FDA says the regulatory frameworks for food and supplements are not appropriate for CBD

BY RACHEL NELSON

Hemp advocates have long hoped the federal government would move to regulate cannabidiol (CBD) as a dietary supplement. On January 26, however, the U.S. Food and Drug Administration (FDA) issued a statement that the existing regulatory frameworks for food and supplements are not appropriate for CBD.

The FDA cited concerns for health and safety as the basis of its decision, especially regarding long-term use.

“Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system,” the statement reads. “CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”

In its statement, the FDA also made claims that CBD poses risks to animals and that humans are at risk of being “unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD.”

Jonathan Miller serves as the General Counsel of the U.S. Hemp Roundtable, a coalition comprised of dozens of companies and organizations committed to safe hemp and CBD products. Clapping back at the FDA’s statement, he issued a statement that flat-out accuses the agency of getting it all wrong.

“Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues,” Miller’s statement reads. “The Roundtable recently met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.”

The Texas Hemp Coalition, a nonprofit that advocates for the Texas hemp industry, took to Instagram to express its disappointment regarding the decision. Regulating CBD as a dietary supplement is something the group has lobbied for in Washington.

“We are saddened to see their stance and hope to see more movement to support our industry in protecting CBD,” the post read. While the FDA said a new regulatory pathway for CBD would provide safeguards and oversight that minimize CBD-related risks, Texas Hemp Coalition Executive Director Ilissa Nolan said it creates more red tape.

“It’s making it so much harder for CBD products to have certain pathways for food, beverage and distribution purposes,” Nolan said. “This is prolonging us being able to move forward as an industry. It’s disappointing that these are the FDA’s concerns when it comes to the safety of CBD.”

While new CBD regulations have not been implemented at the federal level, the FDA said it will likely move to create a set of comprehensive requirements to ensure it’s safe for consumers to use. Those could include labeling requirements, contaminant prevention, CBD content limits and a minimum purchase age.

“In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals,” the FDA’s statement said.

The Texas Hemp Coalition stated that it hopes the FDA will continue to work with the hemp industry to find a path forward that protects CBD and Texas’ growing market.

“We have advocated in Washington, D.C. on this very issue with little to no objection from legislators. However, FDA deems it necessary to create a more lengthy process to regulate, which could cost our industry more issues,” the statement reads.

“Where I think they may be wrong on this is that DSHS is of the opinion that consumable hemp products for inhalation are food items,” Spencer said. “It makes no sense to me because food is defined in the act as an article used for food or drink for a man. … I do think this new interpretation of theirs is susceptible to a carefully crafted challenge that I will not give out to my competitors.”

To sum it all up, Spencer explains, “Retailers can continue to sell. If you are manufacturing or processing (smokable hemp products) here in the state, you should have stopped. Even if you are white labeling out of state but you are the one directing the process to bring it back into the state to sell, they are under the opinion now that that is an illegal act. I was pretty shocked when I read that paragraph.”

According to Spencer, if anyone is caught in noncompliance with the rules, DSHS must provide fair notice of a potential violation and the opportunity to cure any unintentional or negligent violations, which are not defined.

“Every day that you are in violation constitutes a separate violation,” Spencer said. As far as the penalties, Spencer said, “Your guess is as good as mine. It is an administrative agency, so they should have the ability to impose a monetary fine.”

Let your voice be heard

Spencer said she finds the timing of DSHS’ announcement interesting, as it coincided with the early weeks of the legislative session.

“I don’t think they did it with the motivation to spur the hemp industry to blow up legislator’s phones, but that’s the impact it should have because it’s up to you guys listening to go do that,” she said.

Spencer notes that input from constituents is one of the most valuable things a legislator can receive, and they really do listen.

“I know there are several of you out there rolling your eyes thinking, ‘They’re not going to listen to me.’ But listen, I work with these senators. I help draft some of these bills. I have seen research proponents as they’re preparing bills where your comments are in there, so they do hear them,” she said.

For anyone who has questions about the new regulations, Spencer recommends contacting any qualified cannabis counsel. For those who can not afford it, she recommends calling DSHS.

“DSHS is actually really helpful as an agency,” she said. “They have an email for contact and a phone number. I prefer email, obviously. I want to get any advice they give me in writing.”

Spencer also offers paid consultations and is available to represent businesses.

“If you’re a retailer and distributor who is out there who has been white labling your own products, and your revenue is enough that you want to fight for this, give me a call at 214-295-5070,” Spencer said. “They’re not bluffing. They’re going to start enforcing and giving out some citations.