In a rare action, FDA simultaneously alerted consumers not to use Matrixx Initiatives' intranasal Zicam products because of potential safety problems and warned Matrixx to remove the products from market without first consulting with the firm.

Ivan Wasserman, a partner with Washington-based Manatt, Phelps & Phillips, said the situation is "fairly unusual." Prior to consumer warnings, "ideally the FDA would give the company as much of a heads up as possible so the company is prepared to respond to questions from consumers, retailers, medical professionals and others," Wasserman said.

Peter Barton Hutt, a former FDA chief counsel and currently an attorney with Washington-based Covington & Burling, said the action is not representative of business as usual at the agency.

"It is an extraordinary compliance power," Hutt said.

He said the Zicam action is one of only three recent instances he could recall of FDA warning consumers against use of a product without first alerting its maker. The other instances concerned phenylpropanolamine and ephedra, Hutt said in an e-mail.

FDA in November 2000 issued a public health advisory about PPA before issuing a rulemaking to discontinue use of the ingredient in all OTC and Rx products. In December 2003, the agency imposed a ban on sales of all ephedra-containing products before promulgating a final rule on the ingredient.

In a June 16 warning letter, FDA told Matrixx the consumer alert was a response to complaints of anosmia - the loss of the sense of smell - in adverse event reports submitted to the agency (see ¹ Also see "Zicam Lawsuits Multiply, But Matrixx Is Confident History Will Repeat Itself" - Pink Sheet, 29 June, 2009.).

According to a June 18 Securities and Exchange Commission filing, Matrixx called the warning letter a "complete surprise" and said the agency "had not indicated through any communications that the FDA had a heightened concern about consumer reports of smell loss from use of" the products.

FDA also asked Matrixx for more than 800 AERs the firm received but had not forwarded to the agency.

FDA officials learned of the reports during a May 26-28 inspection. They said the anosmia events should be reported to the agency, but the firm's counsel disagreed that the reports met serious adverse event criteria, said Matrixx's acting President William Hemelt.

Matrixx said it submitted a follow-up letter to FDA after the inspection, but was not contacted by the agency until receiving the warning letter.

Perhaps the more proactive FDA action reflects the new administration at the agency and in the White House, which both promised a greater public health focus and more transparent government.

Wes Siegner, of Washington-based law firm Hyman, Phelps & McNamara, said FDA's concern about an unapproved product, awareness of studies suggesting nasal issues related to zinc and knowledge of AERs Matrixx received likely prompted the action.

"FDA's view typically with most homeopathic products is that it is unlikely it will help you but they won't hurt you," he said.

"It's not everybody at FDA, but overall I think that FDA views homeopathic products with considerable skepticism. That's typical with any product" that does not require pre-market approval, Siegner added.

"What FDA's thinking was, 'We have pretty solid evidence that there is a concern here. We don't view the products as providing some really essential public health benefit, so that's why we think we need to get this off the market,'" he added.

Asked about research suggesting nasal problems linked to zinc, a Matrixx spokeswoman said the firm maintains that scientific evidence supports the safety of its products and that anosmia is not a side effect.

A 1938 Journal of Pediatrics study of the use of intranasal zinc sulfate in polio patients - which indicated the substance caused the loss of smell in some - might be responsible for suspicion about intranasal Zicam products, she said in an e-mail.

"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," the spokeswoman said. Further, the "anecdotal" study did not include a follow-up with patients and does not provide scientific support, she said.

- Katie Stevenson (k.stevenson@elsevier.com)

FDA Uses "Unusual" Action To Get Matrixx's Zicam Off The Market

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