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Stephen Barrett, M.D.
Cellulite is a term coined in European salons and spas to describe deposits of dimpled fat found on the thighs and buttocks of many women. Widespread promotion of the concept in the United States followed the 1973 publication of Cellulite: Those Lumps, Bumps and Bulges You Couldn't Lose Before, by Nicole Ronsard, owner of a New York City beauty salon that specialized in skin and body care. Cellulite is alleged to be a special type of "fat gone wrong," a combination of fat, water, and "toxic wastes" that the body has failed to eliminate. Alleged "anticellulite" products sold through retail outlets, by mail, through multilevel companies, and through the Internet have included "loofah" sponges; cactus fibers; special washcloths; horsehair mitts; creams [<A HREF="http://naturalsecrets.com/czarniak/reqceltreat1.html">A</A>, <A HREF="http://www.infotv.com/pcc.htm">B</A>, <A HREF="http://www.lametco.com/body.htm">C</A>] and gels to "dissolve" cellulite; supplements containing vitamins; minerals and/or herbs [<A HREF="http://www.pinnaclebody.com/cellafree.htm">A</A>, <A HREF="http://www.herbalife.com/products/personal_care/buffing_contouring.html">B</A>, <A HREF="http://www.neways.com/replicating/master/products/cellpill1.htm">C</A>]; bath liquids; massagers [<A HREF="http://www.vendusa.com/cellulift.htm">A,</A> <A HREF="http://www.cellulite-rx.com/">B</A>]; rubberized pants; exercise books; brushes; rollers; body wraps; and toning lotions. Many salons offer treatment with electrical muscle stimulation, vibrating machines, inflatable hip-high pressurized boots, "hormone" or "enzyme" injections, heating pads, and massage. Some operators claim that 5 to 15 inches can be lost in one hour. A series of treatments can cost hundreds of dollars.
"Cellulite" is not a medical term. Medical authorities agree that cellulite is simply ordinary fatty tissue . Strands of fibrous tissue connect the skin to deeper tissue layers and also separate compartments that contain fat cells. When fat cells increase in size, these compartments bulge and produce a waffled appearance of the skin. Many years ago, Neil Solomon, M.D., conducted a double-blind study of 100 people to see whether cellulite differed from ordinary fat. Specimens of regular fat and lumpy fat were obtained by a needle biopsy procedure and given to pathologists for analysis and comparison. No difference between the two was found.
More recently, researchers at Rockefeller Institute used ultrasonography, microscopic examinations, and fat-metabolism studies to see "affected" and unaffected skin areas differed in seven healthy adult subjects (five women, two men; four affected, three unaffected). The researchers concluded: (a) certain characteristics of skin make women more prone than men to develop cellulite; (b) the process is diffuse rather than localized; and (3) there were no significant differences in the appearance or function of the fatty tissue or the regional blood flow between affected and unaffected sites within individuals .
Electrical Muscle Stimulators (EMS) and Iontophoresis Devices
Muscle stimulators are a legitimate medical device approved for certain conditions -- to relax muscle spasms, increase blood circulation, prevent blood clots, and rehabilitate muscle function after a stroke. But many health spas and figure salons claim that muscle stimulators can remove wrinkles, perform face lifts, reduce breast size, reduce a "beer belly," and remove cellulite. Iontophoresis devices are prescription devices that use direct electric current to introduce ions of soluble salts (i.e., medications) into body tissues for therapeutic or diagnostic purposes. The only approved use is for diagnosing cystic fibrosis.
<A NAME="relaxacizor"></A>The FDA considers promotion of muscle stimulators or iontophoresis devices for any type of body shaping or contouring to be fraudulent [3,4]. The most infamous of these devices, the Relax-A-Cizor, was claimed to reduce girth by delivering electric shocks to the muscles. More than 400,000 units were sold for $200 to $400 each before the FDA obtained an injunction in 1970 to stop its sale. At the trial, 40 witnesses testified that they had been injured while using the machine. The judge concluded that the device could cause miscarriages and aggravate many preexisting medical conditions, including hernias, ulcers, varicose veins, and epilepsy.
