Hemp industry asks Congress to help on FDA guidance

The industry is seeking pandemic aid from USDA

Frustrated by the FDA's inaction, the hemp industry wants Congress to direct the agency to write regulations for CBD as a food additive and dietary supplement.  (Bill Clark/CQ Roll Call)
Frustrated by the FDA's inaction, the hemp industry wants Congress to direct the agency to write regulations for CBD as a food additive and dietary supplement. (Bill Clark/CQ Roll Call)
Posted June 4, 2020 at 6:00am

The hemp industry is eying the next economic relief bill or must-pass legislation as potential vehicles for provisions to expand the definition of dietary supplements to include hemp-derived cannabidiol products. 

The industry, trying to regain ground lost to the pandemic, is also asking the Agriculture Department to make it eligible for COVID-19 aid.

Jonathan Miller, general counsel for the U.S. Hemp Roundtable, said that the trade association wants lawmakers to require the Food and Drug Administration to start writing regulations for cannabidiol (CBD) products as dietary supplements and food additives.

“The legislation that we’re asking for would legalize the sale of CBD as a dietary supplement and a food additive,” Miller said.

Miller said major retailers and food manufacturers backed away from CBD products after the FDA said it needs more studies to determine the safety of CBD products and is issuing warning letters to companies about their CBD products. Because of the regulatory uncertainty, Miller said CBD prices began to fall in 2019.

“It certainly didn’t stop all sales, but it really hit the market,” Miller said.

The FDA has raised concerns about unsupported health claims on some CBD products and is starting or funding research into CBD exposure during pregnancy and the use of cannabidiol in cosmetics. The agency also is taking data and information from the CBD industry on specific products to develop regulations.

The FDA says it is moving carefully because it has approved a CBD-based drug to treat two rare pediatric epilepsy disorders. Because of that approval and safety testing, the agency says it is reviewing CBD as a drug ingredient and that certain drug ingredients are excluded from the definition of dietary supplement.

Miller said his organization is seeking legislation that would exempt CBD use from the drug review.

“That would prompt the FDA to issue draft emergency regulations and they would then use that two or three year process to finalize [rules]. It would give comfort to a whole lot of folks who’ve been waiting for guidance from the FDA,” Miller said.

The industry has well-placed supporters in Congress.

House Agriculture Chairman Collin C. Peterson, D-Minn., filed legislation in January to amend a law known as the Federal Food, Drug, and Cosmetic Act to include hemp-derived cannabidiol or a hemp-derived cannabidiol-containing substance as part of the definition of dietary supplement. The bill also would direct the USDA to send the House and Senate Agriculture committees a study within a year of enactment on the marketing and regulatory obstacles facing hemp growers.

Senate Majority Leader Mitch McConnell, R-Ky., has had multiple calls and meetings with FDA officials, including FDA Commissioner Stephen Hahn, about regulatory certainty for hemp-derived CBD products, McConnell spokeswoman Stephanie Penn said by email.

Penn said McConnell, who included provisions on hemp that led to it becoming a legal crop under the 2018 farm bill that removed it from the Controlled Substances Act, remains a strong supporter of the industry. The 2018 law built on a 2014 farm bill that allowed limited domestic hemp production for research under state supervision.  

In a statement published by The Owensboro Messenger-Inquirer on Monday, McConnell said, "One of the biggest lessons of the past year is the need for regulatory clarity from the FDA. Without these federal guidelines, Kentucky growers, processors and manufacturers lack the certainty needed to take full advantage of the opportunities hemp offers.”

McConnell said he would work with Kentucky Agriculture Commissioner Ryan Quarles “in urging the FDA to provide reasonable regulations."

In 2020, COVID-19-related disruptions in supply lines, labor and transportation pushed prices down even lower, Miller said.

Pandemic aid

The industry wants price losses linked to the pandemic to be recognized by the USDA and is arguing that hemp growers should be eligible for aid under the department’s $16 billion package of direct payments to farmers and livestock producers adversely affected by disruptions to the U.S. economy because of the pandemic.

Miller said the USDA did not include hemp as an eligible crop because the fledgling industry lacks a history of public market information the department established as a requirement to demonstrate a drop in market prices of 5 percent or more between mid-January and mid-April 2020. Miller said the USDA seems willing to review the decision on hemp and the industry has submitted data from two independent pricing agencies to the USDA. He said the companies show price drops during the period of 19 percent to 55 percent, depending on the product.

Agriculture Secretary Sonny Perdue has said hemp growers could be eligible if they can demonstrate a loss.