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Optimum Nutrition Receives FDA Warning Letter


Optimum Nutrition Receives FDA Warning Letter

CHICAGO--Optimum Nutrition, based in Aurora, Ill., received a warning letter from the Food and Drug Adminstration's (FDA) Chicago district regarding unapproved use of stevia and product misbranding.

After inspecting the company for three days in July 2001, FDA sent a letter dated May 7 stating Natural Opti-Soy 50, Natural PRO COMPLEX and Natural 100% Egg Protein are considered adulterated substances since they contain stevia, an unapproved food additive that has not been generally recognized as safe (GRAS).

In addition, Natural Opti-Soy 50 was considered misbranded since it carried a statement about soy inhibiting the effects of cancer (for which there is no health claim) and atherosclerosis, a claim FDA stated the company should not make since the product is not labeled as having the minimum 6.25 g of soy protein needed to carry a health claim.

Other product complaints included ones for the company's Natural 100 % Whey Protein Dietary Supplement, which did not have a disclaimer for label claims and used the unapproved nutrient claim "Very Low Lactose."

The company did not return calls for comment by press time.

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