Are there any ingredients in processed foods (prepared meals, as opposed to freshly made meals, for example) approved by the FDA (Food and Drug Administration of the USA) that are known to be directly harmful to humans?

I have met a lot of people who claim "X ingredient will cause diabetes, or cancer, or some other health problem..."

From what I understand, the FDA only approves things after ensuring they are not harmful, although there may be cases where some things may be potentially harmful in rare situations or if excess amounts are consumed. I would have thought however for the most-part though, what they approve has shown to be safe for public consumption.

There are people who claim that certain ingredients are simply dangerous and should not be ingested, at all, ever seemingly regardless of amount. Often there seems to be little support for such claims other than belief, still I am curious.

This page links to many substances approved by the FDA yet apparently have been shown to cause harm in studies. I have not looked at each study as I lack the prerequisite knowledge to make sense of them. Surely if the FDA is approving a substance known to be harmful it is only in dosages considered not harmful?

A good example might be BHA which the US dept of health considered a carcinogen, yet the FDA continues to allow its use. Or Acesulfame-K which failed to meet FDA standards (according to the above site).

Is there any evidence that any preservatives/additives/etc approved by the FDA are harmful to humans for the dose they are approved for?

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    A paramedic once told me that "anything taken in excess can be a poison," including water. Did any of those people making those claims tell you how much of the ingredients will cause these problems? This document may be of interest to you (search for "gluten" in particular) as I suspect many of those claims you're hearing may be coming from Naturopathic quackery: quackwatch.org/01QuackeryRelatedTopics/Naturopathy/misrep.html Nov 19, 2011 at 4:17
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    @Randolph, no they seemed to imply that any amount was dangerous. Nov 19, 2011 at 4:19
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    @Borror0 I will limit my question to the FDA and increase the scope of the question to include any amount. Nov 19, 2011 at 4:44
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    @SonnyOrdell: The problem with "any amount" is that it's a bit ridiculous. As I explained in link above, Vitamin C is lethal in high doses. You can ask that question, if you want, but it becomes a pretty trivial question.
    – Borror0
    Nov 19, 2011 at 4:52
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    I'd like to comment on the link (24 Potentially Harmful yadda yadda). The author notes that aspartame can break down to formaldehyde. That's well and fine - but he's ignoring the fact that our bodies PRODUCE formaldehyde during normal metabolic processes. If ANY amount of formaldehyde in our bodies were lethal, we'd already be dead! As it is, an adult metabolizes (IIRC) 22 mg of formaldehyde per minute in the liver with some 55,000 mg metabolized over the course of a day (From HCHO -> CO2). However, that's probably a conservative estimate since some of the HCHO is used in 1 C metabolism.
    – Darwy
    Mar 1, 2012 at 12:08

1 Answer 1


The answer to your question changes with how strictly you ask.

No, there are no FDA approved food or color additives known to be harmful. But yes, it is possible that an FDA approved additive can cause harm.

To start the use of a additive, a sponsor must submit a petition to show that the proposed use of the additive is safe. (This even is true for animal food) The FDA reviews the petition to make the call on if the additive is as safe as the sponsor says it is. If the petition passes, the additive gets to be used.


Because of inherent limitations of science, FDA can never be absolutely certain of the absence of any risk from the use of any substance. Therefore, FDA must determine - based on the best science available - if there is a reasonable certainty of no harm to consumers when an additive is used as proposed.

So the FDA looks into their research and determines if the additive is safe given the current data. Yet just because the FDA has reached this conclusion does not necessarily imply that the additive is safe. When further studies come out, the FDA analyzes the data and once again makes the best call they can on if the additive is safe.

Take, for example, Aspartame; common low-calorie artificial sweetener. Studies by the European Ramazzini Foundation (ERF) have concluded that the sweetener is carcinogenic. But whenever such conclusions are made, the FDA analyzes the new data and reevaluates the safety of the additive. The FDA issued this statement stating that they have analyzed what data from the study they could, and determined that the ERF's study does not support the conclusion that aspartame is carcinogenic. (Incidentally, the European Food Safety Authority agrees with the FDA on this)

In summary, when the FDA approves an additive, they can only do so by making their best guess. If someone says they've made the wrong call, they do their best to investigate the new data. This is, of course, in general. Any further analysis would be best done on a single additive that you're skeptical the FDA has made the right call about.

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    Further: the GRAS database includes ingredients "grandfathered" in from use before 1958. Evidence for safety was (in 1975) graded, and some ingredients "only" had a 5 rating ("In view of the almost complete lack of biological studies, the Select Committee has insufficient data upon which to evaluate the safety of [substance] as a [intended use].")
    – Oddthinking
    Nov 21, 2011 at 23:54
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    What about some of the things listed on this site wereyouwondering.com/… ? For example The US Department of health considers BHA a carcinogen yet the FDA continues to allow its use. Or Acesulfame-K which failed to meet FDA standards (according to the site). Jan 21, 2012 at 9:30

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