• the identity of the product, in English and French in terms of common or generic name or function;
• a statement of net quantity in metric units of measurement;
• the name and address of the manufacturer or distributor; and
• directions, warnings or cautions, in English and French where necessary for safe use of the product.

Cosmetics marketed in the United States, whether manufactured here or imported from abroad, must be in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Fair Packaging and Labeling Act (FPLA), and the regulations published under the authority of these laws.

The regulations published by the Food and Drug Administration (FDA) are all codified in Title 21, Code of Federal Regulations (21 CFR). The regulations applicable to cosmetics are stated at 21 CFR, parts 700 to 740 (21 CFR 700 to 740). The color additive regulations applicable to cosmetics are found at 21 CFR 73, 74 and 82. Copies of the 21 CFR volumes containing these regulations may be obtained at current cost from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, telephone (202) 783-3238.

Return To Top

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law.

Cosmetics that are also Drugs

Products that are cosmetics but are also intended to treat or prevent disease, or otherwise affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., "fluoride" toothpastes), hormone creams, suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.

Karl Note: Note that there is no cateogry for a "cosmetic" which also affects structure or function of the human body which is NOT a drug -- such as what would be classified as a "vitamin." In other words, you can swallow some pill, called a vitamin, more free of restrictions than you can apply a cream intended to deliver the same results as the vitamin, but do it topically.

Presumably if the "cream" is called a "topical supplement" and not a cosmetic, it would not fall under the drug or cosmetic rules?

For further data on the possibility of marketing a "skin cream" which would be neither a "cosmetic" nor a "drug" but could fall under the classification covered by the Dietary Supplement Health and Education Act (click here for summary of the Act) read this page.

Return To Top

Most currently marketed cosmetics which are also drugs are over-the-counter drugs. Several are new drugs for which safety and effectiveness had to be proved to the agency before they could be marketed. A new drug is a drug which is not generally recognized by experts as safe and effective under the conditions of intended use or which has become so recognized but has not been used to a material extent or for a material time under such conditions.

The regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. For example, the FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. See 21 CFR 207. Additionally, drugs must be manufactured in accordance with current good manufacturing practice regulations as codified at 21 CFR 210 and 211.

Return To Top

Adulterated or Misbranded Cosmetics

The FD&C Act prohibits the distribution of cosmetics which are adulterated or misbranded. A cosmetic is considered adulterated if it contains a substance which may make the product harmful to consumers under customary conditions of use; if it contains a filthy, putrid, or decomposed substance; if its container is composed of a harmful substance; if it is manufactured or held under insanitary conditions whereby it may have become contaminated with filth, or may have become harmful to consumers; or if it is not a hair dye that contains a non-permitted color additive.

Coal-tar hair dyes bearing on the label the caution statement prescribed by law and give "patch-test" instructions are exempted from the adulteration provision even if they are irritating to the skin or are otherwise harmful to the human body. Eyelash and eyebrow dyes are not included in this exemption. All dyes used in eyelash and eyebrow dye products must be approved by the FDA for such use.

Return To Top

A cosmetic is misbranded if its labeling is false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner.

Cosmetic Safety

Although the FD&C Act does not require that cosmetic manufacturers or marketers test their products for safety, the FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears the following statement: "Warning - The safety of this product has not been determined." See 21 CFR 740.10.

Return To Top

With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may, on his own responsibility, use essentially any raw material as a cosmetic ingredient and market the product without approval. The law requires that color additives used in food, drugs and cosmetics must be tested for safety and approved by the FDA for their intended uses. A cosmetic containing an unlisted color additive; i.e., a color additive which has not been approved by the FDA for zits intended use, is considered adulterated and subject to regulatory action. The color additives approved for use in cosmetics are listed at 21 CFR 73, 74 and 82.

Return To Top

The use of the following ingredients is either restricted or prohibited in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants, and hexachlorophene. See 21 CFR 700.11 to 700.23 and 250.250. The agency also considers as adulterated cosmetic nail products containing methyl methacrylate monomer or those containing more than 5% formaldehyde. Although not prohibited by law or regulation, in addition, the manufacturers of cosmetic fragrance products have voluntarily agreed to not use or to limit maximum use levels of certain selected ingredients which have been found to cause depigmentation, irritant, neurotoxic, or phototoxic or other allergic reactions.

