OR WAIT 15 SECS
The agency took issue with specific product claims for products marketed as over-the-counter and homeopathic remedies.
In a new warning letter sent to Matrixx Initiatives Inc., makers of the Zicam brand, FDA addressed Zicam Cold Remedy RapidMelts with Vitamin C & Echinacea and Zicam Cold Remedy RapidMelts with Vitamin C, which are marketed as over-the-counter and homeopathic drugs. FDA states that due to their positioning and content, the products are in fact unapproved new drugs.
First, the letter calls the brand out for the following drug claims made in the products’ labeling, marketing, and website: “Reduces duration and severity of a cold,” “Get over your cold faster,” “Reduces severity of cold symptoms: sore throat, stuffy nose, sneezing, coughing, congestion,” and “Reduces the duration and cold symptoms when taken at the first sign of a cold.”
The letter acknowledges that although vitamin C and Echinacea can be marketed separately as dietary supplement ingredients, because they are combined with other drug ingredients in a single dosage form in the Zicam products, the products are classified as drugs.
Moreover, the agency states that although the company identifies vitamin C and Echinacea as inactive ingredients, because the company in fact infers that the ingredients have pharmacologic effects (treating a cold), the ingredients are in fact being marketed as active ingredients. However, vitamin C is not approved as an active drug ingredient for the treatment or prevention of the common cold.
Finally, although Echinacea is an approved homeopathic ingredient, the Zicam products should not be marketed as homeopathic products because they contain vitamin C, which is not a recognized active ingredient according to the Homeopathic Pharmacopeia of the United States.