Which rules apply to hair care and colour?

A label that represents the product as Made in the United States without qualification.

Must meet the conditions of Label a product as Made in the United States only if its final assembly or processing occurs in the United States, all significant processing that goes into it occurs in the United States, and all or virtually all of its ingredients or components are made and sourced in the United States. The same applies to a seal, mark, tag or stamp in a mail order catalog or mail order promotional material. A violation is treated as a violation of a trade regulation rule under section 18 of the FTC Act.

• Claim: Made in USA

In force, start date unknown

The text states only the Federal Register publication date of the rule (July 14, 2021); it states no separate effective date.

If you give a written warranty, put all its terms in one clear document: who and what is covered, what you will do, how long, how to claim, and the required State-rights statements

Disclosure to buyer

Written warranty terms (16 CFR 701.3(a)): a warrantor who gives a written warranty on a consumer product costing the consumer more than $15.00 must clearly and conspicuously disclose, in a single document in simple and readily understood language: (1) who the warranty is extended to, if limited to the original purchaser or otherwise; (2) the products, parts or components covered and, where needed, excluded; (3) what the warrantor will do on a defect or failure, and what it will pay for or provide; (4) when the term starts if not on the purchase date, and how long it lasts; (5) step by step how to claim, with the warrantor's name and mailing address or responsible department, or a free telephone number; (6) any informal dispute settlement mechanism (part 703); (7) any limit on the duration of implied warranties, with "Some States do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you."; (8) any exclusion or limit on incidental or consequential damages, with its State-law statement; (9) "This warranty gives you specific legal rights, and you may also have other rights which vary from State to State." If return of a registration card is a condition of coverage, the warranty must say so (701.4).

• It is a consumer product (tangible personal property normally used for personal, family or household purposes) (16 CFR 701.1(b), 702.1(b))
• You give a written warranty on a consumer product that costs the consumer more than $15 (16 CFR 701.2: the rules apply to "written warranties on consumer products actually costing the consumer more than $15.00"; 701.1(h): a warrantor is "any supplier, manufacturer, or other person who gives or offers to give a written warranty")

In force since 1 Jan 1977

Applies to products manufactured on or after 1 Jan 1977

Parts 701 and 702 apply only to written warranties on products manufactured after December 31, 1976 (16 CFR 700.12); 702.3 was last revised at 81 FR 63669, Sept. 15, 2016 (online warranty terms option).

Make the written warranty's text available to the buyer before the sale (in store, catalog or online listing, door to door); the warrantor supplies the text or posts it online

Disclosure to buyer

Pre-sale availability of written warranty terms (16 CFR 702.3), for consumer products costing the consumer more than $15.00. Seller (702.3(a)): make the warranty text readily available before sale by displaying it close to the product, or by furnishing it on request with signs telling buyers it is available. Catalog and mail order sellers, including any offer whose ordering does not need a visit to the seller (702.3(c)): give the full text, or the warrantor's web address plus where to request a free copy, beside the product description or in a referenced section. Door-to-door sellers: say before the sale that the warranties may be inspected (702.3(d)). Warrantor (702.3(b)(1)): give sellers the warranty materials (a copy with every product, a tag or label with the full text, the text on a display carton, or a sign or poster, with a copy in the box), and give catalog, mail order and door-to-door sellers copies; or (702.3(b)(2)) post the terms on its website, state the web address and a non-Internet way to request them in the manual or on the product or package, and send a free hard copy on request.

• It is a consumer product (tangible personal property normally used for personal, family or household purposes) (16 CFR 701.1(b), 702.1(b))
• You give a written warranty on a consumer product that costs the consumer more than $15, or sell such a product with one (16 CFR 702.3: "The following requirements apply to consumer products actually costing the consumer more than $15.00"; the seller's duties are in 702.3(a), the warrantor's in 702.3(b))

In force since 1 Jan 1977

Applies to products manufactured on or after 1 Jan 1977

Parts 701 and 702 apply only to written warranties on products manufactured after December 31, 1976 (16 CFR 700.12); 702.3 was last revised at 81 FR 63669, Sept. 15, 2016 (online warranty terms option).

