FDA proposes ban on handhelds >5mW

[pmurph5]

The FDA today (May 2 2014) proposed regulations that would effectively ban laser pointers and handheld lasers in the U.S. over 5 milliwatts. Currently these can go up to about 3000 milliwatts.

The FDA's is doing this by stretching -- to put it mildly -- their existing authority over surveying, leveling and alignment (SLA) lasers. Basically, they are saying that because small, handheld, battery powered lasers are used for surveying, leveling or alignment, they are thus are subject to FDA jurisdiction.

In my personal opinion, FDA is wrong. First, pointers do NOT fit the existing FDA regulations which clearly define SLA lasers. Second, if you look at any lasers used for surveying, leveling or alignment, they do NOT look like or operate like handheld laser pointers.

The FDA's proposal asks for public comment for 90 days (submission deadline: August 2 2014). FDA will then consider the comments and may issue the regulation anyway, change it, or drop it.

Here's the FDA's website announcement: Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff

Here is an objective description of FDA's current authority over pointers, plus my personal analysis/opinion stating that FDA's proposed definition is wrong: Laser Pointer Safety - FDA authority over laser pointers and handheld lasers

The FDA's website has instructions on how to submit comments. I believe thoughtful, respectful comments from laser hobbyists would be useful.

Patrick Murphy
writing for myself personally, and not as a representative of any organization

 

[Shakenawake]

good thing they can't ban diodes and drivers. can't stop us, we're on a mission from god.

this saddens me, but even if every member here submitted a well thought out arguement, I doubt they would care or even read them. this has been coming for a long time, clearly they have decided, and just want to make us feel like we have a say

 

[Livinloud]

Anything over 5mW is already illegal so not sure how this is any different :thinking:

 

[Encap]

Anything over 5mW is already illegal so not sure how this is any different :thinking:

Exactly, has been that way for a long time. Nothing new.

 

[Lotus_Darkrose]

Anything over 5mW is already illegal so not sure how this is any different :thinking:

I too would like to know how this is any different, as it's been against the law to import over 5mW into the US for quite a while now. I was almost certain there was a reason for that...lol.

 

[Shakenawake]

to import, yes, I believe they may be talking about ownership here. maybe.

even if this is not the final nail, I still say look for the U.S. to become like Australia or New Zealand in the near future

 

[Lotus_Darkrose]

I'm not allowed to have my cat in my apartment, but yet, here she is.

 

[IsaacT]

Better hoarse now while we can then. I don't know about y'all but I'll be hoarding diodes and wavelengths I cannot build myself.

 

[Livinloud]

If you cant import them then you also cant own them.

BTW USA will never be like AUS when it comes to lasers. Honestly if you think about how much stuff get shipped into the US / leaves the US each day or even each hour! There is no way they can screen that mass amount of packages and catch every laser. Alot of this stuff comes over in large boxes, containers, etc. They are not going to unload those and search each package. We will never have the same issues as AUS.

 

[InfinitusEquitas]

Wonderful. More regulation to steamroll through a problem, cover it up, and expand authority.

I'm not seeing anything about possession being an issue... am I missing something?

@LL - All packages that come into the US do go through specific entry points. The issue would be that more strict screening would be very expensive, and you can bet any increase in costs, or processing time would be met with brutal opposition from importers.

 

[Encap]

What they are saying in the Draft Document issued on May 5, 2014 has been the policy in effect for a long while, however, what is new is that they have now written it up as a draft guidance document, published it and put it out for comment for 90 Days.

I would guess at some point the actual guidance document ," Surveying, Leveling, or Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff" will be published.

Prior to this, we were just reading between the lines from customs alerts and other sources.

Importantly the FDA does say:
"This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance."

 

[hakzaw1]

THANKS-- Mr. Murphy & Dr Chuck for sending...

Sent to us by AixiZ Dr Chuck F Y I

let me know if this has already been posted so I can come back and dele.

__________________________________________________



From Dr Chuck (AixiZ)

posted at both forums
***************************



The FDA on May 5 will announce its intent to limit handheld lasers to be below 5 milliwatts. Since this is a draft document, the FDA is asking for comments within 90 days (August 2, 2014)



The FDA's proposed 5 mW limit would apply to lasers with the following design characteristics.

Compact size (i.e. small, lightweight)
Battery power
Ergonomic design to permit hand-held use
An aperture in the laser product's protective housing to transmit laser emission into open space
Portability to permit use in open spaces or in unrestricted environments
Features that utilize the laser’s straight line emission for surveying, leveling, or alignment


According to the FDA, these types of lasers would be affected:

Laser pointers
Levels
Tools incorporating laser guides
Gun sights
Target designators
Night vision illuminators
Visual disruptors


The FDA's proposed 5 mW limit would NOT apply to lasers with the following design characteristics:

Predictable, stable power input and output
High quality power supply and/or power conditioning components
Adjustability of power and wavelength
Design that facilitates remote actuation2
Non-portability
Hard wire connection to power mains

++++++++++++++++++++++++++++++++++++++


Announcing a Draft Guidance Document on SLA Laser Products


The FDA is taking this action based 1) its existing authority to regulate "SLA" (Surveying, Leveling and Alignment) lasers and 2) its new interpretation of "SLA" to mean compact, battery powered, handheld, portable devices emitting laser light in a straight line.



Below is a link to the FDA's notice,



Announcing a Draft Guidance Document on SLA Laser Products



---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, May 2, 2014 at 10:06 AM
Subject: Announcing a Draft Guidance Document on SLA Laser Products
To: mail@murphypatrick.com




The FDA has developed a draft guidance document, “Guidance for Industry and FDA Staff: Surveying, Leveling, or Alignment (SLA) Laser Products.” This draft guidance outlines FDA’s proposed approach regarding the applicability of the Agency’s performance standard regulations to SLA laser products. SLA lasers are a subcategory of specific purpose laser products used for surveying, alignment, or leveling purposes.

