solarmeter

Oops, I forgot this is only an Ask him forum. Otherwise by now there'd be a response to the Afternoon Bomb #3 post. Like some people express when they call Rush Limbaugh: I agree with almost everything you say, but...

Therefore here is an actual question regarding FDA amendment 3 definition of a manufacturer:

What is so difficult in defining major bed/booth replacement parts "compatibility" that would be excluded from this undesireable amendment? It would seem that only actions that take the unit out of irradiance compliance, and/or could potentially damage the unit should qualify for this sanction.

If I tore apart my new car and added nitrous & slicks, should I expect GM to honor the powertrain warranty? Would that violate the radio warranty too? No to both. If I replace the Delco battery, plugs or wiper blades with off-brand parts does that void wiring, engine or wiper motor warranty? Of course not!

So, compatible lamps (existing stupid version or new scientific version), ballasts (+/- tbd V & A rating), starters, etc, etc could be specified as "OK".

BUT, who can/should do this??? Obviously most mfgrs won't - to keep people buying OEM parts. I'd be happy to help, but don't feel qualified for much beyond MED/hr lamp values. Can TSO take this on, or convince ITA (yeah right) to? May 22 is not that far away!

Don you seem to have (single handedly?) fixed the amendment 4/5 label issue. How can amendment 3 be "fixed" in the next 4 weeks?

Don Smith

Steve:

Good points.

I have been exchanging "ideas" with FDA since the 2/8/02 "disclosure" of what they intended to "recommend" for both Amendment 3 and the Warning Label. Their latest "position" at the Office of Compliance is "...that non-compliant "modifications" are major changes" (that would affect "any aspect" of "performance" or it's "intended function(s)" but "would not cover "generic" parts or COMPLIANT replacement parts." Thus, FDA (at this time) appear to agree with the common sense position taken by tanning salon owners.

And, as a matter of fact, I have just this week been exchanging "ideas" with certain ITA people with the "goal" of coming up with language that we can all live with.

Here is the problem. Everyone (FDA, ITA and TSO) agree that tanning salon owners should not be restricted from replacing parts with those that are "compatible", i.e., that do not change "any aspect" (FDA's language) of the "performance" of the sunbed. As you know, we are a long way from "agreeing" how to measure the "performance" of a sunbed (we haven't resolved how to measure the "performance" of a sunlamp in a single lamp test stand yet and that process is far easier and less complicated than measuring the "performance" of a sunbed). Thus, if we don't have a "standard procedure" for measuring "any aspect" of the "performance" or it's "intended function(s)" according to the provisions of Amendment 3 of a sunbed, how do we "resolve" this dilemma? Who determines whether or not a replacement part has changed "any aspect" of the "performance" or it's "intended function(s)" according to the provisions of Amendment 3 if we can't agree how to measure "performance" when the sunbed is new?

[Note: FDA is aware of the fact (because a formal complaint has been filed with them and because both Michael Stepp and I both presented data on 2/7/02) showing that many sunlamps "claiming" to be compatible to the Wolff Bellarium S are not, in fact, compliant (not by a long shot!). If they haven't taken steps to resolve this "obvious" issue, does anyone REALLY think they will do anything to resolve "performance" disputes regarding replacement parts?]

What I am concerned about (and ITA is, sadly, "silent" on this point) is that the manufacturer will be allowed "de facto" to "define" how performance "compliance" is determined and that will most certainly not be favorable to tanning salon owners.

For instance, what happens if a salon owner wants to use a sunlamp that is "spectrally identical" to the PL sunlamp that the manufacturer states is the "only" one that can be used in their sunbed (or risk losing their product liability and/or warrarty) in order to save money. We have a sunlamp that won't change "any aspect" of the "performance" or of it's "intended function(s)" according to the provisions of Amendment 3 because the two sunlamps are identical spectrally and yet the manufacturer "decides" (unreasonably, I believe) that the alternative sunlamp (that is less costly) IS NOT COMPATIBLE when according to FDA regulations it is compliant. So, how do we resolve this dilemma? Will the manufacturers be allowed "de facto" to serve as judge and jury?

My solution is for us all to agree that AS LONG AS a replacement part doesn't change "any aspect" of the "performance" or it's "intended function(s)" according to the provisions of Amendment 3 of the sunbed, the manufacturer cannot prohibit you from using the less expensive compatible replacement part (nor should they be "allowed" to void their warranty and/or product liability insurance.

Now you and I know that the manufacturer WANTS to force tanning salon owners to buy their PL sunlamp (and parts!) at a "premium" price but that "stance" violates "common sense" and the "spirit" and "intent" of the rule to be promulgated by FDA on 5/22/02.

What will ITA do? Personally, I don't think that they can get all of the manufacturers who control the organization to agree with what "common sense" tells them should be done. Therefore, they will not support the recommendation I have made.

[The problem ITA has of dealing with "conflicting" constituencies (in the example above it is between the sunbed manufacturers and tanning salon owners) is the same reason why they have, sadly, been "silent" on the sunlamp compatibility issue and the "complaint" filed by one "sunlamp group" (who are ITA members) against another "sunlamp group" (who are also ITA members). Logic says that ITA should "take a stand" since the issue is quite clear but "politics" says another!]

Needless to say, I will be there explaining to TEPRSSC that tanning salon owners WILL NOT stand still for an "Amendment 3 - Definition of a Manufacturer" that is, "de facto", a means of improving the profitibility of the manufacturers at the expense of the profitibility of tanning salon owners. We may have to go to court to do so, but we will make sure that FDA does not formulate regulations that would favor manufacturers at the expense of tanning salon owners.

