Importing Cosmetics into the U.S

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Importing Cosmetics into the U.S.

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FDA Cosmetics Consulting
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How to import cosmetics/beauty products into the US

Importing Cosmetics and Voluntary Cosmetic Registration Program (VCRP)

Imports of cosmetics are governed by the provisions of the Federal Food, Drug, and Cosmetic Act, which is administered by the Food and Drug Administration (FDA).

Cosmetics are articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. It also includes articles intended for use as a component of any such articles except that such term shall not include soap.

Some products you might think are cosmetics are actually classified as drugs. These include sunscreen products, fluoride toothpaste, antiperspirants, and anti-aging products. Drug products are intended to affect the structure or function of the body of humans or animals. However, suntan preparations, deodorants, and non-fluoride toothpaste are considered cosmetics because they are not intended to affect the structure or function of the body. You should carefully review the definitions of drug products when determining if a product is a cosmetic or drug.

In-Depth Coverage: Cosmetics Import Requirements

Cosmetic products and ingredients, other than color additives, do not need the approval of the U.S. Food and Drug Administration (FDA) before they go on the market in the U.S. Also, companies and individuals importing products considered to be solely cosmetics are not required to register with FDA, and a registration number is not required for importing cosmetics into this country.

However, all commercial imports of cosmetic products are subject to approval by the FDA, prior to being cleared by U.S. Customs and Border Protection (CBP). When FDA refuses the entry of these goods, CBP will not release them. Therefore, it is pertinent that importers of these products consult with FDA, to ensure they are in compliance with their regulations. 

Companies and individuals who manufacture or market cosmetics have a legal responsibility for the safety and labeling of their products. In general, all imported cosmetics must comply with the same laws and regulations that apply to those produced domestically. Read more about Cosmetics: Regulations and Enforcement by FDA

In-Depth Coverage: Marketing and Advertising Compliance

Voluntary Cosmetic Registration Program (VCRP)

The FD&C Act does not require cosmetic firms to register their establishments or list their product formulations with FDA.  FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory. Read more…

Are all imported cosmetics sampled and examined?

Not all cosmetics are inspected or sampled upon entry into this country. However, FDA closely scrutinizes and controls the importation of cosmetic products by means of Import Alerts if they are

  • marketed with therapeutic claims that cause them to be considered unapproved new drugs under the law,
  • adulterated because of microbial contamination, failure to meet U.S. requirements for color additives, and
  • bulk shipments of high-risk bovine tissue from BSE (bovine spongiform encephalopathy) countries.

While not all imported products are examined at the time of entry, those not examined are still subject to all the legal requirements of the laws and regulations enforced by the FDA. For further information on the Import alerts please refer to Import Alerts for Industry: Cosmetics.

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In-Depth Coverage: Country of Origin

What are some of the reasons cosmetics offered for import are refused entry into the United States?

A cosmetic may be refused entry into the United States if it appears not to comply with applicable U.S. laws and regulations in any way. The following are just some of the most common reasons:

  • Ingredients or contaminants that cause the product to be unsafe.
  • Color additive violations: All color additives must be approved by FDA for the intended use; some must not be used unless they are batch-certified in FDA's own laboratories. Misuse of color additives makes a product adulterated.
  • Prohibited and restricted ingredients: Violating the restrictions on the use of these substances makes a cosmetic adulterated.
  • Microbial contamination: Sterility is not required for cosmetic products, but microbial contamination can pose a health hazard and therefore make a product adulterated.
  • Labeling violations, such as deficiencies in the ingredient declaration, or failure to include all required labeling information in English (or Spanish, in Puerto Rico).
  • Claims that cause a product marketed as a cosmetic to be subject to regulation as a drug under U.S. law. 
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In-Depth Coverage: Importing Medical Device 

What ingredients are prohibited or restricted?

If you are an importer, it is essential for you to verify that the products you import comply with regulations that prohibit or restrict the use of certain ingredients. The country of origin may not have the same ingredient prohibitions and restrictions as the United States. But remember, any ingredient is prohibited if it causes the finished cosmetic product to be unsafe for consumers under labeled or customary conditions for use, even if there is no regulation specifically prohibiting or restricting its use in cosmetics.

For further information please refer to “Ingredients Prohibited or Restricted by FDA Regulations.”

What are the labeling requirements for cosmetics?

All required label information must be in English. However, if the product is marketed only in Puerto Rico, it must be labeled in Spanish. If some labeling information appears in another language, all required label information must also appear in that language. 

Ingredients must be identified by their “common or usual names” in the United States.  INCI (International Nomenclature Cosmetic Ingredient) names for botanical ingredients typically use Latin names for genus and species to identify botanical ingredients. However, U.S. regulations require the use of common or usual names. Latin terms may be included parenthetically following the common or usual name of an ingredient. Example: Aloe (Aloe Barbadensis) Extract.

In-Depth Coverage: USDA-Regulated Products

In-Depth Coverage: Trade Remedies

In-Depth Coverage: Customs Valuation

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Customs Clearance and Import Requirements

Guidance on customs & logistics solution for traditional and e-commerce importers and exporters

Ocean Freight

Importer Security Filing (Ocean Cargo)

An ISF is required when cargo (ocean only) laden on vessel at a foreign port is destined for shipment to the U.S.  Under ISF rule, some importing information and details regarding cargo must be transmitted to the CBP at least 24 hours before goods are loaded onto the vessel, or at least 24 hours prior to the departure to the U.S. 

Customs Brokerage & Consulting

Customs Clearance

The goods imported into the U.S. are required to be declared to CBP. Our customs broker will help you stay in compliance with customs laws and regulations and clear your goods quickly and efficiently with our electronic Automated Commercial Environment (ACE) and Automated Broker Interface (ABI) Single Window System.

Freight Forwarding

Freight Forwarding

Looking for a freight forwarding partner?  To move your cargo from its current location through customs to its final destination we will partner with you to find the best way for your business. Whatever your transportation, logistics or customs clearance needs, we will do our best to customize a solution for your needs. 

Country of Origin

Non-resident Importer Program

If you want to sell your products in the U.S. marketplace, but you are a business owner located outside of the U.S. and do not have an entity or a presence in the U.S., you need to be established as a Foreign Importer of Record before your goods can be imported into the U.S. We can help you. 

Warehousing & Logistics

Warehousing & Distribution

Our warehouse facility offers great potential for serving as a regional hub with over 145,000 SF storage capacity close to Los Angeles Airport & Los Angeles/Long Beach Sea port. With our extensive experience in freight services, your import/export cargo will be handled quickly and effectively.

Section 321 Entry

Section 321 Entry

Section 321 entry allows importing free of duty and tax for shipments imported by one person on one day having a fair retail value in the country of shipment not more than $800. We provide our resident and non-resident clients with dedicated ACE eManifest solutions for Section 321 entry of all modes of transportation. 

FDA-Regulated Products and Import Requirements

Quick Link To U.S. Customs & Import Requirements

Customs Brokerage & Consulting

Customs Brokerage & Consulting

Freight Forwarding

Freight Forwarding & Logistics

Importing FDA Regulated Product & Compliance Consulting

FDA Regulated  Products

USDA Compliance

USDA Regulated Products

EPA Compliance

EPA Regulated Products

E-Commerce

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