of government relations for CRN, said. “Due to continued FDA inaction, more consumers are at risk every day of unsafe or illegal products that are poorly manufactured, incorrectly labeled, or illegally deliver THC or other adulterants. Concurrently, responsible CBD companies that adhere to federal regulations and produce and market safe and beneficial CBD dietary supplements are forced to share the shelf with disreputable companies that compromise public safety for profit.”
A coalition of 18 trade associations representing the dietary supplements, hemp farming, and consumer health products industries have publicly declared support for the bill, including the U.S. Hemp Roundtable, the American Herbal Products Association, Alliance for Natural Health, Citizens for United Health, Consumer Healthcare Products Association, Council for Responsible Nutrition, Hemp Alliance of Tennessee, Hemp Industries Association, Midwest Hemp Council, National Cannabis Industry Association, National Association of State Departments of Agriculture, National Grocers Association, Texas Hemp Coalition, United Natural Products Alliance, U.S. Hemp Authority, U.S. Hemp Building Association, Wisconsin Hemp Alliance, and We Are For Better Alternatives.