Voluntary Registration

Although the FD&C Act does not require cosmetic firms to register manufacturing establishments or formulations with the FDA or make available safety data or other information before a product is marketed in the United States, manufacturers or distributors of cosmetics may submit this information to the agency voluntarily. Voluntary registration and assignment of a registration number by the agency does not denote approval of a firm or product by the FDA. Any use of a registration number in labeling must be accompanied by a conspicuous disclaimer phrase as prescribed by regulation. See 21 CFR 710, 720 and 730.

Return To Top

Cosmetic Labeling

The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FPLA.

Labeling means all labels and other written, printed or graphic matter on or accompanying a product.

The label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper.

FPLA requirements, e.g., ingredient labeling and statement of the net quantity of contents on the principal display panel, only apply to the label of the outer container.

The labeling requirements are codified at 21 CFR 701 and 740. Cosmetics bearing false or misleading label statements or otherwise not labeled in accordance with the codified requirements may be considered misbranded and may be subject to regulatory action.

The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale (21 CFR 701.10) and generally bearing the name of the product. It must identify by descriptive name or illustration the nature or use of the product and bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.

The declaration must be distinct, placed in the bottom area of the panel in line generally parallel to the base on which the package rests, and in a type size commensurate with the size of the container as prescribed by regulation.

The net quantity of contents statement of a solid, semi-solid or viscous cosmetic must be in terms of the avoirdupois pound and ounce, and a statement of liquid measure must be in terms of the U.S. gallon of 231 cubic inches and the quart, pint, and fluid ounce subdivisions thereof. If the net quantity of contents exceeds one pound or one pint, it must be expressed in ounces, followed in parenthesis ( ) by a declaration of the largest whole units (i.e., pounds and ounces or quarts and pints and ounces). The net quantity of contents may additionally be stated in terms of the metric system of weights or measures.

Return To Top

The name and place of business of the firm marketing the product must be stated on an information panel of the label (21 CFR 701.12).

The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ..." or "Distributed by ..." or similar, appropriate wording.

The Tariff Act of 1930 (19 U.S.C. 1304) requires that all imported articles state on the label the English name of the country of origin. See also 19 CFR 134.

Return To Top

All label statements required by regulation must be in the English language and must be placed on the label or labeling with such prominence and conspicuousness that they are readily noticed and understood by consumers under customary conditions of purchase (21 CFR 701.2).

Declaration of Ingredients

Cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration (21 CFR 701.3).

Cosmetics not customarily distributed for retail sale, e.g., hair preparations or makeup products used by professionals on customers at their establishments or skin cleansers made available to persons at their place of work, are exempt from this requirement provided these products are not also sold to consumers at professional establishments or workplaces for their consumption at home.

The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase. It may appear on any information panel of the outer container, i.e., an information panel of the folding carton, box or wrapping if the immediate container is so pack-aged or, if not packaged in an outer container, an information panel of the jar, tube or bottle containing the product.

The ingredient declaration may also appear on a tag, tape or card that is firmly affixed to the outer container. The letters must not be less than 1/16 of an inch in height (21 CFR 701.3(b)).

If the total package surface available to bear labeling is less than 12 square inches, the letters must not be less than 1/32 of an inch in height (21 CFR 701.3(p)). Off-package ingredient labeling is permitted if the cosmetic is held in tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package surface area is less than 12 square inches (21 CFR 701.3(i)).

The ingredients must be declared in descending order of predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients present at one percent or less (21 CFR 701.3(f)(2)) may be declared after the ingredients present at concentrations exceeding one percent without regard for predominance.

The ingredients must be identified by the names established or adopted by regulation (21 CFR 701.3(c)); those accepted by the FDA as exempt from public disclosure may be stated as "and other ingredients" (21 CFR 701.3(a)).

Cosmetics which are also drugs must first identify the drug ingredient(s) as "active ingredients(s)" before listing the cosmetic ingredients (21 CFR 701.3(d)).

Return To Top

Label Warnings

Cosmetics which may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use. The statements must be prominent and conspicuous. Some cosmetics must bear label warnings or cautions prescribed by regulation (21 CFR 740). Cosmetics in self-pressurized containers (aerosol products), feminine deodorant sprays and, children's bubble bath products are examples of products requiring such statements.

