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TABLE OF CONTENTS
FEDERAL FOOD AND DRUGS ACT OF 1906
TITLE 21--FOOD AND DRUGS
CHAPTER 1--ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER I--FEDERAL FOOD AND DRUGS ACT OF 1906
§ 1 Manufacture of Adulterated Foods or Drugs
§ 2 Interstate Commerce of Adulterated Goods
§ 3 Rules and Regulations
§ 4 Chemical Examinations
§ 5 Legal Proceedings
§ 6 Definitions
§ 7 Adulterations
§ 8 Misbranding
§ 9 Guaranty from Manufacturer
§ 10 Seizure of Original Package
§ 11 Examination of Imported Food and Drugs
§ 12 Definitions and Liabilities
§ 13 Effective Date
Amendatory and Supplemental Enactments To the Federal Food and Drug Act of 1906
FEDERAL FOOD AND DRUGS ACT OF 19061
AN ACT For preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SEC. 1. MANUFACTURE OF ADULTERATED FOODS OR DRUGS.2
That it shall be unlawful for any person to manufacture within any Territory
or the District of Columbia any article of food or drug which is adulterated
or misbranded, within the meaning of this Act; and any person who shall violate
any of the provisions of this section shall be guilty of a misdemeanor, and
for each offense shall, upon conviction thereof, be fined not to exceed five
hundred dollars or shall be sentenced to one year's imprisonment, both such
fine and imprisonment, in the discretion of the court, and for each subsequent
offense and conviction thereof shall be fined not less than one thousand
dollars or sentenced to one year's imprisonment, or both such fine and imprisonment,
in the discretion of the court.
SEC. 2. INTERSTATE COMMERCE OF ADULTERATED GOODS.
That the introduction into any State or Territory or the District of Columbia
from any other State or Territory or the District of Columbia, or from any
foreign country, or shipment to any foreign country of any article of food
or drugs which is adulterated or misbranded, within the meaning of this Act,
is hereby prohibited; and any person who shall ship or deliver for shipment
from any State or Territory or the District of Columbia to any other State
or Territory or the District of Columbia, or to a foreign country, or who
shall receive in any State or Territory or the District of Columbia from
any other State or Territory or the District of Columbia, or foreign country,
and having so received, shall deliver, in original unbroken packages, for
pay or otherwise, or offer to deliver to any other person, any such article
so adulterated or misbranded within the meaning of this Act, or any person
who shall sell or offer for sale in the District of Columbia or the Territories
of the United States any such adulterated or misbranded foods or drugs or
export or offer to export the same to any foreign country, shall be guilty
of a misdemeanor, and for such offense be fined not exceeding two hundred
dollars for the first offense and upon conviction for each subsequent offense
not exceeding three hundred dollars or be imprisoned not exceeding one year,
or both, in the discretion of the court: Provided, That no article
shall be deemed misbranded or adulterated within the provisions of this Act
when intended for export to any foreign country and prepared or packed according
to the specifications or directions of the foreign purchaser when no substance
is used in the preparation or packing thereof in conflict with the laws of
the foreign country to which said article is intended to be shipped; but
if said article shall be in fact sold or offered for sale for domestic use
or consumption, then this proviso shall not exempt said article from the
operation of any of the other provisions of this Act.
1Section headings added.
2 Sections 1 to 5 repealed (June 25, 1938, ch. 675, 1 902(a),
52 Stat. 1059).
SEC. 3. RULES AND REGULATIONS.
That the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary
of Commerce and Labor shall make uniform rules and regulations for carrying
out the provisions of this Act, including the collection and examination
of specimens of foods and drugs manufactured or offered for sale in the District
of Columbia or in any Territory of the United States, or which shall be offered
for sale in unbroken packages in any State other than that in which they
shall have been respectively manufactured or produced, or which shall be
received from any foreign country, or intended for shipment to any foreign
country, or which may be submitted for examination by the chief health, food,
or drug officer of any State, Territory, or the District of Columbia, or
at any domestic or foreign port through which such product is offered for
interstate commerce, or for export or import between the United States and
any foreign port or country.
SEC. 4. CHEMICAL EXAMINATIONS.
