Perspectives on How FDA Assesses Exposure to Food Additives When Evaluating Their Safety: Workshop Proceedings

Abstract

Food additives and substances considered "generally recognized as safe" must not be allowed in food unless there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. Scientists determine safety by ensuring that the expected exposure is less than the acceptable daily intake. The U.S. Food and Drug Administration (FDA) provides guidance documents to assist safety assessors in this analysis. A November 2011 workshop sponsored by The Pew Charitable Trusts, the Institute of Food Technologists, and the journal Nature reviewed the agency's exposure assessment approaches. More than 70 experts from government (including FDA), industry, academia, and public interest organizations examined the principles underlying dietary exposure assessments for substances added to human food, and responded to questions about current methods. FDA's approach was seen as serving the agency reasonably well, but participants identified opportunities for improvement. Although reaching a consensus was not a goal, general agreements emerged that FDA should develop a science-based framework to prioritize and reassess prior safety decisions, and conduct more extensive postmarket monitoring. Participants discussed the possibility of harmonizing different approaches to assess dietary exposure. They generally agreed that collaboration, communication, and exchanging scientific information between agencies and stakeholders would help assessors use the most current information to make better decisions. Participants identified data gaps and opportunities to fill the gaps using new tools and technologies. Participants generally agreed on the need to consider all dietary sources in a cumulative dietary exposure assessment. Executive SummaryTo determine whether substances added to human food are safe, the U.S. Food and Drug Administration (FDA) asks 2 basic questions: First, how much of that substance will people consume on a daily basis over a lifetime? And 2nd, how much of that substance is considered a safe amount to eat daily based on scientific studies?The answers to these questions are informed by the calculation of the estimated daily intake (EDI) and acceptable daily intakes (ADI), respectively. These are complex scientific principles and not easy to determine. Complicating matters, the answers may change over time as consumer behavior shifts (for example, more people may seek out specialized diets, such as meat-free or low-carb), or as business practices change (such as when a new sweetener is developed). Similarly, the answers may change as the science of toxicology advances and more information becomes available MS

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

“…Participants at a Pew workshop (Alger and others ) noted that, while FDA currently considers one subpopulation (young children), it should include more groups on a routine basis. Participants mentioned that EPA regularly assesses exposure for a wide variety of subpopulations.…”

“…Workshops participants expressed concerns about the limited amount of data to make informed decisions and generally agreed that methods are needed to identify and fill gaps in toxicology and exposure data (Maffini and others ; Alger and others ).…”

“…We also reviewed the proceedings from 2 Pew workshops held on 2011 to identify whether the issued raised by SCOGS were also raised as concerns by the workshop participants. These workshops dealt with chemical hazard identification and characterization and dietary exposure assessment (Maffini and others ; Alger and others ).…”

“…FDA was a key participant in the discussions and material preparation. The discussions made clear that there are significant questions about hazard assessment, estimating dietary exposure, and the decision‐making process for food additives (Maffini and others ; Alger and others ).…”

Biochemical Changes in Fatty Acids, Hydrocarbons and Sterols as well as Total Lipids of Albino Rats Ingested some Synthetic Colourants and Flavourants as Food Additives

“…They have been used in candy, soft drinks, foods, pharmaceuticals and cosmotics for many years, comparatively little work on their metabolic action was published (Gultekin et al,2013;Martyn et al,2013). With increasing awareness of possible health hazards associated with their use, however, more attention has been focused the biological activity (Brown et al, 1980;Borzelleaca et al, 1983;Abdel-Rahim et al, 1992;Lodi et al, 2011;Alger et al, 2013). Further investigations were carried out on both synthetic food flavourants and colourants to evaluate the acceptability of these compounds as food additives for human and animal feeding (Tsuji et al, 1978;Ramadan and El-Damhogy 1994).…”