Tamper-Resistant Packaging

Liquid oral hygiene products (e.g., mouthwashes, fresheners) and all cosmetic vaginal products (e.g., douches, tablets) must be packaged in tamper-resistant packages when sold at retail. A package is considered tamper-resistant if it has an indicator or barrier to entry (e.g., shrink or tape seal, sealed carton, tube or pouch, aerosol container) which, if breached or missing, alerts a consumer that tampering has occurred. The indicator must be distinctive by design (breakable cap, blister) or appearance (logo, vignette, other illustration) to preclude substitution. The tamper-resistant feature may involve the immediate or outer container or both. The package must also bear a prominently placed statement alerting the consumer to the tamper-resistant feature. This statement must remain unaffected if the tamper-resistant feature is breached or missing. See 21 CFR 700.25.

Return To Top

Law Enforcement Authority

For enforcement of the law, the FDA may conduct examinations and investigations of products, inspect establishments in which products are manufactured or held, and seize adulterated (harmful) or misbranded (incorrectly or deceptively labeled or filled) cosmetics. Adulterated or misbranded foreign products may be refused entry into the United States. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. The FDA may also initiate criminal action against a person violating the law. Examples of products seized are nail preparations containing methyl methacrylate or formaldehyde, various eyebrow and eyelash dye products containing prohibited coal-tar dyes, and products contaminated with harmful microorganisms.

Further questions regarding regulatory requirements for marketing cosmetics should be directed to the Food and Drug Administration, Division of Colors and Cosmetics (HFF-440), 200 C Street, SW, Washington, DC 20204. Questions regarding requirements for marketing products which are cosmetic and drugs should also be addressed to the Division of Drug Labeling, OTC Compliance Branch (HFN-312), 5600 Fishers Lane, Rockville, MD 208567.

Return To Top

*FDA/Industry Activities Staff Booklet: 1992
Hypertext updated 1997-NOV-13 (Source)

____________________________________________________

4. The Fair Packaging and Labeling Act

Return To Top

Contents

What packaging does the FPLA apply to?

The FPLA applies to consumer commodities that are distributed in commerce (§ 1452). However, it's important to know the definition of consumer commodity (§ 1459). Roughly, the Act applies to anything packaged for retail sale to individuals, if it gets eaten, used for personal care, or used within the household; and then only if you consume or expend it when you use it.

For example, it applies to aluminum foil, candles, household cleaning fluids, and light bulbs, all of which get "used up." But the FPLA does not apply to toys, hardware, or sporting goods (not consumed or expended), nor to motor oil (not used within the household).

In addition, the definition (§ 1459) explicitly excludes a number of items, such as meats, poultry, tobacco, prescription drugs, alcoholic beverages, and seeds. Also, the FPLA doesn't apply to packages seen only by the retailer (not by the consumer).

Return To Top

What metric requirements are imposed by the FPLA?

The requirement for metric measurements in statements of net quantity is included in § 1453. This section incorporates an exclusion of its own, namely, metric measurements are not required on foods packaged at a retail store, nor on random packages where each package is weighed separately, although the other provisions of the Act apply to such packages.

The law details the form of non-metric measurements, but says nothing about the specific form of metric measurements. Regulations implemented by the FTC and FDA, mentioned below, give more details on metric labeling.

When were the metric requirements added?

The original FPLA, without a metric labeling requirement, was enacted on November 3, 1966 as Public Law 89-755. It took effect on July 1, 1967. The metric labeling requirement was added by Pub. L. 102-245 on February 14, 1992 and reworded by Pub. L. 102-329 on August 3, 1992, and the metric requirement took effect on February 14, 1994.

What are the implementing regulations?

The FPLA is the law passed by Congress, but it's not really the law regarding package labels because it doesn't get into every minor little detail. If Congress included every minor little detail in the law, then it would require a new bill to be passed by both Houses and signed by the President just to make a trivial change.

Return To Top

Instead, Congress delegates the details to appropriate federal agencies -- in this case, the Federal Trade Commission (FTC, part of the Department of Commerce) and the Food and Drug Administration (FDA, part of the Department of Health and Human Services) -- to write regulations implementing the law. They can do that, and can later change their regulations, as long as they don't exceed the authority granted them by the law, and as long as their regulations are consistent with the law.

So if you want to know the detailed labeling requirements, you can read about the FDA and FTC regulations.

Text of the law

Return To Top

The FPLA is codified as 15 USC 1451 et seq.

Paragraphs like this are comments added here, and not part of the law.

U.S. Code

Title 15
Commerce and Trade

Chapter 39
Fair Packaging and Labeling Program

Sec. 1451. Congressional declaration of policy

Informed consumers are essential to the fair and efficient functioning of a free market economy. Packages and their labels should enable consumers to obtain accurate information as to the quantity of the contents and should facilitate value comparisons. Therefore, it is hereby declared to be the policy of the Congress to assist consumers and manufacturers in reaching these goals in the marketing of consumer goods.

