Zicam Recall Will Not Lead to Reformulation for Return of Cold Remedy

Following a Zicam recall issued earlier this year for nasal gel and nasal swab versions of the popular cold remedy due to a potential risk that they may cause users to lose their sense of smell, Matrixx Initiatives, Inc. indicates that they have no plans to reformulate and reintroduce the homeopathic product. They continue to maintain that Zicam did not cause the smell loss reported by hundreds of users, and are trying to convince the FDA to allow them to bring the products back as they were.

The announcement, which was reported by StreetInsider.com, came amid rumors that the company intended to reintroduce a new version of the nasal swab and spray products. Instead, Matrixx Initiatives, Inc. says that it believes there was nothing wrong with the original formula and will try to convince the FDA to change its determination that it causes anosmia, a loss of the sense of smell which can be permanent.

The FDA warned consumers to stop using the over-the-counter nasal gel and swab versions of the cold remedy on June 15, after receiving more than 130 reports of people who lost their sense of smell from Zicam. Matrixx Initiatives subsequently issued a recall for those Zicam products, and disclosed that they were aware of another 800 reports of Zicam problems, which they never notified the FDA about.

At the time of the recall for Zicam, the FDA indicated that Matrixx Initiatives would not be permitted to market the cold remedy until they submit data establishing that they are safe and effective. When Zicam was first introduced, it was never approved by the FDA, as it was classified as a homeopathic product, which is a designation usually reserved for herbal remedies. However, once a health concern was identified, the FDA was able to force the company to have the product approved, regardless of classification.

The nasal gel swabs and spray versions of Zicam contain zinc gluconate, which can damage nerves in the nose and cause a loss of smell. However, Matrixx Initiatives maintains that Zicam does not deposit zinc deep enough into the nose to cause the smell problems.

Matrixx Initiatives has faced a number of Zicam lawsuits over loss of sense of smell and taste since the products were first introduced in 1999. They reportedly settled about 340 cases out of court for undisclosed amounts several years ago, the lawsuits allege that they continued to sell the products without any change to the formula and without adequate warnings about the risk that users may suffer damage to their ability to smell.