|Company:||Amerilab Technologies, Inc|
|Issuer:||Minneapolis District Office|
|Issued:||March 16, 2010||Closed:||Jan. 3, 2011|
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
March 16, 2010
Refer to MIN 10-11
RETURN RECEIPT REQUESTED
Frederick J. Wehling
Amerilab Technologies, Inc.
2765 Niagara Lane North
Plymouth, Minnesota 55447-4844
Dear Mr. Wehling:
This letter is in reference to your firm's manufacture, distribution and labeling of your product, Drinkin' Mate, identified during our inspection conducted on October 30 and November 3,2009, at your facility located at the above address. Additionally, we conducted a review of your website, www.drinkinmate.com. As a result of the inspection and our review of your website, we have found that your Drinkin' Mate product is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Additionally, even if your product were nota new drug, it would be misbranded as a dietary supplement within the meaning of sections 403(q) (5)(F)(i) and 403(s)(2)(B) of the Act [21 U.S.C. §§ 343(q)(5)(F)(i) and 343(s)(2)(B)]. You may find the Act and CFR through links on our website, www.fda.gov.
Your website contains disease claims in the form of personal testimonials, including:
• "NO HEADACHE - I tried Drinkin' Mate after I had three or four beers and I woke up without a hangover headache. -Brian"
• "BUY IT! After trying it, I'd recommend Drinkin' Mate to all my friends. It's the perfect solution for hangovers. -Alex'
• "IT REALLY WORKS! Wow! Drinkin' Mate really works. I expected a major hangover, but I feel great! -Kati'
• "I took one before I started drinking vodka drinks and green beer (of coursel) and another mid-way through the night. My friends were laughing at me saying it wasnt going to work. ....but guess who had hangovers the next day....and guess who did NOT! Yep, no hangover here. I felt great!"
• "Have your cake and eat it too, for the most part! Typical hangover symptoms: nausea (vomiting), headache, dehydration & fatigue. Drinkin' Mate is pretty much a magic pill. Pop pop fizz fizz, guess who's gonna be just fine tomorrow morning? YOU. (actually tastes good too) Totally prevents the nausea, headache, and dehydration."
• "[I]t was real good, no hangover no head pounding the next morning Kangarage George '
• "It was really easy to use and I felt just fine the next day I have no hangover once [sic] so ever."
• "[I] tryed [sic] it and wow no hang over i felt great the next day i will never go with out this again im giving my friends drinkin mate and now i can party and not worry about a hang over thank you for the great product."
• "I used Drinkin Mate after consuming a few margaritas & a couple beers. The taste was pleasant, remeniscent [sic] of a grape crush. It was extremely easy to use. The next day, I had no hangover at all."
• "I took one package of these Drinkin' Mate's and 1 kid you not I began to feel better in just minutes. Soon enough, my entire hangover was gone."
• "A friend told me about Drinkin Mate so one night before I went out I bought some. The next morning low and behold I did not have my usual hangover! I use this everytime I am going to drink and it saves me a whole lot of headaches (literally) I would recommend this to anyone who suffers from the age old hangover!"
• "These tabs really do work. I woke up with no hang-over."
• "A friend recommended Drinkin Mate and I tried it before I drank and in between and it was the best of the best. Goodbye hangovers Hello day after."
Your product is not generally recognized as safe and effective when used as labeled and/or for the above referenced use and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Your Drinkin' Mate product is misbranded within the meaning of section 403(q)(5)(F)(i) of the Act [21 U.S.C. § 343(q)(5)(F)(i)) because its product label contains a Supplement Facts panel which includes nutrients identified in 21 CFR 101.9(c), namely Calories from Fat, Total Fat and Saturated Fat, declared as zero. According to 21 CFR 101.36(b)(2)(i), when these nutrients can be declared as zero, they shall not be declared in a dietary supplement Supplement Facts panel. In addition, your supplement facts label is not formatted in accordance with 21 CFR 101.36(e)(6) because it does not separate dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) and dietary ingredients for which RDIs and DRVs have not been established with a heavy bar.
Your Drinkin' Mate product is further misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)) because the label fails to identify the product as a dietary supplement [21 CFR 101.3(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 in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/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