Four trade associations representing the dietary supplement industry have joined forces to urge Congress to provide legal clarity regarding the CBD marketplace.
The American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition and United Natural Products Alliance penned a letter to Congress asking lawmakers to “pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient if the dietary supplement containing the CBD meets established product safety and quality criteria.”
The organizations’ full letter highlighted the amount of time the Food and Drug Administration has projected for rulemaking to be complete compared with the boom in the category should compel Congress to act.
“While FDA has been working to craft its policy on hemp-derived products…it could take three to five years for even an expedited rule-making process,” the letter says. “Given the rapidly growing marketplace of products, it is crucial that Congress take quick action to clarify the legal status of hemp-derived CBD dietary supplements. At the same time, it is equally essential for FDA to have the resources it needs to protect the public from unsafe CBD products.”
The letter asks Congress to provide a limited waiver of a provision of the Food, Drug and Cosmetic Act that governs articles used in both drugs and dietary supplements to enable lawful marketing of dietary supplements that contain hemp-derived CBD. It further asks Congress to grant the FDA statutory authority and additional resources to create a regulatory framework for the CBD marketplace and ensure customer protection. The organizations also thanked Congress for the $2 million included in a Senate bill that would help the FDA enforce existing laws regarding the safety, manufacturing and labeling of dietary supplements containing CBD.
The organizations noted that new lawful ingredients also would need to meet other standards and regulations for consumer dietary supplement protection.
“Importantly, these products would also be required to fully comply with all other provisions of the FDCA and FDA’s implementing regulations applicable to dietary supplements, including those requiring accurate product labeling and good manufacturing practices as well as the prohibition against making any drug claims,” the letter says.