Posted: 23 Jun 2019 07:09 PM PDT
FDA published a Consumer Update acknowledging the ubiquitous presence of CBD products in the marketplace, and providing the agency’s current perspective on questions regarding the regulatory status, safety, and quality of such products. The Consumer Update follows closely on the heels of a recent statement issued jointly by FDA’s Principal Deputy Commissioner and Principal Associate Commissioner for Policy. That statement emphasizes the agency’s commitment to “sound, science-based policy on CBD,” and thereby suggests that FDA should not be expected to make significant policy decisions until it has the data and other information needed to answer to its satisfaction the scientific issues identified by the agency thus far (e.g., “How much CBD is safe to consume in a day? How does it vary depending on what form it’s taken? Are there drug interactions that need to be monitored? What are the impacts to special populations, like children, the elderly, and pregnant or lactating women? What are the risks of long-term exposure?”)
Consistent with FDA’s past statements on cannabis and CBD, these more recent statements reiterate FDA’s intent to act against CBD products marketed with medical claims, be they labeled as dietary supplements, pet treats, or cosmetics. The agency regards such products as unapproved drugs that present a risk to consumers’ health and safety. The agency can also be expected to take action against products found to be contaminated with microbiological or chemical substances that pose a hazard to health.
With respect to CBD products that do not make medical claims and that are manufactured to a high standard of quality, the agency’s intentions are less clear. FDA is aware of “products on the market that add CBD to a food or label CBD as a dietary supplement.” The agency maintains that “it is currently illegal [under federal law] to market CBD this way.” Nonetheless, at present, FDA does not appear to be directly challenging the marketing of such products. In the interim, consumer education is a tool FDA can deploy at will to help consumers help themselves. As stated in the closing paragraph of the Consumer Update: “As we learn more, our goal is to update you with the information you need to make smart choices about CBD products.” Stay tuned.
Consistent with FDA’s past statements on cannabis and CBD, these more recent statements reiterate FDA’s intent to act against CBD products marketed with medical claims, be they labeled as dietary supplements, pet treats, or cosmetics. The agency regards such products as unapproved drugs that present a risk to consumers’ health and safety. The agency can also be expected to take action against products found to be contaminated with microbiological or chemical substances that pose a hazard to health.
With respect to CBD products that do not make medical claims and that are manufactured to a high standard of quality, the agency’s intentions are less clear. FDA is aware of “products on the market that add CBD to a food or label CBD as a dietary supplement.” The agency maintains that “it is currently illegal [under federal law] to market CBD this way.” Nonetheless, at present, FDA does not appear to be directly challenging the marketing of such products. In the interim, consumer education is a tool FDA can deploy at will to help consumers help themselves. As stated in the closing paragraph of the Consumer Update: “As we learn more, our goal is to update you with the information you need to make smart choices about CBD products.” Stay tuned.
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