Following through with its promise to take enforcement actions against companies marketing cannabis-derived products that could put consumers at risk, the Food and Drug Administration (FDA) recently issued a warning letter to Curaleaf Inc., a Massachusetts-based company, for illegally selling unapproved cannabidiol (CBD) products online with unsubstantiated claims. Among the claims made by the company was that their products could treat cancer, Alzheimer's disease, opioid withdrawal, pain and pet anxiety, among other conditions.
Acting FDA Commissioner Ned Sharpless declared in an agency press release that selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk by leading them to postpone important medical care. He further asserted that there are many unanswered questions about the science, safety, effectiveness, and quality of unapproved products containing CBD.
Sharpless proclaimed, "Today's action demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved, such as those claiming to treat cancer and Alzheimer's disease."
The warning letter requested a response from Curaleaf within 15 working days outlining how the violations would be corrected, warning that failing to correct the violations could result in legal action, including product seizure and injunction.
Congressional Pressure on the FDA Continues with More Hearings
During the same week that FDA issued its warning letter, two Senate committees convened hearings to examine hemp and CBD issues, perhaps signaling that congressional interest in monitoring agency deliberations on these issues likely will not abate.
In a Senate Agriculture Committee hearing, Dr. Amy P. Abernethy, FDA principal deputy commissioner, emphasized that it can take three to five years to complete even an expedited notice and comment rulemaking process that complies with the Administrative Procedure Act and other requirements. "Completing a rulemaking requires the Agency to develop a robust record to support the rulemaking, including economic analyses, and to consider public comments, which can be voluminous when rulemakings concern substantive topics for which there is extensive public interest, as in the case of CBD," she explained.
Dr. Abernethy acknowledged that three to five years may be too long to wait for regulatory clarity, especially given the strong public interest in hemp and CBD products, adding that the agency is exploring options to reach a resolution quickly and efficiently.
A recent Senate Banking Committee hearing examined the tension between state and federal law relating to cannabis and how the legal risks derived from this tension is preventing financial institutions from serving the cannabis industry. A bipartisan group of committee members expressed concern over the problems in the financial services industry caused by the disconnect between state and federal laws and asserted that Congress needs to act to provide banking services to legitimate cannabis businesses.
Former FDA Commissioner Gottlieb Weighs in
No longer restrained by official government duties, former FDA Commissioner Scott Gottlieb argued in a recent op-ed that the multiyear process for the FDA to issue regulations on CBD "might simply take too long." He declared that there is a way for the agency to meet the political demand for CBD and still be able to fulfill its public health obligations: the FDA can approve the sale of some CBD products immediately, while effecting a framework for their safe and proper regulation and a pathway for an enforceable market for these products.
Gottlieb explained that the FDA could put the onus on manufacturers to bring forward petitions to demonstrate that CBD can be safely added to products such as food. He added that these submissions can take the form of new dietary ingredient notifications or food additive petitions, which would include toxicity studies to evaluate the safety of CBD, noting that any new food ingredients are held to the same standards.
Congress could assist the agency by passing language allowing the FDA to forgo issuing broad CBD regulations and instead rely on petitions filed by individual, prospective producers, Gottlieb suggested. In the meantime, he added, the FDA could exercise enforcement discretion to allow CBD to be marketed in food so long as the products meet certain conditions, including: meeting good manufacturing requirements; demonstrating traceability; adhering to safe levels for the purity and potency of the CBD being added, and demonstrating that CBD is being added to food products only in very low concentrations that are unlikely to pose health risks.
During his time as FDA commissioner, Gottlieb urged a more cautious approach towards CBD regulations. This past April, Gottlieb asserted that it is critical that a number of unanswered questions about CBD be addressed as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods. He argued that the FDA would only consider this path if the agency were able to determine that all other requirements in the Food Drug and Cosmetic Act are met, including those required for food additives or new dietary ingredients.
Will the FDA Really Act Quickly?
Based on recent statements and announcements, it seems that the FDA is attempting to strike a careful balance between exercising its regulatory due diligence in ensuring that CBD products are safe, while giving the perception that the agency is acting quickly to provide industry guidance.
As part of the FDA's statement on the warning letter to Curaleaf Inc., Dr. Abernethy announced that the agency would expedite its work to address the many questions about CBD. However, the expedited action outlined in the statement seemed to be limited to reporting on the FDA's progress by early this fall. This is unlikely to appease the cannabis industry or its congressional supporters.
In her testimony before the Senate Agriculture Committee, Dr. Abernethy acknowledged that the FDA is wrestling with questions not only about the intrinsic safety of CBD, but also about potentially unsafe manufacturing processes for products containing CBD. She declared that the FDA will only consider creating legal pathways for CBD products if it is confident that it can develop a framework that addresses safety concerns.
Dr. Abernethy added that, based on tests the agency has conducted so far, CBD products may not contain the amount of CBD indicated on a label, or they may contain other potentially dangerous compounds that are not listed on the label. "Therefore, FDA must consider questions related to good manufacturing practices for CBD products and potential labeling that might be appropriate for these products to address any potential risks to consumers," she reasoned.
While the FDA professes to want to work expeditiously in drafting regulations for CBD products, its statements and congressional testimony would indicate the continuation of a more deliberative approach in determining the safety of these products. However, if industry demand and congressional pressure continue to intensify and overwhelm the FDA, it is conceivable that the agency could move forward with a plan similar to what former commissioner Gottlieb outlined.