Many salons and spas exist where clients supposedly can trim inches off the waist, hips, thighs, and other areas of the body. These facilities use wraps or garments, with or without special lotions or creams applied to the skin. The garments may be applied to parts of the body or to the entire body. Clients are typically assured that fat will "melt away" and they can lose "up to 2 inches from those problem areas in just one hour." <A HREF="http://www.suddenlyslender.com/">Suddenly Slender</A>, which licenses body-wrap shops in the United States and Canada, claims that "wrapping works because cellulite is water-logged fatty tissue." As part of its sales pitch to prospective owners, the company notes that free publicity may be obtainable. Its Web site states: "Because clients get dressed up as "mummies" and then, almost miraculously, achieve major inch loss and startling improvements to their figures, local and national media have been overwhelmingly receptive to featuring presentations about the service."
Home-use systems are also being marketed through the Internet [<A HREF="http://www.suddenlyslender.com/faqs.htm">A,</A> <A HREF="http://www.pleasers.net/herbal.htm">B</A>] and through multilevel marketing [<A HREF="http://www.vaxa.com/304.html">X</A>, <A HREF="http://www.lifeforce-intl.com/herbalbodywrap.htm">Y</A>]. Many of the systems are claimed to "remove toxins." Some marketers suggest measuring a large number of body areas before and afterward and adding up the differences to get "total inches lost." <A HREF="http://www.lifeforce-intl.com/">Life Force Internationa</A>l, for example, recommends adding the results of 17 measurements. This enables minor changes due to temporary effects or to measurement variations to appear to be large numbers.
No product taken by mouth can cause selective reduction of an area of the body. Although wrapping may cause temporary water loss as a result of perspiration or compression, any fluid will soon be replaced by drinking or eating . The idea that herbal wraps detoxify the body is absurd.
An herbal product called Cellasene is being vigorously promoted as a cellulite remedy. The product was developed by an Italian chemist named Gianfranco Merizzi. Its ingredients are evening primrose oil, dried fucus vesiculosis extract, gelatine, fish oil, glycerol, soya oil, grape seed, bioflavonoids, soya lecithin, fatty acids, dried sweet clover extract, dried ginkgo biloba extract, and iron oxide. The product, to be taken twice daily (or three times per day for an "intensive" program) for two months and then once daily for maintenance costs $1.50 to $2.00 per capsule. Here's what one Internet marketer says [followed by my comments in brackets]:
- Dried ginkgo biloba extract assists in blood circulation and stimulates the metabolism of fats. [Although ginkgo can increase circulation, it does not stimulate fat metabolism. Even if it did, there is no reason why it would exert a localized effect.]
- Dried sweet clover extract can increase blood circulation and assist in removing fluid build-up. [This ingredient may have mild diuretic action, but is not "fluid build-up" is not a factor in the appearance or composition of fatty tissue.]
- Grape seed bioflavonoids are powerful antioxidants that protect cells and blood vessels from damage. [Whether antioxidant supplements help protect tissues is not scientifically settled. Regardless, any such mechanism has nothing to do with the quantity or appearance of fatty tissues.]
- Dried fucus vesiculosus extract stimulates metabolism and can help reduce localized fats. [This herb contains significant amounts of iodine and could adversely effect the thyroid gland. The U.S. Recommended Daily Allowance (USRDA) for iodine is 150 micrograms. The average American woman ingests 170 micrograms per day from food (not including iodized salt). Each capsule of Cellasene contains 240 micrograms of iodine. If enough were taken to increase thyroid function, the result would be unhealthy.]
- Evening primrose oil and fish oil are rich in polyunsaturated fatty acids, a source of energy that increases metabolic levels and helps in diminishing saturated fatty acids. [The "energy" is simply the caloric value. Neither oil increases metabolism or reduces the amount of other fats one eats.]
