Published in the latest issue of Comprehensive Reviews of Food Science and Food Safety, the analysis was led by Pew Health Group, and suggested that the FDA’s scope for effectively regulating food additives was limited due to the structure of the US regulatory system. However, the Grocery Manufacturers Association (GMA) has said that the overall process is overseen by the FDA, and that the system works to ensure the safety of food ingredients.
Food additives project director for the Pew Health Group and lead author of the reviewTom Neltnersaid: "Congress established our food additive regulatory program more than 50 years ago, and it does not stand up well to scrutiny based on today's standards of science and public transparency.”
The paper’s authors said the system – established in 1958 – of allowing manufacturers to self-affirm GRAS (generally recognized as safe) status of food additives is one factor that may have limited FDA awareness of how safety decisions have been made. Manufacturers generally do inform the FDA of their findings, but the system is voluntary.
In an emailed response to the paper, the Grocery Manufacturers Association (GMA) stressed that product safety was the foundation of consumer trust, and ensuring safety was industry’s single most important goal.
“The system in place for ensuring the safety of an ingredient relies on rigorous testing and/or analysis of the relevant data and scientific literature pertaining to the ingredient,” the organization said. “It is a very thorough and comprehensive process that is overseen by the FDA.”
Lack of transparency
The researchers also found that a regulatory process set up in the mid-1990s, which allowed for faster FDA review of companies’ safety assessments, may have led to fewer opportunities for public involvement in the decision-making process.
“On the one hand, the notiﬁcation programs developed in the 1990s allowed manufacturers to bypass the traditional rulemaking process involving public notice and opportunity to comment and expedite a substance’s time-to-market,” the review’s authors wrote. “As a result, FDA appears to have signiﬁcantly increased the overall number of substances and decisions it reviews. On the other hand, the lack of public scrutiny resulted in a less transparent regulatory process.”
After the new process was in place, the number of industry requests for FDA review doubled, from 40 from 1990 to 1997 to 81 from 1998 to 2010.
Nelter 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."
The GMA agreed that this was an area where there was room for improvement.
It said: “The primary area for potential improvement in this process is transparency. GMA is committed to working with Pew and other stakeholders to identify ways of making it easier for any interested party to find out what substances have been approved as food additives and how their safety was determined.”