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Will 3D glasses be regulated by the FDA?

By | April 12, 2010, 3:50 AM PDT

RealD said in a regulatory filing with the Securities and Exchange Commission that the Food and Drug Administration could decide to regulate 3D glasses. The company also cited potential health risks as a worry spot for 3D.

RealD made the comments in its prospectus. The company, which makes the glasses and projectors used to watch 3D movies like Avatar and Alice in Wonderland, filed to raise as much as $200 million in an initial public offering.

The prospects for the company generally look good and the growth rates our impressive. But for our purposes the big question is whether the FDA should regulate things like 3D glasses. As our reality—and entertainment—experiences become increasingly augmented by technology it’s worth asking about how health regulations will come into play.

Here’s a look at RealD’s key passages from its SEC filing:

Currently, polarized eyewear, including our RealD eyewear, is not regulated by the FDA, or by state or foreign agencies. However, certain eyewear, such as non-prescription reading glasses and sunglasses, are considered to be medical devices by the FDA and are subject to regulations imposed by the FDA and various state and foreign agencies. With the rising popularity of polarized 3D eyewear, there has been an increasing level of public scrutiny examining its potential health risks. Polarized 3D eyewear, including our RealD eyewear, may at some point be subject to federal, state or foreign regulations that could potentially restrict how our RealD eyewear is produced, used or marketed, and the cost of complying with those regulations may adversely affect our profitability.

And on potential 3D health risks, RealD said:

Research conducted by institutions unrelated to us has suggested that 3D viewing with active or passive eyewear may cause vision fatigue, headaches, motion sickness or other health risks. If these potential health risks are substantiated or consumers believe in their validity, demand for the 3D viewing experience in the theater, the home and elsewhere may decline. As a result, major motion picture studios and other content producers and distributors may refrain from developing 3D content, motion picture exhibitors may reduce the number of 3D-enabled screens (including RealD-enabled screens) they currently deploy or plan to deploy, or they may reduce the number of 3D motion pictures exhibited in their theaters, which would adversely affect our results of operations, financial condition and prospects. A decline in consumer demand may also lead consumer electronics manufacturers and content distributors to reduce or abandon the production of 3D products, which could adversely affect our prospects.

In addition, if health risks associated with our RealD eyewear materialize, we may become subject to governmental regulation or product liability claims, including claims for personal injury.

Now these risk factors may be overblown a bit. However, if the FDA regulates sunglasses it would stand to reason the 3D glasses may not be that far behind. Meanwhile, these 3D systems including the glasses will only become smarter over time. Spin this forward and you could see that the FDA may become interested in 3D as well as virtual reality setups and the like. After all, reality and entertainment will increasingly be augmented by technology. What’s your take?

Related:

Will 3D glasses fly in the living room?

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Larry Dignan

About Larry Dignan

Larry Dignan is editor-in-chief of SmartPlanet.

Larry Dignan

Larry Dignan

Editor-in-Chief

Larry Dignan is editor-in-chief of SmartPlanet and ZDNet. He is also editorial director of TechRepublic. Previously, he was an editor at eWeek, Baseline and CNET News. He has written for WallStreetWeek.com, Inter@ctive Week, New York Times and Financial Planning. He holds degrees from the Columbia University Graduate School of Journalism and the University of Delaware. He is based in New York but resides in Pennsylvania.

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Larry Dignan

Larry Dignan
Larry Dignan does not hold any investments in the companies he covers.
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RE: Will 3D glasses be regulated by the FDA?
Great bit of reprting! Kudos to RealD for clear full disclosure. Love the acknowledgement that consumer beliefs, not reality, can drive or deter an industry's growth and innovation in general. The FDA should monitor the 3D phenom but unless clear residual health issues can be pinpointed they should let consumer influence prevail.
Posted by George A
12th Apr 2010
0 Votes
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Should be!
Sorry if it may hurt their bottom line, but the safety of the public is a higher priority. I have encountered cheap reading glasses that caused my eyes to water, due to chemicals in their manufacture. I would hate to see (pun intended) a population of individuals with damaged eyesight due to advancing technology.
Posted by FiOS-Dave
12th Apr 2010
0 Votes
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Sensationalist journalism
This is sensationalist journalism, pure and simple. Those
provisos are standard, almost boiler plate, additions to any
prospectus. They are even prompted for automatically in some
form software, and are required by SEC regulation. In fact,
companies often jump through hoops to manufacture these
"caveats" just to give the impression of full disclosure. NOWHERE
in this filing does the language even remotely imply any actual
known, or supposed, or even speculated significant health risks.
Nor does any research exist pointing in this direction. Taking all
things in to account, especially the headline, it is hard to see
this as anything other than fear click baiting and fear
mongering.
Posted by DeusExMachina
12th Apr 2010
0 Votes
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RE: Will 3D glasses be regulated by the FDA?
I do experience motion sickness while using polarized 3D glasses - but I feel this is a result of the image/filming, not the glasses per-se. It is possible to use the 3D capability to provide reality presence in a film, or over-the-top effects show-off. Are you watching the film for the story and acting, or is it just an effects vehicle? I suspect both kinds of films will exist; at most, the customer needs to be informed which kind it is.
Posted by jhoward@...
12th Apr 2010
0 Votes
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Reason for FDA to regulate sunglasses.
Sun glasses are claimed to provide protection from ultraviolet radiation. Any device making a protection claim is required to be regulated by the FDA. 3D movie glasses do not make that claim and therefor are except from FDA oversight.

By the way, polarized glass does provide various amounts of UV protection.
Posted by Dr_Zinj
12th Apr 2010
0 Votes
+ -
Just joking
I get motionsickness in buses. There should certainly be a
healthwarning printed at the side of them. I also get very tired both
looking at and listening to my neighbour, a warningsticker should be
attached to him.

Seriously, should everything be regulated just because one or two
people have a problem? Should everybody suffer just because ONE
person is a blithering moron?

Example: My overregulating country just passed a law that sparklers
may not be sold to persons under the age of 18 (eightteen), because
they are so DANGEROUS. On the other hand, the authorities have not
yet realized that a child of 5 can buy gasoline, and make a molotows
coctail (well, in theory at least).
Posted by Dukhalion
13th Apr 2010
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