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  5. Key Terms for Cosmetics Regulation: Interstate Commerce, Adulterated, and Misbranded
  1. Cosmetics Laws & Regulations

Key Terms for Cosmetics Regulation: Interstate Commerce, Adulterated, and Misbranded

The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits, among other things, the introduction or delivery for introduction into interstate commerce any cosmetic that is adulterated or misbranded. Here is a brief introduction to what those terms mean.

Introduction

The Federal Food, Drug, and Cosmetic Act (FD&C Act), which was amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), prohibits, among other things:

  • "The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded" [FD&C Act, sec. 301(a); 21 U.S.C. 331(a)].
  • "The adulteration or misbranding of any food, drug, device or cosmetic in interstate commerce" [FD&C Act, sec. 301(b); 21 U.S.C. 331(b)].
  • "The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise"[FD&C Act, sec. 301(c); 21 U.S.C. 331(c)].
  • "The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded" [FD&C Act, sec. 301(k); 21 U.S.C. 331(k)].

This means that nearly everyone involved in cosmetics in interstate commerce, such as manufacturers, packers, distributors, and retailers, is responsible for assuring that he or she is not dealing in products that are adulterated or misbranded, even if someone else caused the adulteration or misbranding in the first place. If you introduce it into interstate commerce or receive it in interstate commerce, you are responsible. The law applies to components and packaging as well as to finished products.

The FD&C Act describes what constitutes interstate commerce, adulteration, and misbranding. It also authorizes FDA to take legal action if cosmetics are adulterated or misbranded. In addition, the Fair Packaging and Labeling Act (FPLA) requires specific label information. Violations of the FPLA result in misbranding.

How the FD&C Act Defines "Interstate Commerce"

Section 201(b) of the FD&C Act [21 U.S.C. 321(b)] defines "interstate commerce" as:

(1) commerce between any State or Territory and any place outside thereof, and
(2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.

It is rare that a cosmetic product on the market is not in "interstate commerce" under the FD&C Act. For example, at least some of your ingredients or packaging most likely originate from out of state, or even out of the country. Likewise, your products may leave the state to be distributed or offered for sale. Facts such as these generally cause your cosmetics to be subject to the requirements of the FD&C Act.

What Makes a Cosmetic Adulterated

Section 601 of the FD&C Act [21 U.S.C. 361] describes what causes a cosmetic to be adulterated. MoCRA amends section 601 by adding (f) and (g) below. Section 601 states:

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 that 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) [Note: see below], 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 721(a). [Note: Section 721(a) of the FD&C Act [21 U.S.C. 379e] deems color additives unsafe unless they meet certain conditions.]
    (f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements (GMP) of section 606. [Note: MoCRA required FDA to establish GMPs by regulation. See section 606 of the FD&C Act [21 U.S.C. 364b].] 
    (g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for safety, as defined in section 608(c).

In sum, the FD&C Act’s adulteration provision for cosmetics addresses:

  • the composition of the cosmetic;
  • the conditions under which the cosmetic is manufactured, shipped, and stored; 
  • the container;
  • color additives;
  • GMP requirements; and
  • safety substantiation of a cosmetic product and its ingredients.

What Makes a Cosmetic Misbranded

Section 602 of the FD&C Act [21 U.S.C. 362] describes what causes a cosmetic to be misbranded. MoCRA amended section 602(b) to provide that a cosmetic is misbranded if it is not in compliance with the labeling requirements set forth in section 609. Section 602 states:

"A cosmetic shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing:

(1) the name and place of business of the manufacturer, packer, or distributor;
(2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and
(3) the information required under section 609 [21 U.S.C 364e]: 

Provided, that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d) If its container is so made, formed, or filled as to be misleading.

(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 721 [21 U.S.C. 379e].  This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a) [21 U.S.C. 361(a)]). 

(f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970 [section 1472 or 1473 of U.S.C. title 15].

The FD&C Act also describes what to consider in determining whether labeling or advertising is misleading. Section 201(n) of the FD&C Act [21 U.S.C. 321(n)] states:

If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.

In sum, the FD&C Act’s misbranding provision for cosmetics addresses:

  • False or misleading information; 
  • Lack of required information, including information required under section 609:
    • Section 609(a) cosmetic product labeling
    • Section 609(b) fragrance allergen labeling [Note: MoCRA required FDA to determine substances that are fragrance allergens for the purpose of this labeling requirement by regulation. See section 609 of the FD&C Act [21 U.S.C. 364e].]
    • Section 609(c) professional use labeling
  • Conspicuousness and readability of required information;
  • Misleading packaging;
  • Improper packaging and labeling of color additives; and
  • Violations of regulations issued under the Fair Packaging and Labeling Act Poison Prevention Packaging Act. 

In addition, a cosmetic which is introduced or delivered for introduction into commerce in violation of the FPLA or any regulations issued under its authority is considered misbranded within the meaning of the FD&C Act [15 U.S.C.1456(a)]. For cosmetics that are consumer commodities, the FPLA:

  • requires certain label information, such as the product's identity [15 U.S.C.1453], and
  • authorizes the implementation of regulations to specify the proper presentation of required label information, require an ingredient declaration, and prevent deceptive packaging [15 U.S.C.1454 (c)]

The FPLA defines a consumer commodity as:

"any food, drug, device, or cosmetic (as those terms are defined by the Federal Food, Drug, and Cosmetic Act ..., and any other article, product, or commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use." [15 U.S.C.1459(a)]

Note that labeling a product with words such as “For Professional Use Only” does not necessarily prevent your product from being subject to FPLA requirements. For example, section 609(c)(2)(B) of the FD&C Act states that a cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that, among other things, is in conformity with the requirements of section 4(a) of the FPLA [15 U.S.C. 1453(a)].

Detailed information on cosmetic labeling is available in FDA's Cosmetics Labeling Guide | FDA and the Code of Federal Regulations Sections for Cosmetics Labeling (CFR Title 21, Part 701) | FDA.

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