Matrixx Initiatives’ troubled history with FDA continues with a warning two of its products are unapproved new drugs because they combine supplements with OTC drugs.

Matrixx makes claims for its Zicam Cold Remedy RapidMelts with Vitamin C & Echinacea and Zicam Cold Remedy RapidMelts with Vitamin C including “get over your cold faster” and “reduces severity of cold symptom.”

Based on these statements, the products are drugs, the agency’s Los Angeles district office says in a June 3 letter.

Although echinacea and vitamin C could be marketed separately as dietary supplements, in this case they are combined with drug ingredients: two forms of zinc. FDA maintains that when dietary supplements are combined with drug ingredients, “the combination becomes a drug.”

FDA has made this position clear in five previous warning letters to other firms, the letter to Matrixx says.

FDA previously warned Procter & Gamble about Vicks DayQuil and NyQuil with vitamin C and Bayer about Bayer Aspirin with Heart Advantage, which contained phytosterols, and Bayer Women’s Low Dose Aspirin and Calcium (Also see "FDA Underlines Disapproval Of Drug-Supplement Combos In Letter To P&G" - Pink Sheet, 2 November, 2009., and Also see "Bayer Warning Letters Reinforce FDA Ban On Supplement/Drug Combinations" - Pink Sheet, 3 November, 2008.).

The Matrixx products are also new drugs because vitamin C “is not generally recognized as safe and effective for reducing the duration and severity of the common cold,” FDA says.

The agency specifically points out vitamin C was evaluated for inclusion in the cough/cold monograph but was omitted “because the evidence was insufficient to classify vitamin C as safe and effective for such OTC use” (Also see "Pheniramine, Phenylephrine Combo Excluded From Cough/Cold Monograph" - Pink Sheet, 6 January, 2003.).

Homeopathy At Issue

Although Matrixx markets its products as homeopathic drugs, FDA points out nothing in the Food, Drug and Cosmetic Act “exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding or approval.”

FDA acknowledges that many homeopathic drugs are manufactured and distributed without approval, but disputes that the Zicam products at issue are homeopathic. The agency’s relevant compliance policy guide mandates a homeopathic drug must be listed in the Homeopathic Pharmacopeia of the United States or one of its supplements.

Although zinc and echinacea are established homeopathic active ingredients in the pharmacopeia, vitamin C is not.

“Furthermore, to our knowledge, vitamin C (ascorbic acid) is not listed in any recognized Materia Medica containing information on the preparation of homeopathic medicines,” the agency adds.

FDA also says the products are misbranded because they fail to identify vitamin C and ecinachea as active drug ingredients and have false or misleading labels because they are labeled as homeopathic.

Labeling changes and product reformulations may be required to bring the products into compliance.

A company spokesman said Matrixx is in discussions with FDA and “will be in full compliance with their requirements.”

AERs Still Haunt Matrixx

The agency’s letter also brought up adverse event reporting, long a trouble spot for the firm, and indicates it plans to keep a close eye on the issue.

FDA notes Matrixx in the past failed to submit “certain adverse event reports as required” during inspections. In June 2009 FDA warned customers not to use the firm’s intranasal zinc products because of the potential for anosmia and told Matrixx to pull the products from the market (Also see "FDA Uses "Unusual" Action To Get Matrixx's Zicam Off The Market" - Pink Sheet, 29 June, 2009.).

“We believe that your proposed corrective action plan is adequate and you are submitting reports as promised,” FDA says.

However, the agency says, a regulatory meeting is “warranted to further clarify your reporting requirements” and “to ensure that your firm sustains compliance with the reporting requirements going forward.”

FDA requests Matrixx contact a district official within five days to schedule a regulatory meeting. The agency also asks Matrixx “to provide a detailed status update since the last response” from November 2009.

The meeting will be scheduled after FDA receives Matrixx’s response, which is due July 1, the spokesman said. The agency gave Matrixx extra time to respond because the letter is addressed to former CEO William Hemelt, who recently left the company.

Net sales dropped after the withdrawal of the intranasal products, forcing the company to rely on new products to make up losses (Also see "Matrixx Launches Zicam Products To Rebound During Cold Season" - Pink Sheet, 17 August, 2009.).

Eventually, mounting losses from product recalls and increasing litigation costs from both product liability and shareholder lawsuits resulted in the sale of the firm to a private equity company (Also see "Matrixx Bought By Private Equity Firm H.I.G., Settles Personal Injury Lawsuits" - Pink Sheet, 20 December, 2010.).

By Carolyn B. Phenicie

FDA Warns Matrixx On Combination Supplement/Drug Products

More from Archive

More from Pink Sheet