(Pub. L. 89-755, Sec. 2, Nov. 3, 1966, 80 Stat. 1296.)

Return To Top

Sec. 1452. Unfair and deceptive packaging and labeling; scope of prohibition

(a) Nonconforming labels

It shall be unlawful for any person engaged in the packaging or labeling of any consumer commodity (as defined in this chapter) for distribution in commerce, or for any person (other than a common carrier for hire, a contract carrier for hire, or a freight forwarder for hire) engaged in the distribution in commerce of any packaged or labeled consumer commodity, to distribute or to cause to be distributed in commerce any such commodity if such commodity is contained in a package, or if there is affixed to that commodity a label, which does not conform to the provisions of this chapter and of regulations promulgated under the authority of this chapter.

Return To Top

(b) Exemptions

The prohibition contained in subsection (a) of this section shall not apply to persons engaged in business as wholesale or retail distributors of consumer commodities except to the extent that such persons (1) are engaged in the packaging or labeling of such commodities, or (2) prescribe or specify by any means the manner in which such commodities are packaged or labeled.

(Pub. L. 89-755, Sec. 3, Nov. 3, 1966, 80 Stat. 1296.)

Sec. 1453. Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity

Return To Top

(a) Contents of label

No person subject to the prohibition contained in section 1452 of this title shall distribute or cause to be distributed in commerce any packaged consumer commodity unless in conformity with regulations which shall be established by the promulgating authority pursuant to section 1455 of this title which shall provide that--

(1) The commodity shall bear a label specifying the identity of the commodity and the name and place of business of the manufacturer, packer, or distributor;

(2) The net quantity of contents (in terms of weight or mass, measure, or numerical count) shall be separately and accurately stated in a uniform location upon the principal display panel of that label, using the most appropriate units of both the customary inch/pound system of measure, as provided in paragraph (3) of this subsection, and, except as provided in paragraph (3)(A)(ii) or paragraph (6) of this subsection, the SI metric system;

Thus, 15 USC 1453(a)(2) requires both metric and inch/pound units in the contents statement on packages covered by this law, with a few exceptions noted below.

(3) The separate label statement of net quantity of contents appearing upon or affixed to any package--

(A)(i) if on a package labeled in terms of weight, shall be expressed in pounds, with any remainder in terms of ounces or common or decimal fractions of the pound; or in the case of liquid measure, in the largest whole unit (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart;

(ii) if on a random package, may be expressed in terms of pounds and decimal fractions of the pound carried out to not more than three decimal places and is not required to, but may, include a statement in terms of the SI metric system carried out to not more than three decimal places;

Thus, 15 USC 1453(a)(3)(A)(ii) provides an exception for random packages sold by weight -- packages of varying weights, where each package's label is different -- which need not include a metric weight.

(iii) if on a package labeled in terms of linear measure, shall be expressed in terms of the largest whole unit (yards, yards and feet, or feet, as appropriate) with any remainder in terms of inches or common or decimal fractions of the foot or yard;

(iv) if on a package labeled in terms of measure of area, shall be expressed in terms of the largest whole square unit (square yards, square yards and square feet, or square feet, as appropriate) with any remainder in terms of square inches or common or decimal fractions of the square foot or square yard;

Return To Top

(B) shall appear in conspicuous and easily legible type in distinct contrast (by topography, layout, color, embossing, or molding) with other matter on the package;

(C) shall contain letters or numerals in a type size which shall be (i) established in relationship to the area of the principal display panel of the package, and (ii) uniform for all packages of substantially the same size; and

(D) shall be so placed that the lines of printed matter included in that statement are generally parallel to the base on which the package rests as it is designed to be displayed; and

(4) The label of any package of a consumer commodity which bears a representation as to the number of servings of such commodity contained in such package shall bear a statement of the net quantity (in terms of weight or mass, measure, or numerical count) of each such serving.

(5) For purposes of paragraph (3)(A)(ii) of this subsection the term ``random package'' means a package which is one of a lot, shipment, or delivery of packages of the same consumer commodity with varying weights or masses, that is, packages with no fixed weight or mass pattern.

(6) The requirement of paragraph (2) that the statement of net quantity of contents include a statement in terms of the SI metric system shall not apply to foods that are packaged at the retail store level.

Similarly, 15 USC 1453(a)(6) provides an exception for items packaged at a retail store, which need not include metric measurements.

