food drugs fda food-processing
What determines the legality of whether a non-controlled substance can be included in food?
<p>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?</p>
<p>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?</p>

<p>The FDA maintains a list of substances &quot;generally recognized as safe&quot; and provides that list on their web site at:</p>
<p><a href="https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras" rel="nofollow noreferrer">GRAS</a></p>
<p>To quote their site:</p>
<blockquote>
<p>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principles, and may be corroborated by the application of unpublished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.</p>
</blockquote>
