FDA and NIH reviews of safety of caffeine

(a) FDA review of caffeine as GRAS (1) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, (in this subsection referred to as the Commissioner) shall conduct a review of the safety of caffeine and other stimulants, as the Commissioner determines appropriate, in food (including beverages) and dietary supplements. (2) Elements In conducting the review under paragraph (1), the Commissioner shall consider the following: (A) Whether caffeine should be considered to be generally recognized to be safe, with respect to consumption by healthy populations, under section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)). (B) The safety of added caffeine or other stimulants, or a complex blend containing a combination of caffeine and other stimulants, in food and dietary supplements. (C) The safety of guarana, taurine, and similar substances in food and dietary supplements with added caffeine. (D) Thresholds for the amount of caffeine, or the amount of a complex blend containing a combination of caffeine and other stimulants, that should be generally recognized as safe when included in food or dietary supplements. (E) Whether any regulations relating to caffeine in food and dietary supplements should be issued or updated. (3) Report Not later than 6 months after the date of enactment of this Act, the Commissioner shall submit to Congress and make publicly available a report detailing the results of the review under paragraph (1). (4) Consideration of results Following the completion of the review under paragraph (1), the Secretary of Health and Human Services— (A) shall, in considering the results of such review, make a determination regarding whether caffeine is generally recognized to be safe, with respect to consumption by healthy populations, under section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)); and (B) may consider the results of such review in making a determination pursuant to paragraph (q)(5)(H)(ii)(III) or (z)(3) of section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) (as inserted by subsection (a)(1)(B)(ii), and added by subsection (b), of section 2 of this Act). (b) NIH review of caffeine in vulnerable populations (1) In general The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, (in this subsection referred to as the Director) shall conduct or support a review of the effect of the consumption of caffeine and other stimulants, as the Director determines appropriate, on the vulnerable populations described in paragraph (2). The Director may enter into a contract with an appropriate entity under which such entity will conduct such review. (2) Vulnerable populations The vulnerable populations described in this paragraph are the following: (A) Children and adolescents. (B) Individuals with underlying heart conditions. (C) Pregnant and breast-feeding women. (D) Individuals with seizure disorders. (E) Individuals with mental health conditions that may be worsened by stimulants. (F) Caffeine-sensitive individuals. (G) Such other individuals as the Director determines appropriate. (3) Report Not later than 6 months after the date of enactment of this Act, the Director shall submit to Congress and make publicly available a report detailing the results of the review under paragraph (1). (c) Authorization of appropriations There is authorized to be appropriated— (1) $1,000,000 for the purpose of carrying out subsection (a); and (2) $1,000,000 for the purpose of carrying out subsection (b).