UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA

FEDERAL TRADE COMMISSION, Plaintiff

v.

REXALL SUNDOWN, INC.,

Defendant.

Case No.

COMPLAINT FOR INJUNCTION AND OTHER EQUITABLE RELIEF

Plaintiff, the Federal Trade Commission ("FTC" or "Commission"), through its undersigned attorneys, alleges as follows:

JURISDICTION AND VENUE

1. The Commission brings this action under Section 13(b) of the Federal Trade Commission Act ("FTC Act"), 15 U.S.C. § 53(b), to secure a permanent injunction and other equitable relief, including rescission, restitution and disgorgement, against defendant for engaging in deceptive acts or practices and false advertising in connection with the advertising, marketing and sale of a purported cellulite treatment product called "Cellasene," in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a), 52.

2. This Court has subject matter jurisdiction over plaintiff's claims pursuant to 28 U.S.C. §§ 1331, 1337(a) and 1345, and 15 U.S.C. §§ 45(a), 52 and 53(b).

3. Venue in this District is proper under 28 U.S.C. § 1391(b) and (c) and 15 U.S.C. § 53(b).

THE PARTIES

4. The Commission is an independent agency of the United States Government created by the FTC Act (15 U.S.C. §§ 41-58). The Commission is charged, among other things, with enforcement of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, which respectively prohibit deceptive acts or practices in or affecting commerce, and false advertisements for food, drugs, devices, services, or cosmetics in or affecting commerce. Section 13(b) of the FTC Act, 15 U.S.C. § 53(b), authorizes the Commission to initiate federal district court proceedings to enjoin violations of the FTC Act and to secure such equitable relief, including consumer redress, as may be appropriate in each case.

5. Defendant Rexall Sundown, Inc. ("Rexall") is a Florida corporation with its principal office or place of business at 6111 Broken Sound Parkway, N.W., Boca Raton, Florida 33487-3693. Rexall manufactures and markets a variety of health and other products to consumers throughout the United States. Rexall transacts business in the Southern District of Florida.

COMMERCE

6. The acts and practices of defendant, as alleged herein, are in or affecting commerce, as "commerce" is defined in Section 4 of the FTC Act, 15 U.S.C. § 44.

DEFENDANT'S COURSE OF CONDUCT

7. Since at least March 1999, defendant has advertised, promoted, offered for sale, sold, and distributed a purported cellulite treatment product called "Cellasene" to consumers throughout the United States. Cellasene is a softgel tablet that contains the herbal ingredients ginkgo biloba, bladderwrack extract, sweet clover extract and grape seed extract. Rexall recommends that consumers using Cellasene consume three softgel tablets per day for eight weeks, and then a maintenance dose of one softgel tablet per day for the next eight weeks. Rexall represents that, thereafter, the initial dose can be repeated or the maintenance dose continued indefinitely. The eight-week regimen costs consumers about $180-$240.

8. To induce consumers to purchase Cellasene, Rexall has disseminated or has caused to be disseminated advertisements for Cellasene, including but not necessarily limited to the attached Exhibits A through G. These advertisements contain the following statements:

A. This is the one you've heard and read about.

The ONE and ONLY

CELLASENE

HELPS ELIMINATE CELLULITE . . .

 

Look terrific, feel terrific. You've seen it on Dateline, The Today Show and CNBC and heard about it almost everywhere else. Cellasene™ -- a safe, natural, clinically studied herbal supplement -- helps your legs look healthier, smoother, firmer. Accept only the clinically researched formula. Cellasene.™

 

Exhibit A, emphasis in original. This advertisement appeared as a full-page ad in USA Today and in The Washington Post.

 

Want to Eliminate Cellulite?

CELLASENE

HELPS ELIMINATE CELLULITE

Announcing Cellasene!

 

Cellasene is a dietary supplement that helps eliminate cellulite. It is a proprietary formula imported from Italy exclusively by Sundown. . . . Cellasene features Lipovasculen®, which is a proprietary blend of highly selective herbal extracts. Unlike massages and creams, Cellasene works from within, nutritionally, to help eliminate cellulite at its source.

