I attended an Earth Day event and a local San Diego online clothing company with bamboo sunglasses had a booth. Looking at the bamboo frames, I noticed there were no marking on the temples, no Country of Origin, no CE. I tell the guy, hey this is illegal, eyewear is classified as a medical device and you have the markings on the frame. He got a little defensive, ‘We spent over a year investigating and we have the markings on the case‘.
At that point, I needed to double check, was I right? and I was. Then it struck me how many other online eyewear companies are not in compliance with the USA standards? Is this something that we need to be warning consumers about?
Over the years, issues have come up on how to deal with online sales: Should they give out the RX (yes, it is the law) Should they take the PD? Should they charge for taking the PD? Should they charge for adjustment? Should they refuse to touch or fix? Should they sign a waiver? Bad RX’s, Bad PD’s, Bad Measurements, all are legitimate issues, but rarely if ever has any ever talked about a Legitimate Company that complies with the Rules and Regulations of the FDA for Eyewear and Sunwear.
As online eyewear has grown and your customers are walking out to purchase their frames online or coming in with frames that have been purchased online, what can you say to them? What can you tell them about compliance and the USA’s standards? How can you educate your patients? If they are going to purchase online, what should they be looking for?
We have developed a checklist- education package that can be discussed with your patients.
On the Frame
- Does it have any markings on the temples? If not it is illegal. The manufacturer or importer is not in compliance.
- Does it have a country of origin on the frame? If not, it is illegal. The manufacturer or importer is not in compliance.
Manufacturer: This information is not visible to anyone. But it is something you can warn your patients about.
- If a sunglass, do the lenses meet FDA standards? Eyewear is considered a medical device and thus subject to many other standards. Under 21 CFR 801.410(c)(3), eyewear importers must supply a drop ball test certificate upon customs entry, stating that a statistically significant sample of lenses from each production batch were tested for resistance to breakage.
- Does Company have a website? If so what does it say?
- Is there contact information for the company? There should be a phone or an email address.
- Where are they located? Is there a city, state or country?
- Do they have a cookies policy?
- Do they have a shipping and return policy?
- Is the website up to date? At the bottom of the page does it say copyright 2013 or 2017?
- Are the images updated? Are their broken links?
Social Media: Many companies do not engage in any Social Media, some are only on Instagram, some just on Twitter, maybe Linked In. Just because there is no Social Media pages does not mean they are not legit. The information available depends on the Social Media platform one is using.
- What does the About say?
- When where they established?
- Contact information?
- Where are they located?
- Do they have images?
- Do their links work?
- When was their last update? Do they update any of their other social media?
- What do the comments say?
- How often do they post? If they haven’t posted in the last two years, are they still in business? If they have a blog are they updating it? If not… why not?
There are many legit and luxury lines that do sell online. But with the increase in crowdfunding and sites such as Alibaba, tradekorea, HKTDC.com anyone can start to import eyewear and start a business. Minimum orders can start at only 200 units. Scary.., because you! the health care professional have no idea where the product was made or if compliant to USA Standards. Even non- prescription sunglasses are regulated by the FDA.
Generally speaking, if any Asian company attends an optical trade show, they are legit, especially if they attend a Vision Expo. The Vision Council, checks out the products for compliance.
What is troubling to me and should be to eyecare professionals is the lack of education to the consumer on eyewear as a medical device and to unwitting new business.
The Vision Council has spent alot of time and money educating Asian suppliers of both eyewear and lenses on USA standards. What concerned me, with the San Diego company, is that their Chinese eyewear supplier should have known this. They are suspect as far as I am concerned.
- U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA;
- Foreign manufacturers must register their establishment with FDA and name a United States Agent.
- Manufacturers must list their devices with FDA;
- Manufacturers must meet Quality System (QS) requirements set forth in 21 CFR 820,
- The lens for spectacles and/or sunglasses must be certified as impact resistant under 21 CFR Part 801.410.
- FDA Medical Device Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the Food and Drug Administration (FDA). Although these devices are 510(k) exempt, several other FDA regulations apply:
- Regulatory Information Guidances
- Medical Devices
- Marisol Intl FDA Import Alert Eyewear Products
- Importing Sunglasses and Eyewear From China
- Importing and Exporting Devices into the USA