The FDA has been cracking down on supplement manufacturers for not following Good Manufacturing (GMP) rules.
Gaspari Nutrition of New Jersey was sent a warning letter in March. FDA inspectors had visited the firm and found "serious violations of 21 CFR Part III, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements."
The FDA also holds that Gaspari did not properly address consumer complaints of adverse events attributed to the supplements. Specifically, that Gaspari failed to observe it's own written policies regarding the above. Among the complaints that were not adequately addressed were sores inside a consumer's mouth, "chest pain and abnormal kidney levels" after product consumption. Seven complaints were mentioned involving PlasmaJet, SuperPump 250 and Mitotropin products. Specifically:
SuperPump - a consumer complained of bloody stools and excessive amounts of red color in their toilet water following consumption of the product.
"Gaspari Nutrition, Inc. 3/2/11." U S Food and Drug Administration Home Page. Web. 29 Mar. 2011. <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm246818.htm>