Return To Top

(b) Supplemental statements

No person subject to the prohibition contained in section 1452 of this title shall distribute or cause to be distributed in commerce any packaged consumer commodity if any qualifying words or phrases appear in conjunction with the separate statement of the net quantity of contents required by subsection (a) of this section, but nothing in this subsection or in paragraph (2) of subsection (a) of this section shall prohibit supplemental statements, at other places on the package, describing in nondeceptive terms the net quantity of contents: Provided, That such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight or mass, measure, or count that tends to exaggerate the amount of the commodity contained in the package.

This provision outlaws the practice of referring to a "jumbo quart" or "giant liter" or the like.

(Pub. L. 89-755, Sec. 4, Nov. 3, 1966, 80 Stat. 1297; Pub. L. 102-245, title I, Sec. 107(a), Feb. 14, 1992, 106 Stat. 13; Pub. L. 102-329, Secs. 1, 3, Aug. 3, 1992, 106 Stat. 847, 848.)

Sec. 1454. Rules and regulations

(a) Promulgating authority

The authority to promulgate regulations under this chapter is vested in (A) the Secretary of Health and Human Services (referred to hereinafter as the ``Secretary'') with respect to any consumer commodity which is a food, drug, device, or cosmetic, as each such term is defined by section 321 of title 21; and (B) the Federal Trade Commission (referred to hereinafter as the ``Commission'') with respect to any other consumer commodity.

Return To Top

(b) Exemption of commodities from regulations

If the promulgating authority specified in this section finds that, because of the nature, form, or quantity of a particular consumer commodity, or for other good and sufficient reasons, full compliance with all the requirements otherwise applicable under section 1453 of this title is impracticable or is not necessary for the adequate protection of consumers, the Secretary or the Commission (whichever the case may be) shall promulgate regulations exempting such commodity from those requirements to the extent and under such conditions as the promulgating authority determines to be consistent with section 1451 of this title.

(c) Scope of additional regulations

Whenever the promulgating authority determines that regulations containing prohibitions or requirements other than those prescribed by section 1453 of this title are necessary to prevent the deception of consumers or to facilitate value comparisons as to any consumer commodity, such authority shall promulgate with respect to that commodity regulations effective to--

(1) establish and define standards for characterization of the size of a package enclosing any consumer commodity, which may be used to supplement the label statement of net quantity of contents of packages containing such commodity, but this paragraph shall not be construed as authorizing any limitation on the size, shape, weight or mass, dimensions, or number of packages which may be used to enclose any commodity;

Although there is a school of thought that would outlaw arbitrary package sizes in favor of a set of legal, standardized package sizes, that is not the FPLA's intention. On the other hand, note subsection (d) below.

Return To Top

(2) regulate the placement upon any package containing any commodity, or upon any label affixed to such commodity, of any printed matter stating or representing by implication that such commodity is offered for retail sale at a price lower than the ordinary and customary retail sale price or that a retail sale price advantage is accorded to purchasers thereof by reason of the size of that package or the quantity of its contents;

(3) require that the label on each package of a consumer commodity (other than one which is a food within the meaning of section 321(f) of title 21) bear

(A) the common or usual name of such consumer commodity, if any, and

(B) in case such consumer commodity consists of two or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance, but nothing in this paragraph shall be deemed to require that any trade secret be divulged; or

(4) prevent the nonfunctional-slack-fill of packages containing consumer commodities.

For purposes of paragraph (4) of this subsection, a package shall be deemed to be nonfunctionally slack-filled if it is filled to substantially less than its capacity for reasons other than (A) protection of the contents of such package or (B) the requirements of machines used for enclosing the contents in such package.

(d) Development by manufacturers, packers, and distributors of voluntary product standards

Return To Top

Whenever the Secretary of Commerce determines that there is undue proliferation of the weights or masses, measures, or quantities in which any consumer commodity or reasonably comparable consumer commodities are being distributed in packages for sale at retail and such undue proliferation impairs the reasonable ability of consumers to make value comparisons with respect to such consumer commodity or commodities, he shall request manufacturers, packers, and distributors of the commodity or commodities to participate in the development of a voluntary product standard for such commodity or commodities under the procedures for the development of voluntary products standards established by the Secretary pursuant to section 272 of this title. Such procedures shall provide adequate manufacturer, packer, distributor, and consumer representation.

