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Cannabidiol (CBD)

AHPA Presents Overview of Federal Regulations on Herbal Supplements

by Cristina Goodwin | April 14, 2015

American Herbal Products Association (AHPA) President Michael McGuffin presented an overview of the federal regulations for herbal dietary supplements at the Americans for Safe Access (ASA) National Unity Conference on March 29 in Washington, D.C.

The presentation was part of a panel discussion that examined the implications of several possible regulatory schemes for cannabis products. McGuffin discussed many aspects of federal regulations for supplements, including mandatory manufacturing facility registration, allowed ingredients in dietary supplements, the forms of dietary supplements, NDIs, labeling requirements and advertising claims and current good manufacturing practice (cGMP) requirements. He also went over six warning letters the Food and Drug Administration (FDA) recently sent to companies producing products with cannabidiol (CBD). Warning letters were sent out regarding claims made by the companies that sold the products for health conditions that caused the “products to be drugs.” Although, the FDA never said the ingredient was unlawful or a new dietary ingredient (NDI).

“While it is interesting that FDA did not address the legal or NDI status of CBD in the warning letters, this doesn’t mean that FDA has determined that these ingredients are legal or old dietary ingredients,” McGuffin said.

 Regarding NDIs, McGuffin noted that companies are required to provide FDA with premarket notification including, information that is the basis for the manufacturer or distributor concluding that a dietary supplement containing CBD will reasonably be expected to be safe.
 Also, he presented an overview of cGMP regulations for dietary supplements. In addition, he said that the regulations were the main reference when creating AHPA’s “Recommendation for Regulators on Cannabis Manufacturing, Packaging, Labeling and Holding Operations.”

For more information, call (301) 588-1171 or visit www.ahpa.org.

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