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Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people use sugar substitutes – also called high-intensity sweeteners – to sweeten and add flavor to their foods. They can be used alone to sweeten foods and beverages such as iced tea or coffee, or as an ingredient in other products. There are a number of sugar substitutes on the market from which to choose.
“Sugar substitutes are called ‘high-intensity’ because small amounts pack a large punch when it comes to sweetness,” says Captain Andrew Zajac, U.S. Public Health Service (USPHS), director of the Division of Petition Review at the Food and Drug Administration (FDA).
According to Zajac, unlike sweeteners such as sugar, honey, or molasses, high-intensity sweeteners add few or no calories to the foods they flavor. Also, high-intensity sweeteners generally do not raise blood sugar levels.
The FDA has approved a new high-intensity sweetener called advantame.
Advantame—which does not yet have a brand name (such as Sweet’N Low, a brand name for saccharin, or Equal, a brand name for aspartame)—has been approved as a new food additive for use as a sweetener and flavor enhancer in foods, except meat and poultry.
Examples of uses for which advantame 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.
FDA is required by law to review all new food additives for safety before they can go on the market. The process begins when a company submits a food additive petition to FDA seeking approval. One exception is for substances "generally recognized as safe," or GRAS, because those substances are generally recognized by qualified experts as safe under the conditions of intended use and are exempt from the food additive approval process.
Zajac explains that the agency’s scientists thoroughly review all the scientific evidence submitted by a company to ensure the product is safe for the intended use.
“In determining the safety of advantame, FDA reviewed data from 37 animal and human studies designed to identify possible toxic (harmful) effects, including effects on the immune, reproductive and developmental, and nervous systems,” Zajac says.
Advantame is chemically related to aspartame, and certain individuals should avoid or restrict the use of aspartame. To that end, FDA evaluated whether the same individuals should avoid or restrict advantame, as well.
People who have phenylketonuria (PKU), a rare genetic disorder, have a difficult time metabolizing phenylalanine, a component of both aspartame and advantame. Newborns are tested for PKU using a common “heel-prick” test before they leave the hospital.
Foods containing aspartame must bear an information statement for people with PKU alerting them about the presence of phenylalanine. But advantame is much sweeter than aspartame, so only a very small amount needs to be used to reach the same level of sweetness. As a result, foods containing advantame do not need to bear that statement.
The last high-intensity sweetener approved by FDA was Neotame (brand name Newtame) in 2002. The other four on the market, and are:
- Saccharin, was first discovered and used in 1879, before the current food additive approval process came into effect in 1958. Brand names include Sweet‘N Low
- Aspartame, first approved for use in 1981. Brand names include Equal
- Acesulfame potassium (Ace-K), first approved for use in 1988. Brand names include Sweet One
- Sucralose, first approved for use in 1998. Brand name is Splenda
In addition to the six high-intensity sweeteners that are FDA-approved as food additives, the agency has received and has not questioned GRAS notices for two types of plant/fruit based high-intensity sweeteners: certain steviol glycosides obtained from the leaves of the stevia plant (Stevia rebaudiana (Bertoni) Bertoni) and extracts obtained from Siraitia grosvenorii Swingle fruit, also known as Luo Han Guo or monk fruit.
While these high-intensity sweeteners are considered safe for their intended uses, certain individuals may have a particular sensitivity or adverse reaction to any food substance. Consumers should share with their health care provider any concerns they have about a negative food reaction.
In addition, FDA encourages consumers to report any adverse events through MedWatch: FDA’s safety information and adverse event reporting program.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
May 19, 2014