The current products affected by the FDA’s recent action are Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs. There are 17 other Zicam-branded products (including our oral Cold Remedy, cough, sinus, extreme congestion and allergy products) that are all safe and effective and continue to be sold at your local pharmacy or retailer. Please make sure you read directions and use as directed.

The oral Zicam Cold Remedy products, including Cold Remedy RapidMelts, Cold Remedy Chewables, Cold Remedy Oral Mist and Healthy Z-ssentials are not affected by the FDA’s recent warning. The FDA’s recent warning only affected the two current nasal Zicam Cold Remedy Products – Cold Remedy Nasal Gel and Cold Remedy Gel Swabs. These products are completely safe to use. Please make sure you read directions and use as directed.

Both Zicam Allergy Relief products are not affected by the FDA’s action and are safe to use. The Allergy Relief products do not contain zinc gluconate as their active ingredient. Please make sure you read directions and use as directed.

Yes, Zicam Cold Sore Gel Swabs are safe to use for cold sore treatment. The Cold Sore Gel Swabs are intended for topical use, not nasal use. Please make sure you read directions and use as directed.

The safety of Zicam Cold Remedy is substantiated with multiple studies:

(1)    An epidemiological study demonstrates that three of the most common conditions associated with anosmia are the common cold, sinusitis, and nasal injury.  This population study in 3.7 million patients demonstrated statistically significant associations between anosmia and numerous medical conditions and multiple classes of drugs.  These factors confound any attempt to attribute an association of anosmia with Zicam Cold Remedy zinc gluconate nasal gel.

(2)    Anatomic and behavioral data obtained in animal studies showed no detrimental effects on smell associated with single doses of Zicam intranasal zinc gluconate gel equivalent to between three and 6x the recommended dose for humans.  Even at doses up to 15x the recommended dose, little or no effect to detect odors was uncovered.

(3)    Human in vivo and cadaver studies using our dosage form and nasal pump delivery device confirmed that Zicam intranasal zinc gluconate gel does not reach the upper area of the nasal cavity where smell reception occurs.

(4)    Four peer-reviewed clinicals of intranasal zinc gluconate gel products showed no difference in olfactory function between the treated and placebo subsets.

Based on the FDA’s recommendation, we suggest you not use any Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Gel Swabs. You can either dispose of these two nasal Cold Remedy products or return them to Zicam. Zicam will provide a full refund or you can opt to exchange the products through Zicam for one of our Cold Remedy oral products. Click here for our return/exchange forms. This offer is available through August 2009.

We will be accepting refunds or exchanges at least through August 2009. Please check back here for any updates to this date.

Because of the recent FDA warning, Zicam has conducted a voluntary withdrawal of the Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swab products from the market. We are sharing our safety research with the FDA and hope to resolve this matter. Until then, however, these products will not be available.

Anecdotal reports from the 1930’s polio studies do not provide scientific support for a connection between anosmia and intranasal zinc sulfate application.  There was no follow up to analyze the reports of permanent loss of smell.  Certainly no conclusion can be determined from these studies relative to Zicam, which involves a different compound (zinc gluconate), in a different concentration, applied differently, in a different dose, to a different part of the nasal anatomy. It is also important to note that no scientific studies have ever shown that use of Zicam Cold Remedy intranasal products or zinc gluconate applied instranasally can cause loss of smell.

The three most common causes of anosmia are the common cold, sinusitis, and head trauma. Aging is a major factor as well. Furthermore, incidence rate of anosmia for Zicam users is lower than the incidence rate in the general population.

No. Zicam Cold Remedy intranasal products are over the counter drugs and are regulated by the Food and Drug Administration (FDA).  The active ingredient in Zicam Cold Remedy, zinc gluconate, is recognized as a drug in the Homeopathic Pharmacopeia of the United States (HPUS), a compendium to the Food, Drug, and Cosmetic Act.

Zicam Cold Remedy intranasal products are homeopathic drugs. Both the ingredient, zinc gluconate, and its concentration in the Zicam Cold Remedy intranasal products are in compliance with the Homeopathic Pharmacopeia of the United States (HPUS).

Zicam’s manufacturer, Matrixx Initiatives, is heading the FDA’s request to respond to the consumer warning letter by July 22 to outline the company’s plans to cease marketing the cited products. We are formulating our full response and intend to meet with this regulatory body to resolve this matter by sharing all of our safety and efficacy research as soon as possible. We are confident in the depth of our science and safety data.

We believe it is unfair for any Federal agency to take the kind of precipitous action it took against the company in a situation like this.  Had it talked with us, we would have shared with this regulatory body the compelling data and information showing that Zicam Nasal Gel and Gel Swabs are not unsafe.

Zicam® Cold Remedy nasal gel has been clinically proven to be effective at reducing both the duration and severity of the common cold.  Clinical studies of zinc-based cold relief products that use different active zinc formulations and different ingredients have had differing results.

The FDA warning letter could present a significant challenge for Matrixx Initiatives, Inc. and impact the business in two regards (1) impact to the Zicam brand and its equity (it was one of the fastest growing brands in the medicine aisle over the past decade) and (2) cost of unwarrantedlitigation. We can’t assess at this time the full financial impact of this situation, but we are optimistic that even without our two Zicam intranasal products we can continue to have a successful business. In fact, we will be launching two new unique oral forms of Cold Remedy for this upcoming cold and flu season.

Matrixx has always cooperated fully with the FDA, willingly shared all information requested by the FDA, and fully complied with its understanding of the FDA’s regulations. Any reports to the contrary are simply not true. As required by FDA regulations, Matrixx has always maintained detailed records of all consumer complaints and followed up with them. In the past four years the FDA has conducted two audits of the company, most recently in May 2009. During each audit, Matrixx made available to the FDA all adverse event complaints received by the company, along with complaint trends. These included all consumer complaints alleging loss or diminishment of the sense of smell.

Zinc gluconate works with the cation (Zn++) and binds to the rhinovirus, preventing it from attaching to the ICAM receptors in the nose, working at the source of where most colds begin. Zinc sulfate is a totally different compound and not in any Zicam Cold Remedy products.

This potential side effect is listed clearly on our packaging. In the clinical studies conducted, stinging and burning was noted between both treated and placebo subsets. With a cold, nasal passages are inflamed so any substance in the nose can be irritating.