(e) Report and recommendations to Congress upon industry failure to develop or abide by voluntary product standards

If (1) after one year after the date on which the Secretary of Commerce first makes the request of manufacturers, packers, and distributors to participate in the development of a voluntary product standard as provided in subsection (d) of this section, he determines that such a standard will not be published pursuant to the provisions of such subsection (d), or (2) if such a standard is published and the Secretary of Commerce determines that it has not been observed, he shall promptly report such determination to the Congress with a statement of the efforts that have been made under the voluntary standards program and his recommendation as to whether Congress should enact legislation providing regulatory authority to deal with the situation in question.

(Pub. L. 89-755, Sec. 5, Nov. 3, 1966, 80 Stat. 1298; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102-245, title I, Sec. 107(a)(1), (2), Feb. 14, 1992, 106 Stat. 13; Pub. L. 102- 329, Secs. 1(1), (2), 3, Aug. 3, 1991, 106 Stat. 847, 848.)

Return To Top

Sec. 1455. Procedure for promulgation of regulations

(a) Hearings by Secretary of Health and Human Services

Regulations promulgated by the Secretary under section 1453 or 1454 of this title shall be promulgated, and shall be subject to judicial review, pursuant to the provisions of subsections (e), (f), and (g) of section 371 of title 21. Hearings authorized or required for the promulgation of any such regulations by the Secretary shall be conducted by the Secretary or by such officer or employees of the Department of Health and Human Services as he may designate for that purpose.

(b) Judicial review; hearings by Federal Trade Commission

Regulations promulgated by the Commission under section 1453 or 1454 of this title shall be promulgated, and shall be subject to judicial review, by proceedings taken in conformity with the provisions of subsections (e), (f), and (g) of section 371 of title 21 in the same manner, and with the same effect, as if such proceedings were taken by the Secretary pursuant to subsection (a) of this section. Hearings authorized or required for the promulgation of any such regulations by the Commission shall be conducted by the Commission or by such officer or employee of the Commission as the Commission may designate for that purpose.

(c) Cooperation with other departments and agencies

In carrying into effect the provisions of this chapter, the Secretary and the Commission are authorized to cooperate with any department or agency of the United States, with any State, Commonwealth, or possession of the United States, and with any department, agency, or political subdivision of any such State, Commonwealth, or possession.

Return To Top

(d) Returnable or reusable glass containers for beverages

No regulation adopted under this chapter shall preclude the continued use of returnable or reusable glass containers for beverages in inventory or with the trade as of the effective date of this Act, nor shall any regulation under this chapter preclude the orderly disposal of packages in inventory or with the trade as of the effective date of such regulation.

(Pub. L. 89-755, Sec. 6, Nov. 3, 1966, 80 Stat. 1299; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)

Sec. 1456. Enforcement

(a) Misbranded consumer commodities

Any consumer commodity which is a food, drug, device, or cosmetic, as each such term is defined by section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), and which is introduced or delivered for introduction into commerce in violation of any of the provisions of this chapter, or the regulations issued pursuant to this chapter, shall be deemed to be misbranded within the meaning of chapter III of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 331 et seq.], but the provisions of section 303 of that Act (21 U.S.C. 333) shall have no application to any violation of section 1452 of this title.

(b) Unfair or deceptive acts or practices in commerce

Any violation of any of the provisions of this chapter, or the regulations issued pursuant to this chapter, with respect to any consumer commodity which is not a food, drug, device, or cosmetic, shall constitute an unfair or deceptive act or practice in commerce in violation of section 45(a) of this title and shall be subject to enforcement under section 45(b) of this title.

Return To Top

(c) Imports

In the case of any imports into the United States of any consumer commodity covered by this chapter, the provisions of sections 1453 and 1454 of this title shall be enforced by the Secretary of the Treasury pursuant to section 801(a) and (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381).

(Pub. L. 89-755, Sec. 7, Nov. 3, 1966, 80 Stat. 1300.)

Sec. 1457. Omitted

This section formerly required annual reports to Congress on administration and enforcement of this law, but the reporting requirement was eliminated on May 15, 2000.

Sec. 1458. Cooperation with State authorities; transmittal of regulations to States; noninterference with existing programs

(a) A copy of each regulation promulgated under this chapter shall be transmitted promptly to the Secretary of Commerce, who shall (1) transmit copies thereof to all appropriate State officers and agencies, and (2) furnish to such State officers and agencies information and assistance to promote to the greatest practicable extent uniformity in State and Federal regulation of the labeling of consumer commodities.

