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FDA sets sights on products that purport to fight swine flu

ViraBan is one item that draws FDA scrutiny.
ViraBan is one item that draws FDA scrutiny.
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By Sandra G. Boodman
Washington Post Staff Writer
Tuesday, October 27, 2009

A shampoo that prevents airborne virus particles that settle on the scalp from causing swine flu. Special disposable gloves that offer protection from ATMs, door handles or steering wheels that might be "contaminated" with H1N1. A "natural immunization" that purports to be a safer alternative to a flu shot.

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These are among 140 drugs, devices and pieces of equipment marketed over the Internet that have landed on a list of fraudulent swine-flu-fighting products compiled by the Food and Drug Administration. In May, shortly after Health and Human Services officials declared swine flu a public health emergency, the FDA, in conjunction with the Federal Trade Commission, launched a crackdown on unapproved and unproven products.

While unsuspecting consumers might be attracted to the disease-fighting promises such products make, their manufacturers "are motivated by profit, not concern for public health," said Gary Coody, the FDA's national health fraud coordinator. Health officials say they are concerned that use of these unproven remedies might lead people to delay seeking medical attention and endanger the health of others.

Manufacturers are being told to immediately remove unproven claims or unapproved products from their Web sites and to respond to warning letters within 48 hours, instead of the usual 15 working days. Names of the products, manufacturers and their Web addresses are posted at http://www.accessdata.fda.gov/scripts/h1n1flu and will remain online, accompanied by a note indicating whether the required action has been taken. So far more than 90 percent of manufacturers have complied, removing suspect claims, products or, in some cases, entire Web sites.

One of the most recent additions to the list is a supplement called the Immune Support Formula, sold by a company owned by Andrew Weil, a prominent alternative medicine physician based in Arizona. An Oct. 15 warning letter to Weil Lifestyle states that the marketing claims that the pill boosts immunity, helping to ward off swine flu, violate the Federal Food, Drug and Cosmetic Act because the supplement has not been approved to diagnose, prevent, treat or cure the H1N1 virus.

In a statement released Oct. 16, Weil said he has ordered the claims removed from his site for review by his staff. "I fully support the FDA/FTC task force in its efforts," he wrote.

The most expensive product on the list is a $3,000 device called a "photon genie," which Coody described as a small box that is supposed to stimulate the immune system. It is still being sold, but flu-fighting claims have been taken down.

The agencies are also asking the public to report flu-related criminal activity or products that may be fraudulent. "We are planning ongoing proactive and aggressive" enforcement efforts to respond to swine flu fraud, said Alyson Saben, deputy director of the FDA Office of Enforcement. Those who do not comply could face criminal charges, a court injunction and an order to repay consumers.

The list is updated regularly, and Saben said her agency plans to "focus on those Web sites that have already received warning letters and may not be in compliance." She declined to discuss specific Web sites.

One such warning went out last month to the maker of ViraBan, a hand sanitizer that, according to its Web site, protects "everyone from 99.9 percent of all germs." Until last week the site also said ViraBan was "FDA compliant."

Kevin Lilly, president of Microhealth of Mandeville, La., which makes ViraBan, said he complied with the Sept. 14 order to remove claims that the product had been "proven effective against [swine flu.]" At the time, ViraBan was offering a "swine flu special -- only 29.99."

Lilly said he removed the claims because "we don't want to mislead people." But he added, "I have to question my government: Are we really using the things we should be using to keep ourselves healthy?"

Until recently, the site continued to display the logo of the FDA; it was removed after a reporter questioned its meaning.


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