By Linda Conlin, Pro to Pro Managing Editor

How good are those imported plano sunglasses? According to the Customs & International Trade Law website, “Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun’s ultraviolet (UV) rays on the eyes of a person.”

The FDA designates plano sunglasses as Device Class 1, of three classes of medical devices, making them subject to Quality System Regulation (QSR). The regulation sets “requirements related to methods used and the facilities and controls for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.” At the port of entry, the FDA and Customs and Border Protection require, among other documents, a Drop Ball Test certificate to verify “that the eyewear have been ‘sampled’ and are impact resistant, using a statistically significant method.” That all sounds good, but even with Drop Ball Test certificates, the FDA analyzed some sunglasses and found they were not up to impact-resistance standards. The FDA then created a Red List of Import Alert, which allows for products from those manufacturers to be detained at port of entry without inspection.

Then there’s UV protection, or lack of it. Sunglasses at any price should offer 100% UVA and UVB protection. There may be a sticker on the glasses regarding the level of UV protection, but consumer tests have shown that especially in the case of unknown brands of imported sunglasses, a sticker is no guarantee. There’s the issue of lens quality, too. Optical quality and warpage can be unknown factors with inexpensive imports. 

So how do those inferior sunglasses get to dollar stores, flea markets and convenience stores? While all products sold as sunglasses in the United States must meet FDA standards, those standards don’t apply to products sold as “novelty items” or toys. Although those items must have warning labels that they aren’t intended for use as sunglasses for eye protection, the labels can be removed by unscrupulous sellers, or ignored by bargain hunters. What’s more, importers need only submit batch samples for testing to ensure FDA compliance. Each and every item isn’t tested, leaving a loophole for fraud.

As ECPs, we need to be ready to educate consumers not only about the importance of eye protection from the sun, but the quality of the lenses providing that protection, especially for children. Our CE, Protecting Our Amazing Eyes, will give you more information about the "Eye Protection" conversation that applies to all of us from children to high-performance athletes. Check it out at