Medical Device Daily Washington Editor

FDA has commenced with warning letters to owners of web sites that promote products purported to treat or cure the current version of swine flu (H1N1), addressing a problem that has been percolating for several weeks. The agency collaborated recently with the Federal Trade Commission to attack this brand of fraud, but this week's warning letter agenda is the first indication that FDA has opted to tackle the problem with the standard warning letter mechanism, and in some cases at least, the Center for Food Safety and Nutrition is handling the warnings.

A warning letter dated May 5 to Florida-based Susan Ambrosino's Herb Club states that the company's promotion of several drug products as treatments for swine flu is violative. A product named "Four Thieves Spray" is said to have been described as a product that "defends against swine flu." Another product is Swine Flu formula, which was apparently described as containing anti-viral herbs, and a third product, Amazon A-V, was purported to offer "protection against swine flu pandemic threat."

FDA included a notation that the warning letter was e-mailed to and states that while FDA has "issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products the marketing and sale of unapproved or uncleared H1N1 flu virus -related products that are not authorized" by an emergency use authorization "is a potentially significant threat to the public health."

This warning letter includes some boilerplate language that appears in other warnings addressing violative promotions of products with swine-flu related claims. FDA's letter to Ambrosino's operation urges the company to "ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 flu virus" unless such products have been "approved, cleared, or authorized by the FDA."

The remaining boilerplate language in the warning letter suggested that the company send an e-mail within 48 hours to to detail actions taken to eliminate the violative promotions, and threatened that a failure to "take corrective action immediately" could result in enforcement action, possibly including "seizure or injunction . . . without further notice." The letter also informed the recipient that the matter may be referred to the agency's Office of Criminal Investigations "for possible criminal prosecution."

A May 6 warning letter addressed to Robert Burrows at states that the web site was promoting a product described as "100% pure Immunolin," which according to the warning letter was promoted as offering the ability to "immunize your family against swine flu and influenza mutations."

FDA also informed the company that it "has been added to a published list on FDA's web site of firms and web sites that have received warning letters" for violative promotions in connection to the H1N1 virus, a list that can be found at the URL FDA said it will update the list to reflect that corrective actions have been undertaken by the firm as soon as the violative claims are removed from the company's web site. FDA also indicated that it may detain any such products that are imported, and that the agency "may advise the appropriate regulatory officials in the country from which you operate" of the violations.

At press time yesterday, the web sites for these two companies appeared to have removed the references to swine flu and H1N1. Among the other web sites posted at FDA's web site regarding violative claims is, a site the agency said was promoting an unspecified device in connection with the virus. However, an attempt to reach that URL generated a "404: file not found" error yesterday.

Sharfstein nixes gift card bonuses

Acting FDA commissioner Joshua Sharfstein, MD, has suspended the practice of using gift cards for agency employee bonuses after a purchase of 160 gift cards by the Center for Devices and Radiological Health.

According to a May 20 report in the Washington Post, the practice is common among government agencies, but Sharfstein has nonetheless expressed an interest in reviewing the practice. He said that his view is that he and Margaret Hamburg, MD, who was recently confirmed as the FDA commissioner, are "the new team coming in" and that they are "responsible for how the agency money is being spent." He was also quoted as saying, "it's really important that we're comfortable" with bonus programs.

Officials at CDRH put the bonus cards out for bid, and the lowest of three bids came from Stratford Gifts (Minneapolis), which bid $41,030 for the contract. The contract is said to have consisted of 160 gift cards with an average value of $250, which comes out to $40,000.

Sharfstein said in an interview with the Post that he wanted to review the procedures, noting that as many as 1,500 of the agency's employees received cards last year. Gift cards as bonuses are permitted under the rules of federal employment so long as the value is taxed, and according to the OPM web site, "the only circumstance where a gift certificate may be used to recognize an employee contribution is as an informal recognition award, which may not exceed nominal value." OPM also directs further questions of tax policy to the Internal Revenue Service.

Michael Orenstein, a spokesman for the Office of Personnel Management, said that OPM has advocated for more than a decade the practice of offering cards and other types of informal bonuses for deserving employees.