Inspections, Compliance, Enforcement, and Criminal Investigations
All About You Medspa, LLC 4/5/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Silver Spring, MD 20993-0002|
April 5, 2010
Ms. Deborah A. West
1417 Bear Street
Madison, IN 47250
Dear Ms. West:
The United States Food and Drug Administration (FDA) has reviewed your website, www.allaboutyoumedispa.com. As explained below, as of November 30, 2009, your website contained false or misleading claims related to your Lipodissolve products, causing them to be misbranded in violation 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 website that document these intended uses include, but are not limited to, the following:
• “Lipodissolve can also help to treat the following conditions:
o Fat of the pubic/genital area
o Skin retraction
o Surgical deformities or 'ripples' from surgical liposuction”
• “The mixture of medication causes the fat cells to release their fat deposits. The fat is then absorbed into the bloodstream and ultimately removed through the kidneys and/oliver [sic].”
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 the body 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.
All About You Med Spa’s website contains unsubstantiated efficacy and safety claims concerning Lipodissolve products for the following reasons:
1. Unsubstantiated Efficacy Claims
Your website contains unsubstantiated efficacy claims concerning Lipodissolve products, including:
• “In procedures for fat reduction there has [sic] been no reports until date where unevenness in areas injected have been observed from the injections.”
• “At a lower dosage, minute drops of Phosphatidylcholine which has fat dissolving properties are injected into the fatty area, where it acts to disperse accumulated fat deposits. The result is a significant reduction of the bulge after 2 to 4 treatments. dosages [sic] are used to disperse body fat pads.”
FDA regards these claims as false or misleading. FDA is not aware of evidence that supports these claims.
2. Unsubstantiated Safety Claims
Your website contains unsubstantiated safety claims concerning Lipodissolve products, including:
• “Clinical trials were carried out over two years on this simple non-surgical procedure, and after successfully completing the required criteria, they were submitted for publication to the Medical Journal USA in 2001. Over thousands of cases have already been treated in South America without any single adverse effect.”
These claims imply that these products have been proven safe. 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. 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)].
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
Michael M. Levy, Jr., Esq.
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research