Marisol International Transportation & Logistics Blog

FDA Import Alert: Laser Items

Posted by Chelsea Mitchell on Feb 3, 2016 3:36:35 PM

The U.S. Food and Drug Administration (FDA) issued an update to Import Alert 95-04 on January 28, 2016 for laser items which fail to comply with performance standards and labeling requirements. The affected items include laser pointers, laser pens, laser gunsights, laser levels, laser light shows, laser pointer key chains and similar products.


The U.S. Food and Drug Administration (FDA) can legally detain certain products without physical examination due to a company's history of noncompliance with ingredient or labeling standards. If a firm is found to have a track record of noncompliance, it is added to the 'red list.' If cargo is imported from a company that is on the 'red list' the cargo can be immediately detained upon entry.

In order to remove a company from the list of detention without physical examination, FDA requires information to be submitted which thoroughly demonstrates that the manufacturer has resolved the conditions which caused the violation.

Import Alerts are ultimately designed to protect U.S. consumers from faulty products or misleading information. U.S. Customs and Border Protection (CBP) is the enforcement agency for all Import Alerts at every U.S. port of entry.

FDA issues Import Alerts by country/area, industry, number or by publish date. Industry segments that the FDA currently monitors include: food, color additives, conveyances, cosmetics, vitamins, human drugs, biologics, animal drugs and feed, medical devices and diagnostic products, rad (radiation) health, tobacco products and other miscellaneous imported products.

The FDA has the ability to enforce this procedure through the Federal Food, Drug, and Cosmetic (FD&C) Act which was passed by Congress in 1938. The FD&C protects American consumers' health, safety, and finances from unsafe products. Under the FD&C, all imported products are required to meet the same product standards as domestic manufactured goods.

The scope of the FDA's reach differs from the U.S. Consumer Product Safety Commission (CPSC). The CPSC regulates consumer products such as toys, cribs, power tools, cigarette lighters and household chemicals.

Contact Marisol International today to learn more about import compliance. Or subscribe to our weekly industry newsletter here.

How to Import: A Beginner's Guide

Topics: Importing, Compliance

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