Cosmetics, Drugs, and Combination Products

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Cosmetics, Drugs and Combination Products

Importing cosmetics
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Cosmetics, Drugs, or Cosmetics and Drugs

Classification of products as cosmetics, drugs, or cosmetics and drugs is a concern for manufacturers, as cosmetics are not subject to the same approval, regulatory, or registration requirements as drugs. In addition to saving considerable time and expense, this distinction allows manufacturers of products that are only cosmetics and not drugs or combination products to market their products with less regulatory oversight.

Cosmetics

The term “cosmetics” covers a broad range of FDA-regulated products that may be used externally, orificially, and internally. For regulatory purposes, the term “cosmetics” includes products for the eyes, face, nails, hair, skin, and mouth, which may be in the form of products such as makeup, polish, hair dyes and coloring, sunscreens, fragrances, shave gel, oral care and bath products, and products for infants and children. In some settings, cosmetics are known as “personal care products” because of the wide range of products now regulated as cosmetics that are not strictly facial cosmetics.

The FD&C Act defines “cosmetics” as “(1) 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, and (2) articles intended for use as a component of any such articles; except that the term shall not include soap.” While soap was explicitly exempted from the definition of a cosmetic, and is not defined in the FD&C Act, it is defined in FDA regulations.  Additionally, coal tar hair dye was provided a limited exemption from the FD&C Act’s adulteration provisions.

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In-Depth Coverage: Importing Cosmetics

Drugs

The FD&C Act defines a “drug” as including articles “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” articles that are “intended to affect the structure or any function of the body,” and “articles intended for use as a component” of such drugs. Unlike cosmetics and their ingredients (with the exception of color additives), drugs are subject to FDA approval before they can enter interstate commerce. Drugs must either receive the agency’s premarket approval of a new drug application or conform to a set of FDA regulations known as a monograph. Monographs govern the manufacture and marketing of over-the-counter (OTC) drugs and specify the conditions under which OTC drugs in a particular category (such as antidandruff shampoos or antiperspirants) will be considered to be generally recognized as safe and effective. Monographs also indicate how OTC drugs must be labeled so they are not deemed to be misbranded. Such labeling includes a Drug Facts panel, which provides a listing of the active ingredients in the product as well as the drug’s purposes, uses, and applicable warnings, directions, inactive ingredients, other information, and a telephone number for questions about the product.

Drug manufacturers must comply with good manufacturing practices (GMP) rules for drugs; failure to follow GMP may cause a drug to be considered adulterated. Drug manufacturers also are required to register their facilities, list their drug products with the agency, and report adverse events to the FDA.

In-Depth Coverage: Importing Medical Device 

Cosmetics Containing Drug Ingredients

While reference to “cosmetic drugs” or “cosmeceuticals” has been used by some proponents in referring to combination cosmetic-drug products, there is not an FDA statutory or regulatory definition for this terminology.

Cosmetic-drug combination products are subject to FDA’s regulations for both cosmetics and drugs. Combination drug and cosmetic products must meet both OTC drug and cosmetic labeling requirements, that is, the drug ingredients must be listed alphabetically as “Active Ingredients,” followed by cosmetic ingredients either listed in a descending order of predominance as “Inactive Ingredients” or listed as “Inactive Ingredients” in particular groups, such as concentrations of greater than one percent of color additives.

The determination of whether a cosmetic is also a drug, and therefore subject to the additional statutory requirements that apply to drugs, is based on the distributor’s intent or the intended use. The intended use of a product may be established in several ways, such as claims on the labeling or in advertising or promotional materials, or through the inclusion of ingredients that will cause the product to be considered a drug because of a known therapeutic use.

For example, if a lipstick (a cosmetic) contains sunscreen (a drug), the mere inclusion of the term “sunscreen” in the product’s labeling will cause the product to also be regulated as a drug. The following provide examples of other combination products and compares cosmetic versus drug classifications.

Comparison of Cosmetic and Drug Product Classifications

  • A suntan product is a cosmetic, but a sunscreen product is a drug.
  • A deodorant is a cosmetic, but an antiperspirant is a drug.
  • A shampoo is a cosmetic, but an antidandruff shampoo is a drug.
  • A toothpaste is a cosmetic, but an anticavity toothpaste is a drug.
  • A skin exfoliant is a cosmetic, but a skin peel is a drug.
  • A mouthwash is a cosmetic, but an antigingivitis mouthwash is a drug.
  • A hair bulking product is a cosmetic, but a hair growth product is a drug.
  • A skin product to hide acne is a cosmetic, but an antiacne product is a drug.
  • An antibacterial deodorant soap is a cosmetic, but an antibacterial anti-infective soap is a drug.
  • A skin moisturizer is a cosmetic, but a wrinkle remover is a drug.
  • A lip softener is a cosmetic, but a product for chapped lips is a drug.

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In-Depth Coverage: Country of Origin

Quick Link To U.S. Customs & Import Requirements

Customs Brokerage & Consulting

Customs Brokerage & Consulting

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FDA-Regulated Products and Import Requirements

Customs Clearance and Import Requirements

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

Ocean Freight

Importer Security Filing (ISF)

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.

Customs Brokerage & Consulting

Customs Clearance

All 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.

Logistics Solution

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. 

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. 

Country of Origin

Non-resident Importer Program

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

E-Commerce

E-Commerce

The Internet has made it easy to find and purchase items from almost anywhere in the world. Our e-commerce experts will help you find the right solution for your international transportation, customs clearance, and delivery to your final destination.  We also provide value-added repackaging, warehousing and distribution services. 

Design your own logistics

To move your cargo from its current location through customs to its final destination we will partner with you to find the best solution for your business.