Importing cosmetics into the United States using entry type 86 can be very lucrative even though the process can have many pitfalls. One of the biggest challenges that importers face is that many countries define cosmetics and drugs differently from the United States.
For instance, in some countries, sunscreens are deemed cosmetics and are under cosmetics regulations while they are regulated as drugs in the United States. Given that cosmetics and drugs are subjected to different requirements, it is critical to research to determine the classification of your imports under U.S. law.
How Does the FDA Monitor Imports?
The FDA works with the United States Custom & Border Protection Agency (CBP) in the monitoring of imports. Imported cosmetics are usually examined by the CBP at the port of entry. The HTS code of your product will link to respective PGA flags such as FD2. The FD2 flag tells you that there are PGA requirements for the product you plan to import. The FDA product code will tell you which PGA program code your HTS code falls under. For example, the FDA product code 66 P B L18 is subject to Human & Animal Drugs i.e., Drugs
Any imported cosmetics that appear to be misbranded or adulterated may be denied entry. They will typically have to be re-exported, destroyed, or made compliant.
What Ingredients are Restricted or Prohibited
Importers need to verify that the products they import comply with regulations that restrict or prohibit the use of certain ingredients. It can be the case that the country of origin may not have the same restrictions and prohibitions on ingredients as the United States.
Under FDA regulations, any ingredient is prohibited if it makes the finished product unsafe for consumers under customary or labelled conditions for use. This would apply even if the FDA does not have any regulations or restrictions prohibiting its use in cosmetics.
You should note that the same regulations do apply to the use of organic or natural ingredients in cosmetics. Regardless of whether cosmetics are organic or natural, or not, they will still be required to be safe for use by consumers even though you will not be required to get certification from the FDA.
Do Importers Have to Get FDA Approval Before Importing Cosmetics
Besides color additives, cosmetic ingredients and products are not required to get FDA approval before they are imported into the US. However, these products need not be misbranded or adulterated and will need to be safe for consumers under customary or labelled conditions of use.
Apart from color additives and any ingredients restricted or prohibited by FDA regulations, you may import any ingredient as long as it does not cause the cosmetic product to be adulterated in any way.
It is usually up to the individual importing persons or companies to ensure the labelling of their cosmetics is up to scratch. Manufacturers and marketers of cosmetics also have a legal responsibility for the labelling and safety of their products.
It is important to note that personal care products may be deemed drugs or both drugs and cosmetics under U.S. law. If the products you are importing are deemed drugs they will have to comply with requirements for drugs before they are allowed into the U.S. market.
Do Importers of Cosmetics Need to Register with the FDA?
Importers bringing in products deemed to be cosmetics and not drugs in the United States do not have to register with the FDA. However, the FDA encourages foreign and domestic cosmetic firms to register their companies and file Cosmetic Product Ingredient States with the Voluntary Cosmetic Registration Program.
If your products qualify as drugs or both drugs and cosmetics under United States regulations, you will need to register with the FDA. Similarly, you will have to register with the FDA subject to the Bioterrorism Act of 2002 if imported cosmetic ingredients have a food product classification.
Requirements for Domestically Produced and Imported Products
Imported and domestically produced cosmetics need to comply with the same regulations and laws set by the FDA.
While you do not have to get premarket approval from the FDA for cosmetic ingredients and products unless they are color additives, marketers and manufacturers of cosmetics are responsible for ensuring that their products comply with the laws and regulations of the United States.
Why are Cosmetic Imports Denied Entry into the U.S.?
Cosmetic imports may be denied entry into the U.S. if they are deemed to be not in compliance with U.S. regulations and laws. The following are some of the reasons for the denial of entry:
- Contaminants and ingredients that make the product unsafe
- The product is being marketed as a cosmetic when it is subject to regulations as a drug
- Color Additive Violations – The FDA needs to approve all color additives imported into the United States. Any additives not certified in the FDA laboratories will make your product be deemed adulterated.
- Labeling Violations – Actions such as not making accurate ingredient declarations or failure to include the mandatory labelling information in the required languages.
- Restricted or Prohibited Ingredients – Violating any of the prohibitions and restrictions will make your product be deemed adulterated.
- Microbial Contamination – While cosmetic products do not have to be sterile, microbial contamination is a health hazard and hence cosmetics may be deemed adulterated if they have microbial contamination.
Labelling Requirements for Cosmetics
There are several requirements on labelling that importers need to meet including:
- Labeling Needs to be in English – All required labels have to be in English. For products sold only in Puerto Rico, the labels must be in Spanish.
- Usual or Common Names used in the Country of Origin – Under the law, ingredients cannot use names that are usually or common in the country of origin, but rather by the usual or common names used in the United States.
- INCI nomenclature for Identifying Botanical Ingredients – the International Nomenclature Cosmetic Ingredient uses Latin Names for botanical ingredients. However, under the regulations, cosmetics have to use usual or common names while Latin names may be included on labels after the usual names and must be in parenthesis.
- CI Numbers for Identifying Color Additives on Labels – CI numbers are acceptable for labelling unless the numbers come after color additive names accepted in the United States. As such, the numbers are acceptable if they are in parenthesis after the additive names on the labels.
- Importing Without Labeling – Importers may be exempted from the requirement to label the ingredients in the country of origin if they intend to do so in the United States. This is particularly so if the importer is bringing in bulk cosmetic shipments and is the operator of the establishment where the shipment will then be repackaged and labelled. However, the exemption will not apply if the product is moved from the establishment before it is labelled under the regulations.