Posted February 13, 2013

FDA Warns Maker of Weight Loss and Whey Protein Supplements For Manufacturing Violations and Misbranding

January 25, 2013, the FDA issued a warning letter to dietary supplement manufacturer SciLabs Nutraceuticals, following a facility inspection which found the company’s dietary supplements and supplement ingredients, including N-Large 2, Flo-Gard AB, Nitrogen Glutamine capsules, Nutritech nutritional products, Duzoxin Secret to Slim, Punishment Nutrition nutritional products and Whey Protein Isolate, are adulterated because they have been prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to properly test and verify the identity of certain ingredients which are components of SciLabs’ N-Large 2 whey protein, Flo-Gard AB anti-caking agent, Nitrogen Glutamine capsules and Nutritech whey protein, creatine and workout enhancer products.(Nutritech is a line of nutrition products created for and distributed in Middle Eastern countries but may be available for purchase by U.S. consumers online; all other SciLabs supplements listed are available in the U.S.)

(See’s Review of Muscle-Enhancing Supplements for tests of related products and see the Review Article on Inactive Ingredients in Supplements for more information).

SciLabs' Duzoxin Secret to Slim, Punishment Nutrition and Whey Protein Isolate were also found to be misbranded because the labels did not provide a domestic address or domestic phone number, as required by federal regulations.

Duzoxin Secret to Slim contains guarana extract, Garcinia cambogia, white willow bark, L-tyrosine, citrus aurantulum, ginger root, pantothenic acid, L-Carnitine and magnesium phosphate. It was promoted for weight loss.

(See’s Reviews of Weight Loss Supplements and Magnesium Supplements for tests of related products.)

Punishment Nutrition products are muscle and workout enhancing supplements including Growth Xcellerator whey protein, MuscleFusion whey protein with vitamins and minerals, Anabolic Ignition, a blend of L-Carnitine, citrulline malate, guarana, taurine, alpha lipoic acid and CoQ10, and Thermofuse C4, a blend of vitamin B6, EGCG, caffeine, yohimbe HCL, acai berry extract, magnesium, and other herbs.

(See’s Reviews of Muscle-Enhancing Supplements, Multivitamin and Multimineral Supplements, Green Tea Supplements, Alpha Lipoic Acid Supplements, CoQ10 Supplements, B Vitamins Supplements, Sexual Enhancer Supplements (Including Yohimbe) and Acai Berry Supplements for tests of related products.)

For more information about the FDA’s warning letter, use the link below.