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.