J.B. Williams making Cepacol ColdCare zinc lozenges cold claim despite "courtesy letter".

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.