* '~ . / - :3!

nd Drug Law Hlstory

 

Significant Dates lnFoo

 

v1794
1924
1849

 

1850.

1979-1905
=g1979

189L4395
.1 1397

1992
‘1906

 

1997
[I9II

1912

 

91913

99f1921
’ 71923

745,1924

1927

 

71930

1933
*1937
‘1939

.’ ,‘1939
/ _ 1949
I941
1943

1944
ussu

/;~
I!"

'1983

,1914.

’Administration and then, in 1931, as the Food and Drug Administration (FDA).

 

Since the beginning of recorded hlsfiery, men who h9ve organized themselves into civilized societies
have been concerned about the purity ofI the food and drink offered to the public. "

‘ In 1202, King John of England proIcJ9imed the first English food law, the Assize of Bread. This .
prohibited adulteration of bread with s Eh ingredients as ground peas or beans. /
The following chronology describeséfome of the highlights in the history of food and drug measures

13;: 1 ., r" r~ r“
in the United States: , I525" . _ ;_ 5." I: , T K995 ?< /0
. . , W C;
MassachuSetts enacted the first general £0331“ law in the lgnlted States. : . \JL
Wmavn-m \ ‘ , . ‘ /, (a ,
Flour Inspection Act of Alexandria, Va. ., then in the District of Columbla, passed. ij7 O

C}
The Import Drugs Act-"first Federal statute to insure the quality of drugs—was passed when quinine
used by American troops in Mexico to treat malaria was found to be adulterated.

California passed a pure food and drink law,1 year after the gold rush.

During these 26 years more than 100 food and drug acts we’re introduced in Congress, but none Were
enacted.

Chief Chemist Peter Collier, Division of Chemistry, U. S Department of AgriCulture, began a food and drug
adulteration investigations The following year he recommended enactment of a national food and drug law.

APRIL 9 Dr. Harvey W. Wiley became Chief Chemist of the Bureau of Chemistry. Immediately he 'y'
assigned some members of 111s staff to study the problems of food and drug adulteration.

Acts passed requiring inspection of animals for diseases before slaughter. /'

MARCH 2. The Tea Importation Act (29 Stat: 604) \wastassed, providing for inspectionof all te9 Ci

" entering U. 5. ports.

Congress made appropriations to establish pure icod standards. Congress passed the BiologiCs Control Act
to license and regulate interstate sale of serums, vaccines, etc., used to prevent or treat diseases in humans. ,

jJUNE 30. The original Food and Drugs Act of 1906 (34 Stat. 768) passed Congress and was signed

"by President Theodore Reosevelt. The Act regulated interstate commerce in misbrandéd and

adulterated foods, drinks, and drug9. \The Meat Inspection Act was passed the same day Shocking
disclosures of insanitary conditions in meat packing plants, the use of poisonous preserVatiVes and dyes
in foods, and cure- -all claims for worthless and dangerous patent medicines led to the enactment of 1 , . ‘ 7

these laws. , 1 . , 7 , _ , , 9],. ..

JANUARY 1. The Bureau of JChemlstry, headed by Dr. Wiley, began admimsterlng the .
Food and Drugs Act of 1906

U. S. v. Johnson (221 U. S. 488). The Supreme Court ruled that the 1906 Act did not prohibit false ‘ I i . / \
therapeutic claims even though misleading, but only prohibited false and misleading claims j ,1
as to the identity of the drug (see Sherley Amendment, Aug. 23,1912); , Ms , ' 9

MARCH Dr Carl I. Alsberg succeeded \Dr. Wiley as Chief Chemist of the Bureau of Chemistry.
AUGUST 23. Sherley Amendment (37 Stat. 416) enacted to OverCOme ruling in U. S. v. Johnson labme)
prohibited labeling medicines with false therapeutic Claims intended to defraud the purchaser.

MARCH 3. Could Amendment (37 Stat. 732) enacted, requiring that definite quantity of information
:appear on food packages ' \ .

./ J \I

U. S. v. Lexington Mill and Elevator Co. (232 U. S. 399) The Supreme Court ruled that FDA
is not required to establish that articles containing poisonous or deleterious substances will affect the
'pubhc health, but only that they may do so. , /

JULY. Walter C. Campbell succeeded Dr. Alsberg and became Acting Chief of the Bureau of Chemistry 1

MARCH 4. Filled Milk Act (42 Stat. 1486) prohibited interstate traffic in milk or cream -'
containing any fat other than milk fat. . -

i \

U. S. v. 95 Barrels More Or Less Alleged Apple Cider Vinegar (265 U. S. 438). The Supreme Court 5 \
ruled that the Food and Drugs Act condemns every statement, design, or device which may mislead or \ '
deceive, even if it is technically true. . A / , - 7' 9

JULY. Mr. Campbell toqk over all regulatory Work of the Bureau of Chemistry as a separate function,
and Dr. Charles A. Browne became Chief of the Bureau.

