On May 19, 2014, FDA released a constituent update notifying the public of a newly approved food additive known as Advantame. Developed and produced by Japanese manufacturer Ajinomoto, Advantame (N-[N-(3-[3-hydroxy-4-methoxyphenyl)propyl]-L-α-aspartyl]-L-phenylalanine 1-methyl ester) is a combination of aspartame (popularly sold as NutraSweet) and vanillin (an artificial vanilla flavor) that acts as a high-potency sweetener. The public is permitted to object to this approval for the next 30 days.
FDA regulates food additives by evaluating numerous safety studies regarding acute and chronic toxicity and teratogenicity. This is a different process from the way the agency regulates at least some of the substances deemed "GRAS" (generally recognized as safe). If a substance is deemed GRAS by a third party, the manufacturer is not required to submit safety data to FDA; in fact, only GRAS notifications that are submitted to FDA are evaluated by the agency. Many manufacturers elect not to submit these notifications and rely instead on the publication of their GRAS status on a list such as those produced by FEMA.
Ajinomoto, the manufacturer of Advantame, notes on its website that Advantame has received a GRAS designation and provides a GRAS number (4716) given by the trade group FEMA. Advantame was listed on FEMA's 25th GRAS list, which was published in June 2011. Ajinomoto elected not to submit a GRAS notice to FDA, which is why Advantame is not listed in the GRAS database maintained by FDA. According to Brendan Naulty of Ajinomoto, "The food additive petition is more rigorous, and we decided to take this route."
According to Theresa Eisenman, an FDA spokewoman, "The FDA has concluded that advantame is safe for use as a general-purpose sweetener and flavor enhancer in foods, except meat and poultry. The approval is in response to a food additive petition (FAP 9A4778) filed by the Ajinomoto Co., Inc. Under section 409 of the FD&C Act, a petitioner has to show that an additive is safe under the intended conditions of use, and FDA has to conduct an evaluation of the data submitted by the petitioner as well as other available information in deciding whether to grant the petition."
Whose responsibility is it to monitor this substance's safety in food consumed by humans? According to Eisenman, "Manufacturers are responsible for ensuring that their food products are safe and lawful, and FDA encourages companies to consult with the agency when developing new ingredients [...] Irrespective of whether a substance is deemed to be GRAS or if its safety is established through a premarket approval as a food additive, the safety determination is always limited to the substance's intended conditions of use."