Import Alert 53-06
Import Alert 53-06: Detention of Cosmetics Due to Illegal Colors
Background
FDA originally issued this Import Alert in 1985 because they detected illegal color additives in cosmetics manufactured by Taiwanese firms. Later, FDA noticed manufacturers in other countries were also using illegal colorants in mascaras, eye dust, lipstick and other cosmetic products. FDA created this Import Alert so districts would automatically detain imported cosmetics containing illegal colors. In 2018 the alert was revised to include misbranding charges in addition to the original adulteration charge.
How do Firms get on this Import Alert?
Today, the country-wide Taiwanese automatic detention has been removed from this particular Import Alert. Cosmetics are not subject to automatic detention unless they are from a manufacturer that FDA has added to the Red List. Some companies may be on this import alert simply because they declared legal, permitted colors incorrectly. FDA will interpret such errors to mean the colors discovered or declared to be in the cosmetics are not permitted, illegal and unsafe or are from uncertified batches.
Effects on Businesses Involved
A firm will find this import alert especially expensive to deal with. It is common for imported cosmetic shipments to contain many, many different cosmetics with different colors. Color is one of the primary attributes of most cosmetics. Even if future cosmetic shipments do not contain illegal colorants, FDA will still automatically detain all entries for private testing, prolonging the entry process. Because there are so many different colors in most cosmetic shipments, each cosmetic type has to be separately sampled and tested. That is expensive. In addition, cosmetics are common holiday gifts. When FDA adds a cosmetic company to an Import Alert, it makes it harder for them to meet critical deadlines for holiday sales. Because such a large portion of retail sales in the USA are generated prior to or during holidays, missing the window for holiday products could be very devastating.
How do Companies get off this Import Alert?
Cosmetic Companies on the Red List will be required to identify, correct and document the manufacturing or labeling problems that originally caused FDA to add them to the Import Alert. A firm should consider receiving an Import Alert Petition Viability Review to determine and address the critical issues. In addition, if labeling was involved in FDA’s decision to add the company to the Import Alert, cosmetic companies should consider a Cosmetic Label Review.
