A few months ago, FDA removed a country-wide import alert against cosmetic products from Taiwan for illegal color additives. Notably, the import alert disappeared with little fanfare.
FDA originally issued Import Alert 53-06 in 1985, following the detection of illegal color additives in cosmetics manufactured in Taiwan. As a result, all cosmetics from Taiwan were subject to automatic detention upon import. Although manufacturers in other countries were also found to be using illegal colorants in mascaras, eyeshadow, lipstick and other cosmetic products, shipments from these manufacturers were stopped only if the specific manufacturer was on the Red List.
The impact of this Import Alert on Taiwanese businesses was not insignificant. From 1985 until November 2019, all cosmetic companies located in Taiwan faced automatic detention of their shipments to the United States – regardless of whether their products were actually violative. To facilitate importing, these firms would need to petition to be added to FDA’s Green List (often a cumbersome process in its own right). Affected firms faced a prolonged entry process while providing evidence to let FDA release the shipments, which oftentimes requires going through lab testing. These delays were costly in terms of both time and money, particularly when they caused firms to miss important deadlines. Having a shipment delayed prior to or during the holidays, for example, could be devastating to a firm whose success depended largely on sales in the U.S. market.
FDA’s revision of Import Alert 53-06 relieves compliant Taiwanese cosmetic manufacturers of a long-standing burden. Rather than covering all of Taiwan, this Import Alert now consists solely of Red List specific companies with a history of apparent violations. These violations could be the result of including an illegal color additive, including an uncertified colorant, or failing to properly declare a color additive.
It is not uncommon that FDA withdraws or removes an obsolete policy or guidance. This means that cosmetic products from Taiwan can find easier access to the U.S. market, as long as they are not on the Red List for the Import Alert. Cosmetic importers, especially if they rely on manufacturers impacted by U.S. Section 301 tariffs, may now find Taiwan to be an alternative worth exploring.
If your firm finds itself affected by an FDA Import Alert, give the experts at FDAImports a call or contact us today.
