Yeast Infection Treatment Claims For Supplement Draw “Courtesy” Letter
This article was originally published in The Tan Sheet
Executive Summary
Peak Health Care Products' Yeast Control for Diabetics product name and labeling claims imply the dietary supplement is intended to "treat, prevent, cure or mitigate a disease," according to an Oct. 22 FDA "courtesy" letter to the company
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Peak Health Care Products' Yeast Control for Diabetics product name and labeling claims imply the dietary supplement is intended to "treat, prevent, cure or mitigate a disease," according to an Oct. 22 FDA "courtesy" letter to the company. The agency notes that diabetics are known to have a greater risk of yeast infections due to elevated blood sugar levels and Yeast Control for Diabetics is specifically marketed for preventing yeast infections that are a direct consequence of diabetes. "The product is clearly and unambiguously represented to treat an adverse consequence of a disease (diabetes) that is itself a disease (i.e. yeast infection)," FDA says. Labeling for Yeast Control for Diabetics states: "This product is designed to support the digestion of Candida albicons and other yeasts in the gastrointestinal track of persons with diabetes." A disclaimer following the claim advises that the product is "intended to supplement the nutrient needs of persons with diabetes, without affecting the blood sugar or treating diabetes." In a May 9 letter to the agency, Las Vegas-based Peak argued that the disclaimer adds appropriate context to the labeling establishing that Yeast Control for Diabetics is intended to address specific nutritional needs of diabetics and not for use to treat the disease. FDA's letter admits the agency has "conceded that diet restrictions might contribute to nutritional deficiencies in some diabetics and that claims that a product was intended to meet those nutritional needs...may be legitimate structure/function claims." However, the agency continues: "The claims being made for [Yeast Control for Diabetics] are, for the most part, not even nominally to treat any nutrient deficiency associated with the dietary practices of diabetics." The product is "intended to treat the hallmark symptom of diabetes (i.e. elevated blood sugar levels) in order to prevent a complication of the disease (yeast infection due to elevated blood sugar levels)" instead. Other recent "courtesy" letters address claims for maintaining normal blood pressure and products that are not intended for ingestion and, thus, fail to meet the definition of a dietary supplement (see chart: " 1 Dietary Supplement Claims Subject To FDA 'Courtesy' Letters "). |