Help a newbie : US FDA Importation Requirements

True, but they never mention pointers anywhere and the reason being is because at the time it was written, they didn't exist. So it is up for interpretation, which varies individual to individual. But ultimately common sense dictates anything over 5mW is a danger, and very few people need more than that. So therefore ultimately what matters is what they and the government think. so when it comes down to a court case, I don't see it very contestable. If you have a valid reason to have it then you can submit a variance for one. Even pointers have such paperwork, just that is generally done by model as opposed to by serial number due to the high production.

because there is a void and it does not actually mention pointers, then in a case of trouble it becomes their choice of interpretations on a case by case basis until it is determined and added permanently. They get together & they have a discussion & decide where to classify them in an already existing category. And if I do recall they do have the authority to do that for safety reasons.

I've been a long time buyer from laserglow for a example. Whenever you imported a laser, they would file an ascession and the variance for you. All you had to pay was the bills/taxes. But now they're refusing to give them out to just anyone, in light of all the problems.

One of the new amendments that they're making to it does include portables by name. And it classifies them as I mentioned above if I'm not mistaken. I admit I'm curious to see how it turns out.

Btw: +rep for good citation.

Good points ultimatekaiser!

FDA’s document “Important Information for Laser Pointer Manufacturers” states FDA’s view of its authority over pointers and handhelds.
see: Important Information for Laser Pointer Manufacturers

•If a handheld laser is promoted for pointing out objects or locations, then FDA says it can be regulated either as a demonstration or as a SLA laser product.
•If a handheld laser is promoted for entertainment or amusement purposes, then FDA says it can be regulated as a demonstration laser product.
No matter which category (demonstration or SLA) is applied, the result and current practice is to restrict the laser’s power to less than 5 milliwatts of visible light.

It is almost pointless to argue with them--the have the long arm of the law on their side.

Yes. I partner with several local laser businesses and labs. So trust me when I say I know a lot about this, as I deal with it frequently. CNI is also canceling their handhelds as of 2015 I believe as well. They have been issued a cease and desist just like laserglow now.

ultimatekaiser said:

CNI is also canceling their handhelds as of 2015 I believe as well. They have been issued a cease and desist just like laserglow now.

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I was wondering when this would trickle down the line. I suspected it when we found out DL's 589's were limited supply. Very glad I got mine indeed.

Sigurthr said:

I was wondering when this would trickle down the line. I suspected it when we found out DL's 589's were limited supply. Very glad I got mine indeed.

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Yes. This may well be the final batch. After that, they're practically priceless hobbyist wise. Though labbies will come down a bit. I've got some interesting quotes lately. The market is undergoing a huge flux right now.

ultimatekaiser said:

Aside from the fact that numerous people have been arrested and convicted of this, I think it is in the .11 but I'll check later. I've had this discussion elsewhere a few times. The last time I read them they haven't changed since August 1985,

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ultimatekaiser said:

there are a few pending changes that aren't fully set in stone yet. Handheld lasers fit under demonstration lasers or SLA lasers depending on manufacturing intent.


This has always been the rule it's just that they've always been so expensive, it's never been much of a problem. but with the price of laser technology dropping more, and more people being able to buy stuff at higher power, naturally the number of irresponsible users rises with it. Pointing them at planes and such and ruining it for us.

Don't get me wrong, that doesn't mean that I like it anymore than you do, or that you can't try to bend around the rules, etc... but that is what it says in writing, and anyone who breaks the rules has to be prepared for the potential consequences.

Similar laws are in place all around the world, Canada's in fact are almost identical to ours just limited to class II instead to general consumers. Believe me I've spent a lot of time researching on this as well as asking officially. I'm always open to a discussion about it though but lets not do it here.

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Where should it be discussed?

steve001 said:

Where should it be discussed?

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I was just trying to move it to a seperate topic. I'm also tired of noobs passing neg rep without reading the whole thread just because the don't like a post and think they know everything. Seriously!?

ultimatekaiser said:

I was just trying to move it to a seperate topic. I'm also tired of noobs passing neg rep without reading the whole thread just because the don't like a post and think they know everything. Seriously!?

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Gave you back some positive rep

-Alex

ultimatekaiser said:

I was just trying to move it to a seperate topic. I'm also tired of noobs passing neg rep without reading the whole thread just because the don't like a post and think they know everything. Seriously!?

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Ok. Start a new thread in the safety & legal sub-forum.

ultimatekaiser said:

CNI is also canceling their handhelds as of 2015 I believe as well. They have been issued a cease and desist just like laserglow now.

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Would you mind sharing the source of that intel?

Atomicrox said:

Would you mind sharing the source of that intel?

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ummm I asked? Zach told me too. but i've been told by CNI that they're not doing handhelds anymore.

So its confirmed then.

ultimatekaiser said:

ummm I asked? Zach told me too. but i've been told by CNI that they're not doing handhelds anymore.

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Damn, that sucks. Sucks really hard.

What what I can tell imports into Canada are still fine, right?

delciotto said:

What what I can tell imports into Canada are still fine, right?

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the safest bet would be to ship it as "Laboratory Lighting Equipment" or "Starwars Reenactment Props" (cos STAR WARS IS REAL!) , or Light Oscillation by Stimulated Emission of electro-magnetic waves . Just censor yourself lol

steve001 said:

Show where it's the law >5mw handheld lasers meeting FDA standards can't be imported into the USA. A search does not indicate Congress has given the FDA that authority. Now all that matters is what the law says, not what individuals say.

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Administrative Law is not like Criminal Law. It is, in fact, a area where very few lawyers understand the process.

While your "Strict Interpretation" Adherence to the Constitution is Admirable, you missed the part in advanced Social Studies where Congress delegates its regulatory power to government agencies. FDA has the delegated authority under 21 CFR and used it.


FDA authors "Written Guidance" to U.S. Customs. Once this is issued, and enforced, you need a court challenge or an act of Congress to change it. There actually is a procedure for this "rulemaking" in a Federal Administrative Handbook. That procedure has review steps, so its constitutional. It would have been reviewed by the Office of Budget and Management, or another independent agency. All final regulations are submitted to Congress for a review at their option. A group of Federal agency employees followed the procedure and set the new rules.

So if you can provide the money to challenge the Government in court, which will take years, spend it. If you can convince a member of Congress to review the rule, your welcome to do so. Otherwise, until then understand this is the new way.

To see the actual internal documents, you'll probably need to submit a request under FOIA, to both CDRH and US Customs.

LINK to FDA's Justification:

http://www.fda.gov/Radiation-Emitti...ent/LaserProductsandInstruments/ucm116373.htm

Otherwise if you have a specific legal use for a foreign made handheld other then "Demonstration", you need to file a FDA 2877 form for import and justify the import. Note that 2877 does not let you "keep" the laser, you merely have custody of it, until approved, demonstrated as exempt, exported, or destroyed.

If you read the form, there is a possible minor loophole in line three, but foreign travel is expensive and resale is restricted.

LINK to Rulemaking Process:

http://www.reginfo.gov/public/reginfo/Regmap/index.jsp

General Federal Legal Authority and Procedure for rule making:

Administrative Procedure Act (APA) (5 U.S.C. Chapter 5).


Steve