Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

November 30, 2009

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 10 - 06

Raymond Kent Hann
Owner
Aluwe, LLC
6909 Magda Drive
Maple Grove, Minnesota 55369

WARNING LETTER

Dear Mr. Hann:

This letter is in reference to your firm's manufacture, distribution and labeling of your product, Germ Slayer, identified during our inspection conducted on August 17-18, 2009, at your facility located at 6909 Magda Drive, Maple Grove, Minnesota. Additionally, we conducted a review of your websites, www.aluwe.com and www.GermSlayer.net. These actions were conducted to determine your firm's compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations contained within Title 21 of the Code of Federal Regulations, Part 101 (21 CFR 101). As a result of the inspection and our review of your websites, we have found that your Germ Slayer product is promoted with claims that cause it to be an unapproved new drug within the meaning of section 505 of the Act (21 U.S.C. § 355). Additionally, even if your product were not a new drug, it would be misbranded as a dietary supplement within the meaning of sections 403(e)(1) and 403(s)(2)(B) of the Act [21 U.S.C. §§ 343(e)(1) and 343(s)(2)(B)]. You may find the Act and CFR through links on our website, www.fda.gov.

New Drug

Your firm manufactures and promotes Germ Slayer, which is labeled with claims on your website that cause it to be a new drug. Examples of some of the claims observed on your website include:

"Germ Slayer"

Your website also contains disease claims in the form of personal testimonials, including:

These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)), because the claims establish that the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because your product is not generally recognized as safe and effective when used as labeled, it is also considered a new drug as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505 of the Act [21 U.S.C. § 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).

Misbranding

Your Germ Slayer product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product label fails to accurately declare the place of business of the manufacturer, packer, or distributor. The labels for the product in use at the time of the inspection list the location of the business as Sun Valley, Idaho 83353. However, your business is currently located in Maple Grove, Minnesota 55369.

Your Germ Slayer product is marketed as a dietary supplement. As such, it is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because its product label fails to identify the product as a dietary supplement as part of the product's statement of identity on the principle display panel (21 CFR 101.3(g)).

Your Germ Slayer product is further misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because it fails to bear the nutrition labeling for dietary supplements that is required under 21 CFR 101.36. For example:

In addition, your product fails to properly label the "other ingredient" list and comply with placing it immediately below the nutrition panel in accordance with 21 CFR 101.4(g).

The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are labeled in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that your establishment is in compliance with these requirements. In addition to consulting the Act and Title 21 of the CFR, you may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your labels.

You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.

Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

This page was posted on January 31, 2010.

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