“Time is of the essence.”
The statement, made by Andrew Kline of the National Cannabis Industry Association (NCIA), encapsulates the views of many people who attended a recent public hearing hosted by FDA on cannabidiol (CBD) products.
During the May 31 hearing in Silver Spring, Maryland, several speakers urged FDA to provide clarity to a confused marketplace and do so swiftly.
“We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market,” Kline said.
FDA is mulling whether to issue regulations that would permit CBD in conventional food and dietary supplements, but its search to answer questions over safety, effectiveness and other issues could lead to a years-long proceeding.
Based on its current interpretation of federal law, FDA has opined CBD cannot be added to conventional food or marketed as a dietary supplement because, in large part, it was first studied as a drug.
“Three to five years, at a minimum for rulemaking, is too long,” Megan Olsen, assistant general counsel of the Council for Responsible Nutrition (CRN), told FDA officials during the public hearing.
The debate over safety, she added, should not hamper FDA from promulgating regulations to allow for the use of CBD in supplements.
“There is already a regulatory framework in place that is proven to ensure the safety of dietary supplements and food—one that will automatically be implemented should FDA develop a regulation permitting CBD use in food and supplements,” Olsen said.
She explained safety considerations are addressed based on the type of product marketed, as federal law intended.
For instance, the safety of hemp extracts can be established through a new dietary ingredient notification (NDIN) to FDA or by establishing an ingredient is GRAS (generally recognized as safe), said Karen Howard, CEO and executive director of the Organic & Natural Health Association, during her comments to FDA officials.
Michael McGuffin, president of the American Herbal Products Association (AHPA), requested FDA do one of two things:
- Either “issue a regulation, possibly as an interim final rule with an accelerated effective date, permitting CBD as a lawful ingredient in supplements and foods,” with the caveat that all other applicable federal regulations must be followed;
- Or release guidance, disclosing FDA’s intent to exercise formal enforcement discretion regarding provisions of federal law on which the agency “bases its position that CBD-containing supplements and foods are unlawful.”
Thus far, FDA has focused its enforcement actions on unapproved CBD products that make claims to treat diseases like cancers and epilepsy, but agency officials have recently rejected the notion that they are exercising any kind of formal enforcement discretion.
Even if FDA allows CBD to be sold in dietary supplements, companies would need to submit NDINs to the agency, said David Spangler, who directs legal and international affairs for the Consumer Healthcare Products Association (CHPA).
“Those NDIs would still need to meet the same legal standard of sufficient information to provide reasonable assurance the ingredient does not pose a significant or unreasonable risk,” Spangler advised FDA officials during the hearing.
The 2018 Farm Bill removed hemp and its derivatives from the Controlled Substances Act (CSA), but it preserved FDA’s authority to regulate cannabis-containing products.
Peter Matz of the Food Marketing Institute (FMI), which represents grocery stores and pharmacies, cited “mass confusion in the marketplace for the public, for suppliers and retailers, and also for state regulators.” He urged “FDA to move swiftly to provide additional clarity and establish a pathway forward.”
Matz cited a Consumer Reports survey published in April, which found more than a quarter of Americans said they have tried CBD, while one out of seven of those people reported they use it daily.
“We all see the intense consumer and commercial interest in CBD and hemp-derived products more broadly,” Spangler noted. “But with little regulatory oversight, the marketplace offers a vast array of products of varying degree [of] quality, an array of unapproved drug claims and even fraudulent products.”