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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Medical Cosmetic Enhancements

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Silver Spring, MD 20993-0002

WARNING LETTER

 

April 5, 2010

VIA FEDEX

Dr. Drew Varano
www.medicalcosmetic.org
2 Wisconsin Circle, Suite 220
Chevy Chase, MD 20815

Dear Dr. Varano:

The United States Food and Drug Administration (FDA) has reviewed your website, www.medicalcosmetic.org. As explained below, your website contains false or misleading claims related to your Lipodissolve products, causing them to be misbranded in violation of of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 352(a), 352(n), and 321(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(5)(i) and (e)(6)(i).

Your Lipodissolve products are intended to cure, treat, mitigate, or prevent disease in humans or to affect the structure or function of the body. Statements on your websites that document these intended uses include, but are not limited to, the following:

• “The treatment is often used to diminish the appearance of a double chin and jowls, to remove underarm fat, or to decrease the width of your waist, sometimes by several inches.”
• “Lipodissolve consists of a series of injections using PCDC (phosphatidylcholine/sodium deoxycholate), a natural fat emulsifier, into the fatty tissue which breaks down the fat, allowing it to be eliminated by the body.”

Because these Lipodissolve products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans, or to affect the structure or any function of thebody of man or other animals, they are drugs, as defined by section 201(g)(1) of the FDCA [21 U.S.C. § 321(g)(1)]. In addition, your firm’s injectable Lipodissolve products are prescription drugs, as defined in section 503(b)(1) of the FDCA [21 U.S.C. § 353(b)(1)], because the method of their use is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs.

Under sections 502(a) and 502(n) of the FDCA and FDA’s implementing regulations, a prescription drug is misbranded if its labeling or advertising is false or misleading. Section 201(n) of the FDCA [21 U .S .C. § 321(n)] provides that, in determining whether a drug's labeling or advertising "is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising . . . fails to reveal facts material in light of such representations . . . . " Advertisements that contain a representation or suggestion that a drug is better, more effective, or safer than has been demonstrated by substantial evidence or substantial clinical experience are false or misleading.

Medical Cosmetic Enhancements’ website contains unsubstantiated efficacy, superiority, and safety claims concerning Lipodissolve products for the following reasons:

1. Unsubstantiated Efficacy Claims

Your website contains unsubstantiated efficacy claims concerning Lipodissolve products, including:

• “The Lipodissolve treatment consists of a series of injections (8-10 per area) using a very fine needle (about the size of an acupuncture needle) that convert the fat in a small, targeted area to a liquid form. It does this by breaking down the bonds that connect the fat molecules to one another without damaging any of the surrounding body tissue. The body then filters out the fat naturally over the course of a few weeks.”
• “You can loose [sic] up to 1 inch around the abdomen per session.”

FDA regards these claims as false or misleading. FDA is not aware of evidence that supports these claims.

2. Unsubstantiated Superiority Claims

Your website contains unsubstantiated superiority claims concerning Lipodissolve products, including:

• “Unlike liposuction, where fat is suctioned out of the body, Lipodissolve allows fat to be eliminated through the patient's bodily functions.”

FDA regards these claims as false or misleading. FDA is not aware of evidence that supports these claims.

3. Unsubstantiated Safety Claims

Your website contains unsubstantiated safety claims concerning Lipodissolve products, including:

• “To date, the procedure has a very good safety record with no reported instances of permanent complications.”
• “(PC) phosphatidylcholine and (DC) sodium deoxycholate - Have been FDA approved individually for medical indications, but is not currently approved for aesthetic purposes.”

Although intravenous phosphatidylcholine has been approved in some countries for the treatment of a variety of conditions, it has not been approved in the U.S. Currently there is no FDA approved injectable PC or DC, and therefore, your claim that PC and DC have been FDA approved individually for medical conditions is false or misleading. In addition, FDA is unaware of evidence to support the safety claims for your Lipodissolve products.

As explained above, the claims made for your Lipodissolve products are false or misleading in that they are not supported by substantial evidence or substantial clinical experience. These claims cause your LipoDissolve products to be misbranded under the FDCA [21 U.S.C. §§ 352(a), 352(n), and 321(n)].

Conclusion

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your written response should be addressed to:

Sudha Shukla, PharmD
Consumer Safety Officer
FDA/CDER/Office of Compliance
10903 New Hampshire Avenue, WO51-5238
Silver Spring, MD 20993-0002

Sincerely,
/S/
Michael M. Levy, Jr., Esq.
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research