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

Public Health Service
Food and Drug Administration
  10903 New Hampshire Avenue 
Silver Spring, MD 20993

October 8, 2009

VIA FEDERAL EXPRESS

Mr. Gustavo Lopez
Energy Miracle Enterprises
10 Railroad Avenue
Beacon Falls, CT 06403

Re: Detox Box

Refer to GEN0900982 when replying to this letter

WARNING LETTER

Dear Mr. Lopez:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Detox Box in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website, http://www.rifehealth.com for the Detox Box on September 8, 2009. Under section 201(h) of the Act, 21 U.S.C. 321(h). the Detox Box is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

A review of our records reveals that you have not obtained an investigational device exemption (IDE) prior to investigational use of your device and marketing approval or clearance before you began offering your devices for sale, which is a violation of the law.

Specifically, your website states that you provide "treatment frequencies" for the Detox Box to treat diseases and conditions, including:

Your website also explains a variety of health benefits provided by the Detox Box and the Crystal Resonators that are offered by your website to be used with the Detox Box. For example, your website states:

Your website contains statements indicating that the Detox Box is for experimental use or investigational purposes only. However, you do not have an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The Detox Box is therefore adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). Your device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the internet at http:/www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

The Office of Compliance requests that your firm immediately cease the dissemination of promotional materials for the Detox Box that are the same or similar to those described above on the website, http;//www.rifehealth.com. You should take prompt action to correct the violations described in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing what steps you have taken to correct the problem and how you plan to prevent this from happening again. Please list all promotional materials for the Detox Box that are the same as or similar to those described above, and explain your plan for discontinuing use of such materials. Please direct your response to Ms. Jennifer R. Medicus at the above letterhead address. facsimile at (301) 847-8128. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for this device comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

cc: Department of Public Health
Food and Drug Branch
Medical Device Safety Section
1500 Capitol Avenue, MS
7602, P.O. Box 997435
Sacramento, California 95899-7435

cc: Heather Hippsley
Acting Associate Director for Advertising Practices
Division of Advertising Practices
Bureau of Consumer Protection
Federal Trade Commission
601 New Jersey Avenue, N.W.
Washington, D.C. 20580

cc: Mr. Tacos Los Perros & Mr. Francisco Martinez
915 Aquiles Serdan y calle 8 Colonia Libertad
Tijuana, B.C., 32145 MX

This page was posted on January 31, 2010.

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