Aspartame Consumer Safety Network
P.O. Box 2001
Frisco, Texas 75034 U.S.
Phone/FAX: 214.387.4001

THE THREAT OF NEOTAME

Dr. Roberts letter to FDA

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-certifid 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 off 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 In my opinion, there is already sufficient evidence for aspartame products to be withdrawn from the market as an "imminent public health hazard" NOW!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
"Leaders Fiddle - While U.S. Burns!"

RESPONSE from ASPARTAME CONSUMER SAFETY NETWORK

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)
OFFICIAL OPPOSITION STATEMENT TO FDA
RE: APPROVAL OF MONSANTO'S NEW SWEETENER, NEOTAME
FROM: ASPARTAME CONSUMER SAFETY NETWORK

DALLAS, March 10, 1998 - (Aspartame Consumer Safety Network) - In response to FDA and Monsanto's announcement that FDA has been petitioned for approval of their new sweetener, Neotame as a food additive, our Dallas-based international anti-aspartame organization, Aspartame Consumer Safety Network, issues the following statement:

Seventy eight percent of all FDA complaints are regarding aspartame adverse reactions. ACSN has thousands of serious reactions in our files, including incidents of grand mal seizures, brain tumors and other health-related problems too numerous to mention.

Monsanto's Nick Rosa stated that Neotame is "based on the aspartame formula." Since we believe this to be true, Aspartame Consumer Safety Network vigorously opposes its approval. The aspartame formula is comprised of Phenylalanine, which caused seizures in lab animals and Aspartic Acid, which caused "holes in the brains" of lab animals - bonded by Methyl Alcohol, or Methanol which is capable of causing blindness, liver damage and death. Methanol, or wood alcohol in aspartame breaks down further in heat and in the body, into Formaldehyde (embalming fluid), Formic Acid (venom in ant stings) and the most deadly of all - Diketopiperazine (DKP), a brain tumor agent. Our files contain close to 10,000 responses from the public, including thousands of serious adverse reactions to Monsanto's aspartame.

As a founder of the world's burgeoning anti-aspartame movement, I was the first non-M.D. invited to lecture at a major Medical School on the topic of Aspartame (Jan. 1997). I recently concluded a multi-city lecture tour and find interest in this topic to be extremely high - here and all over the world. Recently, a story appeared in London's Sunday Mirror, featuring an adverse reaction of a child whose parents are members of A.C.S.N. (Aspartame Consumer Safety Network). Aspartame has been identified and denounced as a major risk factor by consumers in over a dozen countries.

According to FDA Toxicologists who gave testimony with me in 1987 at a Senate Hearing on the subject - the tests to get aspartame approved were falsified. Deaths of lab animals were covered up and went unreported.

Based on over a decade of epidemiological research and work with consumers and health care professionals, we urgently implore the FDA to unequivocally deny any form of approval of Neotame.

Signed:

Mary Nash Stoddard, Founder
Aspartame Consumer Safety Network
and Worldwide Pilots Hotline (Division of ACSN)

enclosure: ACSN Newsletter
cc: Blondell Anderson
Center for Food Safety and Applied Nutrition (HFS-206)
FDA, 200 C Street, SW, Washington, DC 20204

U.S. Congressman, Dick Armey
Attention: Bryndan Wright
301 Cannon Building
Washington, D.C. 20515

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

Representative Newt Gingrich, M.C.
Attn: Patrick Burns
3823 Roswell Road, Suite 206
Marietta, Georgia 30062

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98F-0052]
Monsanto Co.; Filing a Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing that Monsanto Co. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of L- Phenylanlanine,N-[N-(3,3-dimethylbutyl)-L--aspartyl]-,1-methyl ester for use as a tabletop sweetener. Monsanto Co. also proposes that this additive be identified as neotame.

DATES: Written comments on the petitioner's environmental assessment by March 12, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Blondell Anderson, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3106.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 8A4580) has been filed by Monsanto Co., 5200 Old Orchard Rd., Skokie, IL 60077. The petition proposes to amend the food additive regulations in 21 CFR part 172 to provide for the safe use of L-Phenylanlanine,N-[N-(3,3-dimethylbutyl)-L- -aspartyl]-,1- methyl ester as a tabletop sweetener and for the additive to be identified as neotame.The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations promulgated under the National Environmental Policy Act (40 CFR 1501.4(b)), the agency is placing the environmental assessment submitted with the petition that is the subject of this notice on display at the Dockets Management Branch (address above) for public review and comment. Interested persons may, on or before March 12, 1998, submit to the Dockets Management Branch (address above) written comments. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the Federal Register. If, based on its review, the agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the Federal Register in accordance with 21 CFR 25.40(c).

Dated: January 23, 1998.