FDA last week told Congress it’s “actively considering potential pathways for certain CBD products to be marketed as dietary supplements” and weighing issuance of a policy related to its enforcement priorities while potentially engaging in a rulemaking process.
FDA’s 15-page report to the House and Senate appropriations committees was met with criticism from some leaders in the natural products and hemp industries, who complain the agency is dragging its heels on actively regulating CBD products.
The U.S. Hemp Roundtable, a coalition of hemp companies, is “not surprised” yet “frustrated that FDA continues to kick the can down the road,” the group’s general counsel, Jonathan Miller, said in an interview. “It’s not just about the struggling hemp industry, it’s about public health and safety.”
Miller expressed hope “Congress will step in and force the FDA to act.”
Asked what the agency is doing to oversee the market, the leader of the Natural Products Association (NPA), Daniel Fabricant, said, “In the words of Dean Wormer,”—the fictional character from the movie Animal House—“zero point zero.”
NPA has repeatedly called on FDA to immediately set a safe level at which CBD can be marketed in supplements. In the U.K., for example, the Food Standards Agency has suggested a daily limit (70 mg) at which the cannabis-derived compound is safe to consume.
“I’m not saying their science is right, not by any stretch of the imagination,” Fabricant, a former FDA official who oversaw the Division (now “Office”) of Dietary Supplement Programs, said in an interview. But he said it’s “telling” that “the UK is willing to draw a line in the sand and the FDA—the world’s preeminent regulatory authority when it comes to food and drugs—is not.”
FDA’s “report amounts to more bureaucratic can-kicking, and Congress should recognize it as such and take action now to declare CBD a lawful dietary ingredient,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a statement. “That will direct FDA to allow CBD in dietary supplements and impose that significant regulatory framework on these products.”
He added: “Every day, more CBD products come to market, some from responsible manufacturers, and some from less reputable companies. By not enforcing the full range of dietary supplement regulations on this category, FDA is essentially an absentee regulator and the public is at risk.”
Kevin Bell, a partner with the law firm Arnall Golden Gregory LLP, described FDA's report to Congress as one that provided clarity regarding how the agency intends to move forward yet fell short of meeting "industry expectations."
The document "sent a message that FDA intends to go through rule-making and will not be rushed due to market demand," he said in an email.
On the other hand, industry attorney Ashish Talati was encouraged by FDA’s report to Congress.
“They’re saying ‘yes’ to dietary supplements with a future rulemaking and potentially a future enforcement discretion prior to the rulemaking,” Talati, a partner with the law firm Amin Talati Wasserman LLP, said in an interview. “The big question for the industry is the timeline.”
Any rulemaking would require notice and comment and could stretch on for years before it is finalized.
"Historically, FDA is a slow-moving organization, such that its evaluation of FDA could extend well beyond 2020, without some form of intervention or other governmental stakeholders to expedite the process," Garrett Graff, managing attorney at Hoban Law Group, said in an email.
It’s also possible FDA’s regulations, once completed, would be challenged in the courts.
“The FDA will likely be concerned about issuing a rule that can be attacked and possibly vacated on grounds that it is arbitrary and capricious,” Greg Kaufman, a partner with the law firm Eversheds Sutherland, said in an emailed statement. “It will be important for the FDA to have a factual basis to support a rule where the underlying rationale and factual assertions can be deemed reasonable.”
John Venardos, CEO of the CBD Association, said FDA’s report didn’t clarify a regulatory pathway for CBD. He wondered when the agency would “define a pathway for inclusion of CBD in non-drug products” without hindering "its further development as a pharmaceutical, which remains an FDA concern."
“Should FDA emulate the UK’s approach to CBD and give CBD brand owners a fixed period of time to file safety data for their specific product(s)?” he asked in an email.
FDA has raised safety concerns about CBD, including the potential for liver injury, drug interactions and male reproductive toxicity. Relative to its goal to gather more safety data about CBD, FDA told Congress it’s “working to establish a clear process by which proprietary information regarding specific products could be submitted to the agency, with appropriate protection against disclosure of trade secret or confidential commercial information.”'
Graff described the report to Congress as "mostly affirmation of the perception held about FDA's position towards CBD, which is a neutral-positive, but remains frustrating in the sense that many hope FDA could or would move more quickly to regulatory certainty than the pace currently embarked upon."
Since 2015, FDA has stated CBD cannot be lawfully marketed in supplements because it was first studied as a drug by GW Pharmaceuticals plc. The agency, however, seemed open to considering marketers’ claims that their “full” or “broad” spectrum hemp extracts are distinguishable from GW’s CBD medicine, Epidiolex.
“Products that are being marketed with such terms can vary widely in their characteristics, but our understanding is that such terms generally are intended to convey that the product is not a CBD isolate, and that the products contain other substances extracted from the plant,” FDA stated in its report to Congress. “At the same time, we are aware that many products currently marketed as ‘full spectrum’ or ‘broad spectrum’ hemp extracts may contain very high concentrations of CBD, and may be derived from varieties of the hemp plant that have been selected specifically for their high CBD content.”
FDA has largely focused its enforcement efforts against CBD marketers on claims that non-FDA-approved products treat diseases like cancer and epilepsy, and Graff is among those industry regulatory experts who expect FDA to continue focusing its enforcement on such behavior.
"Failure to enforce weakens perception of the agency and fosters bad actors," Bell said. "If they [FDA officials] are going to hold enforcement powers, they need to be more nimble and aggressive in using them. If not, asking for forgiveness instead of permission will continue to be the norm."
FDA has stressed it has no official policy of enforcement discretion. Talati said an FDA enforcement policy would signal CBD “products are OK” to market until FDA issues a formal rulemaking. He and others have noted many companies that would like to enter the CBD market have remained on the sidelines due to concerns over regulatory risks.
“Any enforcement policy,” FDA advised lawmakers, “would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities based on the known risks to public health.”
But many industry groups prefer FDA swiftly develop a path to market for CBD supplements through a final rulemaking or interim rule.
“The gray clouds of uncertainty are really what’s plaguing us right now,” Miller concluded.