Public Health Service
Food and Drug Administration
Silver Spring, MD 20993-0002
WARNING LETTER
April 6, 2010
VIA FEDEX
Mr. Jeff Nourse
www.puremedspa.com301 Yamato Road
Boca Raton, FL 33431
Dear Mr. Nourse:
The United States Food and Drug Administration (FDA) has reviewed your website,
www.puremedspa.com. As explained below, your website contains 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 websites that document these intended uses include, but are not limited to, the following:
• “The medications used in the LipoDissolve causes [sic] lysis of the fat cell wall. This allows the fat that is being stored in the cell to be released, and is taken by the lymphatic system to the liver where it is metabolized and excreted in the urine.”
• “
The main ingredient is Phosphatidylcholine, which is actually what causes the fat cell to break down.”
• “LipoDissolve can also aid in the treatment of various medical conditions in both men and women. This includes fat deposits on the face and body, cellulite, lipomas, help with skin retraction, and more.”
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 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.
Pure 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:
• “Its [sic] not a question of whether Lipodissolve will work, but rather how many treatments it will take to attain a goal in reduction.”
• “Generally, the average patient requires approximately 2-4 treatments with the goal of losing AT LEAST 1 inch of fat with each treatment.”
• “The results from Lipodissolve will last permanently in the area treated.”
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:
• “The main ingredient used to cause the fat cells to break down is not a synthetic medication, but rather a natural homeopathic ingredient, which has been used intravenously in Europe over 30 years to treat plaques in blood vessels with extensive research showing safety. In Lipodissolve, this same medication is just being used for a new purpose.”
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)].
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,
/Michael M. Levy, Jr./
Michael M. Levy, Jr., Esq.
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