That the examinations of specimens of foods and drugs shall be made in the
Bureau of Chemistry of the Department of Agriculture, or under the direction
and supervision of such Bureau, for the purpose of determining from such
examinations whether such articles are adulterated or misbranded within the
meaning of this Act; and if it shall appear from any such examination that
any of such specimens is adulterated or misbranded within the meaning of
this Act, the Secretary of Agriculture shall cause notice thereof to be given
to the party from whom such sample was obtained. Any party notified shall
be given an opportunity to be heard under such rules and regulations as may
be prescribed as aforesaid, and if it appears that any of the provisions
of this Act have been violated by such party, then the Secretary of Agriculture
shall at once certify the facts to the proper United States district attorney,
with a copy of the results of the analysis or the examination of such article
duly authenticated by the analyst or officer making such examination, under
the oath of such officer. After judgment of the court, notice shall be given
by publication in such manner as may be prescribed by the rules and regulations
aforesaid.
SEC. 5. LEGAL PROCEEDINGS.
That it shall be the duty of each district attorney to whom the Secretary of
Agriculture shall report any violation of this Act, or to whom any health
or food or drug officer or agent of any State, Territory, or the District
of Columbia shall present satisfactory evidence of any such violation, to
cause appropriate proceedings to be commenced and prosecuted in the proper
courts of the United States, without delay, for the enforcement of the penalties
as in such case herein provided.
SEC. 6. DEFINITIONS.
That the term "drug," as used in this Act, shall include all medicines
and preparations recognized in the United States Pharmacopoeia or National
Formulary for internal or external use, and any substance or mixture of substances
intended to be used for the cure, mitigation, or prevention of disease of either
man or other animals. The term "food," as used herein, shall include
all articles used for food, drink, confectionery, or condiment by man or other
animals, whether simple, mixed, or compound.
SEC. 7. ADULTERATIONS.
That for the purposes of this Act an article Shall be deemed to be adulterated:
IN CASE OF DRUGS:
IN THE CASE OF CONFECTIONERY:
If it contain terra alba, barytes talc, chrome yellow, or other mineral substance
or poisonous color or flavor, or other ingredient deleterious or detrimental
to health, or any vinous, malt or spirituous liquor or compound or narcotic
drug.
IN THE CASE OF FOOD:
SEC. 8. MISBRANDING.
That the term "misbranded," as used herein, shall apply to all drugs,
or articles of food, or articles which enter into the composition of food,
the package or label of which shall bear any statement, design, or device regarding
such article, or the ingredients or substances contained therein which shall
be false or misleading in any particular, and to any food or drug product which
is falsely branded as to the State, Territory, or country in which it is manufactured
or produced.
That for the purposes of this Act an article shall also be deemed to be misbranded:
IN CASE OF DRUGS:
IN THE CASE OF FOOD:
SEC. 9. GUARANTY FROM MANUFACTURER.
That no dealer shall be prosecuted under the provisions of this Act when he
can establish a guaranty signed by the wholesaler, jobber, manufacturer,
or other party residing in the United States, from whom he purchases such
articles, to the effect that the same is not adulterated or misbranded within
the meaning of this Act, designating it. Said guaranty, to afford protection,
shall contain the name and address of the party or parties making the sale
of such articles tosuch dealer, and in such case said party or parties shall
be amenable to the prosecutions, fines, and other penalties which would attach,
in due course, to the dealer under the provisions of this Act.
SEC. 10. SEIZURE OF ORIGINAL PACKAGES.
That any article of food, drug, or liquor that is adulterated or misbranded
within the meaning of this Act, and is being transported from one State,
Territory, District, or insular possession to another for sale, or, having
been transported, remains unloaded unsold or in original unbroken packages,
or if it be sold or offered for sale in the District of Columbia or the Territories,
or insular possessions of the United States, or if it be imported from a
foreign country for sale, or if it is intended for export to a foreign country,
shall be liable to be proceeded against in any district court of the United
States within the district where the same is found, and seized for confiscation
by a process of libel for condemnation. And if such article is condemned
as being adulterated or misbranded, or of a poisonous or deleterious character,
within the meaning of this Act, the same shall be disposed of by destruction
or sale, as the said court may direct, and the proceeds thereof, if sold,
less the legal costs and charges, shall be paid into the Treasury of the
United States, but such goods shall not be sold in any jurisdiction contrary
to the provisions of this Act or the laws of that jurisdiction: Provided,
however, That upon the payment of the costs of such libel proceedings
and the execution and delivery of a good and sufficient bond to the effect
that such articles shall not be sold or otherwise disposed of contrary to
the provisions of this Act, or the laws of any State, Territory, District,
or insular possession, the court may by order direct that such articles be
delivered to the owner thereof. The proceedings of such libel cases shall
conform, as near as may be, to the proceedings in admiralty, except that
either party may demand a trial by jury of any issue of fact joined in any
such case, and all such proceedings shall be at the suit of and in the name
of the United States.
