Pharmavite Remdex Makes Upper Respiratory Treatment Claims, FDA Says
This article was originally published in The Tan Sheet
Executive Summary
Labeling statements for Pharmavite's Remdex with Andropan, which is highlighted in new advertising as the "smarter way to fight colds," suggest the supplement is intended to treat upper respiratory tract diseases, FDA says in a recent "courtesy" letter.
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Labeling statements for Pharmavite's Remdex with Andropan, which is highlighted in new advertising as the "smarter way to fight colds," suggest the supplement is intended to treat upper respiratory tract diseases, FDA says in a recent "courtesy" letter. The agency challenges several structure/function claims for Pharmavite's andrographis extract-containing product in a Sept. 19 correspondence. Claims cited include: "Clinically proven to promote upper respiratory health and wellness and make you feel well faster"; "Helps you get back on your feet quickly"; "Begin taking as soon as you feel the need to support the health of your head and chest"; and "Take temporarily until you feel well again. If desired results are not achieved after five days of continued use, consult your doctor." "The statements [Pharmavite is] making for this product suggest that it is intended to treat, prevent or mitigate a disease of the upper respiratory tract," FDA maintains. Remdex, which is positioned as an "effective and non-drowsy," "all natural" alternative to OTC cough/cold remedies, began reaching store shelves in September (1 (Also see "Pharmavite, Weider Launch Respiratory, Joint Health Supplements" - Pink Sheet, 16 Jul, 2001.)). An ad appearing in October issues of publications including Ladies Home Journal and Family Circle advises: "Take Remdex at the first sign of a cold." "Before you try anything else, try the smarter way to fight colds," the print ad says. "New Remdex is clinically shown to reduce the severity and duration of a cold by helping your immune system attack the germs that can cause colds." Williams-Labadie (Chicago) designed the national campaign, which includes radio spots and outdoor advertising. In an Aug. 8 "courtesy" letter, FDA cites NBTY for claims made on supplements containing butcher's broom and white willow bark. Statements targeted include: "Affecting the valves and causing a backup of fluid"; "Helps treat occasional pain"; and "Helps alleviate minor pain, especially occasional...joint aches." Such claims suggest the products are intended to treat or prevent "edema associated with vein disorders and pain associated with joint disorders," FDA asserts. |