A coalition of 37 state attorneys general urge FDA to cooperate with states on CBD regulation

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In public comment submitted to FDA on July 16, 2019, a coalition of 37 state attorneys general urged FDA to cooperate with the states in protecting consumers from false advertising on cannabis-derived products such as CBD, and the potential hazards of consuming such products in certain populations.

“We write to express our hope that the FDA continues to explore manufacturing, testing, and marketing best practices so that consumers are not at risk of misleading advertising or harm to their health from dangerous additives or undisclosed risks of use,” writes the coalition. “A crucial element of FDA regulation and oversight should be an on-going assessment of the potential risks or benefits of these products, particularly for specific populations such as pregnant women, adolescents and children, and the elderly. How these products interact with other dietary or pharmaceutical products should be included in this assessment. It is also important that companies not mislead consumers. Scientific and medical data from the FDA would assist in meaningful enforcement of advertising laws and regulations by the states.”

An appropriations package recently passed by the House provides funding for FDA to conduct a health hazard evaluation for CBD in order to set a safe use level for consumers. The process would follow the same precedent as red yeast rice, allowing a dietary supplement to contain a level of a naturally-occurring drug ingredient that is deemed safe by FDA.

The coalition states that as the primary enforcers of respective states’ consumer protection laws, state attorneys general offer a unique perspective to this emerging market of cannabis derived products. They want to ensure that FDA, in considering the regulation of these products, incorporates the feedback of state attorneys general and that the states maintain a role as regulators in the marketplace.

Currently, under the recently passed 2018 Farm Bill, which legalized the cultivation of hemp under the authority of the U.S. Department of Agriculture, states have the responsibility of developing plans on how to regulate hemp within its borders. Recently, states such as Missouri, Texas, and Louisiana passed legislation authorizing hemp agriculture. Louisiana, in its law, created specific provision on CBD products, only allowing the sale of foods and cosmetics containing CBD, and preventing them from being marketed as dietary supplements.

“Ultimately, the responsibility for protecting consumers that use cannabinoids and CBD products cannot solely be left to the companies supplying products-that responsibility must include the FDA with meaningful partnerships with the states and State Attorneys General,” writes the coalition. “We applaud the FDA’s recent steps, including the formation of the CBD working group focused on exploring pathways for dietary supplements and food regulation, seeking to clarify code citations, regulating cosmetics, and researching existing science and developments.”