Headache Most Common Adverse Experience In Neotame Study

Neotame (E961) is the next generation of artificial sweetener and flavour enhancer. Critics say it is even more toxic than aspartame, and call for independent research to evaluate its effects. Headache was the most common adverse experience in human studies.

As its patent for aspartame was running out, Monsanto developed a new, more potent version of its synthetic sweetener, Neotame. The new sweetener is decribed as having an intense taste. And while Monsanto was the original creator of neotame back when it owned the NutraSweet Company, J.W. Childs Equity Partners II, L.P. today owns the NutraSweet Company, which includes ownership of neotame as well.

In 1998, Monsanto applied for FDA approval for neotame, “based on the aspartame formula” with one critical addition: 3-dimethylbutyl, which just happens to be listed on the EPA’s most hazardous chemical list. By adding 3-dimethylbutyl to aspartame, scientists at Monsanto drastically increased the sweetening power of the additive. The new version was named neotame.

Both Aspartame and Neotame contain substances that are metabolized into formaldehyde, a highly toxic poison, and an excitotoxic amino acid that agitates, thereby damaging, nerves.

Approved for use in the USA in 2002. Approved in the EU as E961. Unlike Aspartame no warning is required as phenylalanine is not produced and consequently it is safe to consume for people who suffer from phenylketonuria (pku). Because of the tiny amount needed it is not even required to be named in the list of ingredients, but simply to be mentioned by its E number. So if you see E961 you know it contains Neotame.

Neotame is a dipeptide methyl ester that is intended for use in food as a sweetener and flavour enhancer in a variety of applications. Neotame, the common name for N-[N-(3,3-dimethylbutyl)-L-alpha-aspartyl]-L-phenylalanine 1-methyl ester, is chemically related to aspartame. It has a sweetness potency of 7000–13 000 times greater than that of sucrose and 30–60 times greater than that of aspartame, depending on the food matrix in which it is used.

Neotame is intended for use as a tabletop sweetener as well as in a large variety of solid and liquid foods. It is used in foods and beverages, including chewing gum, carbonated soft drinks, ready to drink beverages, tabletop sweetener, frozen desserts, puddings and fillings, yogurt-like foods, baked goods and candies, except meat and poultry.

It is approved for use in more than 35 countries around the world including the USA, Canada, Mexico, Argentina, Brazil, Russia, Australia, China, Philippines, Indonesia, Japan, Nigeria, South Africa.

In the EU, Neotame has been approved by the European Food Safety Agency (EFSA). As is so common in the EU, the product is hidden behind an E-number. So, labels don’t have to say that products contain Neotame. They only need to list “E 961”. Naturally, with hundreds of E-numbers, how many people can be aware of which ones are truly dangerous?

(Note: Products that contain aspartame are required to include a caution for individuals who cannot tolerate the phenylalanine in it. Some manufacturers hide aspartame in foods, supplements, and medicines, by simply saying “contains phenylalanine.”)

Conservative calculations based on its lowest sweetness potency (7000 times that of sugar) suggest that an intake of 2 mg/kg bw per day would correspond to the replacement of 840 g of sugar in the diet of a 60-kg adult.

On the basis of the available studies, appropriate studies indicated that neotame is not carcinogenic, mutagenic, teratogenic or associated with any reproductive/developmental toxicity. The only consistent treatment-related effect observed was an increase in serum alkaline phosphatase activity in the 13-week and 1-year studies in dogs fed diets containing neotame. While the increase in alkaline phosphatase was moderate, reversible, and was not accompanied by other evidence of liver toxicity, the observed change was reproducible, of high statistical significance and treatment-related. There was insufficient data to discount this effect and therefore accepted the dog as the most sensitive species with a NOEL for neotame of 200 mg/kg bw per day, on the basis of the 1-year study in dogs fed diets containing neotame.

Studies of tolerance in humans confirmed the lack of any treatment-related signs or symptoms at a dose of up to 1.5 mg/kg bw per day in diabetic and non-diabetic subjects. Although a 1-year study is not considered to be a long-term study in dogs, an additional safety factor was not considered necessary, in light of the data for humans.

In a 3-month study of tolerance, 151 healthy men and women (mean age ±SD, 35 ±11 years) were enrolled. With respect to clinical symptoms, 82 persons reported at least one adverse reaction during the study. Most of these were determined to be of mild or moderate severity, and were reported in all three treatment groups. Headache was the most common adverse experience.

Bad Aspartame or Neotame Experience or Reaction?

Did you know that only a fraction of all adverse food reactions are ever reported to the FDA? This is a problem that only you as the consumer can have an impact upon.