(b) Nothing contained in this section shall be construed to impair or otherwise interfere with any program carried into effect by the Secretary of Health and Human Services under other provisions of law in cooperation with State governments or agencies, instrumentalities, or political subdivisions thereof.

Return To Top

(Pub. L. 89-755, Sec. 9, Nov. 3, 1966, 80 Stat. 1301; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695.)

Sec. 1459. Definitions

For the purpose of this chapter--

(a) The term ``consumer commodity'', except as otherwise specifically provided by this subsection, means any food, drug, device, or cosmetic (as those terms are defined by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]), 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. Such term does not include--

(1) any meat or meat product, poultry or poultry product, or tobacco or tobacco product;

(2) any commodity subject to packaging or labeling requirements imposed by the Secretary of Agriculture pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], or the provisions of the eighth paragraph under the heading ``Bureau of Animal Industry'' of the Act of March 4, 1913 [21 U.S.C. 151 et seq.], commonly known as the Virus-Serum-Toxin Act;

(3) any drug subject to the provisions of section 503(b)(1) or 506 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(b)(1) and 356];

(4) any beverage subject to or complying with packaging or labeling requirements imposed under the Federal Alcohol Administration Act [27 U.S.C. 201 et seq.]; or

(5) any commodity subject to the provisions of the Federal Seed Act [7 U.S.C. 1551 et seq.].

The preceding subsection describes the products that are covered by the Act; refer to the summary above.

(b) The term ``package'' means any container or wrapping in which any consumer commodity is enclosed for use in the delivery or display of that consumer commodity to retail purchasers, but does not include--

(1) shipping containers or wrappings used solely for the transportation of any consumer commodity in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors thereof;

(2) shipping containers or outer wrappings used by retailers to ship or deliver any commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity; or

Return To Top

(3) containers subject to the provisions of the Act of August 3, 1912 (37 Stat. 250, as amended; 15 U.S.C. 231-233), or the Act of March 4, 1915 (38 Stat. 1186, as amended; 15 U.S.C. 234-236).

The preceding subsection describes the kinds of packaging, when containing the appropriate kinds of products, that are covered by the Act; refer to the summary above.

Return To Top

(c) The term ``label'' means any written, printed, or graphic matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.

(d) The term ``person'' includes any firm, corporation, or association.

(e) The term ``commerce'' means (1) commerce between any State, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States, and any place outside thereof, and (2) commerce within the District of Columbia or within any territory or possession of the United States not organized with a legislative body, but shall not include exports to foreign countries.

(f) The term ``principal display panel'' means that part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.

(Pub. L. 89-755, Sec. 10, Nov. 3, 1966, 80 Stat. 1301; Pub. L. 90-628, Sec. 2, Oct. 22, 1968, 82 Stat. 1320.)

Sec. 1460. Savings provisions

Return To Top

Nothing contained in this chapter shall be construed to repeal, invalidate, or supersede--

(a) the Federal Trade Commission Act [15 U.S.C. 41 et seq.] or any statute defined therein as an antitrust Act;

(b) the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]; or

(c) the Federal Hazardous Substances Labeling Act [15 U.S.C. 1261 et seq.].

(Pub. L. 89-755, Sec. 11, Nov. 3, 1966, 80 Stat. 1302.)

Sec. 1461. Effect upon State law

It is hereby declared that it is the express intent of Congress to supersede any and all laws of the States or political subdivisions thereof insofar as they may now or hereafter provide for the labeling of the net quantity of contents of the package of any consumer commodity covered by this chapter which are less stringent than or require information different from the requirements of section 1453 of this title or regulations promulgated pursuant thereto.

(Pub. L. 89-755, Sec. 12, Nov. 3, 1966, 80 Stat. 1302

(source)

______________________________________________

6. Cosmetic Labeling

Return To Top

U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
March 26, 2003

COSMETIC LABELING

Under the Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), certain information must appear on the labels of cosmetic products.

All cosmetics, whether they are sold on a retail basis to consumers or marketed exclusively for salon or workplace use, are subject to the FD&C Act. This law and regulations enacted under its authority require the cosmetic label to state the name and place of business of the manufacturer, packer or distributor; an accurate statement of the quantity of contents; and any appropriate directions for safe use and/or warning statements. This information must comply with additional regulatory requirements. It must be prominent and appear in the proper location on the label.

