FDA Addresses Company Claims

Can-X Products Inc., for mislabeling thetopical product Can-X Black Salve as a dietary supplement, which would have tobe intended for ingestion. FDA also advised the company it considers the claimsin its marketing literature for this product to be drug claims, which fails tocomply with the final monograph for over-the-counter (OTC) wart removalproducts.

Enzymatic Therapy, in response to the companysintention to claim its HDL Booster product could remove LDL (bad) cholesterolfrom the blood vessel walls. FDA advised such a claim would be considered adisease claim.

Source Naturals, in response to the companysuse of the claim Some scientific evidence suggests that consumption ofantioxidant vitamins may reduce the risk of certain forms of cancer for itsRenewal Antioxidants product. FDA advised this would be a drug claim.

NOW® Foods,for the companys declared use of the claim AHCC supports the immunefunction through its ability to enhance ... NK cell activity, which theagency advised is a drug claim.

Traditional Medicinals, for its inclusion ofthe common cold on the label (product title) of its Just For Kids Organic ColdCare product, which would make the product a drug. FDA also took issue withseveral of the companys throat care products, which are not technicallyintended for ingestion and would, therefore, fail to achieve dietary supplementstatus.

Market America, for blood glucose maintenanceclaims made for its Advanced Level 90s product. FDA advised such claims, as incholesterol maintenance claims, must specify an effect for glucose levelsalready in normal range.

SmartScience Laboratories, for claims andstatements on its ReStore product linking the development and use of the productto the common cold, which constitutes a disease claim.

Highland Laboratories, for its intention to usethe claim Reduce stress; Elevate mood for its Corti Response product. FDA charges this and otherclaims employed suggest the product reduces cortisol as it relates to variousdiseases.

Greenchung USA, for its intention to use thedisease claim Helps to increase the resistance to infection for itsGreenchungkook supplement.

Lidtke Technologies Corp., for its declared useof claims suggesting its GlucoStat product can improve blood glucose,cholesterol and triglyceride levels, which the agency advised must also includestatements that the effects are for levels already in normal range.