FDA allows manufacturers to evaluate the safety of food ingredients.
Over the past 15 years, the vast majority of new ingredients added to U.S. food never received a safety determination from the government. And since 1958, at least 1,000 legally entered the food supply without the knowledge of government officials, according to the Pew Health Group.
http://www.pewtrusts.org/our_work_detail.aspx?id=1203
The U.S. Food and Drug Administration acknowledges that since 1997, it has largely transferred the responsibilities for pre-market safety determinations on ingredients — including flavorings, preservatives, texturizers and binders — from its own scientists to food manufacturers.
The agency characterizes the move as a "pragmatic means to protect health and avoid wasteful use of government and industry resources" at a time when government funding for FDA staffing in this sector is scarce.
But in recent years, a range of experts, advocates and groups, including Pew, the Government Accountability Office and the American Heart Association, have expressed concern about what they see as a lack of oversight and a potential public health threat.
James T. O'Reilly, author of definitive texts on U.S. food and drug law, said he believes the 1997 policy changes put consumers at greater risk.
"I can confidently tell you there is no other area of food law in the developed world that is so badly regulated as this corner of the U.S. food system," he said.
Many industry representatives, however, say the system is working. In the July issue of the journal Food and Drug Policy, Ray A. Matulka, of the food safety consulting firm Burdock Group, responded to recent criticism of the program.
"FDA currently has sufficient authority to evaluate the safety of food ingredients (whether notified to FDA or not) and take the necessary course of action to maintain the safety of food and food ingredients," he wrote.
He characterized recent calls by Pew, the GAO and the heart association to overhaul the program as "an agenda-driven cadre of interest groups."
If a manufacturer wants to introduce a new ingredient to the food supply, it does not need to alert the FDA. But it does need to determine the ingredient is safe, meaning there is "reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use," according to the law. In the jargon of the FDA, this would make it a GRAS ingredient: generally recognized as safe.
Manufacturers can — and many do — present their safety information on a new ingredient to the FDA as part of a voluntary notification program. The agency then examines the company's safety determination and issues a letter of "no questions" or "insufficient basis."
What troubles some is that "competent scientists" can be employees or contractors of the product's manufacturer.
At minimum, the report said, the FDA should require companies to submit basic information — including the name of substance, intended uses and scientists who evaluated it — when they put it on the market.
To Lisa Shames, director for food safety and agriculture at the GAO, this information void is one of the most troubling aspects of the process. "The FDA doesn't know what it doesn't know," Shames said. "It simply has no idea how many self-affirmed GRAS food substances have been introduced into the food supply."
"The FDA no longer writes specific regulations for the use of the substance or puts those rules up for public comment by consumers, academics and competitors," said Tom Neltner, who heads the Pew Health Group project.
The GAO report noted that a few substances initially considered GRAS have later been found to pose health risks and were subsequently banned by the FDA. The most recent of these decisions was in 1986, when the FDA prohibited the use of sulfites as a preservative on raw produce due to severe allergic reactions in those sensitive to sulfites.
http://articles.chicagotribune.com/2012-08-25/health/ct-met-food-ingredients-20120825_1_food-ingredients-pew-health-group-fda