AHPA Alerts

FDA acts to prevent distribution of products containing unapproved food additive

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent. The retail value of the seized

Just because a compound is found in a botanical doesn't mean FDA considers it a part of the food supply, according to Daniel Fabricant, Ph.D., Director, Division of Dietary Supplements, FDA, during his featured presentation at SupplySide West. Thus, if a supplement company introduces an isolated botanical substance to the market without submitting a new dietary ingredient (NDI) notification, the agency is likely to consider it an adulterated product.

Defendants Promised Dietary Supplement Would Cause Substantial Weight Loss
The Federal Trade Commission has sued an Arizona man who markets HCG Platinum diet products by falsely claiming the products will cause consumers to lose substantial amounts of weight. Kevin Wright and his companies must respond to the complaint in federal court.

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[Archive: This guidance was updated in 2017.] This guidance provides information on the regulatory and liability implications of Proposition 65 on heavy metals that may be present in herbal products sold in the State of California.