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Matrixx Faces More Legal Issues

IRVINE, Calif.—FDA sent a sixth warning letter to Matrixx Initiatives Inc. regarding marketing claims made on Zicam.com and on product packaging. This current letter address claims about two of Matrixx Initiatives’s RapidMelts Vitamin C products that position the products as unapproved new drugs.

The other five warning letters are not the only legal problems Matrixx faced in the past, as earlier this month, Charles B. Hensley, the inventor of the zinc-based Zicam cold remedy, was arrested for federal charges of illegally importing and distributing the herbal-based Vira 38 product in the United States and using claims the product could prevent and treat bird flu.

According to the current warning letter, sent to company president and CEO William J. Hemelt, on June 3, 2011, FDA is now looking at claims that the Zicam Cold Remedy RapidMelts with Vitamin C & Echinacea and Zicam Cold Remedy RapidMelts with Vitamin C help consumers “Get over your cold faster," “Reduces duration and severity of a cold," and “[R]educes severity of cold symptoms: sore throat, stuffy nose, sneezing, coughing and congestion"

FDA said the statements are in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 331(d) and 355(a)). The RapidMelts Vitamin C products are also misbranded under section 502 of the Act (21 U.S.C. § 352).

FDA also noted packaging materials place product names in close proximity to the words “Cold Remedy." Further, website claims at issue include “Extra boost of Vitamin C in every RapidMelt,"“Extra boost of Vitamin C and Echinacea in every RapidMelt," “Reduces the duration of cold symptoms when taken at the first sign of a cold," and “Now, I always keep Zicam with me and know I’ve dodged another cold or two since. Zicam is a lot easier to take and carry than my individual zinc, Echinacea & vitamin C tablets."

 FDA said these statements about the RapidMelts Vitamin C products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in violation of section 201(g)(1)(B) of the Act (21 U.S.C. § 321(g)(1)(B)). Also, the statements say the products are intended to affect the structure or function of the body of man in violation of section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)).

Although vitamin C and echinacea could be marketed separately as dietary supplements, in this case they are combined with other drug ingredients. Because drug and dietary ingredients are combined in a single dosage form, FDA said the combination becomes a “drug" under section 201(g) of the act (21 U.S.C. § 321(g)).

 Because FDA considers the products as unapproved drugs, it said Matrixx is subject to the same adverse event reporting requirements for OTC drugs (760(b)(1) of the Act (21 U.S.C. § 379aa(b)(1))), which requires a manufacturer, packer or distributor whose name appears on the label to submit serious adverse event reports (AERs) to FDA. However, FDA inspections found Matrixx did not submit certain serious adverse event reports.

Marc Ullman, in an INSIDER article , partner, Ullman, Shapiro & Ullman, cautioned against following Matrixx’s mistake of not disclosing serious adverse events.

FDA also addressed other issues with Matrixx’s RapidMelts Vitamin C products, including:

  • Describing vitamin C and echinacea as inactive ingredients, despite statements that describe the vitamin C and the echinacea as intended to furnish pharmacological activity or other direct effect in reducing the duration and severity of cold symptoms, which makes them active ingredients.
  • Using vitamin C, which is not approved in over-the-counter drug (OTC) formulations for the treatment or prevention of the “common cold" under the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Use (final monograph for OTC Cold Cough Drug Products) (see 21 C.F.R. part 341) because the evidence was insufficient to classify vitamin C as safe and effective for such OTC use.
  •  Using vitamin C , which is not GRAS (generally recognized as safe) and effective for reducing the duration and severity of the common cold. Thus, any drug product intended for such use that includes vitamin C as an active ingredient, alone or in combination with other active ingredients, is also not GRAS and effective.
  • Using vitamin C without indentifying it as an active drug.
  •  Labeling the RapidMelts Vitamin C products as homeopathic drug products, but they are not  recognized in the official Homeopathic Pharmacopeia of the United States (HPUS). FDA’s Compliance Policy Guide for Homeopathic Drugs defines a homeopathic drug as: “Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements,"  and states “Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products." Although some ingredients in the RapidMelts Vitamin C products (zincum aceticum, zincum gluconicum, and Echinacea) are established homeopathic active ingredients included in the HPUS, vitamin C (ascorbic acid) is not a recognized active ingredient in the HPUS or any of the addenda or supplements.
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