21 USC § 361 - Adulterated cosmetics | Title 21 - Food and Drugs | U.S. Code

USCPrelim is a preliminary release and may be subject to further revision before it is released again as a final version.

Current through Pub. L. 112-238. (See Public Laws for the current Congress.)

A cosmetic shall be deemed to be adulterated—

(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.

(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e (a) of this title.

prev | next

A cosmetic shall be deemed to be adulterated—

(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes.

(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.

(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e (a) of this title.

Source

(June 25, 1938, ch. 675, § 601,52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(1),July 12, 1960, 74 Stat. 398; Pub. L. 102–571, title I, § 107(11),Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(x),Aug. 13, 1993, 107 Stat. 778.)

Amendments

1993—Subsec. (a). Pub. L. 103–80substituted “usual, except that this” for “usual: Provided, That this”.

1992—Par. (e). Pub. L. 102–571substituted “379e(a)” for “376(a)”.

1960—Par. (e). Pub. L. 86–618substituted “and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376 (a) of this title” for “and it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 364 of this title”.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618effective July 12, 1960, subject to the provisions of section 203 ofPub. L. 86–618, see section 202 ofPub. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Par. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Effective Date

Section effective twelve months after June 25, 1938, except par. (a), which, with certain exceptions, became effective on June 25, 1938, see section 1002(a) of act June 25, 1938, set out as a note under section 301 of this title.

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Thursday, March 14, 2013

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

How To Use

Multiple entries for a section are listed most recent first, within the section.

The Session Year indicates which session of Congress was responsible for the changes classified. The Congress number forms the first part of the Public Law number; each Congress has two sessions.

Abbreviations used in the Description of Change column:

An empty field implies a standard amendment.
"new" means a new section or new note, or all new text of an existing section or note.
"nt" means note.
"nt [tbl]" means note [table].
"prec" means preceding.
"fr" means a transfer from another section.
"to" means a transfer to another section.
"omitted" means the section is omitted.
"repealed" means the section is repealed.
"nt ed change" and "ed change" - See the Editorial Classification Change Table [pdf].

The Public Law field is linked to the development of the law in the Thomas system at the Library of Congress.

The Statutes at Large field is linked to the text of the law, in the context of its volume of the Statutes at Large, at the Government Printing Office. Please note that it takes a while for these pages to get posted, so for very recent legislation, you need to look at the "enrolled" version at the Thomas site.

The Statutes at Large references have been rendered in the format used as page numbers in the Public Law web pages to which we link, to facilitate copy-paste into browser "find on this (web) page" tools. We are still working on a more direct link facility.

For serious comparison work, we suggest copying all or a portion of the Public Law text into your favorite text editor, for convenient content traversal and window control.

Sections with change type "new" are a special case, still under development. All are now listed, at the title level only.

You will find that occassionally a specific update you notice in a Public Law listed in a classification table will already have made it into the Code. We assume this is an artifact of the LRC edit process. The LII does not edit the LRC content.

top

General Reference

Refer to the LRC (Law Revision Council) for explanations about the US Code from the folks who put it all together.

You can look for information about what it is and is not, which titles are positive law, the schedule of Supplements, etc. Under download you can find the source data we use here (GPO locator files), as well as, PDF files that look just like the paper books (these may be rather large).

Refer to the Thomas site for changes that have not yet made it into the classification tables.

21 USC	Description of Change	Session Year	Public Law	Statutes at Large

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

21 CFR - Food and Drugs

21 CFR 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

21 CFR 5 - ORGANIZATION

21 CFR 7 - ENFORCEMENT POLICY

21 CFR 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR 20 - PUBLIC INFORMATION

21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR 70 - COLOR ADDITIVES

21 CFR 71 - COLOR ADDITIVE PETITIONS

21 CFR 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

21 CFR 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

21 CFR 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS

21 CFR 300 - GENERAL

21 CFR 310 - NEW DRUGS

21 CFR 505

21 CFR 700 - GENERAL

21 CFR 701 - COSMETIC LABELING

21 CFR 710 - VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS

21 CFR 730

21 CFR 740 - COSMETIC PRODUCT WARNING STATEMENTS

21 CFR 800 - GENERAL

21 USC § 361 - Adulterated cosmetics

U.S. Code Toolbox

Law about... Articles from Wex

Find a Lawyer

Get Involved