The U.S. Food and Drug Administration held a public hearing last week to obtain scientific data about the safety and sale of products containing cannabis or cannabis-derived compounds, including CBD. It was clear from the hearing that FDA will continue to play a key role in shaping cannabis policy federally and that the agency needs more research and data to do so. Presenters from a variety of stakeholder categories pressed for some form of FDA regulation over the myriad products that have already flooded the market and those that are likely to do so in the future. The FDA regulation will not come quickly and the status quo therefore remains in place – companies will continue to sell and introduce new cannabis and cannabis-derived products and FDA will continue to issue Warning Letters to companies making health claims on cannabis products or using cannabis in food products.
As we mentioned in a previous Alert, FDA held a public hearing on May 31, 2019 “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”1 A wide-ranging group of industry stakeholders, including consumers, doctors, retailers, manufacturers, researchers, industry groups, lawyers, and patients attended the hearing. With over 400 applicants vying to present their viewpoints, over 100 individuals were permitted to voice their interests and concerns over the regulation of cannabis plants and derivatives (including cannabidiol (CBD)), and their uses in both products and foods.
Reed Smith’s Cannabis Law Team closely monitored the hearing and has the following key takeaways. In short, while many presenters touted the benefit of cannabis during the hearing, FDA did not seem ready to commit to potential rules and regulations regarding cannabis or cannabis-derived products until it has more data regarding the ingredients’ safety; in fact, during the hearing, the agency repeatedly asked the presenters to submit available data on that point. Throughout the hearing, industry members requested federal regulation and standardization over the use of these ingredients, and the hearing made it clear that FDA will continue to lead the discussion on the use of cannabis and cannabis derivatives in FDA-regulated products.
- FDA continues to play a key role in shaping cannabis policy at the national level. It will come as no surprise that FDA intends to continue to be involved in shaping the regulation of cannabis and cannabis-derived products in the marketplace. Acting FDA Commissioner Norman E. “Ned” Sharpless reiterated this position in his opening remarks wherein he emphasized FDA’s authority to regulate such products and explained that FDA will continue exercising its enforcement discretion against companies putting the health of consumers at risk. Despite advancements at the state level, Commissioner Sharpless made clear that critical questions exist about the safety of cannabis and that FDA will continue to review the relevant data to help formulate the federal rules and regulations on the use of cannabis and cannabis-derived products.
- More research and data is needed on the uses of cannabis and cannabis-derived products and their potential effects on public health. Throughout the hearing, many presenters stressed the benefits of cannabis and its uses while many presenters stressed the risks and negative effects of cannabis and its uses. However, what was evident to both FDA and listeners-at-large was the lack of scientific research and data to back up many of the presenters’ statements, especially those emphasizing the safety of cannabis and cannabis-derived products. FDA periodically probed presenters for more information on the potential negative effects of cannabis on human and animal health, only to come up short; in fact, the agency even asked one of the presenters whether he would give CBD to his children. FDA’s goal for this hearing was to gain a better understanding of the scientific data and information about cannabis in order to inform federal rules and regulations down the road. If industry stakeholders intend to sway FDA one way or the other on the regulation of cannabis and cannabis-derived products, they will need to offer more than mere pronouncements about the potential positive and negative effects on public health. The influencers of the final determinations by the FDA will be those who can offer comprehensive scientific evidence of the positive and negative effects of cannabis so that FDA can use this information in formulating regulations designed to protect public health. FDA explicitly requested that various presenters provide such information via the public comment process that will remain open until July 2, 2019.
- The industry is clamoring for standardization. Although industry representatives were divided on how, and to what extent, FDA should regulate cannabis, all industry stakeholders appeared to recognize the need for standardization in the industry and frequently raised concerns that lack of standards has led to low-quality products in the market and less-reputable manufacturers taking advantage of consumers. Concerns about questionable quality and safety of cannabis products currently being sold led many presenters to ask FDA to formulate labeling standards; offer guidance on the branding and advertising of cannabis products; create guidelines on manufacturing facilities that produce cannabis products; and propose age restrictions on certain cannabis and cannabis-derived products to the extent needed (presenters and the agency also debated the appropriate minimum age requirements). Industry representatives even raised concerns over the lack of standard terminology in the industry and the need for clarity on what terms mean (for example, tetrahydrocannabinol (THC)-free, full-spectrum, broad spectrum, isolate, and the like). Such ideas seemed to resonate with FDA; however, with such a wide-ranging scope of products and players in the cannabis space, it remains to be seen how and to what extent FDA will address these issues. Moreover, some manufacturers requested that FDA place restrictions on the marketing activities of those that are already marketing products containing CBD, if and when FDA legalizes CBD as a food or dietary supplement ingredient. The manufacturers’ rationale was that FDA’s lack of enforcement against those already marketing CBD products provides perverse incentives for the industry to not adhere to the agency’s guidance and legal positions. FDA, however, did not respond to these comments during the hearing, and there is no indication currently that the agency will take this route.
- The status quo remains in place for now. Overall, it was abundantly clear from the hearing that the status quo is not working and that FDA needs to move faster to regulate the manufacture and sale of cannabis products. However, as those that deal with FDA on a regular basis are abundantly aware, FDA moves carefully and deliberately and we are potentially years away from a formalized slate of regulations for the industry. In fact, former FDA Commissioner Scott Gottlieb has said previously that it could take years for the agency to figure out exactly how to regulate CBD. As a result, the status quo remains in place, companies will continue to sell and introduce new cannabis and cannabis-derived products, and FDA will continue to issue Warning Letters to companies making health claims about cannabis products or using cannabis in food products.
As a next step in the process, FDA will accept written comments from industry stakeholders on the issues raised in the public hearing until July 2, 2019.2 FDA has convened a working group, led by Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller, to explore ways that cannabis products might be sold legally, the impact of such products on public health, and whether new FDA rules or congressional legislation may be needed. The working group plans to begin sharing information and/or findings with the public as early as summer 2019. Despite the industry’s repeated requests for regulation and standardization, it appears the regulatory landscape will remain as is for now, and FDA will issue its position following its receipt and review of the data that it believes is critical (for example, data supplied by sources such as industry, research organizations, law enforcement agencies) is.