FMI's Sarasin: FDA needs to provide additional clarity, guidance on CBD — quickly

Leslie G. Sarasin, the president and CEO of the Food Marketing Institute, called on the U.S. Food and Drug Administration (FDA) to quickly provide additional clarity and guidance governing the production, sale, quality and marketing of cannabidiol (CBD) products. The FDA has ruled that CBD may not be legally marketed as an ingredient in food or supplements.

“The lack of federal standards for the use of CBD in manufactured products, coupled with the current patchwork of state laws regulating CBD products, has created mass confusion for the public, for suppliers and retailers and for state regulators,” Sarasin said in a prepared statement. “FMI highly values the role FDA plays in promoting public health and safety, but the absence of a clear pathway to market for these products means consumers currently face a variety of risks, including unsubstantiated health and benefit claims, a lack of standardization in product labeling and packaging, and even products that do not contain the ingredients they purport to contain.”

Sarasin added that the safety concerns and marketplace confusion surrounding CBD products will continue until FDA acts on the matter.

“We hope FDA will move quickly to provide clarity,” she added.

Miriam Guggenheim, a Washington, D.C.-based food regulatory lawyer who recently spoke at the Private Label Manufacturers Association’s 2019 Washington Conference, said FDA’s lack of clarity has stopped a number of companies from entering the CBD market and others from beginning research and development on CBD products.

Guggenheim noted the FDA is under tremendous pressure from Congress to enact federal guidelines that open the CBD market to food and beverage products. FDA stated earlier this year it would take three to five years to come up with guidelines, but Congress wants it done sooner.

According to Guggenheim, the FDA is concerned about the overall accumulated dosage of CBD if consumers use it in several food products during the day.

On a related matter, FMI applauded the U.S. Department of Agriculture’s (USDA) release of a federal regulatory framework for domestic hemp, which establishes a domestic hemp production program as set forth in the 2018 Farm Bill. FMI said the interim rule will help expand production of domestic hemp and help meet the growing consumer demand for hemp-derived products made from hulled hemp seed, hemp seed protein powder and hemp seed oil.

“USDA’s proposed regulations provide more clarity in the regulatory environment surrounding hemp, which continues to generate much enthusiasm among FMI's members' customers in the U.S.,” Sarasin said.