Industry associations say the process saves the government money and supports innovation by reducing red tape. Representatives also say manufacturers have every incentive to make their products safe.
However, even if the FDA disagrees with the supporting science, current law provides no clear recourse to stop companies from adding these GRAS ingredients to food products.
That was the case with a hemp seed ingredient that biologist Vyacheslav Dushenkov notified FDA about in 1999, when he worked for a now-defunct company that wanted to sell hempseed oil and powder.
The FDA rejected his scientific work in 2000, saying Dushenkov's anecdotal and historical examples of the medicinal use of hemp did not prove it was safe for use in food, but Los Angeles-based Chronic Ice Tea now cites Dushenkov's research in a blog advertising drinks made with hempseed powder.
"We were just quoting it to bring awareness to all the scientific work that has already gone on around hemp safety," said Michael Stweart, the company's chief operating officer who says hempseed ingredients have health benefits similar to those of fish oil.
If FDA suspects an ingredient deemed "safe" is actually harmful, the government can take action after a product hits the market, but it does not track how often that has happened. In one case, in 2010, the agency issued warning letters to four makers of popular caffeinated alcoholic drinks, declaring caffeine unsafe in alcoholic beverages. Under threat of product seizure, the companies stopped making the drinks.
Consumers may also petition the FDA to take an ingredient off the "safe" list, although a report by the Government Accountability Office found those requests can take years to review.
Earlier this year, the FDA proposed sweeping new food safety rules regarding contamination of food in the wake of recent listeria and salmonella outbreaks, but no changes were proposed to the GRAS system.
Michael Taylor, FDA deputy commissioner for foods, said in an interview that he feels the program works well but that it is time to consider updating it to ensure the evidence supporting "safe" designations reflects the latest science. He added that FDA would benefit from having access to the scientific evidence companies use to determine that an ingredient is GRAS.
"We're not driven by a sense that there is a pressing public health emergency," Taylor said. "But there are decisions being made based on data that we don't have access to, and that creates a question about the basis on which those decisions are made."
In 1969, President Richard Nixon ordered FDA to review food additives then on the "safe" list. While concluding most ingredients were safe, the review panel questioned the safety of 35 substances. In its 2010 examination of the program, the GAO found FDA had yet to review 18 of those. The agency could not readily explain why, but has in the past pointed to short staffing.
The GAO also recommended that companies be required to tell FDA and the public about any ingredients they deem "safe," and that FDA take steps to prevent scientific conflicts of interest.
Taylor said that over the next year FDA may send out new administrative rules detailing how companies should demonstrate ingredient safety, but he noted it would take an act of Congress to force companies to share all their information with FDA.
George Washington University's Public Health Dean Lynn Goldman, who in 2011 studied the GRAS program at FDA's request, believes letting companies evaluate their own ingredients risks biased science. "The public should expect that the FDA can give some assurance that the safety of our food is not simply determined by the industry," she said.
Recent reports of deaths after the consumption of energy drinks or shots have prompted U.S. Sens. Dick Durbin and Richard Blumenthal, Democrats from Illinois and Connecticut, to ask the FDA to investigate whether specific stimulants in the drinks can be harmful, including some deemed GRAS by beverage makers. FDA has not determined what caused the deaths.