Self-pressurized containers warning

Label required

Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children.

• Sold in a pressurised aerosol can
• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: aerosol dispenser, otc drug claim

In force since 3 Mar 1975

Applies to products placed on the market on or after 3 Mar 1975

In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Records demonstrating the cosmetic has no prohibited cattle materials

Declaration required

Records sufficient to demonstrate the cosmetic is not manufactured from, processed with, or does not contain, prohibited cattle materials, kept 2 years

• Made with or contains cattle-derived material

Depends on: cattle derived material

In force since 7 Sep 2005

Applies to products manufactured on or after 7 Sep 2005

In force from 2005-09-07: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Required label words, statements and information in English

Label required

All required words, statements and information in the English language (predominant language in Puerto Rico or a Territory)

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 15 Mar 1974

Applies to products placed on the market on or after 15 Mar 1974

In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Statement of identity on the principal display panel

Label required

Statement of identity of the commodity (common or usual name, descriptive or fanciful name, or illustration) in bold type on the principal display panel

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 15 Mar 1974

Applies to products placed on the market on or after 15 Mar 1974

In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Ingredient declaration in letters at least 1/16 inch high on an information panel

Label required

Ingredient declaration on an appropriate information panel in letters not less than 1/16 inch in height, without obscuring design or crowding

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 15 Mar 1974

Applies to products placed on the market on or after 15 Mar 1974

In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Declaration of ingredients in descending order of predominance

Label required

Declaration of the name of each ingredient in descending order of predominance (fragrance or flavor may be listed as fragrance or flavor); 'and other ingredients' may replace trade-secret ingredients exempt under 21 CFR 720.8

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 15 Mar 1974

Applies to products placed on the market on or after 15 Mar 1974

In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Name and place of business (street address, city, State, ZIP Code) of manufacturer, packer or distributor

Label required

Name of the manufacturer, packer or distributor (qualified by 'Manufactured for' or 'Distributed by' where not the manufacturer) and place of business with street address, city, State and ZIP Code

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 15 Mar 1974

Applies to products placed on the market on or after 15 Mar 1974

In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Declaration of net quantity of contents

Label required

Net quantity of contents in weight, fluid measure or numerical count on the principal display panel, in the type size prescribed by 701.13(i)

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 15 Mar 1974

Applies to products placed on the market on or after 15 Mar 1974

In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Use of the term 'sunscreen' in cosmetic labeling must be qualified by the cosmetic benefit

Label required

Qualifying statement describing the cosmetic benefit of the sunscreen ingredient, e.g. 'Contains a sunscreen—to protect product color', placed with the term

• Makes a drug claim (for example sunscreen or anti-dandruff): no
• Uses the term 'sunscreen' on a cosmetic

Depends on: otc drug claim, uses sunscreen term

In force since 21 May 1999

Applies to products placed on the market on or after 21 May 1999

In force from 1999-05-21: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Self-pressurized container with halocarbon or hydrocarbon propellant: intentional misuse warning

Label required

Warning—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

• Sold in a pressurised aerosol can

Depends on: aerosol dispenser

In force since 3 Mar 1975

Applies to products placed on the market on or after 3 Mar 1975

In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Warning statements prominent and conspicuous, at least 1/16 inch

Label required

Warning statement prominently and conspicuously in bold type on contrasting background, letters and numbers not less than 1/16 inch high

Every product in the category

In force since 3 Mar 1975

Applies to products placed on the market on or after 3 Mar 1975

In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Warning statement whenever necessary to prevent a health hazard

Must meet the conditions of 21 CFR 740.1(a): the label bears a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product

Every product in the category

In force since 3 Mar 1975

Applies to products placed on the market on or after 3 Mar 1975

In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Warning where safety of a cosmetic product or ingredient has not been adequately substantiated

Label required

Warning—The safety of this product has not been determined.

