FDA says Bee International Distributors hand gel is an unapproved new drug
SILVER SPRING, Md., July 9 /PRNewswire-USNewswire/ -- At the request of the U.S. Food and Drug Administration, on Thursday, July 8, U.S. Marshals seized $230,000 worth of hand sanitizing gel made by Puerto Rico Beverage Inc. of Maunabo and distributed by Lord Pharmaceutical, LLC, doing business as Bee International Distributors. The hand sanitizer is distributed only in Puerto Rico.
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The product Bee-Shield Hand Sanitizer with Aloe Vera (10 fl. oz. or 1 gallon bottles) is an unapproved new drug and in violation of federal law. The seizure warrant was issued in the U.S. District Court for the District of Puerto Rico by U.S. District Senior Judge Salvador E. Casellas.
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The gel was marketed as a product that could kill 99.99 percent of viruses, bacteria, and fungi; however its safety and effectiveness have not been established. Additionally, the active ingredient, benzalkonium chloride, is not recognized as safe and effective for over-the-counter (OTC) antifungal use, making it noncompliant with FDA's final monograph for OTC topical antifungal drug products.
"The safety and effectiveness of the active ingredient in this product have not been demonstrated to the FDA. Thus, this product is an unapproved new drug and violates federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "This seizure action helps ensure that no consumers are harmed by this product."
The hand sanitizing gel is an unapproved new drug under the Federal Food, Drug and Cosmetic Act and is therefore not permitted to be introduced into interstate commerce. Additionally, the product is subject to the final monograph for Topical Antifungal Drug Products because its labeling contains antifungal treatment claims. The product also represents that it prevents the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy. The FDA is unaware of any scientific evidence to support these claims.
Moreover, the product, which is not labeled correctly, is misbranded under the law because its packaging does not list all inactive ingredients, and its label fails to contain the place of business of the manufacturer, packer, or distributor.
The FDA inspected the product manufacturing facility between Aug. 19, 2009, and Sept. 28, 2009, and found numerous violations of U.S. current Good Manufacturing Practice requirements including failure to have a Quality Control Unit; failure to maintain a clean and sanitary processing, packing and holding area; failure to conduct appropriate lab tests; and many other violations.
Following that inspection the firm had agreed to recall and destroy its products but has continually failed to follow through on its commitments. This failure on behalf of the company led the government to request a seizure of the products.
On March 3, 2010, the FDA warned consumers not to use this product because it contained high levels of a bacterium, Burkholderia cepacia, that can cause serious infections in humans.
For more information:
FDA Warns Consumers in Puerto Rico of Harmful Bacteria in Hand Sanitizers http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202955.htm
Media Inquiries: Michael Herndon, 301-796-4673, [email protected] Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
