In CBD rulemaking, FDA may be further ahead on supplements than foodIn CBD rulemaking, FDA may be further ahead on supplements than food
FDA's recent CBD report to Congress perhaps signaled the agency is more willing at this time to move forward with a rulemaking on dietary supplements versus conventional food.
March 16, 2020
Though it fell short of expectations, a report recently submitted to Congress highlighted FDA’s thinking on various issues related to CBD in conventional food, beverages and dietary supplements.
In the 15-page report to House and Senate appropriations committees, FDA noted it’s evaluating a potential rulemaking to allow CBD to be lawfully marketed in supplements, and it encouraged “interested parties to continue to develop and share with FDA information regarding whether there are conditions under which CBD could safely be added to food.”
Chicago-based attorney Ashish Talati, who advises clients on FDA regulatory matters, distinguished FDA’s thinking on supplements from conventional food.
“It definitely seems like for dietary supplements, FDA is saying ‘yes,’” Talati, a partner with Amin Talati Wasserman LLP, said in an interview. “For food, they’re not yet ready.”
He added, “They didn’t close the path for foods, but at the same time, they’re not as far ahead as with dietary supplements.”
That CBD can be taken in myriad food and beverage products from water to chocolate bars perhaps reflects FDA's concerns about the health consequences from consumers' overall daily exposure to the hemp-derived compound.
Other than a CBD medicine approved by FDA, "we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations," Stephen Hahn, M.D., commissioner of FDA, said in a March 5 statement. "This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use."
Several hemp and supplement trade groups expressed disappointment that FDA’s report to Congress didn’t reflect more concrete action.
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 article published by Natural Products Insider. “It’s not just about the struggling hemp industry, it’s about public health and safety.”
Two food groups—FMI and the Consumer Brands Association (previously known as the Grocery Manufacturers Association)—did not respond to requests for comment for this article.
At least one attorney found FDA’s report helpful to industry in understanding the agency’s thinking on CBD. A partner in Washington, D.C., with the law firm Arnold & Porter, Raqiyyah Pippins focuses her practice on FDA’s regulation of food, dietary supplements and other products.
Many “responsible companies” are attempting “to figure out how to navigate this space, and it’s always helpful to have a document to go back to for FDA’s position,” Pippins said in an interview.
FDA recently reopened a public docket in its quest to understand the long-term effects of CBD and other issues related to safety, such as how different methods of exposure affect intake, the effects of CBD on children and how the compound interacts with herbs and botanicals.
In considering whether to allow CBD to be marketed in different FDA-regulated product categories, the agency also is evaluating the effect on the pharmaceutical industry. In the report to Congress, FDA stated its focus includes ensuring there remains sufficient “incentives for clinical research.”
“If the widespread availability of consumer CBD products were to significantly discourage clinical research, our knowledge of CBD’s potential medical uses could be stunted,” the agency advised lawmakers.
FDA’s statement on clinical research, Pippins said, “may be also influencing its position about other forms of CBD being on the market.”
“It’s not solely a safety issue,” the lawyer said. “At least, that’s what that [FDA statement] suggests in my eyes.”
FDA also has signaled plans to issue a policy of enforcement discretion—an announcement Pippins found “incredibly helpful,” particularly for companies in the food industry.
As a public health agency, FDA’s priorities are focused on instances in which the agency feels “there’s an actual risk of harm,” she said. FDA has largely focused its enforcement efforts against CBD marketers on claims that products not approved by FDA treat diseases like cancer and epilepsy.
"The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses–potentially endangering their health or life," Hahn explained in his statement.
But Hahn suggested at a recent conference that it would be a “fool’s game” to try to ban CBD products entirely.
An enforcement discretion policy would “show industry FDA’s thinking on the issues” and help a company make an “internal risk assessment” about entering the CBD market “without selling higher-risk products,” Pippins said.
On the other hand, the lawyer cautioned statements issued by FDA in such a policy could increase the risk of litigation filed by plaintiff’s attorneys or others against the CBD industry. “The risk is that there could be an increase in litigation based on what’s stated in that document,” Pippins explained.
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