SEC. 11. EXAMINATION OF IMPORTED FOOD AND DRUGS.
The Secretary of the Treasury shall deliver to the Secretary of Agriculture,
upon his request from time to time, samples of foods and drugs which are
being imported into the United States or offered for import, giving notice
thereof to the owner or consignee, who may appear before the Secretary of
Agriculture, and have the right introduce testimony, and if it appear from
the examination of such samples that any article of food or drug offered
to be imported into the United States is adulterated or misbranded within
the meaning of this Act, or is otherwise dangerous to the health of the people
of the United States, or is of a kind forbidden entry into, or forbidden
to be sold or restricted in sale in the country in which it is made, or from
which it is exported, or is otherwise falsely labeled in any respect, the
said article shall be refused admission, and the Secretary of the Treasury
shall refuse delivery to the consignee and shall cause the destruction of
any goods refused delivery which shall not be exported by the consignee within
three months, from the date of notice of such refusal under such regulations
as the Secretary of the Treasury may prescribe: Provided, That the
Secretary of the Treasury may deliver to the consignee such goods pending
examination and decision in the matter on execution of a penal bond for the
amount of the full invoice value of such goods, together with the duty thereon,
and on refusal to return such goods for any cause to the custody of the Secretary
of the Treasury, when demanded, for the purpose of excluding them from the
country, or for any other purpose, said consignee shall forfeit the full
amount of the bond: And provided further, that all charges for storage,
cargo, and labor on goods which are refused admission or delivery shall be
paid by the owner or consignee, and in default of such payment shall constitute
a lien against any future importation made by such owner or consignee.
SEC. 12. DEFINITIONS AND LIABILITIES.
That the term 'Territory" as used in this Act shall include the insular
possessions of the United States. The word "person" as used in this
Act shall be construed to import both the plural and the singular, as the case
demands, and shall include corporations, companies, societies and associations.
When construing and enforcing the provisions of this Act, the act, omission,
or failure of any officer, agent, or other person acting for or employed by
any corporation, company, society, or association, within the scope of his
employment or office, shall in every case be also deemed to be the act, omission,
or failure of such corporation, company, society, or association as well as
that of the person.
SEC. 13. EFFECTIVE DATE.
That this Act shall be in force and effect from and after the first day of
January, nineteen hundred and seven.
APPROVED, JUNE 30, 1906.
****
AN ACT TO amend section eight of the Food and Drugs Act approved June thirtieth, nineteen hundred and six.1
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
That that part of section eight of the Food and Drugs Act of June thirtieth, nineteen hundred and six, defining what shall be misbranding in the case of drugs, be, and the same is hereby, amended by adding thereto a third paragraph to read as follows:
So that the said part of said section eight shall read as follows:
SEC. 8. That the term 'misbranded,' as used herein, shall apply to all drug or articles of food or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactured or produced.
That for the purposes of this Act an article shall also be deemed to be misbranded.
IN CASE OF DRUGS:
APPROVED, AUGUST 23, 1912.
****
AN ACT To amend section eight of an Act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," approved June thirtieth, nineteen hundred and six.2
1 37 Stat. 416 (1912)(commonly known as the Sherley Amendment).
237 Stat. 732 (1913) (Gould Amendment)
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SEC. 1. That section eight of an Act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," approved June thirtieth nineteen hundred and six, be, and the same is hereby, amended by striking out the words:
"Third. If in package form, and the contents are stated in terms of weight or measure, they are not plainly and correctly stated on the outside of the package," and inserting in lieu thereof the following:
"Third. If in package form, the quantity of the contents be not plainly and conspicuously marked on the outside of the package in terms of weight, measure or numerical count: Provided, however, That reasonable variations shall be permitted, and tolerances and also exemptions as to small packages shall be established by rules and regulations made in accordance with the provisions of Section three of this Act."
SEC. 2. That this Act shall take effect and be in force from and after its passage: Provided, however, That no penalty of fine, imprisonment, or confiscation shall be enforced for any violation of its provisions as to domestic products prepared or foreign productions imported prior to eighteen months after its passage.
