Last week the Consumer Healthcare Products Association (CHPA) submitted a citizen petition asking the US Food and Drug Administration to quickly issue regulations to allow a lawful path to market for CBDs.
“Intense consumer demand and commercial interest has resulted in a flood of CBD products of uncertain quality and unapproved claims already in the marketplace, and this scenario has created an urgent need for FDA action,” said Scott Melville, president and CEO of CHPA.
In its petition CHPA asks FDA to create an exception for CBD to be a legal dietary ingredient by issuing an interim final rule to that effect. The organization, which represents the manufacturers and distributors of OTC drugs, dietary supplements and medical devices, asks the FDA continue to regulate the CBD drug applications has it has already done.
In addition, CHPA requests that FDA continue to take enforcement action against marketers of hemp-derived CBD products who are making disease claims. And it asks that the agency continue to monitor the developing safety situation.
NDIs would provide adequate safety info
CHPA takes the view, as do many within the supplement industry, that CBD ingredients should be subject to the New Dietary Ingredient Notification requirement. The organization said taking this approach means FDA does not need to make a dosage determination prior to issuing an interim find rule on the substance because the NDI dossiers will provide a significant amount of safety information.
CHPA’s petition also emphasizes the need for FDA to work quickly by either issuing an interim final rule that takes effect right away or by issuing guidance on enforcement discretion for reputable manufacturers that take certain steps to ensure product quality (such as appropriately sourcing and identifying the CBD ingredient) while potentially lengthy notice-and-comment rulemaking is underway. CHPA’s petition also urges FDA to continue and increase enforcement against manufacturers that fail to comply with the law.
FDA convened a meeting on hemp and CBD on May 31. Dozens of speakers and hundreds of pages of submitted information later, the agency has still to make an announcement about its near term strategy on the issue. FDA had at first said it would provide an update by early fall.
New Jersey gets into the act
The natives are getting restless in other jurisdictions. In a resolution passed recently, the New Jersey State legislature urges FDA to quickly set an upper daily exposure limit to bring some rationality to the market.
“Within the past three years, more than 1,500 cannabidiol products have come to the market without a clear approach for regulation or any plan from the FDA to balance consumer access and protect consumer health,” the resolutions notes.
“The lack of clear policy from the FDA and the patchwork regulation of substance by the states create a complex legal framework for companies that sell cannabidiol products for their operations. As a result, interstate commerce for national cannabidiol companies is difficult because banks, insurance companies, and merchant companies are uneasy about providing services to cannabidiol companies at the risk of involvement from the FDA,” the resolution adds.