FDA Cannabis Hearing Probes Regulatory Issues
FDA 5/31 kicked off a long-awaited public hearing on “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds” by reiterating concerns about drug-like claims touted by product marketers. “Our biggest concern is the marketing of products that put the health and safety of consumers at risk, such as those claiming to prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer, in the absence of requisite approvals,” FDA acting commissioner Ned Sharpless said at the hearing.
The hearing is the official beginning of a planned regulatory effort to gather stakeholder input and scientific data for FDA to consider as it weighs important policy options related to regulating products containing cannabis or cannabis-derived compounds. The legal landscape has been quickly changing with states passing laws allowing medical-use marijuana or cannabidiol (CBD), and the 2018 Farm Bill clarifying that hemp and hemp-based products are legal. Shortly after the bill’s passage, the agency issued a statement acknowledging that “Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act... This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways, to the extent permitted by law, for products containing cannabis and cannabis-derived compounds.”
Currently, CBD products are popping up on the shelves of convenience stores, coffee shops and nutrition stores in many states. FDA is facing bipartisan pressure from Congress to come up with a solution. In the meantime, the CBD industry is operating in a gray area and facing uncertainty about what the next steps will be while the agency crafts a regulatory strategy for such products.
Center for Medicine in the Public Interest president and former FDA associate commissioner Peter Pitts told the public hearing that the “absence to date of advanced regulatory thinking relative to CBD has resulted in a maelstrom of false claims and shoddy quality standards.” He said it is time for all the CBD proponents to become part of the solution. Current key issues, he said, include a lack of quality standards for products, no dosing standards, and the potential for harm through chronic use.
National Cannabis Industry Association (NCIA) policy director Andrew Kline presented extensive written testimony compiled by a coalition of more than 100 CBD/hemp entrepreneurs, scientists, medical professionals, and food and drug lawyers. The coalition’s testimony addressed medical benefits, health and safety concerns, manufacturing and product quality, and the need for a robust regulatory structure with guidance for product testing, marketing, and labeling.
NCIA said that additional data should be gathered to support the regulatory process. “Data gathering and research are being conducted in the private sector, but collaboration with regulators will be necessary to validate the process,” the testimony said. “We strongly recommend that the FDA act quickly to clarify the regulatory environment because there is significant confusion in the market. Consumers consistently ask why a federally legal substance is currently prohibited in food and wellness products under FDA regulations. These inquiries will likely remain a source of confusion, especially when so many individuals already use CBD products.”
Additionally, NCIA said that until FDA issues a new regulation, the agency should “continue to exercise its enforcement discretion to allow consumers continued access to hemp-derived CBD products. We support the FDA’s issuing Warning Letters for drug claims that go beyond substantiated claims and believe that this is the best approach until the FDA issues rules establishing a pathway for regulating food and supplements containing CBD.”
Consumer Healthcare Products Association senior vice president David Spangler told the hearing that hemp and CBD products should share FDA’s priorities for over-the-counter products — public safety, product quality and informed consumers. He said the existing new drug approval process is still appropriate for product sponsors to develop data to bring cannabis-derived products to market once shown safe and effective. And he said enforcement efforts should be increased against product marketers making unapproved drug claims.
During the hearing, FDA offered real-time input as to what it was hearing from presenters. FDA principal deputy commissioner Amy Abernethy live-tweeted that she is hearing a “need to further clarify the regulatory framework to reduce confusion in the market. The product questions apply to people and animals. Given the rapid expansion of the market, timely clarification of the path forward is critical, but it’s our responsibility to ensure that the regulatory path is scientifically sound and in the interest of public health.”
Abernathy also acknowledged that key questions about product safety need to be addressed. “Data are needed to determine safety thresholds for CBD; datasets/information should be objective, of adequate quality and available for transparent review,” she tweeted. “Lab testing and data analyses need to be replicable.There are both positive supporters of cannabis and cannabis-derived products including CBD, and also concerned citizens worried that widely available products can be harmful. Consumers need consistent information and labeling.”
She also said that state and government entities need support in knowing what to do. “And we really need to understand the implications for children when they take CBD-containing products at different dosage ranges,” she said.
FDA has established a docket (FDA-2019-N-1482) for public comments on the hearing. Electronic or written comments need to be submitted by 7/2. Several presenters called on the agency to extend the comment due date.