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

Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health

 

2098 Gaither Rd
Rockville, MD 20850

November 19, 1999
WARNING LETTER
VIA FEDERAL EXPRESS

Leah Louis
Cellulite Reduction of New York
1045 Park Ave
New York, NY 10028

Ref. No. ES 1 Therapeutic Massager

Dear Ms Louis:

The Office of Compliance (OC) of the Food and Drug Administration (FDA) has reviewed your web site at the Internet address: www.celluliteusa.com. The site contains certain medical claims for the device commonly known as the ES 1 therapeutic massager. This product is manufactured by LPG USA, Inc., Fort Lauderdale, FL.

Under a United States Federal law, the Federal Food, Drug, and Cosmetic Act, the ES 1 is considered to be a medical device because it is being used to diagnose or treat a medical condition or to affect the structure or function of the body. The law requires that manufacturers and/or distributors of medical devices obtain marketing clearance for their products from FDA before they are allowed to offer them for sale to the public. This serves to protect the public health by ensuring that new medical devices are safe and effective or substantially equivalent to other devices already legally marketed.

In April, 1998, FDA gave LPG permission to market the ES 1 Therapeutic Massager for the following medical claims: relief of minor muscle aches and pains, temporarily increases local blood circulation, relaxes muscles locally, and temporarily reduces the appearance of cellulite (emphasis added). As a result, any distributor of the ES 1 may also make these claims for the device.

However, when a manufacturer or distributor of the ES 1 makes a significant change in the medical claims (intended use), such change(s) must first be cleared by FDA before implementation. On September 7, 1999, Mr Byron Tart, Director, Promotion and Advertising Policy Staff (PAPS), discussed your website and advised you that certain claims made for the ES 1 were not acceptable because they had not been cleared by FDA prior to implementation.

A review of your current website reveals that Cellulite Reduction of New York continues to make some of the same unlawful claims for which you were cited in our September 9 letter. Representative examples are as follows:

We also note that your website contains a box titled "Links of Interest." Clicking on this box takes the reader to several related sites discussing Endermologie and the ES1 device. Some of these sites contain testimonials from physicians and other consumers that also discuss unapproved uses of the ES 1 device. Since these other websites can easily be accessed by anyone in the United States, they may not contain any claims for the ES 1 that have not been cleared by the agency. Representative examples of the sites and testimonial statements that we consider objectionable are as follows:

Claims that the ES 1 can result in weight loss — reduction, loss of inches, body contouring, increases skin elasticity, results in lymphatic drainage or removal of toxins, renews skin tone, eliminates love handles, stretch marks, loose skin, scar tissue, reduces lymphedema, or reduces cellulite permanently, is a serious violation of FDA law. Because the ES 1 is considered under the law to be held for sale each and every time that you use the device, you are considered to be a distributor of the ES 1 and therefore, fall under FDA's jurisdiction.

In legal terms, the ES 1 is adulterated under section 501(o)(1)(B) and misbranded under section 502(o) of the Act. The ES 1 is adulterated because you, as the distributor of the device, failed to obtain premarket approval based on information developed by you to show that your device is safe and effective for the claims that are represented on your web site. You have also misbranded the ES 1 because you failed to submit information to FDA showing that your device is substantially equivalent to other similar devices that are legally in the marketplace.

The claim that Endermologie is the only FDA approved treatment for the temporary reduction in the appearance of cellulite is not accurate. The agency has granted this claim to at least three other manufacturers based on valid scientific evidence.

These violations of the law are not limited to the internet but would also apply to any labeling or promotional materials distributed by Cellulite Reduction of New York. You must review these other materials to assure compliance with FDA regulations.

You should take prompt action to correct these violations of the law. If you don't act immediately, FDA may take further action against you which may result in seizing your product inventory, obtaining a court injunction against further marketing of the ES 1, or assessing civil money penalties against you.

You must take appropriate action to correct these violations now. Please submit a written letter to this office, within 15 working days of receipt of this letter, outlining the specific steps you have taken to correct the cited violations. You should include all steps you are taking to correct the problems identified above. If you need more time, let us know why and when we can expect a complete response. Please direct your response to Mr Steven E. Budabin, Consumer Safety Officer, Promotion and Advertising Policy Staff (HFZ- 302), Office of Compliance, Center for Devices and Radiological Health, 2098 Gaither Rd, Rockville, MD 20850.

A copy of this letter is being sent to FDA's New York District Office. Please send a copy of your response to the District Director, Food and Drug Administration, New York District Office (HFR-NE100), 850 3rd Ave, Brooklyn, NY 11232-1593.

Sincerely yours,
/s/
Byron Tart for
Lillian J. Gill
Director, Office of Compliance

This page was posted on August 20, 2006.

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