 

* * *

 

HOW DOES CELLASENE WORK?

Cellasene is a trade secret formula that works over time at the source of the problem to eliminate cellulite -- below the surface of the skin, where it begins. This unique formula of plant extracts and other beneficial dietary supplements nourishes connective tissue from within and helps eliminate 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 diet and exercise for Cellasene to work. It is simple and effortless to incorporate Cellasene's easy-to-swallow softgels into your daily beauty care regimen. . .

 

* * *

HOW DOES CELLASENE COMPARE TO OTHER OPTIONS?

Before the discovery of Cellasene, there were limited options in the fight against cellulite: cosmetic surgery, or topical massages and creams. Cosmetic surgery can be invasive and costly. It removes fat deposits, but may not address the physical basis of cellulite. Topical massages and creams have been known to show modest improvements in skin appearance but lack the convenience and benefits of Cellasene.

 

Exhibit B, emphasis in original. Exhibit B appeared on Rexall's home page on the Internet, http://www.rexallsundown.com/pages/cellasene.html.

 

C. Want to eliminate cellulite?

get on the fast track to fight cellulite!

 

What is Cellasene?

A proprietary blend of natural products scientifically formulated to help eliminate cellulite.*

* * *

How is Cellasene Different from Creams and Massages?

Cellasene works from within, nutritionally, to help eliminate cellulite at its source. Massages and creams are generally used to reduce the appearance of cellulite.

* * *

You Do Not Need to Diet and Exercise for Cellasene to Work!

In fact, you don't have to make any changes to your normal routine for Cellasene to work. It is easy and effortless to make Cellasene a part of your regular beauty care regimen.

 

How is Success Measured?

You'll notice smoother-feeling legs and a firmer-looking appearance of your skin after just 8 weeks of continuous use as directed.

 

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

 

Exhibit C, emphasis in original. Rexall provided retailers with this advertisement to disseminate at the point of sale.

 

D. This summer, show off your legs.

Fight cellulite from the inside with Cellasene.

Cellasene is a safe, clinically studied dietary supplement to help reduce cellulite. Feel and look terrific with more attractive legs this summer.

 

* * *

[depiction of Cellasene package]

The One That Works

 

Exhibit D. This advertisement was disseminated as a free standing insert in The Washington Post newspaper.

 

E. AN OPEN LETTER

 

TO THE MILLIONS OF WOMEN WHO

ARE TAKING CELLASENE OR WHO

ARE THINKING ABOUT IT

* * *

While hundreds of thousands of women across the country are now enjoying the benefits of Cellasene for themselves, many have asked these questions: How does it work? What science is behind the product? In studies conducted at the internationally recognized University of Pavia in Italy, researchers found Cellasene produced statistically significant results in reducing cellulite. The results were based on scientifically accepted test methodologies of measuring thigh and hip circumference and the use of ultra-sound, laser and plicometry.

 

This is our way of assuring the hundreds of thousands of women using Cellasene that it is a safe and effective dietary supplement, supported by scientific research. Cellasene. The one that works.

 

Exhibit E. This full-page ad ran in The New York Times.

F. When I first heard about Cellasene, I was very skeptical, because there is no previous product that is really effective against cellulite. Then I started looking at some clinical studies, and they were impressive. They showed significant results, and I began to use it in my own patients.

* * *

Cellasene appears to be the first available substance that addresses the problem of cellulite from the inside out.

 

Exhibit F (transcript of video news release).

 

G. The ONE and ONLY

CELLASENE

HELPS ELIMINATE CELLULITE

 

Exhibit G (package label) (emphasis in original).

DEFENDANT'S VIOLATIONS OF THE FTC ACT

9. Section 5(a) of the FTC Act, 15 U.S.C. § 45(a), prohibits deceptive acts or practices in or affecting commerce. Section 12(a) of the FTC Act, 15 U.S.C. § 52(a), prohibits the dissemination of any false advertisement in or affecting commerce for the purpose of inducing, or which is likely to induce, the purchase of food, drugs, devices, services, or cosmetics. As set forth below, defendant has engaged and is continuing to engage in such unlawful practices in connection with the marketing and sale of Cellasene.

