FDA Red-Lists Sunglass Manufacturer

The FDA (U.S. Food & Drug Administration) "red-listed" Linhai Industrial Glasses (LIG) Factory, Duchuan 387 The Road , Linhai City, China, for its non-prescription sunglasses. That means Customs agents can detain without physically examining LIG eyewear with impact-resistant lenses.

The red-listing process began with a U.S. distributor. The firm heard reports about LIG's eyewear. It tested a shipment and found a breakage rate ranging from 40 to 70 percent. That's when the FDA became involved. The federal agency notes, "Due to apparent certificate irregularities SAN-DO collected a sample of children's sunglasses. The manufacturer's certificate indicated that no lenses broke during testing. However, WEAC testing of the sample found that nearly every lens broke completely. More recently, SAN-DO collected a sample of adult prescription lenses. WEAC testing of the sample found that 38% of the lenses broke completely." Eyeglasses and sunglasses imported into the U.S. must comply with 21 CFR 801.410: "Use of impact-resistant lenses in eyeglasses and sunglasses." A certificate of compliance, which testifies that the lens manufacturer has tested lenses for compliance, must accompany each shipment. In the past three years, the FDA has red-listed several manufacturers in China. Read more.