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Shedding Light on FDA LED Regulations

     With the New Year upon us, new regulations are coming into force. One of these that affect businesses operating across borders is the Food and Drug Administration’s (FDA) reporting requirements for all products classified under 8541.40.2000 (light-emitting diodes-LEDs). The FDA is requiring the name and physical address of the original manufacturer in order to trace all “electrically-powered product that can emit any form of radiation on the electromagnetic spectrum.”

     In companies’ efforts to save energy costs, LEDs are becoming a commonly used source of lighting across industries. The U.S. market is the largest overseas market for Chinese companies in regards to LED imports, with the U.S. consuming over 70 percent of Chinese LED exports. These devices can include desk lamps with LED light bulbs, work lamps, flood lights and many decorative lighting devices used across industries. Therefore, purchasing bulk LED lights from China and importing them into the U.S. involves a few more steps than before.

     Firstly, be certain the lamp or bulb is an LED. The FDA has now set an FD2 requirement for all LEDs. This is for “LED products used for general or local area illumination, such as lamps and light bulbs.” Meaning, when importing an LED device, an importer must supply the original manufacturing plant’s name and physical address. In some cases, this can be difficult and involve research beyond where the part was merely purchased. This could involve contacting the LED supplier and asking for the factory from where they sourced the item. Additionally, if importing lamps to be used with LEDs, it is important to make note of this to avoid an FDA hold as well.

     Without being aware of these requirements before the product enters the commerce of the USA, importers are risking having their products delayed until the information can be furnished. While one may think that importing LEDs is straight-forward, this is one of many detailed FDA and Customs regulations that go into force throughout the year. By having a dedicated team monitoring your trade compliance, you can rest assured that you won’t be left in the dark.

Contributor: Justin Kim-Hummel

About Allyn International

     Allyn International is dedicated to providing high quality, customer centric services and solutions for the global marketplace. Allyn's core products include transportation management, logistics sourcing, freight forwarding, supply chain consulting, tax management and global trade compliance. Allyn clients range from small local businesses to Fortune 500 firms. Allyn conducts business in more than 20 languages and has extensive experience in both developed and emerging markets. Highly trained experts are positioned throughout North and South America, Europe and Asia. Allyn’s regional headquarters are strategically located in Fort Myers, Florida, U.S.A., Shanghai, P.R. China and Prague, Czech Republic. For more information, visit


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