FDAnews Drug Daily Bulletin

TEXAS FIRM WARNED TO STOP MARKETING PRODUCTS AS ANTHRAX TREATMENTS

Dec. 8, 2005
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The FDA has warned a Dallas, Texas-based manufacturer to stop marketing its skin cream and aerosol sprays as treatments and cures against infections from anthrax and other pathogens.

The FDA's Dallas District Office sent an Oct. 19 warning letter to Bio-Germ Protection informing the firm that its website contains unsubstantiated claims about several products, including a skin lotion, an aerosol spray and an inhaler spray. Bio-Germ markets the three products together as a kit that the firm claims can protect people from bioterrorism attacks.

Bio-Germ was reportedly marketing its products to police and fire departments in the Dallas-Fort Worth area. The company's products are made from grapefruit seeds and the oil of an Australian tree.

According to the warning letter, which was posted to the FDA's website in late November, Bio-Germ's website claims that the protection kit "will give individuals an effective shield against infection from anthrax and other pathogens that could be released by terrorists."

The claims posted on Bio-Germ's website classify the products as drugs because they are intended to cure, mitigate, treat or prevent disease, the FDA said. The company has not submitted new drug applications for any of the products, the FDA said. Bio-Germ officials did not respond to requests for comment.

To view the warning letter, go to http://www.fda.gov/foi/warning_letters/g5560d.htm (http://www.fda.gov/foi/warning_letters/g5560d.htm).