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On May 4, 2022, the Food and Drug Administration (FDA) issued warning letters to five companies it asserts are illegally marketing products labeled as containing delta-8 tetrahydrocannabinol (Delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FDCA). Simultaneously, FDA issued a new consumer update “5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC.”  The consumer update and warning letters are a continuation and expansion of FDA’s efforts to warn the public about products that are not approved under the FDCA and to rein in the rapidly expanding market of products containing hemp-derived cannabinoids.  This set of warning letters marks the first time FDA has publicly taken enforcement action against products containing Delta-8 THC, and it will likely not be the last.
Continue Reading Warning! FDA Issues Warning Letters for Products Containing Delta-8 THC

The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented.  Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic.  The US Food and Drug Administration (FDA) is closely monitoring the impact of the Coronavirus on the global drug supply chain and is focused on identifying and alleviating drug shortages before they happen.  The FDA also is using emergency measures to provide access to diagnostic tests and other medicines that would not otherwise be available to the public.
Continue Reading How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities

On November 25, 2019, FDA issued Warning Letters to 15 companies illegally marketing cannabidiol (CBD) products. On the same day, U.S. Food & Drug Administration (FDA) published a revised consumer update, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” describing the “very limited” scientific information available about CBD and its health effects. The points made in the Warning Letters and update are nothing new to those closely following the FDA working group on cannabis and CBD, but the actions signal the FDA’s continued enforcement against companies marketing CBD foods, supplements, and cosmetics with unsupported health claims.
Continue Reading FDA Issues Warning Letters to 15 Companies, Consumer Update on CBD Safety

On October 29, 2019, the U.S. Department of Agriculture (USDA) released its long-awaited interim final rule governing the U.S. Domestic Hemp Production Program. USDA has been developing these interim regulations since hemp was federally legalized under the 2018 Farm Bill. These hotly anticipated rules are important not only for hemp producers and hemp-derived product companies, but for cannabis companies interested in diversifying or pivoting into a crop that is legal under federal law.
Continue Reading BREAKING NEWS: USDA Releases Interim Final Hemp Rule