H. J. Roberts,M.D., F.A.C.P., F.C.C.P.

300 27th Street

West Palm Beach, Florida 33407

Phone (407) 832-2408 Fax (407)832 2400

 

March 3, 1998

 

Dockets Management Branch (HFA A-305)

Food an Drug Administration

12420 Parklawn Drive Room 1-23

Rockville,Maryland 20857

 

Subject:  Docket No. 98F-0052 (Food Additive Petition for Neotame)

 

Dear Sir:

I am writing to express my extreme opposition to approving the Food Additive Petition for Neotame submitted by Monsanto Company.

It is my professional opinion that this chemical poses a potential major health and environmental hazard to the American public -- particularly in the absence of extensive, detailed and long-term animal and human studies (which I have been unable to obtain) that could prove its safety to my satisfaction.  I am a Board-certified internist, and have been the unsalaried director of the Palm Beach Institute for Medical Research (not-for-profit) since l964.

This opinion is based on more than a decade of intense, corporate-neutral clinical and epidemiological research concerning the widespread serious medical problems directly attributable to products containing aspartame (NutraSweet, Equal). My own database currently exceeds 1,150 reactors.  I have documented these reactions in more than a score of published articles and letters, and three books. 

The fundamental issue is that Neotame, a synthetic variation of aspartame, requires extensive evaluation before the FDA should accept a superficial opinion about its purported safety based largely on limited short-term data involving potentially flawed protocols that were almost totally funded by corporate contracts.  (For perspective, I have not received a cent of industry money for my researches.)  This matter is discussed at length in my publications relative to both animal and human studies.

The timing and self-serving corporate interests of this petition are suggested by the fact that the patent of aspartame expired several years ago. 

The approval of any analog of aspartame for human use MUST be challenged.  In my opinion, there is already sufficient evidence for aspartame products to be withdrawn from the market as an "imminent public health hazard" NOW!  I have documented severe neurological, intellectual, psychiatric, metabolic, endocrine, allergic and other reactions to aspartame products in hundreds of patients.  Moreover, there is considerable reason to invoke aspartame and its metabolites as a cause of significant contributory factor in the aggravation of precipitation of diabetes and its complications, multiple sclerosis, brain cancer (see enclosed peer-reviewed article), and the acceleration of Alzheimers disease (refer to my book DEFENSE AGAINST ALZHEIMER'S DISEASE).  I summarized these perceived hazards in previous correspondence to Representative Newt Gingrich (copy enclosed) requesting a new Congressional hearing on the safety of aspartame products.

As a physician and citizen, I am appalled at the thought of American consumers being again subjected to an anticipated repeat of the aspartame fiasco withut adequate objective and corporate neutral evaluations that the FDA ought to DEMAND before taking such an action. It is my longstanding belief that aspartame (originally developed as a drug for treating peptic ulcer should not have been approved for human consumption in the first place ... a view shared by other professionals (including former in-house FDA scientists, consultants for the General Accounting Office, and a Public Board of Inquiry). 

The FDA, other regulatory officials and producers of Neotame products are urged to heed these constructive warnings coming from a credentialed doctor.  Concomitantly, they are put on notice that ignoring them will not go unchallenged if proven correct. 

 

Yours truly,

H. J. Roberts, M.D., F.A.C.P., F.C.C.P.

Enclosures

  Letter to Rep. Newt Gingrich

  List of Roberts publications on aspartame reactions

  Dr. H. J. Roberts' Statement for 1987 Senate Hearing

  Brain Cancer Article

  Brochure on Alzheimer's disease book

  "Best Doctor"

 

CC:Ms. Blondell Anderson

Center for Food Safety and Applied Nutrition (HFS-206)

FDA, 200 C Street, SW,

Washington, DC 20204

 

Ms. Laura M. Tavantino

Office of Premarket Approval

Center for Food Safety and Applied Nutrition (HFS-206)

FDA, 200 C Street, SW, Washington, DC 20204

 

Senator Bob Graham

524 Hart Senate Office Building

Washington, D.C. 20510

 

Representative Newt Gingrich, M.C.

Attn:  Patrick Burns

3823 Roswell Road, Suite 206

Marietta, Georgia 30062

 

Representative F. Clay Shaw, Jr., M.C.

222 Lakeview Avenue, Suite 162

West Palm Beach, Florida 33401

 

Representative Mark Foley, M.C.

4440 PGA Blvd, Suite 406

Palm Beach Gardens, Florida 33410