Posted March 28, 2011

FDA Cracks Down on Violators of Supplement Manufacturing Rules

In February and March 2011, the U.S. FDA posted Warning Letters sent, respectively, to a distributor of dietary supplements and a supplement manufacturer for violations of current Good Manufacturing (GMP) rules.

On March 2, 2011 a Warning Letter was sent to Gaspari Nutrition, Inc. based on an FDA inspection of its facilities in Lakewood, New Jersey. Among the serious violations cited were failure to properly investigate complaints for products including PlasmaJet, Mitotropin, and SuperPump. The FDA noted in its letter, for example, that the company failed to investigate "the complaint of a consumer who contacted your firm regarding having bloody stools and excessive amounts of red color in their toilet water following consumption of your SuperPump dietary supplement product."

On February 17, 2011, the FDA sent a Warning Letter to Rasi Laboratories regarding violations documented during an inspection of its facilities in Somerset, New Jersey. According to the Warning Letter, the company failed to determine whether specifications for identity, purity, strength, and composition were met by certain lots of Melatonin 20 Capsules, Vibrance Multivitamin Tablets, and Complete Joint Care tablets. These products were shipped prior to establishing that specifications had been met.

Rasi Laboratories also did not follow sampling procedures for raw materials for certain lots of its Dicalcium Phosphate Dihydrate, Glucosamine Sulfate Potassium, Folic Acid, Goldenseal Root Powder, and Chromium 10% Polynicotinate. The company was also faulted for not having equipment that controls temperature and humidity to ensure the quality of dietary supplements. Investigators found the temperature in a raw material warehouse to be 86 degrees Fahrenheit on a day in August, apparently in conflict with the temperature specification listed in the warehouse logbook.