FDA failed to keep pace with scientific developments, finds review

Related tags Food additive Codex alimentarius Fda

The US Food and Drug Administration (FDA) has failed to keep pace with scientific developments in many cases, according to a review of food additive safety assessments.

Maffini et al recommended that the agency convene a group to conduct a review of science and decision making and plan to modernize food additives safety assessment.

Areas of concern include toxicology test guidelines, conflict of interest in manufacturers’ decisions, lack of a reassessment strategy, and lack of a definition of harm, they added.

Original plan

Maffini et al looked at a 1982 report by the Select Committee on GRAS Substances (SCOGS) that included suggestions to enhance food additive safety.

FDA established SCOGS to review the safety of “generally recognized as safe” (GRAS) substances in response to a directive by President Nixon.

The authors, supported by the Pew Charitable Trust, found that while the FDA acted on some of the suggestions, a significant proportion were unresolved.

They added that although it is difficult to pinpoint the origin of the situation, a key point was in 1997, when the agency proposed the voluntary GRAS notification program.

FDA’s role changed from one of a “judge” making final decisions and adopting regulations to an “auditor” or “peer reviewer” providing a critique of decisions made by food manufacturers.

“When evaluating FDA’s response to SCOGS’ suggestions, we found that many remain unresolved and relevant today. Our analysis demonstrates that in many cases FDA has not kept pace with scientific developments,” said the authors.

“We recommend that the agency convene an unbiased and independent expert workgroup to conduct a comprehensive review of FDA’s science and decision making and develop a path to modernize food additives safety assessment.”

The controversy over bisphenol A (BPA) intensified the questions about whether FDA uses the best scientific evidence to make safety decisions.

Lack of leadership role

FDA has not taken a leadership role in the development and validation of new technologies to identify and evaluate additives for potential endocrine disrupting activity, said the authors.

Unlike Environment Protection Agency (EPA), it has not adopted or made use of validated screening tests and predictive models.

Maffini et al said the FDA should develop and implement a strategy to fix the GRAS process by ensuring that the agency has the opportunity to review and have a final say in safety assessments that allow use of a chemical in food whether new or already on the market.

It should also ask its Food Advisory Committee supported by a workgroup of independent scientists to evaluate the science and decision-making procedures used to assess the safety of food additives, support the subcommittee’s deliberations and recommendations if problems are identified.

Source: Comprehensive Reviews in Food Science and Food Safety, volume 12, issue 4, pages 439-453

Online ahead of print, doi: 10.1111/1541-4337.12020

“Looking Back to Look Forward: A Review of FDA's Food Additives Safety Assessment and Recommendations for Modernizing its Program”

Authors: Maricel V. Maffini, Heather M. Alger, Erik D. Olson, Thomas G. Neltner