Zicam maker responds to FDA warning letter

NEW YORK With the agency’s latest warning letter, one thing is becoming clear: There’s a new sheriff in town. And this sheriff isn’t packing a pea-shooter.

Within eight weeks, the Food and Drug Administration has issued two warning letters to two companies initiating two voluntary product recalls in the over-the-counter self-care arena.Critics have been clamoring for a more aggressive and decisive FDA for some time, pointing to public-safety snafus like the contaminated heparin that leaked into the U.S. market, or the recent pervasive peanut recall prompted by salmonella contamination.

But swinging to such an extreme, heavy-handed approach may have its own adverse events.

For starters, there is potential collateral damage to industries on the whole. The publicized warning letters that resulted in the recall of a number of Hydroxycut products and a pair of Zicam SKUs has called into question the regulation and safety of the dietary supplement and the homeopathy industries, respectively. An Associated Press report published Thursday was critical of both industries. And debating whether or not that writer was entirely accurate in his depiction of the industry is of no consequence. The fact is the AP reaches more than 7,500 consumer media outlets between paper, radio and television. And who doesn’t believe what they read?

Then there is the actual question as to how heavy is heavy-handed? The Hydroxycut recall was based on 23 adverse event reports; Zicam a little more than 130. Even considering that those events are typically under-reported, they are nowhere near the 13,000-plus adverse events associated with Metabolife’s ephedra supplements that prompted the agency several years back to issue an out and out sales ban on that ingredient. Factor in the number of doses consumed by millions over the years for each of the ingredients, and the corresponding adverse events may seem less dramatic, and certainly less than what’s accepted across other product categories.