Representative Diana Harshbarger (R-TN) recently introduced the Dietary Supplement Innovation Act (H.R. 10336), legislation that would amend the Federal Food, Drug, and Cosmetic Act's drug preclusion provisions.
Representative Diana Harshbarger (R-TN) recently introduced the Dietary Supplement Innovation Act (H.R.
10336), legislation that would amend the Federal Food, Drug, and Cosmetic Act's drug preclusion provisions.
The legislation directs FDA to consider factors such as route of administration, dosage, concentration, composition, and safety differences when determining whether a substance marketed as a dietary...
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Representative Diana Harshbarger (R-TN) recently introduced the Dietary Supplement Innovation Act (H.R. 10336), legislation that would amend the Federal Food, Drug, and Cosmetic Act's drug preclusion provisions. The legislation directs FDA to consider factors such as route of administration, dosage, concentration, composition, and safety differences when determining whether a substance marketed as a dietary supplement should be treated the same as a drug for preclusion purposes.
The legislation directs FDA to consider factors such as route of administration, dosage, concentration, composition, and safety differences when determining whether a substance marketed as a dietary supplement should be treated the same as a drug for preclusion purposes. If enacted, the legislation could significantly reshape the relationship between dietary supplement regulation and pharmaceutical development by creating a clearer pathway for certain ingredients to remain available to consumers while preserving FDA's authority over active drug development programs.
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