U.S. Cosmetics Registration Regulations

WFOE Registration, Work Permit, Special Industry Permit application according to Houston Regulations, we need to do KYC (Know your client) before engagement with your assignment.

Email: hou4ww@evershinecpa.com

Or contact by phone in the Texas time zone:
The Engaging Manager Ian Lin, a well-English speaker
Tel: +1-510-996-2685

HLF-TW-10
What are the categories of cosmetics in U.S.? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?

Evershine RD：

FD&C Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance”

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market.
Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.
Among the many nonprescription drug categories covered by OTC monographs are acne medications, treatments for dandruff, seborrheic dermatitis, psoriasis, and sunscreens.

FDA maintains the Voluntary Cosmetic Registration Program (VCRP), for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. The FD&C Act does not require cosmetic firms to register their establishments or list their product formulations with FDA. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA

【Website】https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic

HLF-TW-20
If a foreign company wants to sell cosmetics in U.S., no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests?
What are the required documents and application procedures? Website?

Evershine RD：

No. Firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into this country. FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with our Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory. Please note that the VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States (21 CFR 720.2).

If your products are drugs, or both cosmetics and drugs, under U.S. law, however, they are subject to requirements for drug registration.
Similarly, importers of cosmetic ingredients that are also classified as food products are required to meet the registration requirements of the Bioterrorism Act of 2002.

【Website】

https://www.fda.gov/cosmetics/cosmetics-international-activities/cosmetics-importers

HLF-TW-30
If a foreign company wants to sell cosmetics in U.S., can it assign a U.S. company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

It’s not required. Firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into this country. FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with our Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory. Please note that the VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States (21 CFR 720.2).

If your products are drugs, or both cosmetics and drugs, under U.S. law, however, they are subject to requirements for drug registration. Similarly, importers of cosmetic ingredients that are also classified as food products are required to meet the registration requirements of the Bioterrorism Act of 2002.

【Website】

https://www.fda.gov/cosmetics/cosmetics-international-activities/cosmetics-importers

HLF-TW-40

Do foreign companies need to apply for an approval before importing cosmetics sold to U.S.?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetic packaging and labeling require prior approval? In addition to Chinese, which other languages ​​are allowed? Website?

Evershine RD：

It’s not required. Firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into this country. FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with our Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory. Please note that the VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States (21 CFR 720.2).

If your products are drugs, or both cosmetics and drugs, under U.S. law, however, they are subject to requirements for drug registration. Similarly, importers of cosmetic ingredients that are also classified as food products are required to meet the registration requirements of the Bioterrorism Act of 2002.

The following information must appear on the

1. principal display panel:

An identity 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 [21 CFR 701.11].

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 [21 CFR 701.13].

2. on an information 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 [21 CFR 701.12(a)].

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 [21 CFR 701.12(c)].

Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.

Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.

Ingredients. If the product is sold on a retail basis to consumers, even if 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. [21 CFR 701.3].

All words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.

If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear thereon in the foreign language.

【Website】

https://www.fda.gov/cosmetics/cosmetics-international-activities/cosmetics-importers

https://www.fda.gov/cosmetics/cosmetics-labeling

HLF-TW-50
Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do cosmetic packaging and labeling require prior approval? In addition to Chinese, which other languages ​​are allowed? Website?

Evershine RD：

Yes, firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into this country. FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with our Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory. Please note that the VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States (21 CFR 720.2).

If your products are drugs, or both cosmetics and drugs, under U.S. law, however, they are subject to requirements for drug registration.
Similarly, importers of cosmetic ingredients that are also classified as food products are required to meet the registration requirements of the Bioterrorism Act of 2002.

The following information must appear on the

1. principal display panel:

An identity 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 [21 CFR 701.11].

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 [21 CFR 701.13].

2. on an information 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 [21 CFR 701.12(a)].

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 [21 CFR 701.12(c)].

Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.

Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.

Ingredients. If the product is sold on a retail basis to consumers, even it 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. [21 CFR 701.3].

All words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.

If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear thereon in the foreign language.

【Website】

https://www.fda.gov/cosmetics/cosmetics-international-activities/cosmetics-importers

https://www.fda.gov/cosmetics/cosmetics-labeling

HLF-TW-60
What are the required documents for the application of importing cosmetics registration?
What is the application process? Website?

Evershine RD：

Firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into this country. FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with our Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory. Please note that the VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States (21 CFR 720.2).

If your products are drugs, or both cosmetics and drugs, under U.S. law, however, they are subject to requirements for drug registration. Similarly, importers of cosmetic ingredients that are also classified as food products are required to meet the registration requirements of the Bioterrorism Act of 2002.

【Website】https://www.fda.gov/cosmetics/cosmetics-international-activities/cosmetics-importers

HLF-TW-70
What are the laboratory inspection materials that need to be attached for TFDA verification?

Evershine RD：

Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA. However, companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products.

Manufacturers shall use whatever testing is necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that “the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information.”

【Website】
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated#What_actions

HLF-TW-80

After a foreign subsidiary imports cosmetics and entrusts a distributor in U.S. to sell it, does the distributor need a cosmetics business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

FDA may take regulatory action if we have reliable information indicating that a cosmetic is adulterated or misbranded. For example, FDA can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, FDA may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Cosmetics that are not in compliance with the law may be subject to seizure. “Seizure” means that the government takes possession of property from someone who has violated the law, or is suspected of doing so. FDA also may initiate criminal action against a person violating the law.

https://www.fda.gov/cosmetics/cosmetics-laws-regulations/key-legal-concepts-cosmetics-industry-interstate-commerce-adulterated-and-misbranded

https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated#What_actions

Contact Us

Houston Evershine BPO Service Limited Corp.
E-mail: hou4ww@evershinecpa.com
or
Contact by phone in the Texas time zone:
The Engaging Manager Ian Lin, a well-English speaker
Tel: +1-510-996-2685
or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4hou@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Email address:dalechen@evershinecpa.com
LinkedIn address: Dale Chen

Additional Information

Evershine CPAs Firm Headquarters
6th Floor 378 Chang Chun Rd., Taipei City, Taiwan ROC
Partner Kerry Chen,  USA Graduate School, and a well-English speaker
Tel No.: +886-2-27170515 ext. 105
Mobile: +886-939357000
Email: kerrychen@evershinecpa.com
Skype: oklahomekerry

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(version: 2024/07)