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					          Consumer Health Information

FDA Warns About
Product Claims
    t’s a tempting premise: Get
    a series of drug injections
    and see pockets of fat on
your body go away for good.
   But the Food and Drug Adminis-
tration (FDA) is alerting consumers
about false and misleading claims
being made about products used in
lipodissolve, and about other mis-
branding of these products.
   Recipients of lipodissolve get a
series of drug injections intended to
dissolve and permanently remove
small pockets of fat from various
parts of the body. The process is also
known as injection lipolysis, lipozap,
lipotherapy, and mesotherapy.
   “We are concerned that these com-
panies are misleading consumers,”
says Janet Woodcock, M.D., director
of FDA’s Center for Drug Evaluation
and Research. “It is important for
anyone who is considering this vol-
untary procedure to understand that
the products used to perform lipodis-
solve procedures are not approved by
                                                                          Art should be large on the first
FDA has not approved any products for                                     page, so it shows up clearly when
use in lipodissolve. It also has received                                 the PDF is made into a small JPEG.
reports of unexpected side effects—
including permanent scarring and
skin deformation—in people who’ve
undergone the lipodissolve procedure.

1 / FDA Consumer Health Information / U.S. Food and Drug Administration                               A PR IL 2010
         Consumer Health Information

       “It is important for anyone who is considering
      this voluntary procedure to understand that the
      products used to perform lipodissolve procedures
         are not approved by FDA for fat removal.”
FDA for fat removal.”                     used in the procedure, or for other-       in the future. These firms were told
  The drugs most regularly used in        wise misbranding lipodissolve prod-        that failure to promptly correct the
the lipodissolve injection regimen are    ucts. (Cyber letters are letters sent to   violations may result in legal action.
phosphatidylcholine and deoxycho-         companies whose U.S. online sales of         The Brazilian firm getting a warn-
late (commonly called PC and DC,          products may be illegal.)                  ing letter markets lipodissolve prod-
respectively). Other ingredients may        The U.S. medical spas receiving          ucts on two Web sites:
also be used, including drugs or com-     warning letters make various unsup-        and FDA will notify
ponents of other products such as vita-   ported claims about lipodissolve,          regulatory authorities in Brazil of
mins, minerals, and herbal extracts.      such as assertions that the products       this action. The agency has issued an
                                          used in lipodissolve                       import alert against the
What Consumers Should Know                • are safe and effective                   and entities to prevent
FDA is alerting consumers that            • have an outstanding safety record        the importation and distribution of
• it has not evaluated or approved        • are superior to other fat-loss           unapproved lipodissolve drug prod-
  products for use in lipodissolve          procedures, including liposuction        ucts into the United States. Importing
• it is not aware of evidence                                                        and distributing unapproved drug
  supporting the effectiveness of the       Additionally some of the letters         products is a violation of the Federal
  substances used in lipodissolve for     indicate that the companies have           Food, Drug, and Cosmetic Act.
  fat elimination                         made claims that lipodissolve can
• the safety of these substances,         be used to treat certain medical con-      How to Report Side Effects
  when used alone or in                   ditions, such as male breast enlarge-      Consumers and health care profes-
  combination, is unknown                 ment, benign fatty growths known           sionals may report serious side effects
• it is not aware of clinical studies     as lipomas, excess fat deposits and        with the use of lipodissolve products
  to support medical uses of              surgical deformities.                      to FDA’s MedWatch Adverse Event
  lipodissolve                              The U.S. companies receiving warn-       Reporting Program either online, by
                                          ing letters in regard to lipodissolve      regular mail, by fax, or by phone.
In addition, FDA has reports of unex-     products are                               • online:
pected side effects in people who’ve      • Monarch Med Spa, King of                   medwatch/medwatch-online.htm
undergone the lipodissolve proce-           Prussia, Pa.                             • by regular mail: Use postage-paid,
dure. These side effects include          • Spa 35, Boise, Idaho                       pre-addressed FDA form 35004,
• permanent scarring                      • Medical Cosmetic Enhancements,             available online at www.accessdata.
• skin deformation                          Chevy Chase, Md.                 
• deep, painful knots under the skin      • Innovative Directions in Health,         • by Fax: (800) FDA-0178
  in areas where the lipodissolve           Edina, Minn.                             • by phone: (800) FDA-1088
  treatments were injected                • PURE Med Spa, Boca Raton, Fla.
                                          • All About You Med Spa,                     Find this and other Consumer
FDA Actions                                 Madison, Ind.                              Updates at
On April 7, 2010, FDA announced it                                                     ForConsumers/ConsumerUpdates
had sent warning letters to six medi-       FDA is requesting a written response
cal spas in the United States—and a       from these U.S. companies within 15                  Sign up for free e-mail
cyber letter to a company in Brazil—      business days of receipt of the letters      subscriptions at
for making false or misleading state-     stating how they will correct these vio-     consumer/consumerenews.html
ments on their Web sites about drugs      lations and prevent similar violations

2 / FDA Consumer Health Information / U.S. Food and Drug Administration                                           A PR IL 2010