*This article was originally posted in Law360 on June 4, 2019.
The much-anticipated public hearing last week at the U.S. Food and Drug Administration on cannabis and cannabis-derived compounds drew a wide audience of participants, with strong views on how the FDA should (or should not) regulate the controversial plant.
In an amazingly short period of time, hemp-derived products, including those containing cannabidiol, have moved from the fringe to the mainstream, from state-licensed dispensaries to traditional brick-and-mortar retailers. And yet, the FDA’s position has been clear — it is illegal to sell human food, pet food, dietary supplements and unapproved drugs that contain CBD.
Many comments submitted prior to the public hearing were from individuals describing their personal stories using CBD, including for treatment of chronic pain, pediatric pain and more. Veterans also recounted compelling stories describing their use of CBD to relieve anxiety and symptoms of post-traumatic stress disorder.
Some comments, however, expressed significant concern over product quality and consistency (e.g., adverse events resulting from CBD levels that vary from the labeled amount), the accuracy of information in product labeling (e.g., undeclared or synthetic ingredients), and microbial contamination. Similar praise and concern about restricted access to CBD were echoed in public comments presented at the public hearing.
The hearing focused on the use of CBD in food and dietary supplements, which accounts for a large part of the market growth. Dr. Norman (Ned) Sharpless, acting commissioner of the FDA, stated at the outset that the FDA treats substances derived from cannabis “just like any other substances,” meaning they are subject to the same premarket requirements and other authorities.
For example, any food additive must be approved by the FDA as safe before being put into the food supply, unless the substance is generally recognized as safe, or GRAS. Sharpless explained the current regulatory framework and reiterated the FDA’s position that under current law, CBD cannot lawfully be added to a food or marketed as a dietary supplement. Sharpless commented that American consumers depend on the FDA to help make sure that the food they eat is safe, and that there are “many unanswered questions” related to the safety of CBD in foods and dietary supplements.
The FDA heard testimony from hemp business owners, scientists, farmers, industry associations, health care professionals and consumer advocates. As expected, the FDA did not provide a strategy for regulating cannabis at the hearing or weigh in on specific questions. FDA panelists, however, asked questions that reveal the agency’s concerns over the widespread use of CBD in the food supply, including the scientific evidence to support safe levels of CBD in various forms (e.g., food, oils, topicals), restrictions on youth access, the effects of CBD on food-producing animals, and data collection efforts by consumer product companies to identify adverse events experienced by the larger consumer base. The questions also revealed, on a more basic level, the lack of agreement on common terms that allow both industry and the agency to characterize the plant itself and any proven therapeutic benefits.
Top Takeaways From the FDA Public Hearing
FDA Does Not Intend to Exercise Enforcement Discretion
Sharpless opened the hearing with statements that affirmed the FDA’s position on the illegal nature of CBD in foods and dietary supplements. Sharpless also stated that the FDA does not plan to exercise a policy of enforcement discretion with respect to any CBD products.
The FDA has garnered criticism from some for not aggressively pursuing marketers of online retailers of CBD gummies and edibles, despite the FDA’s stated safety concerns. While the FDA has issued a handful of warning letters to companies making egregious therapeutic claims, such as those claiming to cure cancer or Alzheimer’s, it has not initiated an aggressive pursuit of CBD marketers.
Much Is Unknown, and Industry Needs to Fill the Gaps
The FDA questions of public commenters, and the responses provided, revealed a lack of common understanding of CBD and delta-9-tetrahydrocannabinol, or THC, and the scientific bases for their therapeutic benefits. The FDA questioned commenters, for example, on how to properly define industry terms (e.g., full-spectrum versus broad-spectrum versus CBD isolate), and commenters’ presentations appeared to provide inconsistent information.
Along with the basic lexicon for cannabis, the FDA asked pointed questions on the mechanisms of actions for CBD and its therapeutic benefits. While some patient advocates provided powerful stories of specific benefits, including for preventing pediatric seizures, many consumer advocates spoke of more qualitative effects, such as feelings of “overall well-being” and anxiety relief. It is clear that the FDA wants more data on CBD use in the consumer context, including scientific and empirical data regarding how cannabis-derived compounds affect the public. This included requests for both studies in healthy individuals and larger consumer populations. FDA panelists’ questions focused particularly on understanding safe dosages, and routes of administration (e.g., inhaling versus ingesting versus topical application).
Commenters Largely Agreed That Some Regulatory Protections Would Be Beneficial
Public commenters seemed to agree — at some level — that some FDA regulation is beneficial for the protection of consumers. Some consumers expressed concerns over the quality of CBD in products, including inconsistent purity levels and undeclared ingredients that contaminate the product.
Consumer advocates and business owners recommended, for example, that the FDA apply well-established protections in its current legal framework, such as labeling requirements and good manufacturing practice, or GMP, standards. Some manufacturers urged the FDA to adopt a GMP framework that reflects the natural variability of CBD compounds in the plant. When FDA panelists asked commenters if GMP standards were currently being followed, however, many stated no. These questions, and others, revealed the disparate state of manufacturing and quality controls currently implemented in the industry.
There Is Pressure on the FDA to Act Fast
The very recent explosion of CBD-infused foods, edibles (e.g., gummies, candy), and beverages in the marketplace, coupled with conflicting, lenient or nonexistant state laws on the sale of hemp-CBD products, puts pressure on the FDA to act quickly in an area that is squarely within its domain.
Multiple stakeholders urged the FDA to act fast — researches urged the FDA to move quickly so that cannabis could be more readily available for scientific studies; business owners asked for clarity so that they could understand their legal risks and opportunities; and consumer advocates sought clear post-market requirements, such as labeling and manufacturing standards, to protect consumers from contaminated products.
As in the past, the FDA will apply an evidence-based approach to regulation. The FDA will have to balance, however, the considerable time it will take to wade through the scientific data with industry and public demand for action.
Youth Access Is a Significant Concern
The FDA specifically requested information on how vulnerable populations, and in particular minors, would be affected by the proliferation of CBD products. The FDA asked companies selling CBD products to consumers how they were restricting sales to youth, including physical restraints in stores (for example, prohibiting minors from entering retail stores), and whether the age restrictions were determined based on scientific evidence. With the FDA’s laser-like focus on preventing the marketing of electronic cigarettes to minors, industry can expect similar scrutiny on companies selling CBD products, and in particular those that may be inhaled/vaped.
Click for the full article: What We Learned From FDA’s Public Hearing On Cannabis.