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Neotame Artificial Sweetener Approved by FDA

But is it Safe?


Monsanto's NutraSweet Division Gets FDA Approval For Artificial Sweetener Neotame 

STEPHANIE M. HORVATH / Wall Street Journal 8jul02

WASHINGTON -- The Food and Drug Administration approved a new sweetener that it says is as much as 13,000 times sweeter than sugar.

mindfully.org note: 
Is it safe to use because the FDA approved it?

NutraSweet Co. makes Neotame, as well as NutraSweet.

A more appropriate question is; 
   "Why isn't the EPA regulating it as a pesticide?"

And yet another question;
   "Why should we believe that anything the FDA approves is safe?"

Complaints against aspartame [NutraSweet] constitute 75% of all additive related complaints relayed to the FDA department of consumer complaints. 
Russell L. Blaylock, M.D., Neurosurgeon, Jackson, MS (1999) 

The FDA approved Neotame in spite of serious health concerns voiced prior to approval.  See more below. 

The sweetener, neotame, is made by NutraSweet Co., which also produces aspartame, a widely used sugar substitute that is 200 times sweeter than sugar.

NutraSweet President and Chief Executive Nick E. Rosa said the company plans "to push really hard, really fast" in marketing neotame after the FDA formally publishes its approval Tuesday. The main market is soft drinks, dairy products including yogurt and frozen dairy desserts, and chewing gum. The Mount Prospect, Ill., company plans to sell it primarily to the soft-drink and food industries rather than directly to consumers as a tabletop sweetener.

Because of neotame's strength -- it usually would take 8,000 teaspoons of sugar to equal the sweetening power of one teaspoon of neotame in most products -- Mr. Rosa said the "economic benefit is extraordinary" for makers of soft drinks and other products that use sugar substitutes.

Mr. Rosa said soft-drink companies will be able to get the same taste by using less sweetener and more water, cutting down on production costs.

But Mr. Rosa said he doesn't see neotame, a white crystalline powder, taking the place of aspartame in the sweetener market. "We don't think there's going to be a 1-to-1 replacement," he said. The new sweetener, he said, can be blended with regular sweeteners such as corn syrup as well as with other sugar substitutes.


The FDA has approved neotame for general use in foods, except for meat and poultry. Alan Rulis, director of the FDA's office of food-additive safety, said the FDA found that there were no "risks or concerns" associated with neotame, and that it met the safety standards applied to all food additives. NutraSweet must submit a special request for neotame to be considered for use on meat and poultry because those two foods fall under the jurisdiction of the Department of Agriculture. Dr. Rulis said NutraSweet didn't request such consideration.

Neotame was rolled out in Australia and New Zealand six months ago, and is being used in soft drinks, yogurt and powdered gelatin mixes. Mr. Rosa said three to five more products that use neotame are expected to be introduced shortly.

NutraSweet's aspartame, widely sold under the Equal brand, had come under fire a few years ago when it believed to be a possible cause of brain tumors. But after reviewing a large number of studies, the FDA concluded it was safe and that further study wasn't needed. Mr. Rosa said aspartame is "absolutely safe" and that allegations made against it have never been proved.

WASHINGTON (AP 5jul02) -- Neotame, a nonnutritive sweetener said to be 7,000 to 13,000 times sweeter than sugar, has been approved for marketing as an additive in candies, soft drinks and some other products, the Food and Drug Administration announced Friday.

The FDA said that neotame is a white crystalline powder that dissolves in water and can be used as a mealtime sweetener or added to recipes.

It has been approved for use in baked goods, nonalcoholic beverages, chewing gum, confections, frozen desserts, gelatins and puddings, jams, jellies, fruit, juices, toppings and syrups.

Neotame was approved after the FDA reviewed more than 113 animal and human studies, some of which were designed to detect any cancer-causing, reproductive or neurological effects. The agency said it concluded from the studies that neotame was safe for human consumption.

