An act to amend the Federal Food, Drug, and Cosmetic Act to strengthen the authority under that Act to assure the safety and nutrition of infant formulas, and for other purposes.
PL 96-359 (H.R.6940), enacted 09/26/1980

94 STAT. 1190 
PUBLIC LAW 96-359—SEPT. 26, 1980 
Sept. 26, 1980 
[H.R. 6940] 
Infant Formula 
Act of 1980. 
21 u s e 301 note. 
Public Law 96-359 
96th Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to strengthen the authority 
under that Act to assure the safety and nutrition of infant formulas, and for 
other purposes. 
Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, That this Act may be 
cited as the "Infant Formula Act of 1980". 
SEC. 2. Chapter IV of the Federal Food, Drug, and Cosmetic Act is 
amended by adding after section 411 the following new section: 
Adulterated 
formulas. 
21 u s e 350a. 
Quality control 
procedures. 
Testing. 
Notification to 
Secretary. 
REQUIREMENTS FOR INFANT FORMULAS 
"SEC. 412. (a)(1) An infant formula shall be deemed to be adulter-
ated i
f
— 
"(A) such infant formula does not provide nutrients as 
required by subsection (g); 
"(B) such infant formula does not meet the quality factor 
requirements prescribed by the Secretary under this section; or 
"(C) the processing of such infant formula is not in compliance 
with the quality control requirements prescribed by the Secre-
tary under this section. 
"(2) The Secretary may by regulation— 
"(A) revise the list of nutrients in the table in subsection (g); 
"(B) revise the required level for any nutrient required by 
subsection (g); 
"(C) establish requirements for quality factors for such nutri-
ents; and 
"(D) establish such quality control procedures as the Secretary 
determines necessary to assure that an infant formula provides 
nutrients in accordance with this section and establish require-
ments respecting the retention of records of procedures required 
under this clause (including maintaining necessary nutrient 
testing records). 
Quality control procedures prescribed by the Secretary shall include 
the periodic testing of infant formulas to determine whether they are 
in compliance with this section. 
"(b)(1) On the 90th day after the date of the enactment of this 
section, and on each 90th day thereafter, a manufacturer of infant 
formula shall notify the Secretary that each infant formula manufac-
tured by such manufacturer provides the nutrients required under 
subsection (g). Such notification requirement shall expire upon the 
effective date of regulations relating to quality control procedures 
prescribed by the Secretary under subsection (a)(2)(D). 
"(2) Not later than the 90th day before the first processing of any 
infant formula for commercial or charitable distribution for human 
consumption, the manufacturer shall notify the Secretary whether— 
"(A) such infant formula provides nutrients in accordance with 
subsection (g) and meets the quality factor requirements pre-
scribed by the Secretary; and 
"(B) the processing of such infant formula meets the quality 
control procedure requirements prescribed by the Secretary. 
PUBLIC LAW 96-359—SEPT. 26, 1980 
94 STAT. 1191 
"(3) Before the first processing of any infant formula for commer-
cial or charitable distribution for human consumption— 
"(A) after a change in its formulation, or 
"(B) after a change in its processing, 
which the manufacturer reasonably determines may affect whether 
the formula is adulterated as determined under subsection (a)(1), the 
manufacturer shall notify the Secretary of such changes and that the 
formula provides nutrients in accordance with subsection (g) and 
meets the quality factor requirements prescribed by the Secretary 
and that the processing of such infant formula is in compliance with 
the quality control procedures prescribed by the Secretary. 
"(c)(1) If the manufacturer of an infant formula has knowledge 
which reasonably supports the conclusion that an infant formula 
which has been processed by the manufacturer and which has left an 
establishment subject to the control of the manufacturer— 
"(A) may not provide the nutrients required by subsection (g); 
or 
"(B)(i) may be otherwise adulterated or misbranded, and 
"(ii) if so adulterated or misbranded presents a risk to human 
health, 
the manufacturer shall promptly notify the Secretary of such non-
compliance or risk to health. 
