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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?

Sonny Ordell
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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: http://www.quackwatch.org/01QuackeryRelatedTopics/Naturopathy/misrep.html – Randolf Richardson Nov 19 '11 at 04:17
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    @Randolph, no they seemed to imply that any amount was dangerous. – Sonny Ordell Nov 19 '11 at 04:19
  • I would like to edit my question title to refer to the amounts that are approved, but am not sure of the best way to do that. – Sonny Ordell Nov 19 '11 at 04:20
  • If you don't see an "edit" link below the **nutrition** tag (immediately following your question), then just add to comments for now with a "PLEASE ADD TO QUESTION:" prefix. After you see it added, you may also wish to delete your comment. =) – Randolf Richardson Nov 19 '11 at 04:22
  • Oh I know how to edit, I'm just not sure how to phrase my question without it being too long. – Sonny Ordell Nov 19 '11 at 04:25
  • I'm considering closing this as a duplicate of http://skeptics.stackexchange.com/questions/502/is-any-of-the-e-number-additives-generally-accepted-as-harmful/543#543 since the asker does extend the question to other agencies than the FDA. Thoughts? – Borror0 Nov 19 '11 at 04:37
  • @Sonny Ordell: Don't worry about your question being longer than it is now if you're adding relevant information. For example, if you've heard a range of amounts claimed for a particular substance, you could add that to your "_I have met..._" paragraph a separate sentence that clarifies "_Various amounts suggested range from 3ml to 23ml for 2% cow's milk._" Such an addition is what I would consider to be a constructive and valuable edit. – Randolf Richardson Nov 19 '11 at 04:38
  • @Borror0: I think it would be nice to hold off on closing it for a little while to give Sonny a chance to improve the question. I suspect there is some potential here for this to become a great question, and Sonny seems keen. – Randolf Richardson Nov 19 '11 at 04:39
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    @Borror0 I will limit my question to the FDA and increase the scope of the question to include any amount. – Sonny Ordell Nov 19 '11 at 04:44
  • Also I would like to try and avoid answers such as in the E-Numbers question, where the answer is basically since it is approved to use it is not considered harmful. – Sonny Ordell Nov 19 '11 at 04:52
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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 '11 at 04:52
  • @Borror0 to clarify by any amount, I mean an amount between the minimum amount that could theoretically have an effect on the body and the maximum amount approved by the FDA. I don't think limiting the range in that way make the question trivial. – Sonny Ordell Nov 19 '11 at 04:54
  • @SonnyOrdell: I don't think you can avoid answers gotten like the E-number questions, unless you ask something like "Does the FDA approves consumption of comsuption of some substances beyond their LD50 quantity?" In many cases, the answer is to "Is X harmful?" is "It depends on how you look at it." In many cases, the evidence is unclear and thus reasonable human beings can arrive to different conclusions. – Borror0 Nov 19 '11 at 04:55
  • @Borror0 the link I provided already links to studies showing certain FDA approved substances to be harmful at even their prescribed amounts. As I said however I don't know how reliable that source is. Simply because something is approved for use is not evidence in and of itself that said substance is not harmful, especially if their is contradictory evidence which seems to exist in this case. – Sonny Ordell Nov 19 '11 at 05:06
  • @SonnyOrdell: consider reducing the scope of this question to a single ingredient. As it is, it's a list question (more than one correct answer). – Sklivvz Nov 20 '11 at 10:10
  • @Sklivvz surely the answer is yes or no? If yes, then a relevant source can be shown as well as a possible explanation of why it continues to be FDA approved. I will work on clarifying and making my question more succinct, but would prefer not to limit it to one ingredient. – Sonny Ordell Nov 20 '11 at 11:13
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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 01 '12 at 12:08
  • @Darwy the link has claims for many different ingredients. I don't know enough to know if the claims are ridiculous or not, however what interest me is the claims that certain ingredients have been found harmful by reputable bodies. – Sonny Ordell Mar 01 '12 at 12:11
  • @SonnyOrdell To be blunt; anything, when eaten in excess will be harmful to you. The dose determines the poison. Most incidences of cancer in animals fed these compounds occurs when they're given extremely high doses of the compound. In other words, most of them are eating an unrealistic amount of the compound when compared to the 'average' human consumption. IIRC when they studied Acesulfame-K, they fed rats amounts of around 2-4% of their total body weight in Acesulfame-K daily with no adverse effects. That would translate into over 1000 cans of soda daily for a human. – Darwy Mar 01 '12 at 18:51
  • At that point, it wouldn't be the Acesulfame-K that killed you, it would be water intoxication from all that soda. – Darwy Mar 01 '12 at 18:51
  • I saw that the link to the [FDA page](http://www.fda.gov/Food/FoodIngredientsPackaging/FoodAdditives/ucm208580.htm) is not working. I found a pretty detailed post on [aspartame](https://www.thenutritionalsource.com/nutrition/aspartame-acesulfame-potassium-not-healthy-cause-cancer-with-no-calories/) that talks about the problems with aspartame in excess. Yea, aspartame is a problem, but like @Randolf said, anything in excess is dangerous. And remember, you are what you eat. –  May 16 '16 at 02:40

1 Answers1

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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.

However:

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.

Kevin
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Naelin
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    Further: the [GRAS database](http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/default.htm) includes ingredients "grandfathered" in from use before 1958. Evidence for safety was (in 1975) [graded](http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASSubstancesSCOGSDatabase/default.htm), 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 '11 at 23:54
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    What about some of the things listed on this site http://www.wereyouwondering.com/possible-and-suspected-carcinogens-found-in-food/ ? 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). – Sonny Ordell Jan 21 '12 at 09:30