FDA Cites Five Companies for Illegally Selling Delta-8 THC and CBD Products

FDA Cites Five Companies for Illegally Selling Delta-8 THC and CBD Products
CANNANNEW REPORT

[co-author: Rachel Buff] Martin Hahn Xin Tao The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD). In addition to the various violations outlined by FDA in the letters under the Federal Food, Drug, and Cosmetic Act (FFDCA), the agency particularly highlighted its serious concerns about the potential health effects of delta-8 THC products. While this is the first time that FDA has ever issued Warning Letters for products containing delta-8 THC, we view this set of Warning Letters to signify FDA’s continuing enforcement of federal restrictions on the marketing and sale of products containing cannabis-derived ingredients. The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FFDCA). 1 In these letters, the agency cited various FFDCA violations including the marketing of unapproved new drugs and the unlawful use of delta-8 THC and CBD in food and dietary supplement products. The agency also particularly noted its serious concerns with the potential health effects of delta-8 THC products. Background In light of significant industry interest in the development of consumer products derived from cannabis and its components, FDA has reinforced its position that CBD cannot be legally sold as dietary supplements or in a food under the exclusionary clause. 2 In the recently issued Warning Letters, FDA similarly asserts delta-8 THC cannot be sold as a food. Along with the Federal Trade Commission (FTC), FDA has previously issued Warning Letters to various companies selling CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases in violation of the FFDCA. Like CBD, delta-8 THC is also derived from the Cannabis sativa plant. While THC is a…

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Source : FDA Cites Five Companies for Illegally Selling Delta-8 THC and CBD Products

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