Are there any FDA approved ingredients that are known to be directly harmful when taken at an approved dosage?

Question

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?

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.

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.