Earlier this week, we provided you with five key questions businesses should ask before entering the CBD market.
As a related follow up, we wanted to provide you with an overview of FDA’s recent public hearing on cannabis products in case you were not one of approximately 500 live attendees or just want a refresher on the topics discussed. The main takeaway from the event was that there was a lot of supporters and information presented on both sides, arguing for and against allowing cannabis derived ingredients into consumer products. As a result of the plethora of information presented, FDA has now created a vast administrative record to support almost any position they wanted to take on the issue from cracking down on the CBD industry to allowing it to continue based on supporting the public health.
On May 31, 2019, the Food and Drug Administration (FDA) held a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. This hearing was open to the public and the goal of the hearing was to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds – both from botanical and synthetic sources – to inform the regulatory oversight of these products.
This hearing was one of FDA’s largest with over one hundred presenters, sold out seating, and over six hundreds comments and counting submitted to the public docket. With the status of the CBD market hanging in the balance many people for and against these cannabis derived compounds showed up to sway FDA to take action.
Panel Members and Oral Commentators
FDA’s committee members included the following: Dayle Cristinzio, Presiding Officer Director; Amy Abernethy MD and PhD, Principle Deputy Commissioner; Nick Alexander JD, Director of Intergovernmental Affairs; Jarilyn Dupont JD, Director of Regulatory Policy; Randall Gnatt JD, Regulatory Counsel; Rebecca Goldberg JD, Associate Chief Counsel; Sharon Mayl JD, Senior Advisor for Policy, Erik Mettler MPA and MPH, Assistant Commissioner for Partnerships and Policy, Timothy Schell PhD, Director of the Office of Surveillance and Compliance of FDA, Lowell Schiller JD, Principal Associate Commissioner for Policy, Sherene Sepehri JD, Associate Chief Counsel, and Douglas Throckmorton MD, Deputy Director for Regulatory Programs of the Center for Drug Evaluation and Research.
There were over a hundred presentations and FDA grouped these presentations in to various topics such as health care professionals, agriculture, consumers, manufacturers, patients, public safety advocates, retailers/distributors, and state/government officials.
Ned Sharpless MD, Acting Commissioner of the FDA, gave opening remarks and described FDA’s changing relationship as a regulatory body towards cannabis and cannabis-derived compounds. He cited the 2018 Farm Bill as the authority given to the FDA to regulate the products. Dr. Sharpless then clarified that the relevant legal requirements of the FDA vary depending on which type of product is being discussed (e. the processes differentiate for drug and food products). However, he stated that under current law, CBD, (cannabidiol) and THC (delta-9-tetrahydrocannibinol) cannot lawfully be added to a food or marketed as a dietary substance. Although the FDA can issue regulations to create new exceptions to these statutory provisions, the FDA has never issued a similar regulation like that for any substance. FDA reiterated that there are real risks associated with both of these substances and critical questions remain about the safety of their widespread use in foods and dietary supplements, as well as other consumer products – including cosmetics, which are subject to a separate regulatory framework. Sharpless reiterated that FDA does not plan to institute a policy of enforcement discretion for CBD. He also stated that FDA’s main policy concern is ensuring that no products put the health and safety of consumers at risk. Lastly, he stated that FDA had created an internal working group on CBD and that the public should be hearing more from this internal group in the months to come.
Sharpless comments are available on FDA’s website.
Questions for Consideration
Health and Safety Risk
The primary concern for FDA officials was the health and safety of cannabis and cannabis-derived products. FDA’s panel had a variety of questions for the presenters including: What levels of cannabis and cannabis-derived compounds cause safety concerns? Are there special human populations that should be considered when assessing the safety of products? What are the characteristics of a successful system to collect representative safety information at the national or state level? What end points or outcomes would define a maximal acceptable daily intake from all products? Are there any data known that would support the safe use of these products in general food use? How does the existing commercial availability of food products containing cannabis-derived compounds such as CBD affect the incentives for, and the feasibility of, drug-development programs involving such compounds?
Manufacturing and Product Quality
FDA was also concerned about the production process and the methods used to ensure product quality and consistency. The panel had a variety of questions for the presenters including: Are there particular standards needed to address any safety issues related to the manufacturing, processing, and holding of products? Are there standards or processes to ensure manufacturing quality and consistency of products? What validated analytical testing is needed to support the manufacturing of safe and consistent products? Are there currently used standardized definitions for ingredients in cannabis products? What are the functional purposes of adding cannabis-derived compounds to food, both in terms of manufacturer intent and consumer perceptions and/or expectations?
Lastly, the FDA was interested in information regarding how these products are marketed, labeled, and sold. Their questions for the presenters included: How should consumers be informed about the risks associated with such products? What conditions, restrictions, or other limitations on the manufacturing and distribution of these products have been put in place under State or local law? What statutory or regulatory restrictions are in place under State or local law to warn about the use of these products by certain vulnerable human or animal populations? What other information should the FDA consider in the labeling of specific product categories?
FDA will be looking to answer these questions in the upcoming months based on the information it received at this meeting and the information submitted as comments to the docket.
The overwhelming responses to the FDA’s concerns were that predictability is critical to resolving future FDA guidance and policy related to CBD. The current ambiguity has led to what several presenters called a “Wild West” atmosphere in the country when it comes to CBD, with many marketers either unaware of the FDA’s authority over such products or accepting the regulatory uncertainty as a tolerable business risk in light of the massive consumer demand. Several speakers noted that, unlike CBD, lesser-known hemp derivatives are not prohibited from the food supply because they have never been approved for use as a drug or tested in clinical trials for specific medical uses.
Another point of concern was research barriers. Presenters stated that these barriers have kept them from learning about the drug’s safety and benefits. While CBD can be extracted from both hemp and marijuana, which is in the federal government’s most restricted drug class, CBD research was previously very difficult because it used to be considered a controlled substance as a product derived from marijuana. In the absence of FDA-approved evidence, consumers who think they could benefit from CBD are buying it retail. The route of buying from commercial retailers, that many consumers take, mean that scientists and the FDA have less data and consumers have less medical supervision.
Several presenters challenged the FDA’s interpretation of law that Sharpless summarized in his opening remarks, and suggested that, on at least one occasion, FDA had issued a regulation to allow an ingredient in the food supply.
Another main topic was the lack of standardization in the CBD industry, adherence to quality standards, and the lack of truthful labeling. Several stakeholders presented results of their own laboratory testing of commercially available CBD products that showed a large number of products containing much higher or lower amounts of CBD than the label claims; in some cases containing high levels of THC; and even high levels of unsafe contaminants like lead.
The FDA has signaled that it is closely monitoring the cannabis space with both the public hearing and the announcement in early April 2019 regarding the creation of a “high-level agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”
In the near term, the FDA will collect and review data from the industry on the safety of cannabis and cannabis-derived compounds. The pathway to regulation will be informed by a review of the presented scientific information as well as comments submitted to the docket. The working group assigned to review this data is expected to share their findings in the summer of 2019. Presently, the FDA may continue its current enforcement strategy, which consists of targeting companies making egregious therapeutic claims but nothing can be assured.
Regardless, any company that wants to influence the Agency and has relevant data regarding the use of cannabis derived products should make sure to submit their comments to FDA’s docket on this topic that close July 2, 2019. That docket can be found at regulations.gov - https://www.regulations.gov/docket?D=FDA-2019-N-1482
Buchanan’s Cannabis team will continue to monitor the legislative and regulatory process and provide you information regarding the most recent developments.
Colleen Karlovich, Summer Legislative Assistant, contributed to this advisory.