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Q: According to your Caffeine Content of Beverages, Foods, & Medications page, "The U.S. Food & Drug Administration allows a maximum of 72 mg. of caffeine per 12 oz. serving (6mg / oz)".



I have researched caffeine and have found a number of new drinks that have more then this. I understand Red Bull and others on your list are not US products, but for example "Full Throttle" by Coca-Cola reportedly has about 9.5 mg per oz.



Are you sure that the FDA limits beverages to 72mg per 12 oz? And if so, does this make products like "full throttle" illegal?


A: According to Title 21, Chapter I, Part 182 of the Code of Federal Regulations,

-------------------------------------------------------------
PART 182 -- SUBSTANCES GENERALLY RECOGNIZED AS SAFE
Subpart B -- Multiple Purpose GRAS Food Substances
Sec. 182.1180 Caffeine.

(a) Product. Caffeine.
(b) Tolerance. 0.02 percent.
(c) Limitations, restrictions, or explanation. This substance is generally
recognized as safe when used in cola-type beverages in accordance with good
manufacturing practice.
-------------------------------------------------------------


Section (b) above defines a "tolerance" of .02 percent. This means that a product may contain a maximum of .02% caffeine while still being considered "GRAS" (Generally Recognized As Safe). For a 12 oz beverage, .02% works out to 68mg.



We have looked into the second part of this question several times. How is it that there are products available which exceed the FDA GRAS regulations of 68 mg per 12 oz beverage? We believe that the .02% is by volume, and for drinks or foods only. It seems quite possible that there is some getting around this by calling certain products 'supplements', but some things advertised as drinks seem to clearly exceed this .02% rule. The answer is unclear. In some cases, as you mention, the products are not produced in the United States and are therefore not subject to GRAS regulations (though import rules would then be an issue).



But in other cases it seems likely that the companies/products are in violation of FDA rules. There are a large and complex set of FDA rules and regulations governing the production and sale of food in the U.S. and it may be that the FDA simply doesn't have the manpower to enforce all of them.


Asked By : AC & SC
Answered By : fire
Published Date : 9 / 6 / 2005
Last Edited Date : 3 / 8 / 2007
Question ID : 3099

Categories: [ Caffeine ] [ Law ]




Ask Erowid v1.7 - Jul, 2005

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