• Safety adequately substantiated: no

Depends on: safety substantiated

In force since 3 Mar 1975

Applies to products placed on the market on or after 3 Mar 1975

In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

US: consumer-products-with-button-cells

Must meet the conditions of ANSI/UL 4200A, Standard for Safety for Products Incorporating Button Batteries or Coin Cell Batteries (approved August 30, 2023)

• It is a consumer product containing a button cell or coin battery, or such a battery sold on its own or packaged with one (16 CFR 1263.2 (Consumer product containing button cell or coin batteries))
• Contains a button or coin cell

Depends on: button or coin cell

In force since 23 Oct 2023

Applies to products placed on the market on or after 23 Oct 2023

Effective October 23, 2023 (§1263.1(b)).

Cosmetic must not bear or contain a poisonous or deleterious substance that may render it injurious to users

Must meet the conditions of 21 U.S.C. 361(a): cosmetic must not bear or contain a poisonous or deleterious substance which may render it injurious to users under labeled or customary conditions of use (coal-tar hair dye excepted if labeled with the legend)

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 25 Jun 1938

Applies to products placed on the market on or after 25 Jun 1938

Stored note under 361: section effective twelve months after June 25, 1938, 'except par. (a), which, with certain exceptions, became effective on June 25, 1938'.

Cosmetic labeling must not be false or misleading

Must meet the conditions of 21 U.S.C. 362(a): labeling not false or misleading in any particular

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force, start date unknown

The published text states no commencement date for this provision. In force no later than 2025-01-01 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Adverse event records kept for 6 years (3 years for small businesses that do not manufacture or process)

Declaration required

Records of each adverse event report received, retained for 6 years (3 years for small businesses not manufacturing or processing)

• Makes a drug claim (for example sunscreen or anti-dandruff): no
• Your role: Manufacturer or Importer or Distributor

Depends on: otc drug claim, economic operator role

In force since 29 Dec 2023

Applies to products placed on the market on or after 29 Dec 2023

In force from 2023-12-29: the stored statutory note makes the 2022 amendment effective 1 year after Dec. 29, 2022.

Adequate substantiation of safety, with supporting records

Declaration required

Records supporting adequate substantiation of the safety of the cosmetic product (tests, studies, research, analyses or other evidence sufficient to support a reasonable certainty that the product is safe)

• Makes a drug claim (for example sunscreen or anti-dandruff): no
• Your role: Manufacturer or Importer or Distributor

Depends on: otc drug claim, economic operator role

In force since 29 Dec 2023

Applies to products placed on the market on or after 29 Dec 2023

In force from 2023-12-29: the stored statutory note makes the 2022 amendment effective 1 year after Dec. 29, 2022.

Facility registration with FDA (owners and operators of facilities manufacturing or processing cosmetics for US distribution)

Registration required

FDA cosmetic facility registration, renewed biennially, updates within 60 days

• Makes a drug claim (for example sunscreen or anti-dandruff): no
• Your role: Manufacturer

Depends on: otc drug claim, economic operator role

In force since 29 Dec 2023

Applies to products manufactured on or after 29 Dec 2023

Deadline computed from the stated rule 'not later than 1 year after December 29, 2022' (Dec. 29, 2022 + 1 year = 2023-12-29). New facilities register within 60 days of first engaging in manufacturing or processing (364c(a)(1)(B)); biennial renewal under 364c(a)(2).

Required label information must be prominently placed and conspicuous

Must meet the conditions of 21 U.S.C. 362(c): required words, statements and information prominently placed with conspicuousness likely to be read and understood

Every product in the category

In force, start date unknown

The published text states no commencement date for this provision. In force no later than 2025-01-01 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.

Label domestic address, phone number or electronic contact for adverse event reports

Label required

Domestic address, domestic phone number, or electronic contact information (may include a website) for adverse event reports

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 29 Dec 2024

Applies to products placed on the market on or after 29 Dec 2024

Stored note to 364e: sec. 609(a) takes effect 'the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022]'; computed as 2024-12-29.

Label name and place of business of manufacturer, packer or distributor

Label required

Name and place of business of the manufacturer, packer or distributor

Every product in the category

In force since 1 Jan 1940

Applies to products placed on the market on or after 1 Jan 1940

Stored note under 362: 'Par. (b) effective Jan. 1, 1940, and such subsection effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling'; Jan. 1, 1940 used as the general date.