Food Regulation: Industry Wonders What Ingredients Will Be Next

The Food & Drug Administration’s move last month to revoke the “generally recognized as safe” (GRAS) status of partially hydrogenated oils in foods worries some experts in the food industry. They believe that FDA will use the approach to regulate other ingredients, such as sodium and caffeine. Partially hydrogenated oils are the biggest dietary source of artificial trans fats, which have been shown to raise levels of “bad” cholesterol and have no known health benefits.

The approach “is easier and potentially faster,” than FDA’s traditional process of regulating a food ingredient, says Mitchell Cheeseman, a former official in FDA’s food program and currently a managing director at the law firm Steptoe & Johnson. The traditional process is lengthy and involves writing warning letters and demonstrating potential harm to human health, he notes.

When a substance is deemed GRAS, it is not subject to premarket review and approval by FDA. GRAS status is based on scientific data and information about intended use that are evaluated by experts. A company or other entity can determine a substance to be GRAS. Hundreds of food ingredients are considered GRAS on the basis of industry self-determinations. FDA’s move to crack down on partially hydrogenated oils is, in part, the agency’s attempt to demonstrate that it has a tool that can be used to deal with other GRAS ingredients, Cheeseman says.

Advocacy groups, such as the Pew Charitable Trusts and the Natural Resources Defense Council, are increasingly questioning the safety of GRAS food ingredients. These groups are calling on Congress to pass legislation that would eliminate the GRAS status for all food substances.

Intense scrutiny of FDA’s GRAS program dates back to 2010 when the Government Accountability Office, the investigative arm of Congress, raised questions about FDA’s inability to require industry to submit information about GRAS determinations. Because of this ongoing pressure, “we expect FDA will continue to aggressively target food ingredients marketed based on GRAS self-determinations,” Cheeseman says.

Authority given to FDA under the Food Safety Modernization Act, which was signed into law in January 2011, makes it easier for the agency to access safety information related to GRAS determinations. As FDA begins to implement that law, “it’s more important than ever,” Cheeseman warns, for independent GRAS determinations to be credible and as solid as possible.