REGISTRATION OF COSMETICS IN THE USA

22

Global Regulatory Partners, Inc

• Federal Food, Drug, and Cosmetic Act (FD&C Act),• Fair Packaging and Labeling Act External Link Disclaimer (FP&L Act).

FDA COSMETIC REGULATIONS

Cosmetics marketed in the United States, whether manufactured domestically or imported must comply with the following regulations:

DEFINITION

The US FDA defines a cosmetic is a product, (except soap), intend to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.

33

Global Regulatory Partners, Inc

HOW DOES THE FDA CLASSIFY COSMETICS?

It is a cosmetic

It is a Drug It is a Medical device

It is a soap

Is it intended to affect the structure or any function of the body of man and does not achieve its primary intended purpose through chemical

action within or on the body of man?

Classification of your Product

Is the product

composed mainly of the “alkali

salts of fatty acids,” that is, the material?

Is the product intended to affect the way a person’s body works, or to treat or

prevent disease?

Is the product intended for uses such as cleansing the human body, making a person

more attractive, or changing a person’s

appearance?

If a product has both characteristic of a

cosmetic and drug such as an acne treatment or dandruff shampoo it must be registered

satisfying both regulation requirements

44

Global Regulatory Partners, Inc

HOW TO REGISTER A COSMETIC IN THE USA?

The Law does not require that cosmetic products or ingredients (with the exception of color additives) to have FDA approval prior to entering the market. It is the firm’s responsibility to ensure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. The FDA highly recommends voluntary registration of their cosmetics through the Voluntary Cosmetic Registration Program (VCRP). The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics.

VCRP COSMETIC REGISTRATION PROCESS

Step 1:Check the list of ingredients (ensure none of ingredients are listed on the forbidden

list.)

Step 2: Check the content of Labeling and packaging requirements

Step 3: Register Establishment

Step 4: File the Cosmetic ingredient

Registration of Cosmetics in the USA | www.globalregulatorypartners.com

55

Global Regulatory Partners, Inc

1. Check the List of IngredientsThe following ingredients are prohibited in cosmetics in the United States:

Halogenate Salicylanilides

Mercury compounds

Chlorofluorocarbon Propellants

Methylene chloride

Hexachlorophene (Nabac)

Bithionol

Prohibited Cattle Material

Vinyl chloride

Zirconium- containing complexes

2. Check Content of Labeling & Packaging

Labeling requirements:

FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FDA does not have the resources or authority under the law for pre-market approval of cosmetic product labeling. It is the manufacturer’s and/or distributor’s responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements may result in a misbranded product. All labeling information must be in English. The only exception to this rule is for products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico.

Registration of Cosmetics in the USA | www.globalregulatorypartners.com

66

Requirements for Principal display and Information Panel

Requirements for Principal Display Panel Regulation

Identity statement

• indicating the nature and use ofthe product, by means of eitherthe common or usual name, adescriptive name, a fanciful nameunderstood by the public, or anillustration

[21 CFR 701.11].

Net quantity of contents Statement

• An accurate statement of the netquantity of contents, in terms ofweight, measure, numerical countor a combination of numericalcount and weight or measure.

[21 CFR 701.13].

Required Information on side Panel Regulation

Name and place of business.

• This may be the manufacturer,packer, or distributor. Thisincludes the street address, city,state, and ZIP Code.

• You may omit the street addressif it is listed in a current phonedirectory or city directory

[21 CFR 701.12(a)].

Distributor Statement

• If the name and address are notthose of the manufacturer, thelabel must say “Manufacturedfor...” or “Distributed by...,” orsimilar wording expressing thefacts

[21 CFR 701.12(c)].

Table 1: Information requirements for both the principal display panel and information panel on cosmetics.

77

Global Regulatory Partners, Inc

Required Information on side Panel Regulation

Material facts

• Failure to reveal material facts isone form of misleading labelingand therefore makes a productmisbranded

• An example is directions for safeuse, if a product could be unsafeif used incorrectly.

