• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Bio-Germ Protection, LLC 19-Oct-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145



October 19, 2005

Ref: 06-DAL-WL-04

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Allan Lord
Bio-Germ Protection, LLC
11816 Cheswick Street
Dallas, TX 75218

Dear Mr. Lord:

This letter concerns your firm's marketing of the products "Bio-Germ Protection Skin Lotion," "Bio-Germ Protection Aerosol," and "Bio-Germ inhaler spray," which are included in the "Bio-Germ Protection Kit," on your website, www.bio-germ.com.. Bio-Germ Protection Skin Lotion and Bio-Germ Protection Aerosol are also marketed separately on your website. According to product labeling, all three of these* products are -intended to prevent, treat, or cure serious disease conditions . Statements documenting these intended uses include, but are not limited to, the following:

Bio-Germ Protection Kit (Hard Case and Soft Case)

  • "The Bio-Germ Protection Kit will give individuals an effective shield against infection from anthrax and other pathogens that could be released by terrorists."

  • "The kit consists of a multi-layer protection system including natural antibacterial skin lotion, inhaler spray, aerosol air purifier . . . ."

Bio-Germ Protection Skin Lotion (as marketed separately)

  • " "This formula is tested to be successfully effective against anthrax and gramnegative organisms, staphylococci, streptococci and other pathogens. Bio-Germ Protection formula is successful in eradicating the anthrax bug and is effective against plague, and other pathogens possibly used by terrorists."

  • "The tests found this product to be extremely effective against a majority of Enterobactericae, otherwise known as the gram-negative organisms isolated from the gastrointestinal tract, which include non-enterics such as Pseudomonas aeruginosa."

  • "This product is also effective against the E. coli, K. pneumoniae, E. cloacae, P. aeruginosa, acinetobacter, enterococci sp, streptococci to include VRE. Among the staphylococci both MRSA /MRSE are susceptible."

  • "Bio-Germ Protection also is effective against Beta-hemolytic streptococci. "

  • "The product also promotes wound healing and an [sic] effective antibacterial. "

Bio-Germ Protection Aerosol (a marketed -separately)

  • "Breathable, protective aerosol."

  • "This formula is tested to be successfully effective against anthrax and gramnegative organisms, staphylococci, streptococci and other pathogens. Bio-Germ Protection formula is successful in eradicating the anthrax bug and is effective against plague, -and other pathogens possibly used by terrorists."

  • "The tests found this product to be extremely effective against a majority of Enterobactericae, otherwise known as the gram-negative organisms isolated from the gastrointestinal tract, which include non-enterics such as Pseudomonas aeruginosa."

  • " This product is also effective against the E. coli, K. pneumoniae, E. cloacae, P. aeruginosa, acinetobacter, enterococci sp, streptococci to include VRE. Among the staphylococci both MRSA /MRSE are also susceptible."

  • " Bio-Germ Protection also is effective against Beta-hemolytic streptococci."

  • " The product also is an effective antibacterial."

Bio-Germ Protection Skin Lotion, Bio-Germ Protection Aerosol, and Bio-Germ inhaler spray are drugs, as defined by the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. 321(g), because they are intended to cure, mitigate, treat, or prevent disease. This determination applies to Bio-Germ Protection Skin Lotion and Bio-Germ Protection Aerosol in their capacity as stand-alone products and in kit form. Moreover, all three products are new drugs, as defined by 21 U.S.C. 321(p), because there is no evidence that they are generally recognized as safe and effective for their labeled uses. Under 21 U.S.C. 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA approved application is in effect for it. Bio-Germ Protection Skin Lotion, Bio-Germ Protection Aerosol, and Bio-Germ Protection inhaler spray do not have an approved application and their introduction and delivery into interstate commerce violates 21 U.S.C.331(d)

A description of the new drug approval process can be found on FDA's Internet website at http://www.fda.gov/cder/regulatory/applicationsldefault htm. Any questions you may have regarding these processes should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857

The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Further, if your firm does not manufacture the product, your reply should include the name and 'address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturing firm. Address your reply to the U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Sherrie L. Krolczyk, Compliance Officer.

Sincerely,

/S/

Michael'A. Chapp
Director, Dallas District
.