The Story of Processed Food: How do Companies Legally Add Ingredients?

Every week there seems to be a new petition to get rid of a certain ingredient in processed foods, from azodicarbonamide in Subway bread to Yellow No. 5 and 6 from various Kraft Macaroni and Cheese boxes. It’s no news that there are a lot of ingredients in processed food – many of which we often have no idea exactly what they are – but if ingredients are so controversial that they sometimes have to be removed, how did they get there in the first place?

Some people assume that the federal government has the ultimate say when it comes to which ingredients companies can and can’t use, but as it turns out many federal regulations actually give companies a lot of independence when it it comes to determining which ingredients are safe and which ones are not.

Food Safety News wrote an excellent explanation to that question, essentially giving us the story of processed food and how companies are legally able to add ingredients and substances. The article clearly lays out how approval of additives works, noting that companies can go about that in three different ways: adding the substance as 1) as a food additive, 2) as a listed exception, or 3) as “Generally Recognized as Safe” (GRAS). Both food additives and listed exceptions require FDA pre-approval before a company can add them to products, and because of that, the easiest way for a company to add ingredients is via GRAS.

Now here is where things get a little complicated.

GRAS substances are “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.” Created so that companies could more quickly add substances to their products, GRAS additives are not subject to pre-approval and allow companies to seek out the opinion of “qualified experts” as opposed to having to go through the FDA. The certification is based off of the idea that there are many food additives that don’t really necessitate FDA involvement in approval, mostly because of their safety of history.

If it’s a food additive that has been in use since before 1958, the substance often falls under the GRAS clarification because of its history of safe use. If it’s a food additive from after 1958, it’s up to the company to assess the scientific evidence regarding safety. According to Food Safety News, “the company makes the GRAS determination through scientific procedures. According to FDA, this route ‘requires the same quantity and quality of scientific evidence as required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.’”

So basically, the company can get anyone they determine to be a “qualified expert” and what they deem to be an appropriate amount of scientific evidence to determine whether or not an additive is safe. But with a system that allows companies to self-affirm that their ingredients are safe, it’s no surprise that it gets deemed as a loophole.

A company can submit the GRAS substance, which goes to the FDA for a voluntary review. Yes, voluntary. At this point the FDA can ultimately decide that an additive doesn’t qualify under GRAS, and therefore it would be to go back for pre-approval under one of the two other routes.

Recently the Pew Health Group did a three-year study on food additive regulation and found that out of 10,000 chemicals they looked at, more than 3,000 of them had never even gone through an FDA for review, and 1,000 of those weren’t even submitted to the FDA. That would mean that the FDA doesn’t even have have information on one out of ten chemicals being used in foods. Compare that to the European system where under European Union legislation, all food additives must be approved by the European Food Safety Authority before they can be used.

Essentially, in the United States you have a system where the responsibility of determining whether or not a food additive is safe is up to the company, and when monetary interests are involved, and the definition of “qualified experts” is murky, it’s easy to see how we end up in a situation where processed foods have more and more odd-sounding names of additives and some of them become highly controversial.

Let’s put it this way: when the approval system for food additives is this complicated, it’s certainly reason to consider trying to cut out food additives from our diets entirely.

Photo Credit: Anders Sandberg


Jim Ven
Jim Ven5 months ago

thanks for the article.

Kyle N.
Kyle N2 years ago

Julia, Grammar is a minor thing, Some of us didn't grow up in a city where rich, close minded people live that know nothing of the country. Some of us grew up in the country, had to work nearly every day since we were 14 and combining that with school. Getting farm work done was a priority over school work.

Julia H.
Past Member 3 years ago

Kyle N.

Grammar DOES matter. If you wrote your response with proper grammar I could probably understand what you are trying to say. As-is, not so much. Hard to take someone seriously who does not even know how to form a proper sentence.

Kyle N.
Kyle N3 years ago

Sonali, it's quite simple. If you want cheap food, have plentiful food. We need fertilizer to get the highest potential yield possible, if weather determines the crop may need a fungicide applied to protect it from an early death, reducing yields. Some years there are insect outbreaks, do need to apply an insecticide to get rid of the pests to avoid yield losses, but every year 1 or 2 times we need to apply a weed killer to protect the crop and to get a good yield. Even in my own garden I am unable to avoid using insecticides or fungicices.

Amy Ingalls
Amy Ingalls3 years ago

This is a perfect example of what is wrong with this country. Corporations basically control government, and money is put before safety.

Ellie K.
Ellie K3 years ago


A F.
Athena F3 years ago

thank you

Carole R.
Carole R3 years ago

Thanks for the post.

Sonali G.
Sonali G3 years ago

Lets face it. No food is safe from chemicals, pesticides or pollution. You can try your best to avoid it but we have contaminated everything everywhere that it is impossible to avoid some form of poison. It is a very sad state of affairs indeed.

Kyle N.
Kyle N3 years ago

H. I suggest you study more. I attend many meetings, read many articles over the year, many involving variety research. Do I care about grammar, no, it is pointless in my job. What one determines as processed is quite broad. Specifically anything that is boiled, placed in vinegar (which is also processed from apples, fermented.) even could call bottled orange juice processed. If you get down to it only fresh fruits, vegetables, eggs could be considered non processed. Could you call it manufactured if it contains added ingredients such as preservatives or some mineral or vitamin? Possibly.