FDA Sends Letters to Refute Companies' Claims

FDA Sends Letters to Refute Companies' Claims

WASHINGTON--The Food and Drug Administration (FDA) sent "courtesy" letters [also known as "letters of objection"] to notify several dietary supplement companies of claim provisions that they may be violating. Atkins Nutritionals, Prolab Nutrition, Cognis, Melaleuca, Nature's Life and Pharmavite were among those that received letters.

FDA found that products such as Dr. Atkins Cold & Flu and Dr. Atkins Allergy had labels stating that the products may lower cholesterol, relieve seasonal allergies and help with mild depression. These claims suggest that these products may have a drug-like health benefit and should be subjected to drug regulations; they did not meetFDA standards.

Other claims that were disputed included Prolab Nutrition's ProAla [for maintaining blood sugar levels]; Cognis's Covitol [for maintaining a healthy heart]; Melaleuca's PROVEXCV [for maintaining arterial health]; Nature's Life Sugarless C-Chews [for protecting against bacteria]; and Pharmavite's soy products [for alleviating symptoms of menopause].

Some companies submitted claims for approval beforehand. Weider submitted a Notification on behalf of its Schiff Bone Builder with Calcium, in compliance with Section 6 ofDSHEA. The Notification included research that showed how calcium and the product's other ingredients promote bone health. For additional information, visitwww.cfsan.fda.gov.