A separate law enforcement agenCy was formed, first known as the Food Drug, and Insecticide

’Mr. Campbell became Chief. 7 [,1 4., i L V - A I 9

MARCH 4. Caustic Poison Act (44 Stat. 1406) provided for warning labels and antidotes on 10 dangerous
or corrosive substances packed in containers fOr household use. . /

JULY 30. M-cNary Mapes Amendment (46 Stat. 1019) was enacted, authorizing standards of quality

and fill of container for canned food. \ \

FDA expressed the need for a complete revision of the basic Act. First bill was introduced into the,'\Senate,
launching a fiVe- y-ear legislative battle. ’ ’ - 1 ‘ V i ‘

Elixir of Sulfanilamide killed 107 persons; showed need to establish drug safety prior to marketing.
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 (52 Stat. 1040) Was enacted,

and contained these new provisions
Extended Coverage to cosmetics and devices. , 7
Required predistribution clearance of safety on new drugs. . I \ 1'” ‘
Eliminated Sherley Amendment requirement to prove intent to defraud in drug misbranding cases.
[Provided for tolerances for unavoidable or required poisonous substances. '
Authorized standards of identity, quality, and fill of Container for foods. __ _ »,
Authorized factory inspections. , ' 3 ' .4 V i ‘.
’Added the remedy of court injunction to previous remedies of seizure and prosecution. if

(1

JULY 14. First fobd standards issued (for canned whole tomatoes, tomato puree, and tomato paste).

JULY 1. FDA transferred from the Department of Agriculture to the Federal Security Agency,

and Mr. Campbell became the first Commissioner of Food and Drugs... \

DECEMBER 22. FDC Act amended (55 Stat. 851) to require certification of the safety and efficacy

of insulin. , — , \ 1 _ / , _, _ ,
Federal Security Administrator v. Quaker Oats Company (318 U. S. 218). The Supreme Court r ~

ruled that the FDC Act authorizes the Administrator to use hrs judgment. based on “substantial e1idence,”

to promulgate definitions and standards of identity for certain products where truthful labeling is not ‘

adequate to maintain their integrity. The courts in reviewing the Administrator’s decision will not 7' V \‘

substitute their judgment for his. ' < i 9/
U. S. v. Dotterweich (320 U. S. 277) The Supreme Court ruled that the responsible offit 1.1L of

a corporation as well as the corporation itself, may be prosecuted for violations of the Act ’ '
committed by the corporation. / L I \

MAY 1. Dr. Paul B. Dunbar succeeded Mr. Campbell as Commissionen \ I J I 1

 

 

71945
1949
1950

'41951

x 1952
.1953

I956~

*1957

1959;

1959
71960

1961
.19a2~

1966

1967
1968

1969

., AUGUST 12

1955,

'JUNE 30. The committee recommended a substantial expansion of FDA s facilities, a new building,

, warning labeling on hazardous household chemicals.
‘ Act in 1966. )

1965 ,,

7' Federal Hazardous Substances Labeling Act, and enlarged its coverage.

 

; ‘ c 1' ' TEQCS
r/‘7 r f r . 7 7 1 .
JULY 6. FDC Act amended (59 Stat. 463) to require certification of the safety and efficacy of penicillin.
Later amendments extended this requirement to all antibiotics.

JUNE 24. Miller Amendment (62 Stat. 582) affirmed that the FDC Act is intended to safeguard goods

which have moved in interstate commerce until they reach the ultimate consumer.

Alberty Food PrOducts Co. v. U. S. (185 F2d 32,1 CA 9, 19501. The Court of Appeals held that the
directions for use on a drug label must include the purpose for which the drug is offered.
(Therefore, a person cannot sell a worthless remedy and escape the F DC Act by not stating the condition

, the drug is supposed to treat.)

MARCH 16 Oleomargarine Act (64 Stat. 20) required prominent labeling of colored olemargarine
to differentiate it from butter to prevent consumer deception .

62 Cases . .Jam v. U. S. (340 U. S. 593). The Supreme Court ruled that a standardized food which

does not meet its standard of identity cannot be sold legally unless it is marked‘ ‘imitatidn.” . , ,
JUNE 1. Charles W. Crawford succeeded Dr. Dunbar as commissioner. 7 ’ . 7 _ 4.

OCTOBER 26. Durham-Humphrey Amendment (65 Stat. 648) specifically required that drugs which
cannot be safely used without medical supervision must be labeled for sale, and be dispensed,
only by prescription of a licensed practitioner. , « , ‘ 1

U. S. v. Cardiff (344 U. S 174). The Supreme Court1ruled that the factory inspection provisiOn of the 7‘ ' . 1 ,

F DC Act was too vague to be enforced as criminal law (see factory inspection amendment, A\ug.7,1953). if ( ’

APRIL 11. Federal Security Agency became the U S. Department of Health, Education, and Welfare
(DHEW). , .

