REGISTRATION OF COSMETICS IN THE USA

REGISTRATION OF COSMETICS IN THE USA

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FDA COSMETIC REGULATIONS

Cosmetics marketed in the United States, whether manufactured domestically or imported must comply with the following regulations: ? Federal Food, Drug, and Cosmetic Act (FD&C Act), ? Fair Packaging and Labeling Act External Link Disclaimer (FP&L Act).

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.

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HOW DOES THE FDA CLASSIFY COSMETICS?

Classification of your Product

Is the product intended for uses such as cleansing the human body, making a person more attractive, or changing a person's

appearance?

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

prevent disease?

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?

Is the product composed mainly of the "alkali salts of fatty acids," that is, the material?

It is a cosmetic

It is a soap

It is a Drug

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

It is a Medical device

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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 |

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1. Check the List of Ingredients

The 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 |

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Requirements for Principal display and Information Panel

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

Requirements for Principal Display Panel

Identity statement

Net quantity of contents Statement

? indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration

? An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure.

Required Information on side Panel

Name and place of business.

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

? You may omit the street address if it is listed in a current phone directory or city directory

Distributor Statement

? If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by...," or similar wording expressing the facts

Regulation

[21 CFR 701.11]. [21 CFR 701.13].

Regulation

[21 CFR 701.12(a)].

[21 CFR 701.12(c)].

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Required Information on side Panel

Material facts

? Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded

? An example is directions for safe use, if a product could be unsafe if used incorrectly.

Warning and caution statements

? The FD&C Act and related regulations specify warning and caution statements related to specific products

? Cosmetics that may be hazardous to consumers must bear appropriate label warnings

Ingredients

? If the product is sold on a retail basis to consumers, even it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance

? If the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling

Regulation

[21 CFR 1.21].

[21 CFR part 700]. [21 CFR 740.1].

[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.

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3. Register Establishment with FDA

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

4. File Cosmetic Product Ingredient Statement

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

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