10. For the purposes of Section 12 of the FTC Act, 15 U.S.C. § 52, Cellasene is either a "food" or a "drug" pursuant to Section 15(b) and (c) of the FTC Act, 15 U.S.C. § 55(b) and (c).

COUNT ONE

11. Defendant has represented, expressly or by implication, including through the statements contained in the advertisements attached as Exhibits A through G, that:

a. Cellasene eliminates or substantially reduces cellulite;

 

b. Cellasene eliminates or substantially reduces cellulite without diet or exercise.

12. Defendant did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 11, above, at the time the representations were made.

13. Therefore, the making of the representations set forth in Paragraph 11 above was, and is, a deceptive act or practice and constitutes false and misleading advertising of a food, drug, device, service or cosmetic in or affecting commerce, in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.

COUNT TWO

14. Defendant has represented, expressly or by implication, including through the statements contained in the advertisements attached as Exhibits A through G, that clinical research proves that Cellasene eliminates or substantially reduces cellulite.

15. In truth and in fact, clinical research does not prove that Cellasene eliminates or substantially reduces cellulite.

16. Therefore, the making of the representation set forth in Paragraph 14 above was, and is, a deceptive act or practice and constitutes false and misleading advertising of a food, drug, device, service or cosmetic in or affecting commerce, in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.

CONSUMER INJURY

17. Consumers throughout the United States have suffered and continue to suffer substantial monetary loss as a result of defendant's unlawful acts or practices. In addition, defendant has been unjustly enriched as a result of its unlawful practices. Absent injunctive relief by this Court, defendant is likely to continue to injure consumers, reap unjust enrichment, and harm the public interest.

THIS COURT'S POWER TO GRANT RELIEF

18. Section 13(b) of the FTC Act, 15 U.S.C. § 53(b), empowers this Court to grant injunctive and other ancillary relief, including consumer redress, restitution, and disgorgement, to prevent and remedy any violations of any provision of law enforced by the FTC.

PRAYER FOR RELIEF

WHEREFORE, plaintiff requests that this Court, as authorized by Section 13(b) of the FTC Act, 15 U.S.C. § 53(b), and pursuant to its own equitable powers:

(a) Permanently enjoin defendant from violating Sections 5 and 12 of the FTC Act, as alleged herein, in connection with the advertising or sale of food, drugs, dietary supplements, devices, cosmetics or other products, services or programs;

 

(b) Award such equitable relief as the Court finds necessary to redress injury to consumers resulting from defendant's violations of the FTC Act, including, but not limited to, rescission of contracts, the refund of monies paid, and the disgorgement of ill-gotten gains; and

 

(c) Award plaintiff the costs of bringing this action, as well as such other and additional equitable relief as the Court may deem just and proper.

Respectfully submitted,

DEBRA A. VALENTINE
General Counsel

________________________
DARREN A. BOWIE
STACY FEUER
THEODORE H. HOPPOCK
DANIEL KAUFMAN
SHIRA D. MODELL
Federal Trade Commission
600 Pennsylvania Avenue, NW
Washington, D.C. 20580
(202) 326-2018, -3072, -3087, -2675, -3116 (voice)
(202) 326-3259 (facsimile)
E-mail: dbowie@ftc.gov

GUY A. LEWIS
United States Attorney

By:

LAURIE E. RUCOBA
Assistant United States Attorney
Fla. Bar # A5500052
500 East Broward Blvd., Suite 700
Fort Lauderdale, Florida 33394
(954) 356-7314, ext. 3613 (voice)
(954) 356-7180 (facsimile)
E-mail: Laurie.Rucoba@usdoj.gov
Attorneys for Plaintiff

Dated: FEDERAL TRADE COMMISSION