"Sugar substitutes are called 'high-intensity' because small amounts pack a large punch when it comes to sweetness," Capt. Andrew Zajac, U.S. Public Health Service, director of the Division of Petition Review at the FDA, said in a statement.
Advantame -- chemically related to aspartame -- is approved for 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 scientists "reviewed all the scientific evidence submitted by a company to ensure the product is safe for the intended use," Zajac said.
"In determining the safety of advantame, FDA reviewed data from 37 animal and human studies designed to identify possible toxic effects, including effects on the immune, reproductive and developmental and nervous systems," Zajac said.
In addition, the FDA evaluated whether the same individuals who should avoid or restrict aspartame should avoid advantame.
People who have phenylketonuria -- PKU -- a rare genetic disorder, have a difficult time metabolizing phenylalanine, a component of both aspartame and advantame. Most infants born in developed countries are screened for PKU shortly after birth.
Food with aspartame must include information alerting those with PKU of the phenylalanine.
However, advantame is much sweeter than aspartame, so a very small amount is needed, therefore, food containing advantame does not need special labeling, the FDA said.