FDA to consider revamping food additive rules
Amid growing public concern over the safety of additives in products ranging from caffeinated energy…
Amid growing public concern over the safety of additives in products ranging from caffeinated energy drinks to industrial chemicals in food containers and water bottles, the U.S. Food and Drug Administration is under pressure to reexamine its rules, and there are signs it may do so.
It has been more than half a century since U.S. regulations governing food additives were last revised. In that time, the number of chemicals in the food supply has risen from fewer than 2,000 to an estimated 10,000, many of which are never reviewed by the FDA because companies and their advisers have declared them to be safe.
Under loose regulations created more than 50 years ago to help companies avoid lengthy delays in getting food additives approved, the FDA created a list of products considered "generally recognized as safe" (GRAS).
Companies can either petition to get their ingredients affirmed safe by the FDA, or they can declare them safe based on their own research or that of hired consultants. The FDA has the option to challenge such declarations but has rarely done so.
"Our system really puts the onus on us to prove harm," FDA Commissioner Margaret Hamburg said at the Reuters Health Summit in New York. "It's perhaps a time to look at what the legal framework looks like and what opportunities there are now to ask and answer questions in new ways because of advances in science and technology."
"We are an agency with a wonderful history, but many of our laws are rooted in a different historical era," Hamburg said. "An important question to ask is, would this be a good time to look at this issue again?"
According to research by the Pew Charitable Trusts' food additives project, which is conducting a three-year investigation into food additive regulation, 1,000 chemicals have been self-affirmed by industry as GRAS without notice to the FDA.
Another 2,000 chemicals have been declared GRAS by the Flavor and Extracts Manufacturers Association, which submits information to the FDA, though the FDA does not review it, according to Pew, bringing to about 3,000 the number of chemicals in the food supply never reviewed by the FDA.
Caffeine, when contained in cola-type drinks, was declared decades ago to be a GRAS product in cola-type beverages. Yet the agency has not challenged companies to prove the safety of caffeine in other products or other beverages - including those whose levels exceed the 71 milligrams per 12 ounces typically contained in soda.
One 8.4 fluid ounce can of Red Bull Energy Drink contains 80 milligrams of caffeine, according to its website. Twelve ounces of Red Bull contain 114 milligrams of caffeine.
Last year Democratic Senators Dick Durbin of Illinois and Richard Blumenthal of Connecticut called on the FDA to respond to concerns about the effect on children of caffeine in energy drinks.
Between January 2004 and October 2012, the FDA identified 21 reports of heart rate abnormalities, vomiting, convulsions and other medical problems, some life-threatening, in people who had drunk Red Bull. But Hamburg said the events are not sufficient to warrant regulatory action "at the present time."
"There is not a clear linkage of exposure to caffeine and the adverse events reported," she said, adding that the agency will continue to monitor energy drinks and that further examination of the underlying science "may merit action going forward."
It has been more than half a century since U.S. regulations governing food additives were last revised. In that time, the number of chemicals in the food supply has risen from fewer than 2,000 to an estimated 10,000, many of which are never reviewed by the FDA because companies and their advisers have declared them to be safe.
Under loose regulations created more than 50 years ago to help companies avoid lengthy delays in getting food additives approved, the FDA created a list of products considered "generally recognized as safe" (GRAS).
Companies can either petition to get their ingredients affirmed safe by the FDA, or they can declare them safe based on their own research or that of hired consultants. The FDA has the option to challenge such declarations but has rarely done so.
"Our system really puts the onus on us to prove harm," FDA Commissioner Margaret Hamburg said at the Reuters Health Summit in New York. "It's perhaps a time to look at what the legal framework looks like and what opportunities there are now to ask and answer questions in new ways because of advances in science and technology."
"We are an agency with a wonderful history, but many of our laws are rooted in a different historical era," Hamburg said. "An important question to ask is, would this be a good time to look at this issue again?"
According to research by the Pew Charitable Trusts' food additives project, which is conducting a three-year investigation into food additive regulation, 1,000 chemicals have been self-affirmed by industry as GRAS without notice to the FDA.
Another 2,000 chemicals have been declared GRAS by the Flavor and Extracts Manufacturers Association, which submits information to the FDA, though the FDA does not review it, according to Pew, bringing to about 3,000 the number of chemicals in the food supply never reviewed by the FDA.
Caffeine, when contained in cola-type drinks, was declared decades ago to be a GRAS product in cola-type beverages. Yet the agency has not challenged companies to prove the safety of caffeine in other products or other beverages - including those whose levels exceed the 71 milligrams per 12 ounces typically contained in soda.
One 8.4 fluid ounce can of Red Bull Energy Drink contains 80 milligrams of caffeine, according to its website. Twelve ounces of Red Bull contain 114 milligrams of caffeine.
Last year Democratic Senators Dick Durbin of Illinois and Richard Blumenthal of Connecticut called on the FDA to respond to concerns about the effect on children of caffeine in energy drinks.
Between January 2004 and October 2012, the FDA identified 21 reports of heart rate abnormalities, vomiting, convulsions and other medical problems, some life-threatening, in people who had drunk Red Bull. But Hamburg said the events are not sufficient to warrant regulatory action "at the present time."
"There is not a clear linkage of exposure to caffeine and the adverse events reported," she said, adding that the agency will continue to monitor energy drinks and that further examination of the underlying science "may merit action going forward."