APPROVED, MARCH 3, 1913.
****
That the word "package" where it occurs the second and last time in the Act entitled "An Act to amend section 8 of an Act entitled, 'An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous, deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes'," approved March 3, 1913, shall include and shall be construed to include wrapped meats inclosed in papers or other materials as prepared by the manufacturers thereof for sale.1
****
AN ACT TO define butter and to provide a standard therefor.2
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
That for the purposes of the Food and Drug Act of June 30, 1906, "butter" shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.
APPROVED, MARCH 4, 1923.
1 41 Stat. 271 (1919) (Kenyon Amendment)
2 42 Stat. 1500 (1923)
****
Hereafter the examinations of specimens of foods, drugs, insecticides, paris greens, lead arsenates, and fungicides provided for by section 4 of the Food and Drugs Act of June 30, 1906, and by section 4 of the Insecticide Act of 1910, shall as be made in the Food, Drug, and Insecticide Administration or in such other branches of the Department of Agriculture as the Secretary of Agriculture may direct.1
****
AN ACT TO amend section 8 of the Act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," approved June 30,1906, as amended.2
Be it enacted by the Senate and House of Representatives of the United Stares of America in Congress assembled,
That section 8 of the Act of June 30, 1906, entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," as amended, is amended by adding at the end thereof the following:
"Fifth. If it be canned food and falls below the standard of quality, condition, and/or fill of container, promulgated by the Secretary of Agriculture for such canned food and its package or label does not bear a plain and conspicuous statement prescribed by the Secretary of Agriculture indicating that such canned food falls below such standard. For the purposes of this paragraph the words canned food mean all food which is in hermetically sealed containers and is sterilized by heat, except meat and meat food products which are subject to the provisions of the Meat Inspection Act of March 4, 1907, as amended, and except canned milk; the word class means and is limited to a generic product for which a standard is to be established and does not mean a grade, variety, or species of a generic product. The Secretary of Agriculture is authorized to determine, establish, and promulgate, from time to time, a reasonable standard of quality, condition, and/or fill of container for each class of canned food as will, in his judgment, promote honesty and fair dealing in the interest of the consumer; and he is authorized to alter or modify such standard from time to time as, in his judgment, honesty and fair dealing in the interest of the consumer may require. The Secretary of Agriculture is further authorized to prescribe and promulgate from time to time the form of statement which must appear in a plain and conspicuous manner on each package or label of canned food which falls below the standard promulgated by him, and which will indicate that such canned food falls below such standard, and he is authorized to alter or modify such form of statement, from time to time, as in his judgment may be necessary. In promulgating such standards and forms of statements and any alteration or modification thereof, the Secretary of Agriculture shall specify the date or dates when such standards shall become effective, or after which such statements shall be used, and shall give public notice not less than ninety days in advance of the date or dates on which such standards shall become effective or such statements shall be used. Nothing in this paragraph shall be construed to authorize the manufacture, sale, shipment, or transportation of adulterated or misbranded foods."
APPROVED, JULY 8, 1930.
1 44 Stat. 976-1003 (1927).
2 46 Stat. 1019 (1930) (McNary-Mapes Amendments).
****
AN ACT TO amend the Act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," approved June 30, 1906, as amended.1
Be it enacted by the Senate and House of Representatives of the United Stares of America in Congress assembled,
That the Act entitled "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes," approved June 30, 1906, as amended, is amended by adding after section 10 thereof the following new section:
SEC. 10A. The Secretary of Agriculture, upon application of any packer of any sea food sold in interstate commerce, may at his discretion designate supervisory inspectors to examine and inspect all premises, equipment, methods, materials, containers, and labels used by such applicants in the production of such food. If the food is found to conform to the requirements of this Act, the applicant shall be authorized, in accordance with regulations prescribed by the Secretary of Agriculture, to mark the food so as to indicate such conformity. Services to any applicant under this section shall be rendered only upon payment of fees to be fixed by regulations of the Secretary of Agriculture in such amount as to cover the cost of the supervisory inspection and examination, together with the reasonable costs of administration incurred by the Secretary of Agriculture in carrying out this section. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary of Agriculture for expenditures incurred in carrying out this section. Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized by the provisions of this section or regulations thereunder, shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.
APPROVED, JUNE 22, 1934.
1 48 Stat. 1204 (1934)