- Soya lecithin helps to break down fats. [The body makes all the lecithin it needs. Lecithin supplements do not cause the body to shed fat.]
<A HREF="http://www.rexallsundown.com/">Rexall Sundown, Inc</A>. has been Cellasene's primary marketer in the United States. The company's Web site has claimed:
Cellasene works from within, nutritionally, to help fight cellulite at its source. . . .
Cellasene is a safe, clinically studied formula that works over time at the source of the problem -- below the surface of the skin. This unique formula of plant extracts and other beneficial dietary supplements nourishes connective tissue from within and helps reduce cellulite. The herbal ingredients in Cellasene work to increase blood circulation, reduce fluid buildup, stimulate metabolism and reduce localized fats. CONVENIENT AND EASY TO USE. . . .
You do not need to change your diet and exercise routine for Cellasene to work. It is simple and effortless to incorporate the easy-to-swallow Cellasene softgels into your daily regimen.
On March 15, 1999, during an interview on CNBC-TV, Rexall's chief executive officer claimed that three clinical trials sponsored by the company had demonstrated a 90% success rate, but the results would not be submitted to scientific journals because Rexall did not want to reveal the amounts of each ingredient in its formula . This statement was preposterous because results could published without revealing the exact amounts of each ingredient. Two weeks later, I searched Medline for "cellulite" and "Cellasene" and found no report that any product taken by mouth was proven useful against cellulite.
Near the end of May, apparently in response to criticism in the media , Rexall released various details on two of the studies and posted them to its Science on Cellasene Web site. The first study was performed on 25 healthy female volunteers whose hip and thigh and ankle circumference were measured before and after eight weeks of daily consumption of the product. Although differences between the initial and final measurements were reported, no control group was used, so that it would not be possible to tell whether any changes were related to taking the products or to measurement variations. In addition, neither individual measurements nor weights were reported, so that it is not possible to judge from the data whether the reductions were related to weight loss, whether coincidental or otherwise.
The second study compared 25 people who took the product with 15 people who took a placebo for eight weeks. According to the report, the average weight of both groups varied little but average hip and thigh circumference and skin thickness (measured with an ultrasound test) decreased. However, the experimental design was so seriously flawed that the findings should not be regarded as valid. The participants were not told whether they were receiving Cellasene or the placebo, but the investigators knew who was in each group because only the Cellasene group had blood drawn for testing. This could have influenced the way the measurements were performed, as well as the participants' motivation. No data were given to demonstrate whether the measurement process was accurate or whether the appearance or feel of the women's skin had changed . In addition, although measurements were made at the experiment's beginning, midpoint, and end, the midpoint measurements were not reported on Rexall's Web site.
It seems to me that a valid test should involve: (a) more participants, (b) a longer initial investigative period plus monthly follow-up measurements for at least a year, (c) standardization of the measurement technique, (d) measurements taken by at least three investigators, (e) blinding of the investigators about who received the Cellasene and who did not, (f) measuring several times a week to see whether measurements tend to change or remain constant, (g) weekly ratings of the appearance of the skin by both the participants and the experimenters, and (h) release of the individual data in addition to the group averages. I have suggested these points to Rexall's chief executive officer .
A spokesperson for Cellasene's Italian manufacturer stated that a study involving 200 women would be done at the University of Miami with results expected in the Fall of 1999 . In June 2000, however, the lead researcher study stated that the $400,000 study could not be completed because some of the participants had not come to the testing site to be measured . In the interim a British researcher reported finding no difference in hip and thigh measurements between 11 women taking Cellasene and 8 women using a placebo .
<A HREF="http://web.archive.org/web/19991129041640/cellulean.com/">InHealth America</A>, of Carlsbad, California, competed with Rexall by marketing a similar product called CelluLean. The company's Web site, which was registered during the week Rexall introduced Cellasene, stated:
CelluLean melts away cellulite by increasing your metabolism and blood circulation, breaking down the fats found in cellulite, and removing toxins from your body. The herbal extracts in CelluLean have been proven to be effective in reducing fatty deposits. Simply put, CelluLean helps your body to reach and break down cellulite, enabling your skin to regain its youthful smooth appearance.