Regulations enacted under the FPLA require ingredients to be listed on the labels of cosmetics sold on a retail basis to consumers -- even if the label states "For professional use only." Consumers can use the ingredient declaration to identify ingredients they wish to avoid. Ingredients are listed in descending order of predominance, that is, with the ingredient present in the greatest amount listed at the beginning and those present in the smallest amounts listed at the end.

Return To Top

Special rules apply to the ingredient declaration on products that are both cosmetics and over-the-counter drugs. An example of such a product is an anti-dandruff shampoo: A shampoo is a cosmetic, while an anti-dandruff treatment is a drug. Regulations enacted in 1999 require such combination products to have the drug ingredients listed separately as "Active Ingredients," in alphabetical order, followed by the cosmetic ingredients, which are listed as "Inactive Ingredients" in descending order of predominance.

In addition to the immediate label, FDA regulates all cosmetic product "labeling." The definition of labeling includes all written, printed, or graphic matter that appears on the product, its containers, or its wrappers, as well as any such matter that accompanies the product. Typically, materials such as promotional literature, product catalogs, and flyers fit this definition of labeling. FDA also has considered promotional statements appearing on Internet sites to constitute labeling, especially on those sites where the promoted product can be purchased. However, unfair or deceptive advertising that appears in magazines, in newspapers, or on television generally falls under the authority of the Federal Trade Commission.

Cosmetic firms should refer to FDA's Cosmetic Labeling Manual and the regulations related to cosmetics for more detailed labeling information.

Return To Top

____________________________________________

7. Regulations affecting small business

Return To Top

Source

Under NLEA, some foods are exempt from nutrition labeling. These include:

Karl: note that an "herb" may not be considered to contain nutrients? Certainly a homeopathic remedy would not likely be claimed to have any nutritional value or treatment value -- and be safe to include without showing it on the label.

Food produced by small businesses also may be exempt, under 1993 amendments to the NLEA. Businesses with fewer than 100 full-time equivalent employees may claim an exemption for food products that have U.S. sales of fewer than 100,000 units annually. Companies claiming this exemption must notify FDA that they meet the criteria before they begin marketing their products. U.S. companies, other than importers, with fewer than 10 full-time equivalent employees and selling fewer than 10,000 units of a food in a year also are exempt but do not need to notify FDA. Also exempt are retailers with annual gross sales in the United States of less than $500,000 or with annual gross sales of food to consumers in the United States of less than $50,000.

Although certain foods may be exempt, they are free to carry nutrition information, when appropriate--as long as it complies with regulations. Also, these foods will lose their exemption if their labels carry a nutrient content or health claim or any other nutrition information.

Return To Top

8. Exemption for Personal Shipments

Return To Top

Source

 

SUBCHAPTER

COVERAGE OF PERSONAL IMPORTATIONS

PURPOSE 

To provide guidance for the coverage of personal-use quantities of FDA-regulated imported products in baggage and mail and to gain the greatest degree of public protection with allocated resources.

 

BACKGROUND

  Because the amount of merchandise imported into the United States in personal shipments is normally small, both in size and value, comprehensive coverage of these imports is normally not justified. This guidance clarifies how FDA may best protect consumers with a reasonable expenditure of resources.There has always been a market in the United States for some foreign made products that are not available domestically. For example, individuals of differing ethnic backgrounds sometimes prefer products from their homeland or products labeled in their native language to products available in the United States. Other individuals seek medical treatments that are not available in this country. Drugs are sometimes mailed to this country in response to a prescription-like order to allow continuation of a therapy initiated abroad. With increasing international travel and world trade, we can anticipate that more people will purchase products abroad that may not be approved, may be health frauds or may be otherwise not legal for sale in the United States.

In addition, FDA must be alert to foreign and domestic businesses that promote or ship unapproved, fraudulent or otherwise illegal medical treatments into the United States or who encourage persons to order these products. Such treatments may be promoted to individuals who believe that treatments available abroad will be effective in the treatment of serious conditions such as AIDS or cancer. Because some countries do not regulate or restrict the exportation of products, people who mail order from these businesses may not be afforded the protection of either foreign or U.S. laws. In view of the potential scale of such operations, FDA has focused its enforcement resources more on products that are shipped commercially, including small shipments solicited by mail-order promotions, and less on those products that are personally carried, shipped by a personal non-commercial representative of a consignee, or shipped from foreign medical facility where a person has undergone treatment.

9. Term "Sample - Not For Sale" has relevance for drugs, not found for supplements.

Source

Return To Top

 

203 -- PRESCRIPTION DRUG MARKETING

Subpart D--Samples

Return To Top