"(2) For purposes of paragraph (1), the term 'knowledge' as applied "Knowledge, 
to a manufacturer means (A) the actual knowledge that the manufac-
turer had, or (B) the knowledge which a reasonable person would 
have had under like circumstances or which would have been 
obtained upon the exercise of due care. 
"(d)(1) If a recall of an infant formula is begun by a manufacturer, 
the recall shall be carried out in accordance with such requirements 
as the Secretary may prescribe under paragraph (2), and— 
"(A) the Secretary shall, not later than the 15th day after the 
beginning of such recall and at least once every 15 days thereaf-
ter until the recall is terminated, review the actions taken under 
the recall to determine whether the recall meets the require-
ments prescribed under paragraph (2); and 
"(B) the manufacturer shall, not later than the 14th day after 
the beginning of such recall and at least once every 14 days 
thereafter until the recall is terminated, report to the Secretary 
the actions taken to implement the recall. 
"(2) The Secretary shall by regulation prescribe the scope and 
extent of recalls of infant formulas necessary and appropriate for the 
degree of risk to human health presented by the formula subject to 
the recall. 
"(e)(1) Each manufacturer of an infant formula shall make and 
retain such records respecting the distribution of the infant formula 
through any establishment owned or operated by such manufacturer 
as may be necessary to effect and monitor recalls of the formula. No 
manufacturer shall be required under this subsection to retain any 
record respecting the distribution of an infant formula for a period of 
longer than 2 years from the date the record was made. 
"(2) To the extent that the Secretary determines that records are 
not being made or maintained in accordance with paragraph (1), the 
Secretary may by regulation prescribe the records required to be 
made under paragraph (1) and requirements respecting the retention 
of such records under such paragraph. Such regulations shall take 
effect on such date as the Secretary prescribes but not sooner than 
the 180th day after the date such regulations are promulgated. Such 
regulations shall apply only with respect to distributions of infant 
formulas made after such effective date. 
Recall. 
Review. 
Report to 
Secretary. 
Regulations. 
Records. 
94 STAT. 1192 
PUBLIC LAW 96-359—SEPT. 26, 1980 
Exemptions. 
Nutrient 
contents. 
"(f)(1) Any infant formula which is represented and labeled for use 
by an infant— 
"(A) who has an inborn error of metabolism or a low birth 
weight, or 
"(B) who otherwise has an unusual medical or dietary problem, 
is exempt from the requirements of subsections (a) and (b). The 
manufacturer of an infant formula exempt under this paragraph 
shall, in the case of the exempt formula, be required to provide the 
notice required by subsection (c)(1) only with respect to adulteration 
or misbranding described in subsection (c)(1)(B), and to comply with 
the regulations prescribed by the Secretary under paragraph (2). 
"(2) The Secretary may by regulation establish terms and condi-
tions for the exemption of an infant formula from the requirements of 
subsections (a) and (b). An exemption of an infant formula under 
paragraph (1) may be withdrawn by the Secretary if such formula is 
not in compliance with applicable terms and conditions prescribed 
under this paragraph. 
"(g) An infant formula shall contain nutrients in accordance with 
the table set out in this subsection or, if revised by the Secretary 
under subsection (a)(2), as so revised: 
"NUTRIENTS 
4.5. 
Protein (gm) 
1.8" 
Fat: 
gm 
3.3 
percent cal 
30.0 
Essential fatty acids (linoleate): 
percent cal 
2.7 
mg... 
300.0 
Vitamins: 
A (lU) 
250.0 (75 ixg)' 
D (lU) 
40.0 
K(ug) 
4.0 
E (lU) 
0.7 (with 0.7 lU/gm lin-
oleic acid). 
C (ascorbic acid) (mg) 
8.0 
B, (thiamine) (jug) 
40.0 
Bj (riboflavin) (fxg) 
60.0 
Be (pyridoxine) (fxg) 
35.0 (with 15 ixg/gm of 
protein in formula). 