Neotame is manufactured by NutraSweet Co. of Mount Prospect, Ill.

Food and Drug Administration: www.fda.gov 

FDA Press Release 5jul02

T02-29 Media Inquiries: 301-436-2335

July 5, 2002 Consumer Inquiries: 888-INFO-FDA

The Food and Drug Administration today announced its approval of a new sweetener, neotame, for use as a general-purpose sweetener in a wide variety of food products, other than meat and poultry. Neotame is a non-nutritive, high intensity sweetener that is manufactured by the NutraSweet Company of Mount Prospect, Illinois.

Depending on its food application, neotame is approximately 7,000 to 13,000 times sweeter than sugar. It is a free-flowing, water soluble, white crystalline powder that is heat stable and can be used as a tabletop sweetener as well as in cooking applications. Examples of uses for which neotame has been approved include baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings and syrups.

In determining the safety of neotame, FDA reviewed data from more than 113 animal and human studies. The safety studies were designed to identify possible toxic effects, such as cancer-causing, reproductive, and neurological effects. From its evaluation of the neotame database, the FDA was able to conclude that neotame is safe for human consumption.

New food additives, including new sweeteners, must be approved by FDA as safe before they may be marketed in the United States.



NEW YORK, N.Y. 10022- 1987

TEL: (212) 753-7500
FAX : (212) 688-2870



June 11, 2002 


Dockets Management Branch (HFA-305) 
Food and Drug Administration 
5630 Fishers Lane 
Room 1061 
Rockville, MD 20852 

                 Re: Docket No. 99F-0187; FAP 9A4643; Neotame

On August 16, 2000, on behalf of our client, the undersigned submitted comments to the above-referenced docket. Those comments identified a number of concerns that pertain to the adequacy of the safety data submitted in support of FDA’s approval of neotame. In particular, the comments questioned the adequacy of the data in resolving issues regarding the body weight gain of test animals consuming neotame, and their reported food consumption values.

Our client has monitored developments on this petition through periodic reviews of the docket and Freedom of Information Act requests. These reviews have not uncovered any material submitted by the petitioner that addresses the body-weight gain issue. Our client continues to believe that there is insufficient data concerning the toxic effect on growth to resolve this issue. The body weight gain issue impacts the establishment of a no effect or no adverse effect level and must, therefore, be evaluated closely. Our client believes these issues can be resolved only through the generation of additional data, as outlined in our earlier comments.

Serious concerns raised by our client require definitive resolution to remove any remaining doubts about the safety of neotame prior to its introduction into the marketplace, and, equally important, to assure reasonable certainty that no harm will result from consumption of neotame. The Agency and public should have the opportunity to review the additional data needed to address these issues, along with appropriate explanations prior to the issuance of a final rule.

Thank you for your attention to this matter.

Very truly yours,
Richard H. Koby

cc:  Dr. Blondell Anderson
       Dr. Alan Rulis

source: http://www.fda.gov/ohrms/dockets/dailys/02/Jun02/061202/8004828e.pdf 6jul02

George R. Schwartz, MD 
P.O. Box 1968 
Santa Fe, NM 87504 
Fax: 505-983-1733 

[ mindfully.org note: Dr Schwartz is a well-known author of consumer guides on such subjects as MSG. ]

March 29, 1999 

Dockets Management Branch (HFA-305) 
Food and Drug Administration 
5630 Fishers Lane, Rm. 1061 
Rockville, MD 20852 

Re: Neotame Identifying Information

I am enclosing a scientific paper accepted for publication by the Western Journal of Medicine. As such there has to be a confidentiality until publication.

I believe publication is scheduled for April 1999, although this timing is out of my control. The issues of possible cancer induction need to be fully addressed since the “neotame” metabolism appears to be similar to that of aspartame. Please include this data in your analysis.

