When a product is in violation of the FD&C Act, FDA considers many elements in deciding whether or not or not to provoke an enforcement action. Those components embody, amongst other issues, agency sources and the risk to the public health. FDA additionally may consult with its federal and state companions in making choices about whether or not to initiate a federal enforcement motion. Based on obtainable evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under part 201 of the FD&C Act [21 U.S.C. § 321]. FDA considers a substance to be “licensed for investigation as a model new drug” if it is the topic of an Investigational New Drug software that has gone into impact.
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