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Why GRAS Works

How the FDA’s final rule helps ensure safety

In 2016, the Food and Drug Administration (FDA) published its final rule regarding substances in food that are “generally recognized as safe” or GRAS. This rule formalizes the steps food manufacturers must take to ensure GRAS substances are safe for human consumption and reaffirms a process that has worked well for many years.

GRAS is one of two methods by which a substance can be lawfully added to food in the U.S. In order for a substance to be GRAS, there must be general recognition by qualified experts that it is safe when consumed in accordance with its intended use in a food or beverage. This final rule clarifies and strengthens the FDA’s oversight of food ingredients by better explaining how general recognition of safety is demonstrated under the law and by requiring companies to provide additional information when submitting GRAS notifications for FDA review.

The GRAS concept, which is rooted in the 1958 Food Additives Amendment to the Food, Drug and Cosmetic Act, is intended to address ingredients that have a long history of use or where a general recognition of safety exists in the public domain.  While the FDA does an excellent job of policing food and food ingredients to ensure they are safe for consumers, Congress recognized that the Agency simply doesn’t have the resources to look into every ingredient and should instead focus on substances where a general recognition of safety doesn’t exist. GRAS therefore puts the onus for determining safety on the ingredient manufacturer rather than the FDA, and provides strict direction that manufacturers are legally responsible to follow to ensure the safety of the products they produce before they can be used in food.

This is why the GRAS system works so well for consumers, FDA and food manufacturers.  It allows the food industry to step in and provide the resources to review substances and help determine their safety. These expert determinations can be submitted voluntarily to the FDA for review, a common practice employed by many companies. Over the last several decades, the content of these submissions has evolved to include research and information on a particular substance, its intended use, how much is expected to be consumed in foods and other information in order to provide the FDA with enough information to determine whether they agree with the GRAS determination. Since the process has evolved over time, this ruling brings additional transparency and establishes the burden of proof to determine if a substance is GRAS.

The GRAS process represents the pinnacle of public and private sector collaboration. Because of it, FDA resources can be directed at activities that have the greatest impact on public health, such as implementing the FDA Food Safety Modernization Act, while providing a clear legal framework under which food manufacturers can produce innovative, safe ingredients. This final rule is a positive step towards the continued collaboration with groups like IFAC and food manufacturers that work with the FDA to ensure it has as much information and research as possible about the ingredients used in food.  IFAC and its members look forward to working with FDA and other stakeholders to implement this final rule and achieve our common goal of maintaining the safest food supply in the world.

New study proves no adverse effects of carrageenan in human cells

WASHINGTON, D.C. (August 10, 2016) – A new study on carrageenan, an ingredient key to delivering stability, texture and nutrients in many foods and beverages, clearly demonstrates that the ingredient does not induce inflammation in human cells as claimed by carrageenan critics.  The study, which was conducted by internationally recognized toxicologist and carrageenan expert Dr. James M. McKim, Jr., was recently accepted for publication by the peer-reviewed journal Food and Toxicology. This pivotal study represents the culmination of two years of research that was unable to replicate any of the findings of carrageenan critics, including Dr. Joanne Tobacman, who claim the food ingredient contributes to certain adverse health outcomes.

Publication of McKim’s study raises major questions about the validity of Tobacman’s conclusions and underscores the importance of replicating scientific results in different laboratories and by multiple researchers. McKim’s research was carefully designed to investigate several recent studies Tobacman has cited as evidence of her claims that carrageenan causes inflammation and is harmful. Not only was McKim unable to replicate the negative effects Tobacman has reported, his research showed carrageenan has no measurable effects on cells and provides strong evidence that carrageenan consumed in foods and beverages would not cause inflammation in humans.

“Dr. McKim’s research confirms what we have known for decades—carrageenan has no impact on the human body when consumed in food,” said Robert Rankin, Executive Director of the International Food Additives Council (IFAC), which commissioned the study. “Carrageenan producers have taken very seriously claims that the ingredient is unsafe, thoroughly investigated the research supporting those claims and found them to be baseless.”

Carrageenan is a common food ingredient used in many foods, such as ice cream, chocolate milk, yogurt and soy milk, for its stabilizing and thickening properties. It is also an approved additive for use in infant formula, where it is ensures that essential nutrients remain mixed throughout liquid products. It occurs naturally in red seaweed that is grown and harvested sustainably by tens of thousands of family farmers around the globe. Carrageenan is popular as a plant-based, eco-friendly alternative to animal-derived thickeners and has been used safely in foods for hundreds of years.