George R. Schwartz, MD

The Western
Journal of Medicine
PO Box 7690. San Francisco, CA 94120-7690. Tel: 41 5/974-5977 . Fax: 41 5/882-3379
221 Main Street l 5an Francisco, CA 94105

George R. Schwartz, MD 
PO Box 1968 
Santa Fe, NM 87504

Dear Dr. Schwartz:

Given the quick acceptance of your report and its passing toward publication we would much appreciate a copy of the report on diskette. We prefer that it be a PC-formatted diskette with the manuscript in Word 6.0/95 or 97 format. Please also do not forget to add the reference number (99-83) to the label of the diskette.

Thanks very much,
Western Journal of Medicine Editorial Office

The Western Journal of Medicine is published by BMJ Publishing Inc
333 Bush Street, San Francisco CA 94104, USA

source: http://www.fda.gov/ohrms/dockets/dailys/040799/let0002.pdf 6jul02

        (561) 588-7628                                      DIPLOMATE, AMERICAN BOARD OF
      FAX (561) 547-8008                                       INTERNAL MEDICINE (RECERTIFIED)

[Handwritten letter transcribed by mindfully.org]

April 7, 1999

Dockets Management Branch (HFA-305) 
Food and Drug Administration 
5630 Fishers Lane 
Room 1061 
Rockville, MD 20852 

Dear Sirs,
        You have received my previous letters of March 3, 1998 and February 25, 1999, expressing my extreme professional opposition to the approval of Neotame as an all-purpose sweetener (copies of both are enclosed) without further data.
        This correspondence is prompted by my analysis of Monsanto's "Environmental Assessment," dated December 17, 1998, which I have just read today. I am troubled by its shortcomings, based on my 15-year interest and researches on its analog, aspartame. In view of the deadline of April 10, 1999, I am writing my criticisms as a supplement to my prior letters. They only can be summarized here.

I.   Environmental Impact
      I believe that there is a potentially significant impact that cannot be necessarily shown by the rat and dog studies, or in the extremely short (13 weeks) tests on healthy subjects.
      Contrary to the Monsanto submission, I have considerable data that point to aspartame being toxic, mutagenic, carcinogenic, diabetogenic and teratogenic. These assertions stem in part from the experience of over 1,200 (!) aspartame reactions in my own database.

II   Animal Testing
      It is a gross error to project the animal studies onto humans where the massive consumption of this chemical is envisioned. (Currently, over half of the population consumes aspartame products.) For example, these species metabolize phenylalamine 4-5 times faster than humans. Moreover, phenylalamine concentrates much more on the fetal side of the placenta, and readily crosses the blood-brain barrier to affect the fetus brain.
      Comparable arguments could be made for aspartic acid and methanol, which I have addressed in many publications.

IV.   Diabetics
      The assertion that aspartame/neotame does not affect glycemic control is WRONG ! As a Board-certified internatl and endocrinologist, I have repeatedly found that aspartame products aggravate both diabetes control and its complications--and have written on this subject. My requests of corporate-sponsored researchers in this realm to justify their published "negative" conclusions have not been answered.

V.   "Small Amounts"
      It is erroneous to assume that "a dietary concentration of less than 10ppb [parts per billion] of each minor degradant. . ." is innocuos. From my work on pesticides, there are several molecules in each cell even in parts per trillion.

      I am a totally corporate-neutral physician who is concerned about the ongoing exposure of the population to aspartame and numerous other chemicals that were approved without adequate long-term pertinent studies by corporate-neutral investigative and politically-neutral regulators.
      Let me repeat: it will be a public health tragedy if the aspartame problem is allowed to be repeated in the absence of these safeguards !

Yours truly, 
H.J. Roberts, MD

2 enclosures
[for complete handwritten letter please see http://www.fda.gov/ohrms/dockets/dailys/041299/c00001.pdf 6jul02]

More documents on the FDA website:
92 page letter condemning Neotame: http://www.fda.gov/ohrms/dockets/dailys/041499/c000002.pdf



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