RE:Docket No.98N-0148;International Drug Scheduling; ... Ephedrine...
 
                    DURK PEARSON & SANDY SHAW
    People for the Constitution, Box 3666, Tonopah, NV 89049

TO:  Dockets Management Branch (HFA-305)
     Food and Drug Administration
     12410 Parklawn Dr., Rm. 1-23
     Rockville, MD 20857
     Comments for Docket No. 98N-0148
 
 

                           Before the
                  FOOD AND DRUG ADMINISTRATION
                          Rockville, MD

In re: Comments Concerning Abuse)
Potential, Actual Abuse, Medical)
Usefulness, Usefulness as a     )    Docket No. 98N-0148
Dietary Supplement Under DSHEA, )
and Trafficking in Ephedrine and)
Ephedra Sinica Herb             )
Fed. Reg. 63(52): 13258-13259   )
March 18, 1998                  )

                                             3 April, 1998

      INTRODUCTION TO COMMENTS OF DURK PEARSON & SANDY SHAW

     Note: These comments pertain to ephedrine, ephedra herb, ephedra herb and ephedrine containing dietary supplements, and the family of ephedra alkaloids found in ephedra sinica.  No comments are hereby tendered regarding dihydroetorphine or remifentanyl.  These comments apply to "isomers of psychotropic substances" only insofar as any FDA recommended WHO rules would apply to the family of ephedra alkaloids found in ephedra sinica.

     Durk Pearson and Sandy Shaw are scientists and authors, maintaining residences in Nevada and California.  Their three best-selling books include the million plus copy #1 best-seller Life Extension, a Practical Scientific Approach (Warner Books, 1982).  Their fourth book, Freedom of Informed Choice: FDA v. Nutrient Supplements argues that truthful, non-misleading speech on labels and in labeling is protected by the First Amendment of the United States Constitution against FDA censorship and discusses the cost to public health of such censorship.

     Pearson and Shaw design dietary supplement formulations and license them to small marketing and manufacturing companies.  The formulations designed by Pearson and Shaw include dietary supplements containing ground ephedra herb leaves and stems.  Pearson and Shaw and their licensed marketers and manufacturers (all are small businesses) would suffer substantial economic harm if the FDA were to recommend, and WHO were to implement, restrictions on the sale of ephedra herb itself or on DSHEA compliant dietary supplements containing ephedra herb.  Furthermore, Pearson & Shaw believe that consumers of ephedra herb dietary supplements would actually be endangered by any such restrictions.

     DSHEA (Dietary Supplement Health and Education Act) places a substantial statutory burden of proof on FDA to demonstrate that an herbal dietary supplement is unreasonably unsafe when used as directed before FDA is legally permitted to take any action to restrict or prohibit the sales of such a supplement or its ingredients.  Under the provisions of DSHEA,  FDA has no statutory authority to recommend that WHO restrict ephedra herb, ephedra herb containing dietary supplements, or their constituent ingredients unless FDA has met their DSHEA burden of proof.

     Pearson & Shaw do not believe that the FDA has met their statutory burden of proof under DSHEA that ephedra herb and ephedrine containing and ephedra herb containing dietary supplements are unreasonably risky to consumers when used as directed.

     On the contrary, the evidence presented by the FDA's own Expert Committee on Ephedrine Alkaloid Containing Dietary Supplements (which we review at length in the attached 107 page public comment document previously filed by Pearson & Shaw with the FDA) shows that extant ephedra herb supplements with extant labeling are generally safer than food in common form.  Please see Pearson & Shaw's 107 pages of Comments (attached).  We filed these comments on FDA's Docket No.95N-0304: Dietary Supplements Containing Ephedrine Alkaloids, and they address the abuse potential, actual abuse, potential dangers, actual dangers, and usefulness as DSHEA regulated dietary supplements of ephedrine and ephedra herb containing products.

     Note that the aforementioned FDA Expert Committee on Ephedrine Alkaloid Containing Dietary Supplements found that millions of Americans were using ephedrine containing dietary supplements.  They identified only a few abusers among these many millions of American users, and found no evidence of abuse of either ephedra herb itself or of ephedra herb containing dietary supplements.
 

     Re illicit trafficking:

     There is no illicit trafficking in ephedra herb or in dietary supplements containing ephedra herb.  Ephedrine itself has already been designated as a listed chemical and is subject to chemical diversion regulations under 21 CFR part 1310 which are enforced by the Drug Enforcement Administration, due to its potential for use as a precursor in illicit methamphetamine manufacturing.

     Any recommendation by FDA to WHO (or any other party) that ephedra herb (or ephedra herb containing dietary supplements) be subject to the same restrictions as ephedrine itself would be arbitrary, capricious, contrary to fact, and a violation of the Administrative Procedure Act.

     There is no record of ephedra herb ever having been used as a precursor for illicit methamphetamine.

     To make one kilogram of illicit methamphetamine would require about 1.5 kg. of ephedrine, and a few kilograms of other chemicals (e.g., red phosphorous) and solvents.  The conversion would be performed in reaction vessels of a few liters volume, and the whole operation can be (and often has been) performed in a residential kitchen or bathroom.

     To make 1 kg. of illicit methamphetamine from ephedra herb, however, would require that the ephedrine first be extracted from approximately 200 kg. of raw ephedra sinica herb with the use of approximately 2,000 kg. of solvents in an extraction vessel of approximately 3,000 liters volume.  Obviously, an operation of this scale cannot be readily hidden, and extraction solvent purchases of this magnitude would be both prohibitively expensive and highly suspicious, to say nothing of the difficulties involved in the illicit disposal of such huge amounts of used solvents.  It is obvious, therefore, why ephedra herb has never been used as a source of ephedrine for illicit methamphetamine manufacture.  It is also obvious that ephedra herb containing dietary supplements would be an even more difficult and less economic source of ephedrine than ephedra herb itself.

     For these reasons, and additional reasons stated in the attached 107 pages of comments, if FDA makes any recommendations to WHO regarding ephedrine, FDA must distinguish between ephedra herb (and DSHEA regulated dietary supplements containing ephedra herb) on the one hand and pure ephedrine on the other.  

     FDA, in accord with U.S. law, must recommend to WHO that ephedra herb itself and ephedra herb containing dietary supplements NOT be subject to any additional regulation, and under no circumstances be regulated the same as ephedrine; any other recommendation would be a clear violation of the intent of the DSHEA and of the APA.
 

                                   Sincerely,
 
 
 

                                   Durk Pearson
                                   Sandy Shaw
 


© Copyright 1999 by Durk Pearson & Sandy Shaw

NOTICE: The "Durk Pearson & Sandy Shaw Life Extension News" is for informational purposes only. Its contents are not intended as advice for the diagnosis, treatment, or cure of any medical condition. Pearson & Shaw are scientists, not doctors. If you have a medical condition, see a physician. Durk Pearson & Sandy Shaw® do not own any part of any dietary supplement company. They license their formulations and receive royalties on sales. The formulations they design and use are those which contain their names on the label.

FREE Subscription

  • You're just getting started! We have published thousands of scientific health articles. Stay updated and maintain your health.

    It's free to your e-mail inbox and you can unsubscribe at any time.
    Loading Indicator