Disease claims, no testing and other failures

Disease claims, no testing and other failures

FDA finds fault and then some with one company.

AHPA notes: FDA inspected this facility and found no finished-product testing, no master manufacturing records, incomplete batch records, and other failures. Claims on the website include those for respiratory infections, cystic fibrosis, Alzheimer's, and other diseases. Additionally, the products do not include "Supplement Facts" labels or serving sizes, and are not labeled as dietary supplements. The company was inspected in September and October of 2012, and there is no indication in FDA's warning letter that it responded in writing to FDA's observations.

Food and Drug Administration
April 5, 2013

Warning Letter: The Glutathione Corporation

The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located at 8 Westchester Plaza, Elmsford, New York on September 19, 2012 through October 1, 2012, and found that you have serious violations of FDA's Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] because they have been prepared, packed or held under conditions that do not meet the CGMP regulation for dietary supplements.

In addition, we have reviewed the labeling for your products and your website at www.glutathionescience.com. Based on our review, we have concluded that certain of your products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You may find the Act and its implementing regulations through links on FDA's home page at fda.gov.



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