There’s no telling just how many reports they might need before considering taking another look at the safety of aspartame or neotame, but the only way to press them is by reporting any and all adverse effects!

And in the meantime, do your health and the health of your family a favor and treat all foods and drinks that contain aspartame or neotame as if they were dangerous to your optimal health. Because, in my opinion, they are.

It is sold by Nutrasweet as Neotame, but not to the consumer market. It is mainly used by food producers. It is the cheapest sweetener and is used to reduce cost of manufacture. Whether this saving is passed on the the consumer is another matter! It is also used to sweeten cattle feed.

Sold As

Neotame can even be ingested second-hand because it is used in animal feed. A product called Sweetos, containing Neotame, is fed to cattle in place of molasses, to cover up the smell of rancid food they are fed. This will never make it into any label.

A line of neotame-based blends, produced by Sweetener Solutions LLC (Savannah, Ga.), a strategic partner of The NutraSweet Co., and distributed exclusively by Univar USA (Kirkland, Wash.), provides formulators with ingredients that can be used as both a general sweetener and flavor enhancer.

Although so far its use appears to be very limited, it is in some products. Keep your eyes on ingredient lists.

Letter sent to Neotame:

Is there a list of foods that contain neotame?

Response: The NutraSweet Company does not manufacture products sold directly to the consumer.  We are the manufacturer of bulk neotame which is sold to food and pharmaceutical companies for use in their products.  You can determine if neotame is an ingredient in a product by reading the ingredients listing on the product label.

Regards,
NutraSweet Customer Service

Products containing Neotame

• Sunny D, Sunny Delight®
• Cepacol Sore Throat Spray, Maximum Strength, Cherry Flavor
• Lip Smacker Bonne Bell Lip Smacker Trio with SPF 24, Fruit Flavors
• Bonnie Bell Lip Smackers Party Pack, Assorted
• Lip Smacker Bonne Bell Lip Smacker Skittles Tropical Trio, Tropical Fruit Flavors
• Lip Smacker Bonne Bell Lip Smacker Starburst Tropical Fruit Flavors Candy Flavor Lipgloss Trio, Tropical Fruit Flavors, Vitamin Water Focus Flavored Lipbalm, SPF 20, Kiwi Strawberry
• Vitamin Water Power-C Flavored Lipbalm, SPF-20. Dragonfruit

 Sweetener Substances

• Acesulframe K | Artificial Sweetener (E950)
• Advantame – Artificial Sweetener
• Agave Syrup | Modified Sugar
• Alitame | Artificial Sweetener (E956)
• Aspartame – Artificial Sweetener (E951)
• Aspartame-Acesulfame Salt – Artificial Sweetener (E962)
• Barley Malt Syrup – Modified Sugar
• Birch Syrup – Sugar Extract
• Blackstrap Molasses – Sugar Extract
• Brazzein – Natural Sweetener
• Brown Rice Syrup – Modified Sugar
• Cane Juice – Sugar Extract
• Caramel – Modified sugar
• Coconut Palm Sugar – Sugar Extract
• Corn Sugar (HFCS) – Modified sugar
• Corn Sweetener (HFCS) – Modified sugar
• Corn Syrup (HFCS) – Modified sugar
• Curculin – Natural Sweetener
• Cyclamate – Artificial Sweetener (E952)
• Dextrose – Sugar
• Erythritol – Sugar Alcohol (E968)
• Fructose Glucose Syrup (HFCS) – Modified sugar
• Fructose – Sugar
• Galactose – Sugar
• Glucitol (Sorbitol) – Sugar Alcohol (E420)
• Glucose – Sugar
• Glucose Fructose Syrup (HFCS) – Modified sugar
• Glycerol (Glycerin) – Sugar Alcohol (E422)
• Glycyrrhizin – Natural Sweetener (E958)
• Golden Syrup – Modified sugar
• High Fructose Corn Syrup (HFCS) – Modified Sugar
• HFCS-42 – Modified Sugar
• HFCS-55 – Modified Sugar
• HFCS-90 – Modified Sugar
• Honey – Natural Sugar
• HSH – Sugar Alcohol
• Hydrogenated Starch Hydrolysate (HSH)- Sugar Alcohol
• Isoglucose (HFCS) – Modified sugar
• Inulin – Sugar Fiber
• Inverted Sugar – Modified sugar
• Isomalt – Sugar Alcohol (E953)
• Lactitol – Sugar Alcohol (E966)
• Lactose – Sugar
• Levulose (Fructose) – Sugar
• Luo Han Guo – Natural Sweetener
• Maltitol – Sugar Alcohol (E965)
• Maltodextrin – Sugar
• Maltose – Sugar
• Mannitol – Sugar Alcohol (E421)
• Maple Syrup – Sugar Extract
• Miraculin – Natural Sweetener
• Molasses – Sugar Extract
• Monellin – Natural Sweetener
• Monk Fruit (Luo Han Guo) – Natural Sweetener
• Neohesperidin DC – Artificial Sweetener (E959)
• Neotame – Artificial Sweetener (E961)
• Oligofructose – Sugar Fiber
• Palm Sugar – Sugar Extract
• Pentadin – Natural Sweetener
• Rapadura – Sugar Extract
• Refiners Syrup – Modified Sugar
• Saccharin – Artificial Sweetener (E954)
• Saccharose (Sucrose) – Sugar
• Sorbitol – Sugar Alcohol (E420)
• Sorghum Syrup – Sugar Extract
• Stevia – Natural Sweetener
• Stevioside – Natural Sweetener (E960)
• Sucralose – Artificial Sweetener (E955)
• Sucrose – Sugar
• Tagatose – Modified Sugar
• Thaumatin – Natural Sweetener (E957)
• Trehalose – Sugar
• Xylitol – Sugar Alcohol (E967)
• Yacon Syrup – Natural Sweetener

