More Than 10,000 Chemical Food Additives Ended Up in the U.S. Food System — Here's Why
The FDA's GRAS designation, while well-intentioned on paper, is flawed in its execution and enforcement — making it ripe for exploitation.
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Food additives are attracting considerable attention, especially within the impending Trump administration. Robert F. Kennedy Jr., President-elect Trump's choice for secretary of the Department of Health and Human Services, has been an outspoken critic of them, putting them front and center in his “Make America Healthy Again” plan. But what, exactly, are food additives, and what would happen if we took them away?
What are food additives?
Before you fall for fear-mongering, you need to understand what food additives are. Food additives, the U.S. Food and Drug Administration (FDA) explains, are “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any food.” That’s a whole lot of legal speak that can be translated to “food additives are ingredients intentionally added to products for a specific purpose.” This could be improving a food’s taste, texture, color, shelf life, or even its nutritional value. And that can include everything from ascorbic acid (aka vitamin C), which helps keep foods fresh, to iodine, which was added to salt in the 1920s to help combat iodine deficiency in the general public.
Who oversees food additives in the U.S.?
The FDA is the primary regulator of food additives. However, the U.S. Department of Agriculture (USDA) also has a say, particularly when it comes to additives used in meat, poultry, and certain egg products. A lot of the onus is also on food manufacturers, who remain independently responsible for “marketing safe foods, including ensuring the safety and regulatory status of the ingredients they use in foods before they are available to consumers,” the FDA explained.
But, the FDA also noted that food additives must be “generally recognized as safe” (GRAS), and “must be supported by science that demonstrates its use meets the FDA’s safety standard. Specifically, the information must demonstrate that there is a reasonable certainty of no harm to consumers when an ingredient is proposed or intended for use in food.” And most importantly for consumers to understand, it added that “Because of inherent limitations of science, the FDA can never be absolutely certain of the absence of any risk from the use of any ingredient.”
How many food additives are allowed in the U.S.?
There are thousands upon thousands. As the USDA reported, “Today, more than 3,000 substances are used as food additives. Salt, sugar, and corn syrup are by far the most widely used additives in food in this country.” However, according to a 2013 report by the Pew Charitable Trusts, that number is much, much higher. It reported that more than 10,000 chemical additives have found their way into the U.S. food supply, including both direct additives (aka those colors and flavor enhancers) and substances that can migrate into food from packaging and processing.
The FDA maintains a list of approved additives and those considered GRAS, which can be found at fda.gov. However, reading through it can be incredibly time-consuming.
Why are so many allowed and what is the "GRAS loophole?"
The abundance of food additives in the U.S. food supply partly results from how the FDA’s GRAS designation works.
Pew wrote in its 2013 report that the laws contain a legal loophole “intended for common food ingredients; manufacturers have used this exception to go to market without agency review on the grounds that the additive used is ‘generally recognized as safe.’” It noted that the FDA has interpreted this law as having no obligation “on firms to tell the agency of any GRAS decisions. As a result, companies have determined that an estimated 1,000 chemicals are generally recognized as safe and have used them without notifying the agency.” But, those same firms, Pew added, use their own consultants and experts to reach the conclusion that what they are adding is safe, which is a clear conflict of interest.
Secondly, Pew noted, “The law does not give the FDA the authority it needs to efficiently obtain the information necessary to identify chemicals of concern that are already on the market, set priorities to reassess these chemicals, and then complete a review of their safety. Moreover, the agency has not been given the resources it needs to effectively implement the original 1958 law.” Because of this, the federal agency hasn’t reevaluated thousands of chemicals it approved decades ago or reviewed thousands of new ones added to the market.
According to CBS News, while the U.S. allows for thousands of chemicals, the European Union only allows for a little over 400. (You can access the EU’s database here.)
“Different societies have different degrees of tolerance for uncertainty and different laws that determine what the regulators can do as substances are added,” Dr. Robert Califf, the commissioner of the Food and Drug Administration, said in a statement. “America is a country that likes individual choice and access in general. And I think our laws reflect that sort of national sentiment.”
Are states regulating any food additives now?
States are increasingly taking matters into their own hands. In October 2023, California enacted legislation known as AB 418 that bans the sale of certain foods containing specific additives, including red dye No. 3 and brominated vegetable oil. Both of these additives are allowed at the federal level. Now, several other states, including Illinois, New York, and Pennsylvania, are trying to do the same.
Related: These Are 4 of the Most Nutrient Dense Vegetables to Add to Your Diet, According to the CDC
In December, F&W also reported that the FDA is finally considering a potential ban on red dye No. 3. As Jim Jones, the FDA’s deputy commissioner for human foods, told the Senate Health, Education, Labor, and Pensions Committee, “With Red 3, we have a petition in front of us to revoke the authorization board, and we’re hopeful that in the next few weeks, we’ll be acting on that petition.”
But are there some food additives that are helpful?
Not all food additives are cautionary tales. Some have played a key role in improving public health like that iodized salt we mentioned before. Similarly, fortifying milk with vitamin D has helped improve bone health, especially in children and the elderly. So, while the word “additive” can make you jump, it’s not always the case. But as many advocates note, it’s likely time the FDA took a look at the chemicals it has permitted over the last few decades with a harder lens. As Senator Bernie Sanders shared with CBS, “I think the FDA has been negligent…and I think we want to make sure that they’re more aggressive in reviewing the products that are getting onto the market.”
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