Comments should be submitted via the Federal Register docket.
Food and Drug Administration
Center for Devices and Radiological Health

thanks AixiZ for sending this to us

hak

 

[zyxwv99]

A few weeks ago there was an article in paper about new EU rules on laser pointers, restricting them to <1mW. The World Health Organization (WHO) has been pushing this for years. I was worried the US would go that route.

Laser Pointer Safety - Statistics, laws, and general laser pointer news

By the way, if anybody want my laser they can have it...

...when they take it from my cold, dead hands.

 

[pmurph5]

Livinloud, Encap and Lotus_Darkrose: I believe you have been given wrong information by friends, FDA, or others.

• There are no federal restrictions on possession of lasers. (There may be some restrictions at the state or local level.)
• There are currently no federal restrictions on sales of lasers above 5mW, as long as those lasers are not pointers and they have required safety features and paperwork.
• The only restrictions on laser usage are for medical, demonstration, laser show, surveying, leveling or alignment purposes.

Below are some details explaining FDA regulations, to the best of my research and understanding. If you, FDA, or anyone else feels I am inaccurate, I invite any comments or corrections.

1) At the federal level, there is no law against owning or responsibly using a laser of any type or power -- except for three specific uses: medical, demonstration (which includes laser light shows), and "surveying, leveling or alignment" lasers. Demonstration and SLA lasers are restricted to being below 5 mW unless the user has obtained a "variance" from the FDA regulations.

2) FDA asserts that lasers sold as "pointers" or marketed for pointing purposes are demonstration and/or SLA lasers. This is why pointers must be below 5 mW. (Note that this explains why so many >5 mW handheld lasers on the Internet are not called “pointers” and are not sold for pointing purposes. Depending on your view, the sellers are either exploiting a loophole or are lawfully complying with FDA regulations.)

3) It is the sale or marketing of >5 mW pointers that the FDA asserts is illegal. The person who could be prosecuted is the seller or marketer. It is NOT the buyer or owner. If FDA issues a recall, the buyer or owner is not legally required to return the laser.

4) When FDA takes action to block imports of pointers or handheld lasers, it is for one of two main reasons:

4A) The laser is over 5 mW and is incorrectly labeled as a “pointer” or is incorrectly marketed for pointing purposes.

4B) The laser does not meet federal standards for its classification (e.g., Class 3B or 4) in one or more areas such as safety features, labeling, documentation, etc. Some violations may be truly unsafe, others may be more bureaucratic paperwork-not-done-right mistakes.​

Livinloud, Encap and Lotus_Darkrose, think about it: If “anything over 5mW is already illegal”, why would FDA have submitted their May 5 proposal to make handhelds over 5 mW illegal? The answer is...

• ...because FDA wants new powers to regulate compact, battery-powered, handheld, portable lasers, so they will have to be less than 5 mW.

This may be an admirable goal for FDA. There are increasing problems with aircraft and eye safety. The U.S. is one of the few developed countries that does not restrict sale and/or possession of lasers above 1 or 5 mW.

However, in my personal view as an ordinary citizen, I believe FDA is doing this the wrong way. They are using incorrect facts and faulty logic to arrive at a bizarre conclusion. You can read my analysis and opinion here. In a day or two, I will also post a summary explaining my position; I am waiting for one piece of information before posting.

 

[hakzaw1]

THANKS for the clarifcation Mr Murphy--

I could not agree with you more...

Looks like a VERY big cost for very little in the way of good results IMO..

 

[Encap]

Livinloud, Encap and Lotus_Darkrose: I believe you have been given wrong information by friends, FDA, or others.

Livinloud, Encap and Lotus_Darkrose, think about it: If “anything over 5mW is already illegal”, why would FDA have submitted their May 5 proposal to make handhelds over 5 mW illegal? The answer is...

• ...because FDA wants new powers to regulate compact, battery-powered, handheld, portable lasers, so they will have to be less than 5 mW.

I never said anything about illegal and it still seems to me that what the draft guidance document is saying has been the internal policy for a while. Not sure for how far back but the handwriting on the wall was clear last August 2013 when there was a change in the wording of the scope of Import Alert 95-4-- wording that indicated what the "new" guidance was was in effect and the STR trade report indicated a new stronger effort to enforce was published. See: FDA Seeks CBP Help in Cracking Down on Illegal Laser Product Imports: STR & STTAS International Trade and Customs What is new is they finally got around to writing it up and publishing it as a "draft guideline". FDA issues rules, regulations, and guidelines concerning lasers which evolve and change over time and with the times as they see fit to do.

Not sure about FDA wanting new powers. From what I see they have always had the powers under the Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C - Electronic Product Radiation Control. FDA regulates all laser products, even handheld, battery-powered lasers that are available for purchase FROM manufacturers, importers, assemblers, dealers or distributors in the United States and its territories. This includes lasers manufactured or obtained on a continuing basis for the purpose of sale or resale.
The FDA has the authority to regulate all lasers period, regardless of what they are called, purpose, or output power, or origin.
A good overview of their authority is here: Overview of Laws and Regulations

Perhaps from your comments on the Draft Guidance Document and the comments of others FDA will revise the wording to make the situation more clearly stated. Probably at some point they will get around to a revision of 21 CFR 1040.10 and 1040.11.
One thing seems certain and clear. FDA does not believe there are any lasers that escape their authority, rules and regualtions because of semantic loopholes. They claim authority over all lasers.