Study calls for review of food additive approval process

by Keith Nunes
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A study published in the Oct. 25 edition of the peer reviewed journal Comprehensive Reviews in Food Science and Food Safety has raised concerns about the level of transparency in the U.S. food additive regulatory program. The study found that safety decisions relating to one-third of the more than 10,000 substances that may be added to food and beverages were made by food manufacturers and related associations with-out review by the Food and Drug Administration.

“Congress established our food additive regulatory pro-gram more than 50 years ago, and it does not stand up well to scrutiny based on today’s standards of science and public transparency,” said Tom Neltner, food additives project director for the Pew Health Group, an arm of the Pew Charitable Trusts.

The Pew Health Group said that when Congress passed the Food Additives Amendment in 1958, it created a structure that has limited the F.D.A.’s ability to regulate substances added to food, because the law allows food manufacturers to determine that the use of an additive is generally recognized as safe (GRAS) and then use that substance without notifying the F.D.A. As a result, the agency may not be aware of some substances being added to food.

The group added that the law also does not require that manufacturers inform the F.D.A. when health reports suggest new hazards associated with additives already used in food. Thus, the F.D.A. has to expend its resources reviewing published information to identify potential problems and set priorities.

The study noted that the expedited process developed by the F.D.A. in the 1990s eliminated the opportunity for public involvement in decision making prior to the F.D.A.’s determination of safety. The Pew report said the practice is counter to the procedures used by other federal regulatory decisions regarding drug, workplace and environmental safety, which require public notice and comment before a decision is made.

“While the shift to a new regulatory process — one in which companies make safety decisions and ask F.D.A. to confirm them — has sped up agency review, it has also bypassed the public,” Mr. Neltner said. “Subjecting safety decisions to comment from competitors, academic scientists, public interest groups and the general public can result in stronger protections for consumers. In an age of growing demand for government transparency, there is virtually no meaningful opportunity for participation in decisions about large classes of substances added to the food supply.”

This past April, the Institute of Food Technologists and the scientific journal Nature co-sponsored a two-day workshop to review how the F.D.A. evaluates the potential hazards posed by substances added to food. In a separate article published in the Oct. 25 issue of Comprehensive Reviews in Food Science and Safety issues discussed at the workshop were reviewed.

The I.F.T. meeting identified several areas of review, including the need for clear procedures to develop validated toxicological tests and regularly revise guidance documents to reflect advances in science; opportunities to improve academic research to make it more usable for regulatory decision making and enhance coordination between federal agencies; and the challenges to reassessing a chemical’s safety after it is on the market.

“As a scientific society, one of I.F.T.’s goals is to ensure food policy and regulations are based on sound science, and the workshop was designed to foster an interactive dialogue to share a variety of opinions on the issues surrounding food additives,” said William Fisher, vice-president of science and policy initiatives at the I.F.T.

The peer review study comes on the heels of a report published in September by the United Kingdom-based Leatherhead Food Research that outlined the size and outlook of the global food additive marketplace. The research firm estimated the size of the marketplace to be $27.4 billion in 2010 and the best performing sectors included enzymes, acidulants and hydrocolloids.

Leatherhead said that while the global economic slowdown has affected the food additive marketplace, it anticipated that future market growth for the ingredients will be influenced by consumer demand for more natural ingredients and the regulatory environment.
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