"FDA Enforcement Update"

35 Firms Get FDA Warning Letters Regarding Various Swine Flu Claims

THREE COMPANIES ADVERTISING laboratory tests for swine flu A/H1N1 were among those firms targeted for warning letters by the Food and Drug Administration (FDA) last month.

Between May 4 and May 29, the FDA sent warning letters to 35 companies. The warning letter typically noted that the FDA had reviewed each company’s Website and had determined that the site offered a product for sale that is intended to diagnose, mitigate, prevent, treat, or cure the A/H1N1 flu virus in people. “This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the 2009 H1N1 Flu Virus,” the FDA said in the 35 warning letters.

Web Claims Examined

In the letters, the FDA stated that the marketing of these products violates federal law. The FDA further requested that the companies cease marketing these unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the A/H1N1 flu virus “immediately.”

Three lab testing companies were among the 35 firms that received the FDA warning letters. They are: Becton Dickinson & Company for its BD Directigen EZ Flu Test; Luminex Corporation for its xTAG Respiratory Viral Panel; and, Prodesse, Inc., for its Prodesse ProFlu+ Assay.

It is not known if the FDA has taken further enforcement action against any of the 35 companies that received these warning letters. But the collective list of 35 products shows why regulators face a difficult time. Other types of products targeted for warning letters run the gamut from nutritional supplements and drugs that claimed to be effective against swine flu, to medical devices and protective products, such as masks and gloves.

For example, the Skilling Institute offers the “Proton Genie,” which claims, among other things, to “stimulate and strengthen the entire immune system.”

Another company which received an FDA warning letter is LifeSecure. Among its swine flu product offerings is the “On- The-Go Swine Flu Personal Infection Protection Kit.” Offered at $19.95, the product description says, “The kit is designed to accommodate one person for up to two days and includes such items as N95 respirators, eye protection, vinyl gloves, disposable thermometers, tissues, hand sanitizer, and biohazard bags.”

In these 35 warning letters, the FDA advised each company that, “You should take immediate action 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 2009 H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA.”

Some publications that closely watch the FDA have interpreted the warning letters to BD, Luminex, and Prodesse as a sign that the FDA is using this opportu- nity to more tightly regulate molecular testing. But, given that these three warning letters were sent during the same May 4-29 period as the other 33, it is likely that regulators wanted to establish a public record that they were actively monitoring for any and all products advertised as effective for swine flu without proper regulatory review of those claims.

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