WSGR ALERT

FDA Signals a Deliberative Approach to Cannabis at Public Hearing

June 6, 2019

While it was ostensibly convened to gather scientific input from stakeholders on how to appropriately regulate cannabis-infused products, the Food and Drug Administration (FDA) also used the May 31, 2019 public hearing as a platform to issue a call for safety data for these products. For stakeholder groups hoping for the FDA to act quickly on regulating or providing guidance on cannabis products, agency officials seemed to temper those expectations through their requests to the public witnesses for additional evidence of safety.

The ten-hour public hearing, titled "Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds," included remarks from a wide range of groups representing academia, agriculture, consumers, public health professionals, manufacturers, patients, retailers, and state government officials.

Acting FDA Commissioner: Many Questions Remain

In his opening remarks, Acting FDA Commissioner Dr. Norman Sharples noted that cannabis contains more than 80 biologically active chemical compounds, including the two best known ones, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). He reminded the audience that, under current law, CBD and THC cannot be added to a food or marketed as a dietary supplement.

While he acknowledged that the Federal Food, Drug & Cosmetic Act allows the FDA to issue regulations creating new exceptions to these statutory provisions, Dr. Sharples declared that the FDA has never issued a regulation like that for any substance.

"So, if we were thinking about doing that for a substance like CBD, it would be new terrain for the FDA," he asserted.

Dr. Sharples explained that the FDA carefully evaluates the risks and benefits of a specific formulation, dosage form, and strength for a particular population when it approves a drug. He added the FDA often concludes that a prescription or other medical supervision is required for a drug to be safely used and protect against potentially dangerous misuse. Dr. Sharples declared that THC and CBD are no exception.

According to Dr. Sharples, there are real risks associated with THC and CBD, and critical questions remain about the safety of their widespread use in foods and dietary supplements, as well as other consumer products, including cosmetics. When hemp was removed as a controlled substance, he emphasized that the lack of research and evidence to support CBD's broader use in foods and dietary supplements has resulted in unique complexities for its regulation, "including many unanswered questions related to its safety."

Dr. Sharples concluded that there are a number of questions remaining that will need to be answered to ensure that the FDA is taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.

The statements from various stakeholder groups proceeded as expected, with industry groups urging the FDA to move quickly in issuing regulations on safety and testing. Patient advocacy groups expressed support for more clinical trials and testing standards, as well as labeling of drug interactions. Food retailers also urged the FDA to expedite the pathway to regulation in order to alleviate the mass confusion in the marketplace for manufacturers, retailers, and state regulators.

State Government Concerns

Pam Miles from the Virginia Department of Agriculture, and also representing the Association of Food and Drug Officials (AFDO), acknowledged that state and local governments are struggling from a lack of sound scientific research available on CBD and its long-term health impacts, including those to children. In response to a question from an FDA panelist, Miles acknowledged that AFDO is compiling a collection of adverse event reporting for CBD products and would provide that information to the FDA when it is available.

Joseph Reardon from the North Carolina Department of Agriculture and Consumer Services cited the rapidly growing industrial hemp market in his state in urging the FDA to resolve any statutory issues and establish a legal pathway for CBD products. He warned that, without any guidance from the FDA, states might carve out their own exceptions that would hinder the growth of this market.

Erin Bubb from the Pennsylvania Department of Agriculture, and on behalf of the Association of American Feed Control Officials (AAFCO), noted the presence of CBD-infused products in his states, especially pet treats. When asked by the FDA panel to what extent CBD is being used in the feed of food producing animals, Bubb admitted that, while Pennsylvania has not encountered that yet, there is interest in adding CBD to animal feed.

Questions from the FDA Panel

The lines of inquiries that the FDA panel directed toward the hearing witnesses echoed the concerns outlined in Dr. Sharples' remarks.

The following is a sampling of the questions asked by the FDA panel, which could provide some insight on the issues the FDA will be focused on as it deliberates on a regulatory scheme for CBD products.

  • One witness claimed that cannabis has an incredible safety profile compared to other over-the-counter (OTC) products and FDA-approved drugs on the market, adding that it is 400 times safer than caffeine and 200 times safer than aspirin. The FDA panel asked for his data to be submitted to the public record.
  • When one small retailer noted that she does not sell CBD products to those under 21, the FDA panel inquired how that age threshold was selected. The retailer acknowledged the age limit was established as a safety net and that it was not based on scientific evidence.
  • Similar to their question to AAFCO, the FDA panel inquired to a representative of the American Veterinary Medical Association (AVMA) about the impact of CBD in animal feed on human food. The AVMA acknowledged that it is concerned about it and intends to examine the issue.
  • The FDA panel asked one manufacturer how it determined safe dosage amounts, factoring in the condition and age of patients, and about potential side effects encountered in the study conducted by the manufacturer.
  • The FDA panel pushed one advocate to submit data supporting his claim that hemp products provided health benefits, and is non-psychoactive and non-intoxicating.
  • One advocacy group was urged by the FDA panel to submit its data on pregnancy and drug interaction, as well as adverse events and consumer complaints. The panel also encouraged another advocacy group to submit data on the impact CBD products have on children.
  • When asked by the FDA panel why some epilepsy patients use unapproved CBD products when there is an FDA-approved drug available, a representative from the American Epilepsy Society explained that the approved drug only is effective for a small group and is very costly. He added that, as it relates to choosing dosage amounts for unapproved CBD products, patients are "making it up as they go along."

Is a Deliberative Approach Forthcoming?

Based on Acting Commissioner Sharples' remarks, and the pointed questions asked of witnesses by the FDA panel during the hearing about the need for more data, it appears unlikely that the FDA will expedite the process for determining a regulatory scheme for CBD products. The need for more data was a sentiment shared at the hearing by medical professionals, academics, patient groups, and state regulators.

Stakeholders unable to participate in the public hearing still are able to submit comments to the FDA docket on cannabis until July 2, 2019. However, some presenters at the hearing requested that the FDA extend the deadline by one month.

In another signal that a deliberative approach by FDA is forthcoming, Dr. Sharples indicated in his remarks that the FDA has formed an internal working group to address these data gaps specifically, and that the public would be hearing more from this group "in the months to come." For those who monitor and scrutinize the activities of regulatory agencies, such a statement typically does not lend itself to an expedited process.

Overall, the message from the FDA to the food, beverage, and dietary supplement industries was fairly clear: while the agency is exercising enforcement discretion for CBD-infused products, companies should be aware that these products still are unlawful and subject to enforcement actions, especially for those with questionable label claims. Also, if companies possess any data that demonstrates the safety and efficacy of CBD-infused products, it should be submitted to the agency.

Wilson Sonsini Goodrich & Rosati's FDA group is actively following developments on regulations impacting hemp and CBD. For more information, please contact Brian Ronholm, David Hoffmeister, Georgia Ravitz, Jamie Ravitz, or any member of WSGR's FDA group.

Charles Andres contributed to the preparation of this WSGR alert.