What Is The FDA Saying About Full Spectrum Hemp? Key Takeaways From Rejections Of NDINs

CANNANNEW REPORT

Almost three years since the legalization of hemp production in the United States, the U.S. Food and Drug Administration (FDA) is still in the process of determining the regulatory framework for CBD and other hemp derivatives. Despite the continuously growing hemp marketplace, the FDA has long maintained the position that many food and dietary supplements containing hemp and CBD are prohibited from being sold or marketed as such under the Federal Food, Drug and Cosmetic Act (FDCA). This provision is colloquially known as the “Drug Preclusion Provision.” “…a product that contains an article that is an approved new drug or licensed biologic cannot be a dietary supplement unless the article was marketed as a dietary supplement or as a food before its approval as a new drug or licensing as a biologic. Dietary supplements also may not include articles that are authorized for investigation as a new drug or biologic (and for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public), unless the article was marketed as a dietary supplement or as a food before it was authorized for investigation.” But how does this FDCA provision apply to CBD? In one word: Epidolex. The “article” in question is cannabidiol, which just so happens to be the active ingredient in the FDA-approved drug Epidiolex. While an important exception rests in the language “unless the article was marketed as a dietary supplement or as a food before it was authorized for investigation,” the FDA has concluded that “this is not the case for THC or CBD.” Despite its multi-year process of assessing potential exceptions from the Drug Preclusion and evaluating the safety and science of CBD, the FDA has not changed its prohibitive approach. However, the plain language of the Drug Preclusion,…

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Source : What Is The FDA Saying About Full Spectrum Hemp? Key Takeaways From Rejections Of NDINs

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