[21 CFR 1.21].

Warning and caution statements

• The FD&C Act and relatedregulations specify warning andcaution statements related tospecific products

• Cosmetics that may behazardous to consumers mustbear appropriate label warnings

[21 CFR part 700].

[21 CFR 740.1].

Ingredients

• If the product is sold on a retailbasis to consumers, even it islabeled “For professional useonly” or words to that effect, theingredients must appear on aninformation panel, in descendingorder of predominance

• If the product is also a drug, itslabeling must comply with theregulations for both OTC drugand cosmetic ingredient labeling

[21 CFR 701.3].

Packaging Requirements

The FDA requires all liquid oral hygiene products such as mouthwashes and all cosmetic vaginal products to 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) which, if breached or missing, alerts a consumer that tampering has occurred.

FDA Testing Requirements

Testing of Cosmetics is not required by the US FDA.

88

Global Regulatory Partners, Inc

3. Register Establishment with FDA

4. File Cosmetic Product Ingredient Statement

To register an establishment with the FDA one must first request a new account from the FDA. Once the account is created the owners or operators of cosmetic manufacturing or packing facilities can complete (FDA Form 2511) and upload it onto VCRP platform. It is important to note that distributors cannot register an establishment.

To complete Form 2511 the following information is required:

• Parent Company name

• Address

• Owner or Operator of the Facility

• Other businesses Trade names

• Establishment Authorized individual

Once Form 2511 is completed and submitted one may continue to complete File their Cosmetic

Product Ingredient using Form 2512. To file a Cosmetic formulation with the FDA one must complete

Form 2512 - the Cosmetic Ingredient Statement (CPIS).

To complete Form 2512 the following information is required:

• Labeler information

• Manufacturer Information

• Packer information

• Indicate whether filed product is already distributed in the USA

• Product information

» Select product category

» Product code

» Brand name/ specific product name

» Product website

» Upload label images

• Ingredient Information

» Can enter either CAS/ VCRP code number or common, usual, chemical name.

• Authorized individual name

99

Global Regulatory Partners, Inc

REFERENCES:

Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA. (n.d.). Retrieved May 4, 2020, from https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act

Fair Packaging and Labeling Act: Regulations Under Section ... (n.d.). Retrieved May 4, 2020, from https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/fair-packaging-labeling-act-regulations-0

Summary of Cosmetics Labeling Requirements | FDA. (n.d.). Retrieved May 4, 2020, from https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/summary-cosmetics-labeling-requirements

ABOUT GLOBAL REGULATORY PARTNERS, INC

Address: 400 Fifth Avenue, Suite #115, Waltham, MA 02451

Email: info@globalregulatorypartners.com

Website: www.globalregulatorypartners.com

Telephone: 781.672.4200

Corporate Office

Brazil

Rafael Marino Street, NETO 600Karaiba GardenUBERLANDIA – 38411-186Minas Gerais (MG)Telephone: (+55) 34-3235-1971

Japan

Ark Mori Building, Suite 50, 12/F1-12-32 Akasaka Minato-KTokyo, 107-6012Telephone : (+81)-3-4360-9287

China

21st Centry Tower, Suite 6030, 6/F210 Centry Avenue, Pudong DistrictShanghai, 200120Telephone: (+86) 021-517-27278

Mexico

Lake Alberto 442 – 5th floorTower A – Office 509Col. Anahuac 1st SectionDelegation Miguel Hidalgo, C.P. 11320Telephone: (+52) 55 7312 4169

For additional information, please contact us at info@globalregulatorypartners.com

Global Regulatory Partners, Inc

Global Regulatory Partners Inc, (GRP) provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. As a qualified and licensed legal representative with offices in USA, China, Japan, Brazil, Mexico and Argentina, the company can represent life science companies in those countries and help them register their products in compliance with local regulations and in record time.