FMI nudges FDA to clarify CBD product regulation

The Food Marketing Institute (FMI) has submitted comment to the Food and Drug Administration on the commercialization of food, beverage and other products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD).

FMI said Wednesday that its letter to the FDA comes in response to the agency’s request for scientific data and information about such products, notably those with hemp and hemp-derivatives like CBD. The grocery industry trade group noted that although various CBD offerings are making their way into stores, many retailers remain uncertain about the regulatory framework regarding the sale and labeling of hemp-containing products. Scientific research on CBD’s potential health benefits also is still in its early stages.

Kroger plans to roll out CBD topical products to 945 stores.

“Consumer interest in hemp and hemp-derived products, especially those containing CBD, continues to grow rapidly, and the market is far too large to remain unregulated. Food retailers need a clear and comprehensive regulatory framework for the sale and labeling of these products in order to ensure they are marketed in a safe, responsible fashion,” FMI President and CEO Leslie Sarasin said in the July 16 letter.

Late last year, the federal government changed its classification of cannabis with the enactment of the Agriculture Improvement Act of 2018, or the Farm Bill. The legislation removed hemp — cannabis or derivatives with a very low content of psychoactive ingredient THC — from the Federal Controlled Substances Act’s definition of marijuana. That meant hemp was no longer a controlled substance under federal law, even though marijuana remains a Schedule I drug.

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“More and more companies are taking steps towards entering this space. Sold in pill form, foods, oils, tinctures, topical lotions, and even in bottled water and cosmetics, CBD is already in countless products on the market. That said, the absence of a clear pathway to market for CBD-containing foods, beverages and dietary supplements to date means consumers currently face a variety of risks, from unsubstantiated health and benefit claims, to a lack of standardization in product labeling and packaging, to products that may not contain the ingredients it purports to contain,” Sarasin explained in her comments.

“Furthermore, given the consumer demand and the desire of our members to provide products their customers are seeking, we are fielding more and more questions from companies that are understandably seeking clarity about the current regulatory framework for the sale and labeling of products containing CBD,” she added.

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Under current federal law, CBD and THC can’t be added to a food or marketed as a dietary supplement according to Acting FDA Commissioner Ned Sharpless. FDA maintains regulatory oversight of food, cosmetics, drugs and other products within its jurisdiction that have CBD, THC or the cannabis plant itself as an additive.

Sarasin (left) noted in the letter that FMI understands that the Farm Bill didn’t pre-empt state law on the manufacturing and/or sale of products containing hemp or hemp-derivatives or change the FDA’s authority over the use of hemp or hemp-derivatives in products it regulates.

“The current lack of FDA regulation is creating significant confusion in the marketplace. FMI respectfully urges FDA to move expeditiously to provide additional clarity and establish a pathway forward for the use of hemp-derived ingredients, including CBD, in FDA-regulated products,” she said. “The safety concerns and marketplace confusion surrounding hemp and hemp-derived products will continue until FDA provides guidance governing the production, sale, quality and marketing of these products.”

In its comments to the FDA, FMI cited a 2019 Consumer Reports survey of over 4,000 Americans finding that more than a quarter have tried CBD, and one out of seven of those people said they use it every day.

Retailers large and small have been responding to that demand. Last month, for example, supermarket giant The Kroger Co. said it will sell hemp-derived CBD items such as lotions, balms, oils and creams in 945 stores — including its Kroger, Mariano’s, Pick ‘n Save, Dillons, King Soopers, Fry’s, Fred Meyer, QFC and Smith’s banners. Also in June, Dierbergs Markets announced the rollout of hemp-derived CBD oil products to all 25 of its stores in Missouri.

Thrive Market has pulled its CBD product offerings in response to a request by its merchant processor.

Perhaps reflecting the confusion in the marketplace, online grocer Thrive Market reported that as of June 20 it stopped selling hemp- and CBD-based products in response to a request by its merchant processor. According to CEO Nick Green, Thrive began carrying a full assortment of hemp-based supplements and topical products about a year-and-a-half ago, making it the nation’s first national e-commerce retailer to do so.

“We believe that ethical and sustainable hemp is another cause worth fighting for, so rest assured that we will be working behind the scenes in the coming weeks to get hemp products back on Thrive Market,” Green said in a letter to customers.

The U.S. hemp-derived CBD market could grow to a $6 billion industry with the legalization of sales of food and beverages containing CBD from hemp, according to Nielsen. The market researcher reported that future CBD consumers may look to CBD-infused food offerings to promote health and wellness, including to enhance focus and relaxation as well as to alleviate certain ailments such as feminine pain, digestive problems and sleep disorders.