One way to attract browsers to a Web site is to place "meta tags" into the site's source code. The words in the meta tags are not visible when looking at the page, but search engines search engines use them as hints about the relevance of a site. For example, if a user searches for "cancer," and a web site uses "cancer" as a meta tag, the search engine may consider the site to be relevant to the search, regardless of the site's actual content. InHealth America's "keywords" meta tag read:
Cellasene, Cellulean, selesene, neurosharp, cellesene, selasene, selleseen, cellasene, celesene, celasene, SlimRX, Rexall, cellulite, Cellulene, Cellutrim, Inhealth America, InHealthAmerica, In Health America, Pharmaceuticals, interactive, InHealth, In Health, America, Metabolife, Metabo, 356, Herbalife, Nu-way, MegaTrim, Mega Trim, Megatrim, Adaptogenol, Adaptagenol, Adaptogen, Adaptagen, Adaptotrim, Adaptatrim, Lipuramine, Liporimine, Arthranol, Artharanol, stress, Stress, health, liver, arthritis, San Diego, Carlsbad, California, NASA, diet, weight loss, heal, herbal, MLM, network marketing, marketing, unilevel, binary, multi-level marketing, interactive, business, home business, downline, sponsors, products, compensation, joints, business opportunity, remedy, pain, relief, natural, performance, endurance, mental, concentration, sleep, research, immune system, fatigue, weight gain, California, inflammation, supplement, science, doctor, energy, recovery, future, Fat, Cortisol, eat, food, high fat, low fat
Thus people searching for any of the above topics could find a link to InHealth America's site.
In 1998, the FDA approved a high-powered, handheld massage tool that consists of a treatment head and two motorized rollers with a suction device that compresses the affected tissue between the two rollers. The manufacturer is permitted to promote it for "temporarily improving the appearance of cellulite." The procedure -- called Endermologie -- usually takes 10 to 20 treatments to get the best results, and one or two maintenance treatments per month are required to maintain them. Without the maintenance, the benefits will soon be lost. The typical cost is $45 to $65 per session. A recently published study of 85 women between the ages of 21 to 61 found that 46 patients who completed seven sessions showed a mean index reduction in body circumference of 1.34 cm, while 39 patients who completed 14 sessions of treatments showed a mean index reduction in body circumference of 1.83 cm . However, another study, involving 52 women, found no objective difference in thigh girth (at two points) or thigh fat depth (measured by ultrasound). 
The FTC has taken successful action against many marketers of alleged cellulite-reducing products:
- In 1991, Slender You, Inc., signed a consent agreement prohibiting unsubstantiated claims that its continuous passive motion (CPM) tables enable the user to lose weight; lose inches; remove cellulite; flush out toxins; tone and firm muscles; or achieve physical fitness benefits comparable or superior to those provided by rigorous exercise .
- In 1993, a similar action was taken against Fleetwood Manufacturing, Inc., of Mesa, Arizona, and its owner, Thomas A. Fleetwood. 
- In 1993, Nature's Cleanser, based in Beverly Hills, California, and Donald Douglas-Torry agreed not to make unsubstantiated claims that its herbal tablets would promote weight loss by "cleansing" the bowel. The company had claimed that weight could be immediately controlled by without dieting or watching calories by eliminating waste such as fatty tissues, cellulite, toxins, mucus, hardened fecal matter and harmful drug residues .
- In 1993, Revlon, Inc. and its subsidiary, Charles Revson, Inc., signed a consent agreement not to make unsubstantiated claims that their Ultima II ProCollagen anti-cellulite body complex would: (a) significantly reduce cellulite, help disperse toxins and excess water from areas where cellulite appears; (b) reduce skin's bumpy texture, ripples or slackness caused by cellulite; (c) help disperse toxins and excess water from areas where cellulite appears; and (d) increase sub-skin tissue strength and tone .
