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If there was a food or chemical substance that was not listed as a controlled substance either federally or at the state level, and it is never explicitly mentioned in any FDA food guidelines, does that mean that it can be included in food and sold to consumers without any special labeling? What laws regulate whether a chemical substance or plant product can be included in food when it is not explicitly banned or regulated by the FDA, assuming it isn't harmful at amounts present in a normal serving?

What if that substance has potentially harmful effects when taken in much larger amounts than included in a standard serving of the food product? (For instance, caffeine is legal to sell without warning labels, but in excessive doses can result in hospitalization or death). If a product is safe in the suggested serving size, are food processors liable for harm caused when people abuse their products and consume excessive amounts of them?

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    Are you asking if FDA on food works as “allowed unless banned/regulated” or “not allowed unless specifically listed as so”? By the way, many common things have harmful effects in large doses. Salt and nutmeg came to mind immediately.
    – Damila
    Feb 22, 2023 at 21:38
  • Yes, I'm trying to determine (A) if "allowed unless banned/regulated" is how things work; and (B) if someone harms themselves through excessive use of a consumable product with some unregulated ingredient, is the producer liable? (by "excessive" I mean many times more than the serving size suggested on the label)
    – J. Taylor
    Feb 22, 2023 at 21:41
  • And as far as many common things being harmful in large amounts, yes, I agree. That's why I'm curious about this question: if a substance used in normal amounts is safe, does that relieve a producer of liability if someone does something stupid and consumes some massive amount of it?
    – J. Taylor
    Feb 22, 2023 at 21:45
  • @Damila - water as well. Too much and you can get hyponatremia (too low sodium in your blood).
    – Jon Custer
    Feb 23, 2023 at 14:04

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The FDA maintains a list of substances "generally recognized as safe" and provides that list on their web site at:

GRAS

To quote their site:

Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.

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