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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Spa 35 4/5/10

   

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


Mr. Warren Danforth
www.spa35.com
403 South 11th Street, Suite 135
Boise, Idaho 83702


Dear Mr. Danforth:


The United States Food and Drug Administration (FDA) has reviewed your website, www.spa35.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:


• “LipoDissolve uses a pharmaceutical compound called phosphatidylcholine deoxycholate, or PCDC, which is administered through a series of microinjections to permanently dissolve fat.”


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.


Spa35’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:


• “LipoDissolve Fat Reduction, will dissolve your fat ... without surgery ... without downtime ... and with GREAT results.”


• “…phosphatidylcholine deoxycholate, or PCDC, which is administered through a series of microinjections to permanently dissolve fat.”


• “After a PCDC is administered to the targeted areas, the fat cells absorb the PCDC, become slightly inflamed, and then harden. Within a few weeks the fat cells break down or are "melted" and are then expelled naturally through the body's immune system.”


• “If an individual gains weight, the fat cells located in the non-treated area will naturally get larger. The treated area, however, will remain unchanged.”


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:


• “To date, over 50,000 treatments have been performed with no serious side effects ever being reported.”


• “The use of PCDC is considered off label by the FDA bust [sic] is widely used for its safety profile, much like the use of Botox.”


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 PCDC; therefore, any claim that PCDC is being used “off-label” 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,
/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