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.