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Article: FDA report finds many CBD product labels misleading

14 July 2020

FDA's congressionally mandated report on the current CBD marketplace adds to growing evidence that CBD products are often mislabeled and could put more pressure on the agency to intervene and proactively regulate the non-psychoactive cannabinoid.

The agency compiled the report at the request of Congress, as lawmakers added language to the appropriations package approved last December requiring FDA to provide an update on the current CBD marketplace to "determine the extent to which products are mislabeled or adulterated."

The sampling effort is ongoing - so far, FDA has tested some 147 CBD products including gummies, beverages, oils, tinctures and pet products, finding many do not contain the listed amount of CBD and nearly half contain traces of THC.

The agency reported that nearly 60% of the 102 products that listed a specific amount of CBD contained either more or less than the amount on the label. FDA tested 20 edible and beverage products, finding five with less than 80% of the listed amount of CBD and six that contained more than 120% of the CBD advertised on the label.

Only one of the 147 products tested had levels of heavy metals that could present a health concern, the agency said.

FDA noted that its testing results - as well as information submitted to the agency on CBD products - have yielded useful information but "have been limited in scope and have not provided for a comprehensive understanding of the marketplace," the agency told Congress last week. "These uncertainties leave questions about how these findings should be interpreted and whether they can accurately be extrapolated to the CBD marketplace in the United States, which makes it challenging for FDA to determine the variability in CBD product characteristics."

The agency said it is undertaking a "more extensive CBD product sampling effort" that will use a sampling methodology to create a "representative, random sample of the current CBD product marketplace."

Action demanded

Dietary supplement makers, hemp growers and other CBD industry stakeholders said the study provides more evidence that FDA needs to move swiftly to rein in the marketplace for CBD products.

"There's not much news here," according to the US Hemp Roundtable. "The FDA revealed what we already knew - while more work needs to be done to ensure CBD products consistently meet label claims, the majority of products do not contain unsafe contaminant levels, specifically heavy metals."

The report shows that it is "high time for FDA to regulate CBD as a dietary supplement and food additive," the Roundtable added. "The agency's current public stance not only impairs hemp farmers and small businesses - an unregulated marketplace poses real health and safety concerns."

FDA currently contends that CBD can't be added to foods or supplements because cannabidiol has been approved as the active ingredient in a drug developed to treat epilepsy.

The agency says since CBD does not meet the exemption criteria under the Federal Food, Drug, and Cosmetic Act (FDCA) that would permit use in foods or supplements, crafting an exemption would require a formal notice-and-comment rulemaking that could take three-to-five years - if the agency is assured the safety data exists to support such regulations. The last formal update from the agency came in March and offered no timetable for action.

FDA's position has frustrated hemp advocates, supplement manufacturers, and food companies keen to take advantage of the booming market for CBD and wary of a growing patchwork of state regulations. Several states permit sales of CBD supplements while some have adopted FDA's position and others are effectively turning a blind eye. Disputes over CBD product labels have also caused a wave of litigation, with more than a dozen class actions pending in federal courts.

Dietary supplement manufacturers have petitioned FDA to carve out an exemption for CBD under the FDCA and some stakeholders continue to press Congress to intervene.

"This is a federal regulatory issue, FDA needs to do its job, and they need to do it now," said Kyle Turk, director of government affairs for the Natural Products Association (NPA). "Further delay by FDA is not good for public health or for the CBD industry, because the best approach is one uniform national standard based on sound science that is enforceable."

FDA's new sampling report "further affirms the need for federal regulatory clarity," added Betsy Booren, senior vice president of regulatory and technical affairs at the Consumer Brands Association (CBA). "Allowing bad actors to continue to put products on the market, unchecked, is a threat to consumer safety everywhere. The consumer packaged goods industry applauds FDA's efforts and urges Congress to provide more funding and resources to FDA to move quickly through this process."

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