On August 4th, the comments period ends on the draft report on the US Commission on Dietary Supplement Labels. Following this message I have a form letter which I urge you to fax or mail in to the Commission on Dietary Supplements, as well as to your Senators and Congressmen.
The reason you must do this is simple: we must try to extend the comments period so that more people can have the time necessary to procure copies of the 77 page draft report in order to have sufficient time to review it, discuss it, and draft comments to its many highly controversial recommendations, which includes creating an Over the Counter (OTC) drug category for herbs and botanicals and giving broad new powers to the FDA that they would use against the dietary supplement industry (to the detriment of consumers).
When the pharmaceutical industry wants to try to push their agenda past consumers, they often wait until the summer when people are on vacation and it's much harder to get organized in opposition. As a lobbyist working to defend the rights of dietary supplement consumers, I've seen this happen time and time again.
The Report of the Commission on Dietary Supplement Labels doesn't carry the force of law, however this report is STILL very dangerous to consumers because legislators who know nothing about health freedom issues will be influenced by it, and will get behind a legislative push to give FDA added new powers to attack the dietary supplement industry and to create an OTC drug definition for herbs and botanicals. This is Codex harmonization. We worked hard to define dietary supplements and herbs as foods under DSHEA, and it is unwise to blur the line between foods and drugs that we worked so hard to create. If we don't push for an extension on the comments period on the Report of the Commission on Dietary Supplement Labels, we will be allowing a blueprint to stand unchallenged which will be used to guide a legislative campaign that will hasten the destruction of health freedom in the US.
Please forward this alert widely, copy the enclosed form letter to your word processor, fax it in to the Commission on Dietary Supplement Labels, your Senators and Congressmen, and set up tables in front of your health food store to get people to sign lots of them which you can send in en masse. Go on the radio to talk about this, and discuss it in usenet and on online mailing lists. Remember, its summer. Each of us has to work 10x harder to compensate for all the people who aren't around to help right now
To: Kenneth D. Fisher, Ph.D.
Commission on Dietary Supplement Labels Office of Disease Prevention and Health Promotion
R. 728G Hubert H. Humphrey Building
200 Independence Ave. S.W. Washington, D.C. 20201
Ph. 1-202-401-5811 Fax: 1-202-205-0463
Dear Dr. Fisher:
I understand that the Commission was (supposedly) created "as an independent agency under the executive branch" by the passage of the Dietary Supplement Health and Education Act of 1994 to... "conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims." I understand that in making its recommendations, the Commission is to... "evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families." (How can the Commission be said to have been "independent under the executive branch" when it was set up under HHS, the same cabinet dept. which includes FDA??? Was the Commission legally established in accordance with the Federal Advisory Committee Act, PL 92-463? Were all meetings TRULY open? Shouldn't it have been set up as a TRULY "independent agency"???)
I gather that if I call the Commission's Information Response Center at 301-650-0382, they will send me the 77 page draft report of the Commission on Dietary Supplement Labels. Given the time constraints in obtaining this report fast enough to read it in entirety in order to file comments prior to your August 4, 1997 deadline, I am formally requesting an extension on the comments period in order to allow me sufficient time to procure the report, read it as well as to draft more extensive comments. I am appraising my Senators and Congressmen of the following concerns about the draft, which were called to my attention by International Advocates for Health Freedom:
On p.ii, pp.16-17, and p.20 I feel that you should strike all references to ephedra posing a "safety issue" given the fact that a Medline Search indicates that you have no peer reviewed evidence to support your contention that ephedra has caused death, and given the fact that we are currently undergoing a comments period with regards to ephedra regulation.
I do not feel that it is appropriate for you to cite ephedra as an example of an "unsafe" product being marketed. A search of Medline turned up zero reports of deaths caused by ephedra, and several reports of death caused by ephedrine, and pseudoephedrine products, including many commonly used OTC drugs such as children's cough syrup. If FDA is concerned with safety, let FDA regulate ephedrine, and pseudoephedrine products which have been documented to cause death. Leave ma huang/ephedra alone. We don't need or want the FDA's double standards incorporated into this report. This information comes from the affidavit of Miloslav Nosal, a biostatistician, who is serving as an expert witness in a lawsuit filed by Freedom of Choice in Health Care against the Canadian HPB.
I feel strongly that the creation of an OTC drug category for herbs and botanicals (as described on p.vii in your report), is not in the long range best interests to consumers. Foods are not drugs. By law, DSHEA established a food definition for dietary supplements. We object strongly to the proposal to create an OTC drug category for herbs and botanicals. Our gains under DSHEA would be put at risk if an OTC drug category were created. We feel that expanded health claims should be allowed under DSHEA based on overwhelming scientific evidence attesting to both the safety and efficacy of dietary supplements for many medical conditions, and we feel that to deny these truthful claims violates our first amendment rights to free speech. We favor a split label in which FDA can say what they want on their half, and the manufacturer can offer validated information on the other half.
We object to a comments period which effectively excludes the views of millions of concerned dietary supplement consumers who have not had sufficient time to procure your draft report, much less to read it and to submit comments. Given the enormous consumer push behind DSHEA, we feel strongly that consumers are being largely disenfranchised, and we would like the comments period to be extended until the end of October, 1997. We are outraged by the ongoing push to regulate foods as "drugs." We would like until the end of October to review your draft report and to file comments. I am appraising my Senators and Congressmen of these concerns.
City: ______________________ State: _______________ Zip: __________
(Info courtesy I.A.H.F. 800-333-2553, www.iahf.com, email@example.com)
International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St.#2 Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,
FAX ON DEMAND 954-927-8795,firstname.lastname@example.org