B,2 i^ig) 
0.15 
Niacin (jug) 
250.0 
Folic acid ifxg) 
4.0 
Pantothenic acid (/a,g) 
300.0 
Biotin {^lg} 
1.5* 
Choline (mg) 
7.0" 
Inositol (mg) 
4.0'' 
Minerals: 
Calcium (mg) 
50.0* 
Phosphorus (mg) 
25.0* 
Magnesium (mg) 
6.0 
Iron (mg) 
0.15 
Iodine (ju,g) 
5.0 
Zinc(mg) 
0.5 
Copper (;xg) 
60.0 
Manganese (fig) 
5.0 
Sodium (mg) 
20.0 
60.0. 
Potassium (mg) 
80.0 
200.0. 
Chloride (mg) 
55.0 
150.0. 
6.0. 
54.0. 
750.0 (225 ug).' 
100.0. 
"Stated per 100 kilocalories. 
"The source of protein shall be at least nutritionally equivalent to casein. 
' Retinol equivalents. 
" Required to be included in this amount only in formulas which are not milk-based. 
'Calcium to phosphorus ratio must be no less than 11 nor more than 2.0." 
PUBLIC LAW 96-359—SEPT. 26, 1980 
94 STAT. 1193 
SEC. 3. Section 201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) is amended by adding at the end the following: 
"(aa) The term 'infant formula' means a food which purports to be 
or is represented for special dietary use solely £is a food for infants by 
reason of its simulation of human milk or its suitability as a complete 
or partial substitute for human milk.". 
SEC. 4. Section 704(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 374(a)) is amended— 
(1) in the first sentence, by inserting "(1)" before "For pur-
poses" and by redesignating clauses (1) and (2) as clauses (A) and 
(B), respectively; 
(2) in the third sentence, by inserting "or by paragraph (3)" 
after "preceding sentence"; 
(3) in the sixth sentence, (A) by striking out "The provisions of 
the second sentence of this subsection" and inserting in lieu 
thereof the following: 
"(2) The provisions of the second sentence of paragraph (1)", 
and (B) by redesignating paragraphs (1) through (4) as subpara-
graphs (A) through (D), respectively; and 
(4) by adding at the end the following: 
"(3) An officer or employee making an inspection under paragraph 
(1) for purposes of enforcing the requirements of section 412 applica-
ble to infant formulas shall be permitted, at all reasonable times, to 
have access to and to copy and verify any records— 
"(A) bearing on whether the infant formula manufactured or 
held in the facility inspected meets the requirements of section 
412, or 
"(B) required to be maintained under section 412.". 
SEC. 5. (a) Section 301 of the Federal Food, Drug, and Cosmetic Act 
is amended by adding at the end the following new paragraph: 
"(s) The failure to provide the notice required by section 412(b) or 
412(c), the failure to make the reports required by section 412(d)(1)(B), 
or the failure to meet the requirements prescribed under section 
412(d)(2).". 
O
b
) Section 301(e) of such Act is amended (1) by striking out "section 
703" and inserting in lieu thereof "section 412 or 703", and (2) by 
striking out "section 505" and inserting in lieu thereof "section 412, 
505". 
(c) Section 301(j) of such Act is amended by inserting "412," before 
"505". 
SEC. 6. Section 412 of the Federal Food, Drug, and Cosmetic Act 
(added by section 2) shall apply with respect to infant formulas 
manufactured on or after the 90th day after the date of the enact-
ment of this Act. 
SEC. 7. (a) The Secretary of Health and Human Services shall 
conduct a study to determine the long-term effect on infants of 
hypochloremic metabolic alkalosis resulting from infant formulas 
deficient in chloride. The Secretary shall report the results of such 
study to the Congress. 
O
t
)
) The Secretary of Health and Human Services shall conduct a 
review of existing Federal requirements for the labeling of infant 
formula to determine the effect of such requirements on infant 
nutrition and proper use of infant formula. Not later than the 180th 
day after the date of the enactment of this Act, the Secretary shall 
"Infant 
formula." 
