A cannabis nonprofit group has requested a meeting with the top official of the U.S. Department of Health and Human Services (HHS) and his staff to discuss regulation of hemp-based CBD.
In a Dec. 12 letter to HHS Secretary Xavier Becerra, representatives of the Council for Federal Cannabis Regulation (CFCR) said it is crucial “to overcome a choke point” identified by FDA, which is limiting the agency from regulating cannabinoids low in THC.
That choke point is a provision of law that FDA interprets as barring the sale of CBD in dietary supplements or food. The cannabis-derived compound was first the subject of substantial clinical investigations made public, according to the agency, or in plainer terms, FDA has found CBD was studied as a drug before its use in food and dietary supplements.
FDA’s reading of the law “as preventing regulation of products containing CBD has needlessly hamstrung the agency while untested, unregulated, sometimes dangerous CBD products continue to proliferate throughout the country,” according to CFCR’s letter. “This not only creates needless risks to public health, it also impedes sound scientific discovery in a rapidly growing and promising domestic industry.”
The regulatory bottleneck has permitted such psychoactive substances as hemp-based delta-8 THC and delta-9 THC to be introduced into drinks, food and tinctures without any “restrictions, all the while claiming to have been legalized by the Farm Bill of 2018,” CFCR wrote to Becerra.
In a webpage published in September, FDA noted that from December 2020 through July 2021, it received adverse events from consumers and law enforcement describing 22 patients who used delta-8 THC products. Delta-8 has “intoxicating” and “psychoactive” effects that resemble effects from delta-9 THC, and some manufacturers may use potentially unsafe household chemicals to produce delta-8 THC through a process of chemical synthesis, according to FDA.
CDC in September issued a health advisory on delta-8 THC, warning about the growing availability of cannabis products containing delta-8 THC and the potential for adverse events due to inadequate labeling of products containing THC and CBD.
“The agencies are rightly concerned that contamination may occur during the manufacturing of delta-8 THC products, and that misleading marketing and labeling may lead to consumer harm,” CFCR stated in its letter to Becerra.
The cannabis nonprofit also suggested "FDA’s recent objections to two new dietary ingredient notifications [NDINs] for full spectrum hemp … CBD products” has created “confusion in the marketplace for retailers, manufacturers, farmers, and most importantly, consumers.”
In its responses to the ingredient notifications filed by Charlotte’s Web and Irwin Naturals, FDA raised safety concerns about the sufficiency of the evidence provided to the agency, such as evidence related to reproductive toxicity. Charlotte's Web and Irwin Naturals sent the NDINs to FDA to establish the safety of CBD-containing hemp extracts marketed as dietary supplements.
CFCR advised Becerra it has made arrangements for one of its international partner organizations to share with FDA confidential toxicology testing conducted for regulators in Europe.
CFCR’s letter was signed by three of its representatives, including Sarah Chase, who was named in August as the group’s first executive director.
HHS did not immediately respond Tuesday to a request for comment concerning the letter, which also was sent to FDA Acting Commissioner Janet Woodcock.
CBD bills, citizen petitions
U.S. lawmakers in recent years have introduced several bills to legalize CBD in supplements and/or food, including the CBD Product Safety and Standardization Act of 2021. The bills have not advanced to hearings or otherwise gotten close to passage in Congress.
Despite provisions in the Federal Food, Drug & Cosmetic Act (FDCA) described by CFCR as the “exclusionary clauses,” FDA—through authority vested in Becerra—could issue regulations for CBD-containing food and supplements. However, the agency has yet to commence a notice-and-comment rulemaking proceeding.
That’s not due to indifference by food and dietary supplement interests.
For instance, some trade organizations representing the dietary supplement industry have filed citizen petitions with FDA, requesting the agency issue CBD regulations. The Consumer Healthcare Products Association (CHPA) filed a citizen petition in 2019, followed by a similar petition in 2020 from the Council for Responsible Nutrition (CRN).
CHPA was advised in June 2020 that FDA needed “additional time to issue its final response because of the complexity of issues raised in your petition.”
“FDA will issue a final response to your citizen petition after completing the analyses of all of the legal and policy issues related to this petition,” the agency wrote to the trade group.
FDA also advised CRN in November 2020 that it needed more time to review its citizen petition for the same reasons it cited in the letter to CHPA.
“The continued lack of regulatory clarity along with insufficient oversight around hemp and hemp-derived CBD has led to bad actors entering the marketplace, exposing consumers to potentially unsafe products that contain illegal synthetic ingredients like delta-8 THC and lack consistency in product quality,” David Spangler, CHPA’s senior vice president of legal, government affairs and policy, said via email.
Added Spangler: “We continue to advocate for legislation consistent with CHPA’s 2019 citizen petition calling on FDA to utilize its existing authority and establish a lawful regulatory pathway for responsible manufacturers to bring dietary supplements containing CBD to market.”