February 28, 2003

Mr. Robert Chinery
President
Cytodyne Technologies
2231 Landmark Place
Manasquan, NJ 08736

Dear Mr. Chinery:

The recent death of 23-year old Baltimore Orioles pitcher Steve Bechler, who reportedly used Xenadrine RFA-1, an ephedra-containing supplement manufactured by your company, has raised questions about whether Federal action should be taken to address safety concerns related to ephedra supplements. The Committee on Energy and Commerce has jurisdiction over matters relating to food and drugs, and has initiated a review of safety issues surrounding the use of ephedra supplements. The Broward County Medical Examiner in charge of Mr. Bechler's autopsy indicated that the ephedra product taken by Mr. Bechler may have contributed to his heatstroke-related death.

According to various media accounts, ephedra has been linked to reports of numerous deaths and 1,400 reports of health related problems, including strokes, heart attacks and seizures. A recent study published in the Annals of Internal Medicine that compared the safety of ephedra supplements to other herbal supplements concludes that the relative risk for an adverse reaction from ephedra supplements was more than 100-fold higher compared with all other herbs. The study also notes that 64% of all adverse reactions came from supplements containing ephedra, while these products represented only 0.82% of herbal product sales. It appears from your website, www.cytodyne.com, that your company has conducted and/or commissioned several studies supporting the safety of your products, including Xenadrine RFA-1. At the same time, Cytodyne has recently introduced Xenadrine-EFX, a product that you tout as "ephedra-free." This raises questions about whether your company is seeking to replace ephedra-containing products and why you decided to develop an ephedra-free alternative dietary supplement.

In light of the recent press reports raising additional questions about the safety of ephedra supplements, we are requesting that, pursuant to Rules X and XI of the U.S. House of Representatives, you provide the Committee with the information requested below by Monday, March 13, 2003.

1.  State whether you have received consumer complaints or notifications concerning adverse health events associated with Xenadrine RFA-1. If so, for each year beginning when your product was first available for consumption, provide the following information:

(a)  The name of complainant;
(b)  The date of complaint;
(c)  A summary of consumer's adverse event(s);
(d)  A summary of company's response to complaint;
(e)  Whether any information about the complaint was reported to the Food and Drug Administration ("FDA") or any other government entity, and if so, a summary of the information that you provided; and
(f)  All records relating to such complaints.

2.  State whether your company has reporting or tracking procedures for adverse health events reported by consumers of your products. If so, identify the entities to which these reports are made, the individual(s) responsible for retaining such information, and describe the specific procedures. Provide a copy of all procedures described in this question.

3.  State whether a customer has filed any lawsuits against your company alleging health-related problems associated with taking Xenadrine RFA-1. If so, provide the following information:

(a)  The name of the complainant(s);
(b)  The date the lawsuit was filed;
(c)  A summary of health-related allegations of lawsuit; and
(d)  The status of the lawsuit (i.e., pending, settled, verdict).

4.  Identify all studies or reports (whether or not published) that relate to Xenadrine RFA-1, including, but not limited to, the studies cited on your website www.cytodyne.com, in the Journal of the American Dietetic Association, and in The International Journal of Obesity. For each such study or report, provide the following information:

(a)  The name of the author(s) and/or physician(s) that participated in such study;
(b)  The number of participants in the study or report;
(c)  Whether you provided any compensation or benefit, monetary or otherwise, to any participant in the study or report;
(d)  Whether you provided any compensation or benefit, monetary or otherwise, to an author and/or physician associated with the study or report;
(e)  Whether you commissioned the study or report or contributed any monies to the research associated with the study or report; and
(f)  A copy of all studies or reports identified.

5.  All records relating to the safety and/or health effects of ephedra supplements, including, but not limited to, records concerning the health effects of Xenadrine RFA-1 in general and the Bechler case in particular.

6.  Identify who is responsible for determining the dosage that consumers are directed to take on Xenadrine RFA-1 bottles. Include in your response the person(s) name, the entity with which the person is affiliated, the person's title, and a description of the process by which your company determined the product dosage.

7.  State whether your company is aware of any adverse health-related consequences that may occur if the recommended dosage of Xenadrine RFA-1 is exceeded. If so, summarize how you have been made aware of these adverse health effects, and provide all records relating to potential adverse health effects that can occur if the daily dosage is higher than what is recommended on the product label.

8.  From the inception of your company to the present, state the company's overall annual revenue and the amount of revenue per year generated from sales of Xenadrine RFA-1.

9.  State the reason for your decision to manufacture an "ephedra-free" product known as Xenadrine-EFX, and whether the decision to develop an "ephedra-free" product was the result of concerns about the adverse health-related effects of supplements containing ephedra.

10.  All records relating to the development and manufacture of Xenadrine-EFX through the use of ingredients other than ephedra.

11.  For each year from 1998 through the present, identify and describe all investigations by state or Federal agencies of your company relating to your products. Include in your response the identity of the investigating agency; the nature of the investigation; and, if applicable, the resolution of the investigation.

12.  Please note that, for purposes of responding to this request, the terms "records" and "relating" should be interpreted in accordance with the attachment to this letter. The term "you" or "your" means Cytodyne Technologies or one or more of its divisions, subsidiaries or affiliates, or related entities.

If you have any questions, please contact Alan Slobodin, Majority Committee Counsel, at (202) 225-2927 or David Nelson, Minority Committee Counsel, at (202) 226-3400.

Sincerely,

W.J. "Billy" Tauzin
Chairman

John D. Dingell
Ranking Member

Michael Bilirakis, Chairman
Subcommittee on Health

Sherrod Brown, Ranking Member
Subcommittee on Health

Cliff Stearns, Chairman
Subcommittee on Commerce, Trade & Consumer Protection

Jan Schakowsky, Ranking Member
Subcommittee on Commerce, Trade & Consumer Protection

James C. Greenwood, Chairman
Subcommittee on Oversight & Investigations

Peter Deutsch, Ranking Member
Subcommittee on Oversight & Investigations