J.B. Williams making Cepacol ColdCare zinc lozenges cold claim despite "courtesy letter".
This article was originally published in The Tan Sheet
Executive Summary
J.B. WILLIAMS CEPACOL COLDCARE ZINC LOZENGES COLD CLAIM will remain on packaging, the firm said in response to an Oct. 9 "courtesy letter" from FDA. On Sept. 25, the firm notified FDA it would be marketing the dietary supplement Cepacol ColdCare Zinc Acetate Lozenges with the structure/function claim, "Taken as a dietary supplement, Cepacol ColdCare helps promote general well-being during the cold season." FDA states the claim and the product name, "taken together, suggest that it is intended to treat, mitigate, or prevent a disease, namely the common cold," and the product is thus an unapproved new drug.
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J.B. WILLIAMS CEPACOL COLDCARE ZINC LOZENGES COLD CLAIM will remain on packaging, the firm said in response to an Oct. 9 "courtesy letter" from FDA. On Sept. 25, the firm notified FDA it would be marketing the dietary supplement Cepacol ColdCare Zinc Acetate Lozenges with the structure/function claim, "Taken as a dietary supplement, Cepacol ColdCare helps promote general well-being during the cold season." FDA states the claim and the product name, "taken together, suggest that it is intended to treat, mitigate, or prevent a disease, namely the common cold," and the product is thus an unapproved new drug. The company said it does not plan to change its labeling, despite the agency's letter but "clarified" its position in a Nov. 24 response to FDA. In the letter, J.B. Williams argues the claim is justified because the Dietary Supplement Health & Education Act allows claims for "general well-being." Additionally, the firm maintains the name ColdCare is a brand name, not a description of the product type. J.B. Williams launched the zinc lozenge, an extension to its Cepacol throat lozenges, in August, promoting it with ads in magazines and in-store announcements. Weider Nutrition also received a recent courtesy letter regarding purported cold treatment claims made for its Cold-Free zinc acetate lozenges and echinacea product. The "Cold-Free" name itself is problematic in FDA's view. In September, Weider filed structure/function claims for its zinc lozenges, stating they are "Fast acting," the "Most active zinc form" and have a "Track record for effectiveness." The Cold-Free Echinacea claim reads: "Everyday our bodies are burdened with a multitude of potential pathogens. In order to ward off these pathogens, give your immune system the support it needs. Cold-Free Echinacea features a unique blend of Echinacea purpurea and goldenseal root for enhanced effect and support." The agency also sent courtesy letters to: The Daily Wellness Company for the Elix Cold/Flu claim "To help soothe cold and flu"; Immmu, a division of Advanced Plant Pharmaceuticals, for the claim "Natural cold relief for any season" for Alaskan Comfort; and HealthMark for the claims "Increased natural resistance to seasonal health problems" and "An especially popular dietary supplement during the cold and flu season...often recommended by health care specialists" made for its Herbal Dietary Supplement Standardized Potency Echinacea. The letters demonstrate FDA's continued concern with supposed claims for treatment of the common cold made for both zinc lozenges and echinacea-containing dietary supplement products. The agency already has sent letters to a number of companies including Rx Vitamins, Mason Vitamins and George Eby Research for zinc lozenge claims and Action Labs, Nature's Life and Pacific BioLogic for echinacea product claims ("The Tan Sheet" Aug. 25, 1997, p. 10). |