|Company:||Vitality Distributing, Inc.|
|Subject:||Unapproved New Drugs/Misbranded|
|Issuer:||Cincinnati District Office|
|Issued:||April 24, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Cincinnati District Office
April 24, 2012
WARNING LETTER CIN-12-286877-15
Brian M. Pitzer
Vitality Distributing, Inc.
342 Moss Ct.
Marysville, OH 43040
Dear Mr. Pitzer:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.myavitae.com in March 2012 and has determined that your “avitae caffeinated water” product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act.
Examples of the claims observed on your website include the following:
• On the webpage titled, "Questions?":
"Q: Is avitae safe?"
"A: ... [S]tudies show that caffeine may reduce chances of many types of cancer, alzheimer's [sic] disease, Parkinson's disease, among others."
•On the webpage titled, "Mommy, Why?" on page 7 of the illustrated story titled, "Mommy, Why
Is There Caffeinated Water in Our Refrigerator?":
"Did you know that caffeine could cut down a terrible disease called Alzheimer's by over 50%?
It can also do all sorts of other great things like reduce heart disease in women by over 24%."
We also note that FDA collected promotional material for your product at the 2012 Natural Products Expo West trade show that was held on March 8-11, 2012 at the Anaheim Convention Center. Claims included in the promotional literature collected at the trade show include the following:
•" [A] study of 27,000 women found that those who drank one to three cups of coffee a day reduced their risk of heart disease by 24 percent."
•“Caffeine helps cut brain cancer risk.”
•“Caffeine may be protective against the cognitive decline seen in dementia and Alzheimer’s disease.”
Your product is not generally recognized as safe and effective for the above referenced conditions and therefore, this 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 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.
Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], that labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling 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 action without further notice, such as seizure and/or injunction.
In addition to the above violations, we have the following comment regarding claims made on your Facebook account (accessible at: https://www.facebook.com/avitae) and your Twitter (@avitaeusa) account (accessible at http://twitter.com/#!/avitaeusa). Posts made by the page administrator on November 9, 2011 on both your Facebook Timeline and your Twitter page include a link to an article entitled, “A Coffee A Day May Keep The Doctor Away.” That article makes the following claims:
•"[W]omen who regularly drink caffeinated coffee have a 20 percent lower risk of depression ... "
•"It lowers the risk of cancer and diseases"
•"Scares off Alzheimer's disease"
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Stephen J. Rabe, Compliance Officer, Food and Drug Administration, Cincinnati District, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions regarding any issue in this letter, please contact Mr. Rabe at 513-679-2700 ext 2163.
Paul J. Teitell