7 AUGUST 7. Factory inspection amendment (67 Stat. 476) clarified previous law and required FDA 7

’ to give manufacturers written reports on inspections and analyses ofs factory samples 7 '7 7

‘ JULY 22. Miller Pesticides Amendment (68 Stat. 511) streamlined procedures for Setting safety limits

(See U. S v. Cardiff abOVe). \\ 7 _ 7,
APRIL 15. Hale Amendment (68 Stat. 54) simplified method of promulgating food standards

when no controversy was involved.

for pesticide residues on raw agricultiiral commodities and greatly strengthened consumer protection.
George P Larrick suCCeeded Mr.C1‘anord as Commissioner.

(177'.

DHEW Secretary Oveta Culp Hobby appointed a committee of714 distinguished citizens to study the
adequacy of FDA’ 5 facilities and programs.‘ \-
and more use oF educational and informational prOgrams.

The 50th anniversary of the Act of 1906 was commemorated in a year of tribute and rededication
on the part of Government and industry to the came of effective food and drUg protection.

U. S. v. Adolphus Hohensee (243 F2d 367; CA 3,1957; cert. denied) The Court of Appeals held that
oral representations may be used to show the intended purpose of a drug to establish that it is misbranded.

SEPTEMBER Food Additives Amendment (72 Stab 17841 enacted, prohibiting use of new food
additives until sponsor establishes safety and FDA issues regulations specifying conditions of use.

The first new District Office 11124 years was opened in Detroit, Mich. ., i711 fac1l1t1es espec1ally equlpped

for scientific enforCement. "F 7 \

JULY 12. Color Additive Amendments'i(74 Stat. 397) enacted to allow FDA to establish by regulations the
conditions of safe use fer color a‘dditivbs in foods, drugs, and cosmetics, and 40 require manufacturers ‘ '
to perform the necessary scientifiC/ investigations to establish safety. 1 / ,

JULY 12. Federal Hazardous Substances Labeling Act (74 Stat. 372) passed {6 require prominent -

(Name changed to Federal Hazardous Substmces ,

OCTOBER First AMA- FDA conference on medical quackery held. 8 I \ / "

JULY 15. News repOrts on the role of Dr Frances O. Kelsey, FDA Medical Officer, in keeping thalidomide
off the American market aroused- public intereSt in drug regulation. The drug had been associated

with the birth of thousands of- malformed babies in Western \Europe. 5 ~ , 1 / , ~ s » ' _ g ~

OCTOBER 10. Kefauver- Harris Drug Amendments (76 Stat. 780) passed to assure a greater degree .
of safety and to strengthen new drug clearance procedures. For the first time, drug manufacturers “
were required to prove to FDA the effectiveness of their products before marketing them. “ /

JULY 15. Drug Abuse Control Amendments (79 Stat. 226) enacted (to deal .with problems caused by abuse
of three groups of dangerous drugs—depressants, stimulants, and hallucinogens. The law allowed FDA

to require all legal handlers of controlled drugs to keep records of their supplies and sales, \_ i " / '7
to seize illegal supplies of controlled drugs, to SerVe Warrants, and to arrest violators. .. - '

NOVEMBER 23. New FDA Washington headquarters laboratory dedicated. 7 7 ,0 - 7

\

1 Commissmner LaI'I'le retires.

FDA contracted with the National Academy of Sciences— National Research Council to evaluate the ‘
effectiveness of 3, 000- 4, 000 new drugs which were approved on the basis of safety alone between
1938 and 1962. 1 . 1

JANUARY 17. Dr. James Lee Goddard succeeded Mr. Larrick as Commissioner.

NOVEMBER 3. Child Protection Act (80 Stat. 1303 t deleted the word “Labeling” from the

Banned from interstate commerce
were hazardous toys and articles intended for children and other articles so hazardous that adequate
warnings cannot be written. The Act also applied to unpackaged articles intended for household use.

NOVEMBER 3. Fair Packaging and Labeling Act (80 Stat. 1296) enacted to require that consumer ’
products in interstate commerce“ be honestly and infermatively labeled. FDA to enforce provisions which
affect foods, drugs, cosmetics,7a7nd medical devices. , _. ’

\

FDA National Center for Drug Analysis to study intensively the Nation 5 drug supply, established at
St. Louis, Missouri.

/

APRIL 8. FDA Bureau of Drug Abuse Control transferred to new Bureau of Narcotics and Dangerous

Drugs in Department of JUStice, to consolidate policing of illegal drug traffic. .
JULY 1. Dr. Herbert L. Ley, Jr., M. D., succeded Dr. Ceddard as Commissioner.
Expanded FDA begins administration of programs transferred from other units of the Public Health Service, '

for milk, food service, shellfish and interstate travel sanitation; poisoning and accident prevention,
and pesticide research.

DECEMBER 11. FDA reorganization announced by Robert H. Finch, Secretary of Health, Education,
and Welfare Dr. Charles C. Edwards, M. D., succeeds Dr. Ley as Commissioner. ,

l. S DE PARIMEN T OF HE AI TH, EDUf ATION AND WELFARE
l'nnd and Drug Administratioin Washington DC. 20204

FDA Publication No 20
(Ruised January 1970):;"7172 A,
n 0 ’A ‘k I

1‘! U. S. GOVERNMENT PRINTING OFFICE 2 1970 O - 384-259