Ante, p. 1190. 
21 u s e 331. 
Effective date. 
21 u s e 350a 
note. 
Health study. 
Report to 
eongress. 
Federal labeling 
requirements, 
review. 
Submittal to 
congressional 
committees. 
94 STAT. 1194 
PUBLIC LAW 96-359—SEPT. 26, 1980 
Export issues, 
review. 
Ante, p. 1190. 
Submittal to 
congressional 
committees. 
Controlled 
substance with 
highest abuse 
rate. 
21 u s e 830, 841, 
842, 843. 
Penalties. 
submit a report to the Committee on Labor and Human Resources of 
the Senate and the Committee on Interstate and Foreign Commerce 
of the House of Representatives containing the results of the review 
and including recommendations for any legislative or administrative 
action with respect to the labeling of infant formula as the Secretary 
determines appropriate. 
(c) The Secretary of Health and Human Services shall conduct a 
review of issues concerning the export of infant formula that, if 
marketed in the United States, would be in violation of section 412 of 
the Federal Food, Drug, and Cosmetic Act. Not later than the 180th 
day after the date of enactment of this Act, the Secretary shall submit 
a report to the Committee on Labor and Human Resources of the 
Senate and the Committee on Interstate and Foreign Commerce of 
the House of Representatives, containing the results of the review 
and including recommendations regarding appropriate legislative or 
administrative action to improve current export policies, as the 
Secretary determines appropriate. 
SEC. 8. (a) Section 503 of the Controlled Substances Act (21 U.S.C. 
873) is amended by adding at the end the following new subsection: 
"(c) The Attorney General shall annually (1) select the controlled 
substance (or controlled substances) contained in schedule II which, 
in the Attorney General's discretion, is determined to have the 
highest rate of abuse, and (2) prepare and make available to regula-
tory, licensing, and law enforcement agencies of States descriptive 
and analytic reports on the actual distribution patterns in such 
States of each such controlled substance.". 
Ot)) Section 203 of the Psychotropic Substances Act of 1978 (Public 
Law 95-633) is amended by striking out subsection (d). 
(c) Section 401 of the Controlled Substances Act (21 U.S.C. 841) is 
amended— 
(1) by striking out "except as provided in paragraphs (4) and (5) 
of this subsection" in the first sentence of subsection (b)(1)(B) and 
inserting in lieu thereof "except as provided in paragraphs (4), 
(5), and (6) of this subsection"; and 
(2) by adding after paragraph (5) of subsection (b) the following 
new paragraph: 
"(6) In the case of a violation of subsection (a) involving a quantity 
of marihuana exceeding 1,000 pounds, such person shall be sentenced 
to a term of imprisonment of not more than 15 years, and in addition, 
may be fined not more than $125,000. If any person commits such a 
violation after one or more prior convictions of such person for an 
offense punishable under paragraph (1) of this paragraph, or for a 
PUBLIC LAW 96-359—SEPT. 26, 1980 
94 STAT. 1195 
felony under any other provision of this title, title III, or other law of ^^ use 801, 951. 
the United States relating to narcotic drugs, marihuana, or depres-
sant or stimulant substances, have become final, such person shall be 
sentenced to a term of imprisonment of not more than 30 years, and 
in addition, may be fined not more than $250,000.". 
Approved September 26, 1980. 
LEGISLATIVE HISTORY: 
HOUSE REPORT No. 96-936 (Ck)mm. on Interstate and Foreign Commerce). 
SENATE REPORT No. 96-916 accompanying S. 2490 (Comm. on Labor and Human 
Resources) 
CONGRESSIONAL RECORD, Vol. 126 (1980): 
May 20, considered and passed House. 
Sept. 8, considered and passed Senate, amended, in lieu of S. 2490. 
Sept. 9, House concurred in Senate amendment, 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 16, No. 39: 
Sept. 26, Presidential remarks and statement.