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FDA WANTS PUBLIC HEARINGS FOR CBD - Legal limbo creates strain on industry.

Next month public hearings are scheduled by the US Food and Drug Administration to discuss developing a regulatory framework for the use of CBD in consumer products, including foods and beverages. FDA Commissioner Dr. Scott Gottlieb said that the move was part of an effort to build "lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed" and made "more predictable and efficient."

Scheduled for May 31, the notice received immediate reaction from Rep. Chellie Pingree, who said in a statement, "It's clear that Commissioner Gottlieb is prioritizing this issue and taking it seriously. I hope the FDA will operate with the same sense of urgency. I will consider any legislative avenues that may be necessary to resolve this issue." CBD, the abbreviation for cannabidiol, is one of the non-psychoactive ingredients in cannabis, increasingly thought to offer wide-ranging health benefits, with few side effects and low risk of addiction or abuse. Tetrahydrocannabinol or THC is the main psychoactive component of the cannabis plant. It's illegal under the Food Drug & Commerce Act to introduce CBD or THC into the food supply or market it as a dietary supplement, regardless of whether the substances are hemp-derived. In Tuesday's statement, Gottlieb warned that "open questions remain regarding the safety" of widespread use of CBD products, including CBD concentration and the possible impacts of long-term exposure. "It's critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA's regulatory oversight of these products," he said. "Especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods." Gottlieb has made clear in the past that foods derived from parts of the hemp plant that may not contain CBD or THC could be marketed with FDA approval. In December, he announced that hulled hemp seeds, hemp seed protein, and hemp seed oil could be marketed as long as they made no disease treatment claims.

Background story:

  • Last month, the FDA sent warning letters to Advanced Spine and Pain in New Jersey and PotNetwork Holdings in Florida, Nutra Pure in Washington state and for "making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores, and social media websites."

  • In February, a bipartisan group of lawmakers sent a letter to Gottlieb about crackdowns on selling CBD food and beverages by officials in New York City, Ohio, and Maine, saying that the actions "spurred a tremendous amount of confusion among product manufacturers, hemp farmers, and consumers of these products. We are calling on FDA to swiftly provide guidance on canonical pathways for food products with CBD."

  • FDA isn't interested in immediately doing away with that restriction, because both "CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements," Gottlieb said in a statement in December.

  • In December 2018, the Farm Bill became federal law; among other things, it legalized the production of hemp, which contains high levels of CBD.

A questionable first step, and possibly outside the intent of the Farm Bill. Granted, the FDA must confirm its policies to the mandate and establish guidelines that will maintain the integrity of the Farm Bill. Does the FDA have the authority in deciding new law by selective interpretation while claiming to protect both consumers and the industry? Only Congress has the power to do so.

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