Inspections, Compliance, Enforcement, and Criminal Investigations
Aluwe, LLC 11/30/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142
November 30, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 06
Raymond Kent Hann
6909 Magda Drive
Maple Grove, Minnesota 55369
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.
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"
• "Germ Slayer killed 100% of the Borrelia bacteria without allowing it to convert to the cyst stage. This is a significant finding in the fight against Lyme disease."
• "Independent lab studies have shown a 60 day regimen of Germ Slayer improves symptoms.... Quality of life improves dramatically for those suffering from bacteria/parasite driven diseases, including Lyme disease."
• "'Foggy brain' syndrome is often caused by bacteria in the brain above the blood/brain barrier. Germ Slayer kills these bacteria because of its tiny size and the germ killing characteristics of our silver."
• "With Germ Slayer's help, your body is doing battle with Lyme disease."
• "Lyme disease depletes your child's body of its physical and mental strength.... It is essential to use Germ Slayer to kill off the Borrelia...."
• "Unfortunately, as of today, there is no known cure for Lyme disease. What Germ Slayer can do is to dramatically improve your quality of life to allow you to function normally and get back to living!"
• "Several years ago, we introduced Germ Slayer into Africa to treat malaria and other diseases."
• "Here are Case Studies submitted by various medical professionals using Germ Slayer in the treatment of Lyme Disease, and other maladies, in their patients."
• "[Patient] with severe psychological symptoms of disorientation, confusion, obsessive compulsive disorder, bipolar depression, paranoia, and word confusion...began Germ Slayer in mid January, 2007, at 2 oz four times daily. She returned after two months, mania better, mental abilities all improved, obsessive compulsive disorder better, paranoia resolved.... Conclusion: 6 months of antibiotics had no impact on psychiatric symptoms, whereas 2 months of Germ Slayer 2 oz 4 times daily has shown marked improvement, and her tests are now negative for borrelia within the blood stream."
• "Began Germ Slayer 2 ounces four times daily.... After one week, patient
indicated that his joint pain was 80% better, and he had increased activity
• "[Patient] diagnosed with Lyme Disease... [c]ontinued Germ Slayer for three months, symptoms improved with less muscle and joint pains, fatigue, mental difficulty, and less disorientation. Stopped Germ Slayer... [a]ching and fatigue returned."
• "[Patient] diagnosed with Amyotrophic Lateral Sclerosis... [b]egan Germ Slayer 2 oz 4 times daily for next two months. Decreased muscle spasm, increased muscle tone, exygen [sic] saturation now 95%, no drooling, no respiratory infections, increased balance."
• "[Patient] [t]ested convalescent Epstein Barr. History included over 100 symptoms consistent with Lyme Disease. Began Germ Slayer 4/10/07 at 1 TBS 4 times daily. Herxheimer reaction, then moved to 2-3-4 TBS 4 times daily. Dimished [sic] imbalance, increased energy.... Pain was 10/10, now 6/10. Mental clarity has returned...."
Your website also contains disease claims in the form of personal testimonials, including:
• "[I]f Germ Slayer can clear up all of my other problems (severe depression, mental fog, dysfunction of the thyroid, parathyroid, an intestinal valve, carpel tunnel, hiatal hernia, as well as adrenal glands and other alzheimer type symptoms, etc.), then it has got to help the Lyme patient because it is the wonder cure of the century."
• "I used to suffer from something like chronic fatigue syndrome, but now I have plenty of energy. Mentally, I was always in a fog, unable to concentrate, but now my memory is returning! .... My son also has Lyme disease.... School was really a problem because he just couldn't follow directions and do what was asked of him. After about three months on Germ Slayer, he just got a report card with 5 As and one C (in Chemistry). He is also working 3 to 4 days a week in addition to school! We have both been using Germ Slayer for about 3 months now, and we have no intention of ever giving it up!"
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).
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:
• Your product is represented as a "proprietary formula" containing silver and platinum. Therefore, silver and platinum are dietary ingredients and must be declared by name and identified by the term "Proprietary Blend" or other appropriately descriptive term or fanciful name in the supplement facts panel in accordance with 21 CFR 101.36(c).
• Dosage guidelines should not be placed within the Supplement Facts panel.
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.
W. Charles Becoat