McKim’s study comes just months before the U.S. National Organic Standards Board (NOSB) is expected to vote on whether to reapprove the use of carrageenan in organic foods sold in the United States. Groups touting Tobacman’s research have lobbied the U.S. Food and Drug Administration to ban carrageenan in all foods and the NOSB to remove it from organic products. Despite these efforts, regulatory bodies around the world have repeatedly reviewed and dismissed their claims, finding carrageenan to be safe for use in all foods.

McKim’s research exposes fundamental flaws in Tobacman’s evidence, adds to the vast body of scientific research demonstrating carrageenan safety and thoroughly debunks certain groups’ claims that carrageenan is harmful and should be removed from foods. For more information about carrageenan and other ingredients and additives used in food production, please visit www.foodingredientfacts.org.

About IFAC

The International Food Additives Council (IFAC) is a global association representing manufacturers of food ingredients. Founded in 1980, IFAC strives to promote science-based regulation and the global harmonization of food ingredient standards and specifications.

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Contact:
Randy Spoon

678-303-3017

rspoon@kellencompany.com

To view the complete study, click here.

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IFAC Statement on Claims Linking Emulsifiers to Negative Gastrointestinal Health Outcomes

Safety is and always will be the number one priority of members of the International Food Additives Council (IFAC). The food ingredients IFAC members produce have been determined to be safe by regulatory authorities and are consumed by billions of people every day around the world. As a result, IFAC is working diligently to understand the implications on human populations of the findings of research, including a 2015 study by Chassaing et al., which has examined how food ingredients interact with GI microbiota. Potential effects of dietary constituents on the human microbiome is a complex and emerging area of study, but an important one for further research given the emerging evidence and the importance of the microbiome on human health.

However, IFAC has very serious concerns about the validity of broadly extrapolating the results observed by Chassaing et al. in mice to human populations. Based on IFAC’s review of the research, there is no cause for concern at this time that CMC, P80 or other emulsifiers are unsafe for human consumption or should be removed from products. IFAC is committed to fully investigating this subject, but current understanding of the safety of CMC, P80 and other emulsifiers do not substantiate claims that Chassaing et. al. make on the effects observed in mice and whether the findings in the study have any relevance in humans or that the substances studied in mice have similar impacts when consumed by humans in food. Without more scientific substantiation of the Chassaing et al. results, the overwhelming scientific consensus is that all of these materials remain safe and consumers and users should feel confident using and consuming them.

In February 2015, the Journal Nature published a study, “Dietary emulsifiers impact the mouse gut microbiota promoting colitis and metabolic syndrome” by Chassaing et. al, in which the authors allege that carboxymethylcellulose (CMC) and/or polysorbate-80 (P80) may negatively impact gut microbes and are the cause of several adverse health impacts in humans, including inflammation of the gut and symptoms associated with colitis, metabolic syndrome, and other chronic inflammatory diseases.

In the study, mice were fed water and feed supplemented with CMC or P80. Through analysis of feces and gastrointestinal (GI) tissue, the researchers found that CMC and P80 altered the composition of the microbiota in both the feces and intestines of the mice adversely impacted the mucosal layers of the mouse intestinal lumen. Based on the results, the researchers extrapolated their observations in mice to suggest the possibility that dietary emulsifiers “may have contributed to the post-mid-twentieth century increase in incidence of inflammatory bowel disease, metabolic syndrome, and perhaps other chronic inflammatory diseases.”

A number of media outlets reported on these allegations stemming from broad extrapolations simplifying the complex study to claim that the research demonstrates a link between human consumption of CMC, P80 and, in some cases, all emulsifiers and negative GI health outcomes, obesity, diabetes and other inflammation related diseases.

 

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Controversial New Research Says Carrageenan is Safe

05/02/2016 – New research funded in part by the International Food Additives Council (IFAC) seems to confirm the safety of carrageenan as a food additive. The new study, published in the journal Food and Toxicology, has failed to replicate extensive research from the University of Chicago and the University of Illinois at Chicago that suggests carrageenan causes intestinal inflammation.

View the article on Organic Authority