04.06.15
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. Mr. McGuffin provided an overview of 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.
Mr. McGuffin also reviewed six warning letters FDA recently sent to companies marketing products with the ingredient cannabidiol (CBD). The warning letters focused on claims made by companies that promoted the products for conditions that caused the "products to be drugs." However, FDA did not say the ingredient is 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," Mr. McGuffin said.
Regarding NDIs, Mr. 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 the NDI will reasonably be expected to be safe.
Mr. McGuffin also provided an overview of the current good manufacturing practice (cGMP) regulations for dietary supplements and noted that these regulations were the primary reference used to create AHPA's "Recommendation for Regulators on Cannabis Manufacturing, Packaging, Labeling and Holding Operations."
The presentation was part of a panel discussion that examined the implications of several possible regulatory schemes for cannabis products. Mr. McGuffin provided an overview of 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.
Mr. McGuffin also reviewed six warning letters FDA recently sent to companies marketing products with the ingredient cannabidiol (CBD). The warning letters focused on claims made by companies that promoted the products for conditions that caused the "products to be drugs." However, FDA did not say the ingredient is 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," Mr. McGuffin said.
Regarding NDIs, Mr. 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 the NDI will reasonably be expected to be safe.
Mr. McGuffin also provided an overview of the current good manufacturing practice (cGMP) regulations for dietary supplements and noted that these regulations were the primary reference used to create AHPA's "Recommendation for Regulators on Cannabis Manufacturing, Packaging, Labeling and Holding Operations."