The Food and Drug Administration (FDA) has caught itself in a trap of precedent and logic that should force it, finally, to regulate homeopathic products. FDA regulations require that drugs and treatments be “scientifically proven safe and effective.” Homeopathic remedies, except when people rely on them to treat serious conditions, are usually safe as water – which they actually are. Some homeopaths claim that shaking and serial dilutions – even to the point that not one molecule of the “active” ingredient remains – create a “memory” of the long-gone ingredient. So far, though, the FDA has ignored the multi-million dollar fraud. After all, what’s the harm?
Well, one harm, according to hundreds of people and dozens of lawsuits, is that some of Matrixx Initiatives’ homeopathic Zicam cold “treatments” cause anosmia – the loss of smell, a sense necessary both to enjoy a summer day and to detect gas leaks, fires and spoiled food.
Rather than the usual homeopathic magic water, some Zicam products contain pharmaceutically significant amounts of zinc, which was shown in the 1930s to cause anosmia when used intranasally. Some Zicam homeopathics also include an unspecified amount of benzalkonium chloride, which “disrupts signaling between molecules, a mechanism that could allow it to have widespread unanticipated effects,” says Peter Montague of Rachel’s Democracy and Health News. The U.S. Material Safety Data Sheet lists it as a hazardous, potentially mutagenic chemical; Canada bars it from products “applied to mucous membranes.”
But the giant regulatory loophole that is homeopathy allowed Matrixx, either by accident or design, to slap on the label “homeopathic,” slip under the regulatory wire and sell 1 billion doses of untested Zicam. Despite Zicam’s decade on the market and numerous lawsuits, the National Center for Homeopathy never condemned the mislabeling.
Under the Obama administration, the FDA requested that Matrixx recall a number of Zicam intranasal products. On June 16, the FDA warned, “Because they are not generally recognized as safe and effective for their labeled uses, these products [must undergo] well-controlled clinical investigations … regardless of their homeopathic status [before re-marketing.]”
While there is conflicting evidence that oral zinc shortens colds, it likely does little harm. The FDA, however, found Zicam ineffective, thereby fitting it under the agency’s definition of “health fraud.” It also ruled that Zicam’s moneymaking innovation of delivering the chemical into the nose rendered it unsafe.
The Zicam recall followed an earlier tough (and witty) FDA ruling that if General Mills continued to claim whole-grain Cheerios reduces cholesterol, the cereal would be regulated as a drug. In June, the agency made Bayer withdraw claims that One A Day for Men “supports prostate health.”
In addition to the 130 anosmia reports received by the FDA, Matrixx failed to notify the agency of more than 800 Zicam-related complaints. Furthermore, since Zicam was labeled for use by children, a class of underage victims may have gone unnoticed.
Nonetheless, Matrixx CEO William Helmut called the Zicam recall “a complete surprise.” And it is an expensive one. The zinc-based nasal products comprised 40 percent of Matrixx’s $112-million sales last year. The Scottsdale, Ariz., firm used some of the profits to pay $12 million in 2006 to settle hundreds of lawsuits by Zicam users claiming anosmia, plus $4 to $6 million in annual legal costs. Matrixx is currently under investigation by the Securities and Exchange Commission over its handling of the FDA warning and by the Federal Trade Commission for deceptive marketing.
Questionable marketing may come naturally to Zicam through its co-founders Robert Steven Davison and Charles B. Hensley. Davidson got his Ph.D. from an unaccredited, now-defunct diploma mill in Spain. Hensley, who holds the Zicam patents, got a warning letter from the FDA about the online sale of an unapproved drug that his current company, PRB Pharmaceuticals, claims treats bird flu and SARS. And the Washington Post reported: “Hensley previously developed a weight-loss remedy that involves sniffing ‘specially developed aromas.’ “
Meanwhile, Zicam users, who can no longer smell a rat, might develop a nose for bullshit and discover that sometimes the only thing worse than homeopathic products that have no effect are the ones that do.
For more on the subject, see this column I wrote a few years ago.
CONTACT Terry J. Allen at firstname.lastname@example.org