The information, which was last updated in October 2009, highlights the fact that imports continue to be monitored by the US Customs and Border Protection (CBP) but that actual regulation of both ingredients and the products themselves are largely not subject to approval.
On the subject of imports, the FDA reiterated that this is the primary concern of the CBP, but the FDA does continue to issue Import Alerts to the CBP concerning trending issues that relate to hazardous or toxic formulations, which can trigger heightened inspections.
Cosmetic and personal care products that may be refused importation to the country for a variety of reasons, including:
- Unsafe ingredients or contaminants
- Color additives violations
- Prohibited or restricted ingredients
- Microbial contamination
- Labeling violations (all labeling is required to be in English)
- Irregular product claims
The communication also confirms that US regulations continue to be some of the most liberal in the world, especially compared to European regulations, which have recently become much more complicated and stricter since the introduction of the REACH chemical registration program.
With respect to this, the FDA update confirms that, beyond its Voluntary Cosmetic Registration Program, companies are not required to register the importation of their products, unless they are drugs or a combination of drugs and cosmetics.
Definition of a drug varies from country to country
The FDA points out that the definition of what is or is not a drug, does vary from country to country, so it is important to define what category the product falls into in the US market before the importation process is complete.
On top of this, there is also a list of ingredients that are restricted or prohibited in the US, which makes it essential for companies to verify before starting the import process. This can be determined by checking the list of Ingredients Prohibited or Restricted by FDA Regulations, on its website.
For more specific information pertaining to the FDAs update on cosmetic import information, please go to this link.