Congress introduces bill to legalize CBD once and for all
Losing its patience with the FDA, a bipartisan bill was introduced to allow CBD into foods and supplements.
![Congress introduces bill to legalize CBD once and for all Congress introduces bill to legalize CBD once and for all](https://eu-images.contentstack.com/v3/assets/blt09e5e63517a16184/bltfe8c63977ee7f2bd/64d6c3e7e6ac378080855788/US-capitol-Congress.jpg?width=850&auto=webp&quality=95&format=jpg&disable=upscale)
Legislation was unveiled Monday in the U.S. House of Representatives to allow hemp-based CBD to be marketed in dietary supplements and conventional food.
The bill, introduced by House Agriculture Committee Chairman Collin Peterson (D-MN), is a simple, three-page bill that would explicitly include hemp-derived CBD in the definition of a dietary supplement.
It also would create an exception for CBD to a “prohibited act” in Section 301(ll) of the Federal Food, Drug & Cosmetic Act (FDCA), which essentially bars the introduction into interstate commerce of a food (including a dietary supplement ingredient) that was first studied as a pharmaceutical drug.
The FDA has continually cited the FDCA as the reason it cannot declare hemp CBD as a legal dietary ingredient—and thus has done little to regulate the booming market other than occasionally send out a dozen or so warning letters to companies making egregious disease claims around products.
Peterson’s bill also would require the Agriculture Secretary, “in consultation with other relevant federal and state agencies,” to “complete a study on the market and regulatory barriers for producers operating under the domestic hemp production program specified” in USDA’s regulations.
An end-around to the FDA
Since 2015, FDA has reiterated in public speeches, written statements and warning letters that CBD was first authorized for investigation as a new drug and the subject of substantial clinical investigations by GW Pharmaceuticals plc. Consequently, under the FDCA, CBD cannot be marketed in dietary supplements or added to conventional food, according to the FDA.
CBD, nonetheless, has flourished on the U.S. market and is sold virtually everywhere from e-commerce sites to gas stations, grocery stores and restaurants.
FDA’s public stance that CBD cannot be sold in food and supplements has not been incorporated in a formal regulation or adjudicated in the courts. Marketers with collectively tens of millions of dollars in annual sales are expected to tangle with FDA in the judiciary if the agency moved to shut down the industry.
If passed into law, HB 5587 could avoid a protracted battle between industry and regulators over the compound’s legality. But members of Congress may be reticent to interfere with FDA, which has raised growing concerns and unanswered questions about the safety of CBD.
Although FDA has been exploring whether to create a legal pathway for CBD in food and supplements, it has not begun a formal rulemaking.
“Since it’s probably not going to be resolved for two to three years, it’s great that someone in Congress wants to quicken the process,” Geoff Whaling, chairman of the National Hemp Association, a nonprofit organization, said in an interview. “But I think that Congress has got a lot of other priorities, and they want the FDA to be able to do their job and not interfere, and that’s what I’m hearing from some congressional members.”
On the other hand, “FDA is saying, ‘We’re working within the laws and rules that Congress has given us,’” Whaling noted. “So what do you do? You need to get Congress to change those rules. And that’s what this piece of legislation would do.”
“It seems that both parties [FDA and Congress] were waiting for someone else to make the first move,” said Tami Wahl, a strategic policy advisor with experience in the natural products industry, in an interview.
Added Mike Greene, a consultant with Greene GR Strategies and seasoned lobbyist who previously served as senior vice president for government relations with the Council for Responsible Nutrition (CRN): “It is Congress’ job to tell the agencies what to do, when to do it, how to do it, and to be as clear as possible in the legislative language so that they understand it.”
Greene said he and Wahl worked with Peterson to introduce the legislation. He expressed hope that the House Committee on Energy and Commerce, which oversees FDA, would consider the legislation at some point in 2020 during a hearing.