IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO

Civil No.

FEDERAL TRADE COMMISSION, Plaintiff,

v.

AST NUTRITIONAL CONCEPTS & RESEARCH, INC., a Colorado corporation, and PAUL DELIA, individually and as an officer and director of the corporation, Defendants.

COMPLAINT FOR PERMANENT INJUNCTION AND OTHER EQUITABLE RELIEF

Plaintiff, the Federal Trade Commission ("Commission"), by its undersigned attorneys alleges:

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 obtain permanent injunctive relief and other equitable relief for defendants' deceptive acts or practices in connection with the advertising and sale of androgen hormone supplements, in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.

JURISDICTION AND VENUE

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

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

PLAINTIFF

4. Plaintiff, the Commission, is an independent agency of the United States government created by statute, 15 U.S.C. §§ 41 et seq. The Commission enforces Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, which respectively prohibit unfair or deceptive acts or practices in or affecting commerce, and false advertisements for food, drugs, devices, cosmetics or services in or affecting commerce. The Commission is authorized to initiate federal district court proceedings to enjoin violations of the FTC Act and to secure such equitable relief as is appropriate in each case. 15 U.S.C. § 53(b).

DEFENDANTS

5. Defendant AST Nutritional Concepts & Research, Inc. ("AST") is a Colorado corporation with its principal place of business at 400 Violet Street, Golden, Colorado 80401. AST also does business under the names of AST Research and AST Sports Science. Since at least 1998, and continuing thereafter, AST has manufactured, marketed and sold nutritional supplements, including androgen supplements that purportedly increase muscle mass, strength and libido. AST transacts or has transacted business in the District of Colorado.

6. Defendant Paul Delia ("Delia") is the founder, chief executive officer and owner of AST. Individually, or in concert with others, Delia directs, controls, formulates, or participates in the acts and practices of AST, including the acts and practices complained of below. Delia resides and transacts or has transacted business in the District of Colorado.

COMMERCE

7. At all times material to this complaint, defendants' course of business, including the acts and practices alleged herein, has been and is in or affecting commerce, as "commerce" is defined in Section 4 of the FTC Act, 15 U.S.C. § 44.

DEFENDANTS' COURSE OF CONDUCT

8. Defendants advertise, promote, offer for sale, sell, and distribute androgen supplements to consumers throughout the United States via the Internet at < www.ast-ss.com >, and through magazines, the mail, a toll-free telephone number, and retail stores, among other means. The defendants'androgen supplements contain androgens, which are steroid hormones that cause the development of male sex organs and other male physical characteristics. Specifically, defendants' androgen supplements contain the steroid hormones androstenedione, androstenediol, norandrostenedione, and/or dehydroepiandrosterone ("DHEA.")

9. Defendants' androgen supplements include "Andro 100," "Andro 250," "19-Nor 250," "4-Diol 250," "5-Diol 250," "19-Nor 3-Andro," "AndroPlex 700," and "3-Andro Xtreme." These supplements contain various amounts and combinations of the steroid hormones androstenedione, androstenediol, norandrostenedione, and DHEA. Defendants collectively refer to these products as "andro supplements" or "prohormones."

10. In addition to steroid hormones, defendants' androgen supplement 3 Andro Xtreme contains ephedra extract and caffeine. Ephedra extract, which is extracted from the herb ephedra and also is known as ephedrine, stimulates the central nervous system and the heart. Combining ephedra extract with caffeine enhances the stimulant effects of ephedra extract.

11. Defendants represent or have represented that their androgen supplements are completely safe and produce no negative side effects, in addition to representing that these products will increase strength and muscle mass. True and correct copies of some of the promotional materials that defendants have disseminated are attached as Exhibits 1 through 6. Defendants' advertisements and promotional materials for their androgen supplements contain the following statements, among others.

12. On defendants' website and in their promotional magazine Muscle, defendants represent:

Q: Is Andro Safe?

A: Yes! Used as directed androstenedione is completely safe and very effective.

Q: What are the side effects of taking Andro?

A: Taken as directed you'll experience no negative side effects.

Q: Is Andro "like" a steroid?

A: Andro is not like a steroid aside from the fact that it increases muscle growth. Steroids are synthetic derivatives of testosterone. When you are taking steroids you are actually injecting synthetic testosterone. Androstenedione is completely different. . .

When you take anabolic steroids you are subjecting your system to the full dose of synthetic testosterone all at once. Ready or not, there it is. Steroids are also designed to remain in your system over a long period of time. It's the extended half-life engineered into steroids that is believed to be responsible for a large portion of the steroids' side effects. So comparing steroids to Androstenedione is quite unrealistic. It is like comparing pasta to table sugar. Though ultimately they are both converted to the same thing by your body - glycogen - they are two totally different compounds. One is good for you; one is not so good for you.

Q: If Andro is safe, why is it banned by the IOC [International Olympic Committee]?

A: Androstenedione is banned because it enhances performance not because it isn't safe. There are many substances that are banned and safety is not the issue.

Because androstenedione converts into testosterone people automatically think it is a steroid. This is not the case. And because it is not a steroid it will not cause "steroid-like" effects.

