Dr. David Kessler Office of the Commissioner 5600 Fishers Lane Rockville, MD 20857 11 July 1995 An open letter to Commissioner Kessler: It has come to my attention that "pressure from the FDA" is behind the proposed reclassification of DHEA (dehydroepiandrosterone) as an anabolic steroid with Schedule III status by the Drug Enforcement Administration (DEA). At least that is what DEA officials are saying. I am writing to you because that action on the part of your agency is not only an end run around the specific 'wording of the newly passed Dietary Supplement Health & Education Act (DSH&EA) it may be a violation of your oath of office as Commissioner of the FDA. At this time, I don't know whether this alleged "pressure" is real, or the DEA is merely using your agency as an excuse to do something that they cannot legally and scientifically justify on their own. However, it is quite clear to me from my research into DHEA that DHEA is not a "testosterone-like" compound, nor does it have "anabolic activity." Somebody is playing fast and loose with the scientific information about DHEA, and thought you should know - personally - that your agency is one of the candidates. Should a subsequent Congressional investigation uncover testimony that FDA employees were in fact behind this reclassification of DHEA, I want you to accept personal responsibility for your agency's purposeful violation of the Congressional intent behind the DSH&EA. It is my opinion that the DSH&AE was intended to cover DHEA as a "dietary substance" with all the statutory projections from overzealous attempts by your agency to restrict them to drug-only status. Certainly the language of the act specifically covers cholesterol, pregnenolone and DHEA as dietary substances and pregnenolone and DHEA as "metabolites" of cholesterol. The law would not be more clear. Using the steroid-analogues act to contravene the DSH&EA is underhanded, fallacious, and illegal. Furthermore, if you are personally involved in that campaign, you have violated your oath of office to defend the Constitution and laws of the United States. You and your agency are charged with the responsibility to carry out Congressional legislation, not subvert it. The DSH&EA requires you to secure an open hearing under the auspices of the Department of Health and Human Services (DHHS) before you can remove any dietary ingredient from over-the-counter status. This notification is intended to offer you an opportunity to "clean house" before such time as Congress does it for you. Copies of this letter will be forwarded to appropriate Congressional staff charged with oversight and funding of your agency. I trust that you will forward a copy of this to your legal department, and take appropriate actions to speedily remedy this bureaucratic boondoggle. Should I become aware that your agency has used this reclassification to take actions to remove DHEA from the US dietary supplement market without the requisite HHS hearing, I will see that your complicity is brought to the attention of the court with jurisdiction over the matter. Sincerely, Steven Wm. Fowkes, Executive Director