Sweetener Brand Names

• Aclame: Contains Alitame – Artificial Sweetener (E956)
• AminoSweet: Contains Aspartame – Artificial Sweetener (E951)
• C*Eridex: Contains Erythritol – Sugar Alcohol (E968)
• Candarel: Contains Aspartame – Artificial Sweetener (E951)
• ClearCut™: Contains: Isomalt – Sugar Alcohol (E953)
• Cologran: Contains Saccharin, – (E954) and Cyclamate – (E952)
• Cweet: Contains Brazzein – Natural Sweetener
• DiabetiSweet: Contains Isomalt – (E953) and Acesulfame K – (E950)
• Equal: Contains Aspartame – Artificial Sweetener (E951)
• EZ-Sweetz: Contains Sucralose – Artificial Sweetener (E955)
• Ideal: Contains Xylitol – (E967) and Sucralose – (E955)
• Just Like Sugar: Contains Inulin – Sugar Fiber
• Heremesetas: Contains Saccharin, – Artificial Sweetener (E954)
• Lacty: Contains – Lactitol – Sugar Alcohol (E966)
• Lakanto: Contains Erythritol – (E968) and Luo Han Guo – Natural Sweetener
• Maltisweet: Contains Maltitol – Sugar Alcohol (E965)
• NatraTaste: Contains Aspartame – Artificial Sweetener (E951)
• Necta Sweet: Contains Saccharin – Artificial Sweetener (E954)
• Nevalla: Contains Sucralose – (E955) and Maltodextrin – Sugar
• NuStevia: Contains Stevia – Natural Sweetener
• NutraSweet: Contains Aspartame – Artificial Sweetener (E951)
• Polysweet: Contains Xylitol – Sugar Alcohol (E967)
• PUREFRUIT: Contains Luo Han Guo – Natural Sweetener
• PureVia: Contains Stevia – and Maltodextrin
• SomerSweet: Contains Inulin – Sugar Fiber and Erythritol – (E968)
• Splenda: Contains Sucralose – (E955) and Maltodextrin – Sugar
• Sucaryl: Contains Saccharin, – (E954) and Cyclamate – (E952)
• Sunett: Contains Acesulfame K – Artificial Sweetener (E950)
• Sweet’N Low: Contains Saccharin, – Artificial Sweetener (E954)
• Sweet Fiber: Contains Inulin – Sugar Fiber and Luo Han Guo
• Sweet Pearl: Contains Maltitol – Sugar Alcohol (E965)
• Sweet Perfection: Inulin – Sugar Fiber and Erythritol – (E968)
• Sweet One: Contains Acesulfame K – Artificial Sweetener (E950)
• Sweet Sensation: Contains Luo Han Guo – Natural Sweetener
• Sweetzfree: Contains Sucralose – Artificial Sweetener (E955)
• Swerve: Contains Inulin – Sugar Fiber and Erythritol – (E968)
• Tagatesse: Contains Tagatose – and Sucralose – (E955)
• Talin: Contains Thaumatin – Natural Sweetener (E957)
• Truvia: Contains Stevia and Erythritol
• TwinSweet: Contains Aspartame (E951) and Acesulfame K (E950)
• Whey Low: Contains fructose, lactose and sucrose
• Xylosweet: Contains Xylitol – Sugar Alcohol (E967)
• Zerose: Contains Erythritol – Sugar Alcohol (E968)
• ZSweet: Contains Erythritol – Sugar Alcohol (E968)

The history of sugar is only about 2,500 years old, but the final chapter has not been written yet!