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Tuesday, November 2, 2010


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)

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.


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

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.

Laura M. Tarantino,
Acting Director, Office of Premarket Approval, Center for Food Safety
and Applied Nutrition.
[FR Doc. 98-3296 Filed 2-9-98; 8:45 am
] BILLING CODE 4160-01-F
Word Matches: NEOTAME
Archive-Name: gov/us/fed/nara/fed-register/1998/feb/10/63FR6762
Posting-number: Volume 63, Issue 27, Page 6762
[Federal Register: February 10, 1998 (Volume 63, Number 27)]
[Page 6762]
From the Federal Register Online via GPO Access []
What is it used in?
Beverages, tabletop sweeteners, frozen desserts, ice cream, yogurt, chewing gum, candy, bakery products, toppings, fillings, fruit spreads, cereal

New products that have recently come to the market that contain neotame include,Kroger's fruit juice and certain powdered ice-teas. Neotame is also now used in some Detour energy bars and certain confectionary products, such as Wrigley Chewing Gum in Australia, Roman Meal Bread line and Herr's pretzels in the US.
Many food products bound for the US are Made in China. What are the permitted sweeteners in Hong Kong?

According to the Schedule to the Sweeteners in Food Regulations (Cap. 132U), permitted sweeteners include the followings:

(1) Acesulfame Potassium
(2) Alitame
(3) Aspartame (aka Equal/AminoSweet/Canderel, etc.)
(4) Aspartame - acesulfame Salt
(5) Cyclamic Acid (and Sodium, Potassium, Calcium salts)
(6) Saccharin (and Sodium, Potassium, Calcium Salts)
(7) Sucralose
(8) Thaumatin.
(9) Neotame (aka Sweetos)
(10) Steviol Glycosides

8. What are the maximum permissible levels for the permitted sweeteners in foods?

There are no maximum permissible levels set for those permitted sweeteners as prescribed in the Schedule to the Sweeteners in Food Regulation (Cap. 132U). The quantity of the permitted sweeteners to be used in foods shall be in accordance with the good manufacturing practice.(?????)