Bee-Shield Hand Sanitizer with Aloe Vera Seized by Federal Agents
Last week, U.S. Marshals at the request of the U.S. Food and Drug Administration seized $230,000 worth of hand sanitizing gel, Bee-Shield Hand Sanitizer with Aloe Vera.
Bee-Shield Hand Sanitizer with Aloe Vera (10 fl. oz. or 1 gallon bottles) is an unapproved new drug and is in violation of federal law. The gel is marketed as a product that can kill 99.99% of viruses, bacteria, and fungi.
Neither its safety nor its 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 which makes the product noncompliant with FDA’s final monograph for OTC topical antifungal drug products.
Bee-Shield Hand Sanitizer with Aloe Vera is 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.
The hand sanitizing gel, Bee-Shield Hand Sanitizer with Aloe Vera, is an unapproved new drug under the Federal Food, Drug and Cosmetic Act and is therefore not permitted to be introduced into interstate commerce. The product claims to prevent the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy, but the FDA is unaware of any scientific evidence to support these claims.
Recently, 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.
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.
“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.”