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Dietary supplement industry urges Congress to intervene on CBD

Industry groups pressuring lawmakers to pass legislation allowing hemp-derived CBD to be used as dietary ingredient

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Dietary supplement manufacturers are urging Congress to amend federal law to legalize use of hemp-derived cannabinoid (CBD) as a dietary ingredient, calling the move vital to protect consumers and to provide legal clarity for the industry.

Four supplement and natural product industry groups — the Council for Responsible Nutrition, the American Herbal Products Association, the Consumer Healthcare Products Alliance and the United Natural Products Alliance — sent a letter last week to lawmakers outlining their plea for action and voicing frustration with FDA's view that it will likely take several years for the agency to craft a regulatory pathway for CBD in foods and supplements.

"While we can appreciate the FDA’s deliberative interest in making sure that consumers have access to safe CBD products, we are concerned that continuing to leave the marketplace without clarity and adequate oversight for an extended period of years will both endanger consumers and the bright future of the hemp-derived products they seek," the groups said in their Oct. 8 letter. "Since it appears FDA is unlikely to provide a timely and effective resolution to this challenge, Congress must act."

The issue for FDA is its approval of CBD as an active drug ingredient — in a treatment for epilepsy — means it must craft an exemption under the Federal Food, Drug and Cosmetic Act (FDCA) to allow uses in food and supplements.

Agency officials have repeatedly said they lack the safety data to approve such uses and have cautioned that the regulatory bar for approving an exemption to the statute is high. But the agency is also clearly worried about the proliferation of CBD products as a patchwork of state regulations — and growing consumer demand for the non-psychoactive cannabis extract — has created a market for CBD foods and supplements that topped $200 million last year.

Several states, including Colorado, Connecticut, Maine, and Oregon, have passed legislation allowing use of CBD in foods and supplements while many other states have followed FDA's lead and declared such uses illegal. Last month FDA sent a letter to supplement manufacturer Alternative Laboratories for labeling and distributing a CBD oil as a dietary supplement, warning the Florida-based company that its product is illegal under the FDCA.

The supplement industry's letter to federal lawmakers noted FDA has said it could take three to five years for "even an expedited rule-making to establish a legal regulatory pathway for use of CBD in dietary supplements and conventional foods.”

That timeframe is untenable given consumer interest in CBD, the growth in products and sales, and the "need for clarity among consumers, retailers and manufacturers about the legal status of these products," the industry groups said.  They suggest Congress should intervene swiftly and amend the FDCA to provide a "limited waiver" for CBD supplements from the statute's provision that governs articles used in both drugs and supplements. 

“We urge you to pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient if the dietary supplement containing the CBD meets established product safety and quality criteria," the letter said.

The industry groups recommended that to qualify for the waiver, CBD would have to be derived from hemp as defined by the 2018 Farm Bill and that any dietary supplement with CBD would have to "fully comply" with existing requirements for new dietary ingredients.

"Importantly, these products would also be required to fully comply with all other provisions of the FDCA and FDA’s implementing regulations applicable to dietary supplements, including those requiring accurate product labeling and good manufacturing practices as well as the prohibition against making any drug claims," according to the letter.

The call from the industry groups comes amid clear interest from a growing number of lawmakers to find a solution to the CBD issue — and Congress may be tempted to use the appropriations process to tackle the concern. There is language in the Senate FDA appropriations bill providing $2 million for the agency to work on CBD regulatory issues and calling for it to issue a formal enforcement discretion policy within 120 days. The House FDA spending bill earmarks $100,000 for FDA to specifically use to evaluate the safety of CBD use in foods and supplements and to set a safe daily use level.

The industry groups see an opportunity for language to be added to the pending appropriations bill to provide the FDCA waiver they are seeking, along with additional FDA funding for "efficient and timely review" of new dietary ingredient notifications and enforcement activities.

"We urge you to provide FDA statutory authority and additional resources with explanatory report language to regulate CBD products as dietary supplements without the need for a multi-year rulemaking process," the letter concluded. "This is the best, most efficient, and most timely way to both set a clear regulatory framework for the marketplace and better assure consumer protection."

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