- In 1993, Synchronal Corp agreed to stop unsubstantiated claims for its Anuska Bio-Response Body Contouring Program cellulite cream and to pay $3.5 million in consumer redress.
- In 1993, National Media Corp./Media Arts International, Ltd., agreed to a consent agreement and $275,000 in consumer redress in connection with infomercials claiming that its Cosmetique Francais would substantially reduce or eliminate cellulite, was more effective than diet or exercise, and would prevent recurrence if used once or twice a week .
- In 1995, a federal judge in California permanently banned Silueta Distributors, Inc., a Chatsworth, California-based company, and its president, Stanley Klavir, from deceptively claiming that their "Sistema Silueta" cream and tablets would reduce cellulite. The judge concluded said that Sistema Silueta was nothing more than moisturizer and diuretic tablets, neither of which would cause cellulite loss. The defendants were also ordered to pay $169,339 in consumer redress .
- In 1995, European Body Concepts and its and its president James Marino signed a consent agreement prohibiting it from making unsubstantiated claims that its body-wrapping system would cause the user to lose inches, pounds, and cellulite quickly and easily, without dieting or exercising, and that the system could reduce the size of specific areas of the body .
- In 1995, National Dietary Research, Inc. (NDR) and its owner William H. Morris agreed to pay $100,000 to settle FTC charges of deceptively advertising Food Source One (FS-1) as a weight-loss and cholesterol-reducing product . The product was a compressed tablet made largely from plant fiber. The consent agreement included a clause that prohibited unsubstantiated claims of cellulite reduction .
- In 1998, an Australian federal judge ordered the Swiss Slimming and Health Institute and its director to pay the Commission $1.47 million in penalties and interest, some of which would be refunded to defrauded clients .
- In 1999, the Iowa Attorney General obtained an order prohibiting Lipo Slim, Inc., of New York City from continuing to marketing its "Lipo Slim Briefs" in Iowa. Ads said wearing the briefs would "get rid of your cellulite" and "dissolve fat and hydric deposits that accumulate in your hips, stomach, buttocks and thighs." An ad in the National Enquirer said that "thousands of thermo-active micropore cells" in the briefs "produce a gentle massage that destroys deep fat particles and liquid molecules which are the cause of excess fat." The order required the company to offer full refunds to its Iowa buyers and pay $12,000 to the state consumer education fund .
- In 1999, the FDA ordered Cellulite Reduction of New York to stop suggesting that Endodermology could have more than a temporary effect on cellulite .
- In July 2000, the FTC charged Rexall Sundown, Inc., with making false and unsubstantiated claims for Cellasene .
The Bottom Line
The amount of fat in the body is determined by the individual's eating and exercise habits, but the distribution of fat in the body is determined by heredity. In most cases reduction of a particular part can be accomplished only as part of an overall weight-reduction program. Endermologie may temporarily improve the appearance of dimpled areas, but the procedure is time-consuming and expensive. Liposuction may permanently help in some cases.
- Fenner L. Cellulite: Hard to budge pudge. FDA Consumer 14(4):5-9, 1980.
- Rosenbaum M and others. <A HREF="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9623840&dopt=Abstract">An exploratory investigation of the morphology and biochemistry of cellulite</A>. Plastic and Reconstructive Surgery 101:1934-1939, 1998.
- FDA. <A HREF="http://www.fda.gov/ora/fiars/ora_import_ia8901.html">Electrical Muscle Stimulators and Iontophoresis Devices.</A> Import Alert #89-01, revised 3/17/97.
- FDA. <A HREF="http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg355-200.html">Electrical Muscle Stimulators (CPG 7124.26)</A>, Revised March 1995.
- Wills J. About body wraps, pills, and other magic wands for losing weight. FDA Consumer 16(9):18-20, 1982.
