Sen. Ron Wyden expressed hope that FDA would release “sensible” guidance related to CBD, but he left open the door that Congress would intervene if necessary.

Josh Long, Associate editorial director, Natural Products Insider

September 1, 2020

3 Min Read
U.S. senator hoping for ‘sensible’ FDA guidance on CBD

A U.S. senator who successfully advocated for removal of hemp from the Controlled Substances Act (CSA) signaled a willingness to seek a legislative solution for the CBD market if a pending enforcement discretion policy from FDA is not workable.

The White House’s Office of Management and Budget (OMB) has been reviewing FDA guidance related to CBD. The ingredient is widely sold in the U.S., despite FDA’s long-held but controversial view that CBD cannot be lawfully marketed in dietary supplements or added to conventional food.

An enforcement discretion policy would function as “an interim step that would give CBD more market access,” while providing FDA additional time to issue a “formal regulation,” Sen. Ron Wyden (D-Oregon) said Aug. 27 during the Hemp-CBD Supplement Virtual Congress, an event hosted by the American Herbal Products Association (AHPA).

Wyden expressed hope that FDA would release “sensible” guidance, but he left open the door that Congress would intervene if necessary.

Sen. Ron Wyden

“Depending on what FDA does, I believe that we always have the option of going forward with legislation,” said Wyden, who along with others supported a bill (the Hemp Farming Act) incorporated into the 2018 Farm Bill, which removed hemp and its derivatives from the CSA. “If the FDA won’t do it alone, then I and other members of Congress will consider a legislative approach.”

“Before you do a legislative fix, though, you need to make sure you get it right,” the senator added, “and I appreciate all of you working very hard to find common ground between dietary supplement groups and food and beverage interests.”

During the event, AHPA’s president, Michael McGuffin, asked Wyden about reports that farmers were moving away from hemp due to an oversupply of the crop over the last year.

Wyden pointed the finger at antiquated regulations.

“People simply can’t get the products to market because of outdated rules,” he responded.

Wyden added: “If the FDA would allow a clean and easy path for CBD to get to the market and for consumers to buy a regulated product, I believe the demand for CBD and the supply would begin to even out.”

He pointed out countries outside the U.S. have taken steps to regulate CBD. Earlier this year, for example, the Food Standards Agency (FSA) in the United Kingdom set a deadline of March 2021 for CBD businesses to submit valid novel food authorization applications—a process intended to ensure novel foods meet legal standards, including on content and safety. FSA also advised healthy adults to take no more than 70 mg a day of CBD.

“Countries like the U.K. are moving forward to ensure responsible use of CBD in a way that balances public health concerns and responsible consumer use,” Wyden said. “The United States can do this as well, and if CBD stays unregulated, there will be continued questions about human health and safety.”

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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