Q: Will the use of Andro result in obvious or subtle mood changes like "roid-rage?"

A: No. If anything Andro elevates mood and feeling of well-being. Again, Andro is not a steroid and does not have steroid side effects.

The Ultimate Andro Q & A, < www.ast-ss.com > (Exhibit 1) and The Ultimate Andro Q & A, Muscle Magazine (Exhibit 2) (emphasis added).

13. In response to a consumer inquiry about how defendants' Androstenedione 100 works, defendants represent:

We all know that testosterone helps build muscle and increase recuperation, but until Androstenedione 100 there was not a safe, legal way to effectively harness these muscle building effects.

Supplementation Questions and Answers,< www.ast-ss.com > (Exhibit 3 at 3) (emphasis added).

14. In a discussion of their androgen supplement 19-Nor 250, defendants represent:

Q: Are there any side effects with 19-Nor 250?

A: Taken as directed 19-Nor 250 is free of negative side effects. . . . Pro hormones are unlike steroids which are synthetic derivatives of testosterone. Associating "steroid-like" effects to pro-hormones is journalistic sensationalism and void of any scientific or medical facts.

19-Nor 250 Questions and Answers, <www.ast-ss.com> (Exhibit 4 at 1) (emphasis added).

15. In a discussion about their androgen supplement AndroPlex 700, defendants represent:

Think about it. Testosterone is the most powerful hormone involved in muscle growth. With AndroPlex 700, you can harness this anabolic power and experience gains once only privy to those willing to step into the dangerous underground world of steroids.

AndroPlex 700 The World's Most Potent Natural Testosterone Enhancer, <www.ast-ss.com> (Exhibit 5 at 4) and Supplement Update - AndroPlex 700, Muscle (Exhibit 6 at 2) (emphasis added).

DEFENDANTS' VIOLATIONS OF THE FTC ACT

16. As set forth below, defendants have violated Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, in connection with the offer, sale or advertising of androgen supplements, including, but not limited to, Andro 100, Andro 250, 19-Nor 250, 4-Diol 250, 5-Diol 250, 19-Nor 3-Andro, AndroPlex 700, and 3-Andro Xtreme.

17. Defendants' androgen supplements are either "foods" or "drugs" for purposes of Sections 12 and 15 of the FTC Act, 15 U.S.C. §§ 52 and 55.

COUNT ONE

18. Through their advertising and promotional materials, including, but not limited to representations contained in advertisements attached as Exhibits 1 through 6, defendants have represented, expressly or by implication, that their androgen supplements, in the doses recommended or in other reasonably foreseeable amounts:

A. are safe;

B. produce no or minimal negative side effects; and

C. do not pose health and safety risks similar to those associated with the use of anabolic steroids.

19. Defendants did not possess and rely upon a reasonable basis to substantiate the representations set forth in Paragraph 18. No reliable scientific data or studies demonstrate that defendants' androgen supplements are safe and produce no or minimal side effects. Further, endocrinologists and other health professionals raise serious concerns regarding lack of safety testing on androgen supplements and the potential health risks and negative side effects of using such products. In addition, the use of androgen supplements that contain ephedra extract, alone or in combination with caffeine, can adversely affect the heart and central nervous system. Therefore, defendants' representations set forth in Paragraph 18 are false and misleading, and constitute deceptive acts or practices and false advertising for food or drugs, in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.

COUNT TWO

20. Through their advertising and promotional materials, including, but not limited to, representations contained in advertisements attached as Exhibit 1 through 6, defendants, individually or in concert with others, have represented, expressly or by implication, that defendants' androgen supplements do not contain steroid hormones.

21. In truth and in fact, defendants' androgen supplements do contain steroid hormones.

22. Therefore, defendants' representation, as set forth in Paragraph 20, is false and misleading and constitutes a deceptive act or practice and false advertising for foods or drugs, in violation of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.

CONSUMER INJURY

23. As a result of defendants' unlawful acts or practices, consumers throughout the United States have suffered and continue to suffer the risk of injury. Absent injunctive relief by this Court, the defendants are likely to continue to injure consumers and harm the public interest.

THIS COURT'S POWER TO GRANT RELIEF

24. Section 13(b) of the FTC Act, 15 U.S.C. § 53 (b), empowers this Court to grant injunctive and other ancillary relief to prevent and remedy any violations of any provision of law enforced by the Federal Trade Commission.

PRAYER FOR RELIEF

WHEREFORE, plaintiff Federal Trade Commission requests this Court, pursuant to Section 13(b) of the FTC Act, 15 U.S.C. § 53(b), and the Court's own equitable powers, to:

1. Permanently enjoin defendants from violating the FTC Act as alleged herein; and

2. Award plaintiff such other and additional equitable relief as the Court may determine to be proper and just.

Dated: , 1999

Respectfully submitted,

DEBRA A. VALENTINE
General Counsel

Mamie Kresses
Laura M. Sullivan
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580
(202) 326-3327; 326-2070 (telephone)
(202) 326-2445 (facsimile)

ATTORNEYS FOR PLAINTIFF
FEDERAL TRADE COMMISSION