Inspections, Compliance, Enforcement, and Criminal Investigations
ZEO Health Ltd. 29-Jun-07
Department of Health and Human Services
Public Health Service
College Park, Maryland 20740
JUN 29 2007
RETURN RECEIPT REQUESTED
ZEO Health Ltd.
29 Sunset View Drive
West Nyack, New York 10994
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.zeohealth.com and has determined that the products Esdifan, Destroxin, and Zeo are promoted for conditions that cause the products to be drugs 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 web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your web site include:
"Destroxin - Cancer Prevention and Treatment"
"The scientific community has recently had very positive results on the effect of Zeolite on certain types of cancers. In tests on a variety of tumor types, the treatment with Zeolite led to improvement of overall health status, prolongation of life span, and a decrease in tumor size. Also, in local applications of Zeolite to skin cancer, it reduced tumor formation and growth."
"For prevention: As a nutritional supplement, take 2 capsules twice daily. As part of Cancer therapy: As a dietary supplement, take 6 capsules three times daily."
"Stops Diarrhea Fast and Naturally."
"Esdifan is the most effective relief for diarrhea and bad stomach. Better than any drug on the market...."
"Irritable bowel, Crohns and others that suffer with chronic diarrhea rave about how well Esdifan really works!"
"ZEO - The Hangover Preventive"
"When you drink alcohol, the body tries to break down the toxins.... These toxins are not fully broken down and cause damage to your organs. The side effects of this damage, we call a `hangover' such as headache and nausea, as well as other ill effects that we can't see (liver damage). ZEO absorbs the toxins from the alcohol before they are processed into your organs."
The above claims about individual products are supplemented by claims on your homepage about your products in general and by metatags you use to bring consumers to your website. Examples of the metatags include "cancer prevention," "toxin removal," and "Natural supplements that... are proven to inhibit cancerous tumor growth, and will even prevent hangovers.... Effective diarrhea cure." Claims about disease prevention and treatment on your homepage include:
"We have products that remove toxins from your body, stop diarrhea... and even one that is proven to prevent hangovers if taken before drinking alcohol. The mineral used in our products has been shown in studies to be beneficial in treating cancer."
Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs" 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.
In addition, we note that your website states the following: "This form of Zeolite is approved by the FDA as completely safe...." We have cited several examples in this letter to demonstrate that you are not in compliance with FDA requirements. Further, FDA has not reviewed the safety of Zeolite, nor its interactions with other substances. Therefore, the use of this statement to promote your products is false or misleading in that it implies FDA approval or sanction of your product and its purported uses. The false and misleading information misbrands your Zeolite products under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)].
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 products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.
Please notify this office, in writing, within fifteen (15) working days of the 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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Kristen L. Moe, Compliance Officer, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-608), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.
Joseph R. Baca
Office of Compliance
Center for Food Safety
And Applied Nutrition