Collapse to view only § 363. Regulations making exemptions
- § 361. Adulterated cosmetics
- § 362. Misbranded cosmetics
- § 363. Regulations making exemptions
- § 364. Definitions
- § 364a. Adverse events
- § 364b. Good manufacturing practice
- § 364c. Registration and product listing
- § 364d. Safety substantiation
- § 364e. Labeling
- § 364f. Records
- § 364g. Mandatory recall authority
- § 364h. Small businesses
- § 364i. Exemption for certain products and facilities
- § 364j. Preemption
§ 361. Adulterated cosmetics
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.
(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 364b of this title.
(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for 1
1 So in original. Probably should be “of”.
safety, as defined in section 364d(c) of this title.(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; Pub. L. 117–328, div. FF, title III, § 3503(a)(2), Dec. 29, 2022, 136 Stat. 5858.)
§ 362. Misbranded cosmetics
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 364e of this title: 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 chapter 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 379e of this title. 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 361(a) of this title).
(f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.
(June 25, 1938, ch. 675, § 602, 52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(2), July 12, 1960, 74 Stat. 398; Pub. L. 91–601, § 6(f), formerly § 7(f), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 102–571, title I, § 107(12), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 117–328, div. FF, title III, § 3503(a)(3), Dec. 29, 2022, 136 Stat. 5858.)
§ 363. Regulations making exemptions
The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter cosmetics which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
(June 25, 1938, ch. 675, § 603, 52 Stat. 1054.)
§ 364. DefinitionsIn this subchapter:
(1) Adverse event
(2) Cosmetic product
(3) Facility
(A)In general.—The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
(B) Such term does not include any of the following:
(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in section 3508(b)(2) of title 26), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
(iii) Hospitals, physicians’ offices, and health care clinics.
(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.
(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
(viii) An establishment that solely performs one or more of the following with respect to cosmetic products:(I) Labeling.(II) Relabeling.(III) Packaging.(IV) Repackaging.(V) Holding.(VI) Distributing.
(C)Clarification.—For the purposes of subparagraph (B)(viii), the terms “packaging” and “repackaging” do not include filling a product container with a cosmetic product.
(4) Responsible person
(5) Serious adverse eventThe term “serious adverse event” means an adverse event that—
(A) results in—
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity;
(v) a congenital anomaly or birth defect;
(vi) an infection; or
(vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or
(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).
(June 25, 1938, ch. 675, § 604, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5847.)
§ 364a. Adverse events
(a) Serious adverse event reporting requirements
(b) Submission of reports
(1) Serious adverse event report
(2) New medical information
(3) Consolidation of reports
(c) Exemptions
(d) Contact information
(e) Maintenance and inspection of adverse event records
(1) Maintenance
(2) Inspection
(A) In general
(B) Authorized person
For purposes of this paragraph, the term “authorized person” means an officer or employee of the Department of Health and Human Services who has—
(i) appropriate credentials, as determined by the Secretary; and
(ii) been duly designated by the Secretary to have access to the records required under this section.
(f) Fragrance and flavor ingredients
(g) Protected information
A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered to be—
(1) a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and
(2) a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the “Freedom of Information Act”), and shall not be publicly disclosed unless all personally identifiable information is redacted.
(h) Effect of section
(1) In general
(2) Personally identifiable information
Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—
(A) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or
(B) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.
(3) Use of reports
(4) Rule of construction
(June 25, 1938, ch. 675, § 605, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5848.)
§ 364b. Good manufacturing practice
(a) In general
(b) Considerations
(c) Timeframe
(June 25, 1938, ch. 675, § 606, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5850.)
§ 364c. Registration and product listing
(a) Submission of registration
(1) Initial registration
(A) Existing facilities
(B) New facilities
(2) Biennial renewal of registration
(3) Contract manufacturers
(4) Updates to span
(5) Abbreviated renewal registrations
(b) Format; contents of registration
(1) In general
(2) Contents
The registration under subsection (a) shall contain—
(A) the facility’s name, physical address, email address, and telephone number;
(B) with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information;
(C) the facility registration number, if any, previously assigned by the Secretary under subsection (d);
(D) all brand names under which cosmetic products manufactured or processed in the facility are sold; and
(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
(c) Cosmetic product listing
(1) In general
(2) Cosmetic product listing
(3) Abbreviated renewal
(4) Contents of listing
(A) In general
Each such cosmetic product listing shall include—
(i) the facility registration number of each facility where the cosmetic product is manufactured or processed;
(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
(iii) the applicable cosmetic category or categories for the cosmetic product;
(iv) a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and
(v) the product listing number, if any previously assigned by the Secretary under subsection (d).
(B) Flexible listings
(5) Updates to span
(6) Submission
(d) Facility registration and product listing numbers
(e) Confidentiality
(f) Suspensions
(1) Suspension of registration of a facility
(2) Notice of suspension
Before suspending a facility registration under this section, the Secretary shall provide—
(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and
(B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.
(3) Hearing on suspension
(4) Post-hearing corrective action plan
(5) Vacating of order; reinstatement
(6) Effect of suspension
(7) No delegation
(June 25, 1938, ch. 675, § 607, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5851.)
§ 364d. Safety substantiation
(a) Substantiation of safety
(b) Coal-tar hair dye
(c) Definitions
For purposes of this section:
(1) Adequate substantiation of safety
(2) Safe
(June 25, 1938, ch. 675, § 608, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5854.)
§ 364e. Labeling
(a) General requirement
(b) Fragrance allergens
(c) Cosmetic products for professional use
(1) Definition of professional
(2) Professional use labeling
A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—
(A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and
(B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15.
(June 25, 1938, ch. 675, § 609, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5854.)
§ 364f. Records
(a) In general
(b) Rule of construction
(June 25, 1938, ch. 675, § 610, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.)
§ 364g. Mandatory recall authority
(a) In general
(b) Hearing
(c) Order resolutionAfter an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—
(1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;
(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or
(3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.
(d) Action following order
(e) Notice to persons affected
(f) Public notificationIn conducting a recall under this section, the Secretary shall—
(1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification—
(A) of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and
(B) that includes, at a minimum—
(i) the name of the cosmetic subject to the recall;
(ii) a description of the risk associated with such article; and
(iii) to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and
(2) ensure publication, as appropriate, on the website of the Food and Drug Administration of an image of the cosmetic that is the subject of the press release described in paragraph (1), if available.
(g) No delegation
(h) Effect
(June 25, 1938, ch. 675, § 611, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5855.)
§ 364h. Small businesses
(a) In general
(b) Requirements applicable to all manufacturers and processors of cosmetics
The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:
(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
(2) Cosmetic products that are injected.
(3) Cosmetic products that are intended for internal use.
(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
(June 25, 1938, ch. 675, § 612, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)
§ 364i. Exemption for certain products and facilities
(a) In general
(b) Exception
(June 25, 1938, ch. 675, § 613, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)
§ 364j. Preemption
(a) In general
(b) Limitation
(c) Savings
(d) Rule of construction
(June 25, 1938, ch. 675, § 614, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)