FDA Struggles with How to Regulate CBD Products
FDA is struggling to figure out how best to regulate hemp-based cannabidiol (CBD) products after a provision in the 2018 Farm Bill clarified that hemp and hemp products are legal. Shortly after the bill’s passage, former FDA commissioner Scott Gottlieb 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. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. 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.”
In particular, FDA has said that it continues to be concerned about drug claims being made with products purporting to contain CBD or other cannabis-derived compounds. “Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” Gottlieb said in a statement before he left the agency last month. “This is the same standard to which we hold any product marketed as a drug for human or animal use.”
Currently, CBD products are popping up on the shelves of convenience stores, coffee shops and nutrition stores in many states, according to a report in The Hill. The agency 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. “Nobody knows if it’s legal or not or what to do,” Greenspoon Marder attorney Jessica Wasserman, who represents several CBD companies told The Hill. “FDA can’t just ignore it or regulate it out of existence.”
During budget hearings in April, Gottlieb was pressed on the agency’s next steps. “We’ve heard Congress loud and clear. There was an intent to provide a regulatory pathway that allowed for lawful marketing of products derived from hemp, including CBD,” Gottlieb said. “So we’re trying to work expeditiously to create a pathway.” Gottlieb had already hinted that one potential approach would be to regulate the amount of CBD in certain products; any dosage above a certain level would be considered a drug and subject to a stricter approval process.
According to The Hill, some states have been cracking down on CBD-infused food. Officials in Maine, Ohio, Florida, New York City and others this year banned stores and restaurants from selling CBD-infused food and ordered existing products removed from shelves. The federal government hasn’t been directly involved in any of the actions, and most experts agree FDA can’t order every single CBD product off the market. “FDA is taking the position that any CBD is illegal, but that doesn’t mean it has the regulatory or enforcement resources to go after these products,” said Marc Scheineson, an attorney at Alston & Bird and a former associate FDA commissioner.
FDA has announced a 5/31 public hearing for stakeholders to share their experiences and challenges with these products, including information and views related to product safety. Additionally, the agency has formed a “high-level internal agency working group to explore potential pathways for dietary supplements or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health. For FDA to develop such a pathway could take years through the rulemaking process, and current acting commissioner Ned Sharpless has gone on the record to maintain the agency’s current course of action in every area.
Attorney Wasserman told The Hill that industry is skeptical that FDA can do it alone. “They will not resolve this issue on their own without some kind of congressional pressure,” she said. “The idea of getting a deadline is of interest to people; the concern is [the FDA] will never move forward on this.”