(June 25, 1938, ch. 675, § 1003, formerly § 903, as added Pub. L. 100–607, title V, § 503(a),Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100–690, title II, § 2631,Nov. 18, 1988, 102 Stat. 4244; Pub. L. 105–115, title IV, §§ 406,
414,Nov. 21, 1997, 111 Stat. 2369, 2377; renumbered § 1003 and amended Pub. L. 111–31, div. A, title I, §§ 101(b)(2),
(m),June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, § 201(b),Jan. 4, 2011, 124 Stat. 3925.)
2011—Subsecs. (h), (i). Pub. L. 111–353
added subsecs. (h) and (i).
2009—Subsec. (d)(2)(C). Pub. L. 111–31
, § 103(m), struck out “and” after “cosmetics,” and inserted “, and tobacco products” after “devices”.
1997—Subsec. (b). Pub. L. 105–115
, § 406(a)(2), added subsec. (b). Former subsec. (b) redesignated (d).
Subsec. (c). Pub. L. 105–115
, § 414, added subsec. (c). Former subsec. (c) redesignated (e).
Subsecs. (d), (e). Pub. L. 105–115
, § 406(a)(1), redesignatedsubsecs. (b) and (c) as (d) and (e), respectively.
Subsecs. (f), (g). Pub. L. 105–115
, § 406(b), added subsecs. (f) and (g).
1988—Subsec. (b)(2). Pub. L. 100–690
substituted “shall be responsible for executing this chapter and” for “shall be responsible”.
Effective Date of 1997 Amendment
Amendment by Pub. L. 105–115
effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115
, set out as a note under section
of this title.
Pub. L. 100–607
, title V, § 503(c),Nov. 4, 1988, 102 Stat. 3121
, provided that:
“(1) Except as provided in paragraph (2), the amendments made by this title [enacting this section and amending sections
, Government Organization and Employees] shall take effect on the date of enactment of this Act [Nov. 4, 1988].
“(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section) [now 1003(d)(1), 21
] shall apply to the appointments of Commissioners of Food and Drugs made after the date of enactment of this Act.”
Office of Minor Use and Minor Species Animal Drug Development
Pub. L. 108–282
, title I, § 102(b)(7),Aug. 2, 2004, 118 Stat. 905
, provided that: “The Secretary of Health and Human Services shall establish within the Center for Veterinary Medicine (of the Food and Drug Administration), an Office of Minor Use and Minor Species Animal Drug Development that reports directly to the Director of the Center for Veterinary Medicine. This office shall be responsible for overseeing the development and legal marketing of new animal drugs for minor uses and minor species. There is authorized to be appropriated to carry out this subsection $1,200,000 for fiscal year 2004 and such sums as may be necessary for each fiscal year thereafter.”
Regulations for Sunscreen Products
Section 129 ofPub. L. 105–115
provided that: “Not later than 18 months after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn.”
Construction of 2011 Amendment
Nothing in amendment by Pub. L. 111–353
to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections
of this title.
FDA Study of Mercury Compounds in Drugs and Food
Section 413 ofPub. L. 105–115
“(a) List and Analysis.—The Secretary of Health and Human Services shall, acting through the Food and Drug Administration—
“(1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and
“(2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 [Nov. 21, 1997] and shall provide the analysis required by paragraph (2) within 2 years after such date of enactment.
“(b) Study.—The Secretary of Health and Human Services, acting through the Food and Drug Administration, shall conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study shall include data from other studies that have been made of such use.
“(c) Study of Mercury Sales.—
“(1) Study.—The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—
“(A) the scope of mercury use as a drug or dietary supplement; and
“(B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used.
In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any other Federal or private entity.
“(2) Regulations.—If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or inhalation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious ceremonies.”
Management Activities Study
Pub. L. 102–571
, title II, § 205,Oct. 29, 1992, 106 Stat. 4502
, directed Comptroller General to conduct a study of management of activities of the Food and Drug Administration that are related to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances and submit an interim report to Congress, not later than 6 months after Oct. 29, 1992, with a final report to be submitted not later than 12 months after Oct. 29, 1992.
Section 502 ofPub. L. 100–607
provided that: “Congress finds that—
“(1) the public health has been effectively protected by the presence of the Food and Drug Administration during the last eighty years;
“(2) the presence and importance of the Food and Drug Administration must be guaranteed; and
“(3) the independence and integrity of the Food and Drug Administration need to be enhanced in order to ensure the continuing protection of the public health.”