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FDA finds no safety concerns with common emulsifiers at current consumption levels

New research from scientists at the U.S. Food and Drug Administration (FDA) found no safety concerns with several ingredients commonly found in food. The research, which focused on ingredients known as emulsifiers and in particular, sodium carboxymethylcellulose (CMC) and polysorbate80 (P80), was conducted in response to research claiming these two ingredients have negative effects on the human body.

Emulsifiers are used in food to produce a consistent blend of two or more ingredients. They ensure the ingredients remain mixed and don’t separate at any point from processing to consumption, which reduces food waste and makes the food look and taste more appealing. Common examples of foods containing emulsifiers include ice cream, salad dressings, margarine, chocolate, breads and other baked goods, desserts, candy, cheese and some beverages.

Over the last two years, a few researchers have made claims about the potential impacts these ingredients may have on microbes in the human gut. Due to the importance of gut microbes in the digestive tract and on overall health, it was important to investigate these claims and ensure that the use of these common food ingredients remains safe.

To understand whether the researchers’ claims were valid, a team of scientists from the U.S. Food and Drug Administration (FDA) conducted a review of several emulsifiers commonly used in food to determine whether these ingredients could pose any risk to human health. The study focused on CMC and P80, which were implicated in the negative research.

The FDA’s findings directly refute the earlier research linking these two ingredients to disruptions in gut microbes. These findings also raise serious questions about the validity of claims that CMC and P80 specifically, and all emulsifiers in general, cause other negative effects on the body.

The study reviewed dietary exposure to the emulsifiers over the course of two different time periods. It relied on Acceptable Daily Intake (ADI) levels established by the Joint FAO/WHO Expert Committee on Food Additives, an international expert scientific committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The key findings from the FDA study included the following:

  • The amount of emulsifiers found in consumer food hasn’t substantially increased over the past 15 years.
  • Of the seven emulsifiers tested, both CMC and P80 were on the lower spectrum for exposure at their current levels.

The FDA’s findings provide significant evidence that emulsifiers remain safe at the levels currently consumed and that claims suggesting these ingredients are harmful are not valid. While it is important to continually review the ingredients used in food and ensure they remain safe, it is equally important to review new research that draws negative conclusions and validate it through additional research and investigation by qualified scientists like those at FDA.

To read the abstract and full study, click here.

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.