- DeSantis D. Interview on Power Lunch, CNBC-TV, March 15, 1999, 1:20 pm
- Srinivasan K. Feds want the skinny on cellulite pill's claims. Associated Press. May 28, 1999.
- Barrett S. Email message to D. DeSantis, June 2, 1999.
- Murawski J. <A HREF="http://www.gopbi.com/partners/pbpost/epaper/editions/tuesday/business_5.html">Anti-cellulite drug's test results were jilted</A>. Palm Beach Post, June 27, 2000.
- Lis-Balchin M. <A HREF="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10548762&dopt=Abstract">Parallel placebo-controlled clinical study of a mixture of herbs sold as a remedy for cellulite</A>. Phytotherapy Research 13:627-629, 1999.
- Chang P and others. <A HREF="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9502849&dopt=Abstract">Noninvasive mechanical body contouring: (Endermologie) A one-year clinical outcome study update</A>. Aesthetic and Plastic Surgery 22:145-153, 1998.
- Collis N and others. <A HREF="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10654775&dopt=Abstract">Cellulite treatment: a myth or reality: a prospective randomized, controlled trial of two therapies, endermologie and aminophylline cream</A>. Plastic and Reconstructive Surgery 104:1110-1114, 1999.
- <A HREF="http://www.ftc.gov/opa/predawn/F93/slender-y8.htm">FTC charges marketer of "CPM" tables with making unsubstantiated weight-loss claims; consent agreement would settle charges</A>. FTC news release, Nov 27, 1991.
- <A HREF="http://www.ftc.gov/opa/predawn/F93/fleetwood4.htm">FTC charges marketer of "CPM" tables with making false weight-loss claims; consent agreement would settle charges</A>. FTC news release, Feb 25, 1993.
- <A HREF="http://www.ftc.gov/opa/predawn/F93/naturescl8.htm">Nature's Cleanser Settles FTC charges that it made deceptive health and weight-loss claims for herbal products</A>. FTC News release, April 23, 1993.
- <A HREF="http://www.ftc.gov/opa/predawn/F93/revlon-2.htm">Revlon, Inc. to settle charges of unsubstantiated ad claims for "anti-cellulite" and sunscreen products.</A> FTC news release, Aug 24, 1993.
- <A HREF="http://www.ftc.gov/opa/predawn/F93/mediaarts2.htm">Infomercial marketer agrees to pay $275,000 to settle FTC charges over deceptive advertising of several products.</A> FTC News release, March 30, 1993.
- <A HREF="http://www.ftc.gov/opa/predawn/F95/silueta-5.htm">Federal court bans claims for sham cellulite reduction cream featured on national Spanish-language television</A>. FTC news release, March 10, 1995.
- <A HREF="http://www.ftc.gov/opa/predawn/F95/european-body.htm">Body wrapping salons settle FTC charges that weight and inch-loss claims were false.</A> FTC news release, March 29, 1995.
- <A HREF="http://www.ftc.gov/opa/1995/9505/natldie.htm">Florida-based company agrees to pay $100,000 to settle FTC charges of deceptively advertising weight-loss and cholesterol-lowering products</A>. FTC news release, May 4, 1995.
- Australian Competition and Consumer Commission. <A HREF="http://www.accc.gov.au/media/mr114-98.html">Refunds ordered for former Swisslim clients</A>. News release, June 22, 1998.
- Iowa Attorney General. <A HREF="http://www.state.ia.us/government/ag/liposlim.htm">Lipo Slim Briefs: "Not Available in Iowa</A>." News release, March 10, 1999.
- Gill LJ. <A HREF="http://www.fda.gov/foi/warning_letters/m3378n.pdf">Warning letter to Leah Lewis</A>, Nov 19, 1999.
- <A HREF="http://www.mlmwatch.org/04C/RSI/rexall-ftc.html">Rexall Sundown Charged By FTC with Making False and Unsubstantiated Claims for "Cellasene."</A> FTC news release, July 20, 2000.