As I mentioned in my letter to FDA the dilemma is that "As always is the case in disputes like this, the devil is in the details" and that is why we must carefully and thoughtfully define the following:

1. What exactly will be considered a "modification" of either the product's "performance" or it's "intended function(s)" according to the provisions of Amendment 3?

2. What exactly will be considered to be "any aspect" of either the product's "performance" or it's "intended function(s)" according to the provisions of Amendment 3?

3. What exactly WILL a tanning salon owner be able to do regarding reparing a sunbed without voiding the warranty?

4. And more importantly, why would FDA be interested in formulating regulations that would favor manufacturers over tanning salon owners?

Don [ This Message was edited by: Don Smith on 2002-04-20 13:12 ]

solarmeter

Don,

Well, free enterprise as it is here in the USA, no way should salon owners be prevented from performing the kind of work you mention above on their equipment using "compatible" bits.

Without meaning to over-complicate the issue, there MUST be a short list of things the FDA would care about. There may be a long list some mfgrs would care about, but that's a different agenda.

This can't be much different than a car part change would be, where "or equivalent" is often the buzz word. I'll check out some specs and language in owner's manual to see how they handle safety related items like seat belts, air bags, tires, brakes. Of course they encourage "genuine GM goodwrench" stuff .. but they don't generally FORCE it on customers.

Practically everything you swap or have changed on a car can affect performance, but not necessarily modify it's intended function. As for tanning equipment, I would think the following three things are all that matters to any significant degree:

1. LP lamps (tubes).
2. HP lamp/filter assemblies (and glass itself)
3. Power supply boosters/transformers.

Am I missing anything? Everything else should be exempt: acrylic, pistons, fans, starters, etc.

For 1. & 2. the +/- 10% compatibility should suffice (yes SOP test data is needed!) Glass alone can have transmittance +/- 10% required as well. Schott has data.

For 3. all that is needed would be not to exceed mfgr max V/A limit (I think).

Sounds easy, politics aside. Other industries have overcome this concern. So can we. Generic spec ranges for "or equivelent" is all that should be needed, for a SHORT list of stuff the FDA cares about.

Don Smith

Steve:

I agree. That's why we have to define (1) what is meant by a "modification" and (2) what will be considered "any aspect" of either the product's "performance" (more later about this) or it's "intended function (no worry here because the "intended function is quite clear; to help the user develop a cosmetic tan) and (3) what a tanning salon owner will (a) be able to do regarding repairing a sunbed, and, (b) what a tanning salon owner will not be able to do regarding repairing a sunbed.

Speaking of "performance", here is another "issue" that must be considered. Lets suppose that a sunbed is sold as a 20 minute MTI (maximum timer interval) unit BUT it has a te (time to 4.0 MED) time of 25 minutes. Question: What is the "performance" criteria that must be met? Is it 20 minutes or 25 minutes.

Think about it this way. IF it is sold as a 20 minute MTI unit and reaches te in 25 minutes, is the manufacturer selling a product that does not meet the "performance" claim of 20 minutes and does that mean that it is not compliant when it is sold?

The "bottom line" I have come up after thinking about this issue for some time is that it is absolutely crazy to move forward on "Amendment 3 - Definition of a Manufacturer" unless and until a standardized means of determining "sunbed performance" is agreed to and set forth by FDA. If it is set into motion now, it will end up being just one more regulation that will not, and cannot, be enforced (like the existing "Sunlamp Compatibility" standard).

Don

PS To Everyone: If you think about these issues long enough, you get as goofy as me!

solarmeter

quote:
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Think about it this way. IF it is sold as a 20 minute MTI unit and reaches te in 25 minutes, is the manufacturer selling a product that does not meet the "performance" claim of 20 minutes and does that mean that it is not compliant when it is sold?
-------------------------------------------

Theoretically yes.. because 25 min is 25% longer than 20. But does the FDA care? Of course not - it has a greater safety factor. They care about the opposite condition: a bed labeled 25 min that reaches Te in 20 min.

Uncompatible (-25% Te) replacement lamps would be the compliance fault they (and us) should care about.

All the more reason why amendment 3 can't be a positive rule unless/until uniform lamp test protocol is agreed with and uniformally adopted. And what's so darn hard about that? Nothing really.

Steve

Don Smith

Tanning Salon Owners:

Here is the "new" FDA "language" for "Amendment 3 - Definition of a Manufacturer":

"The modification of a sunlamp product, previously certified under 21 CFR 1010.2 by any person engaged in the business of manufacturing, assembling, or modifying sunlamp products shall be construed as the manufacturer under the act if the modification affects any aspect of the product's performance or intended function(s) for which this section (21 CRF 1040.20) have an applicable requirement. The manufacturer who performs such modification shall re-certify and re-identify the product in accordance with 21 CFR 1010.2 and 1010.3."

The "keywords" to keep in mind are:

1. "...or modifying".
A. Who defines what constitutes a "modification" of a product? The manufacturer? The FDA?
B. Does a "repair" with a "generic" part (that does not change the "performance" or "intended function(s)" but that is nonetheless considered to be a "modification" BY THE MANUFACTURER (who wants you to buy their parts which are ususally priced much higher), constitute a violation of the "modifying" clause?
C. Does the "replacement" of a sunlamp with another sunlamp that meets the FDA guidelilnes for sunlamp compatibility constitute a violation of the"modifying" clause IF THE MANUFACTURER states that only their PL sunlamp is compatible?

2. "...shall be construed as the manufacturer under the act." This means that the salon owner will become the "manufacturer of record" and thereby make "null and void" the manufacturers warranty and product liability insurance AND will most likely make "null and void" their salon liability insurance.

3. "...the modification affects any aspect of the product's performance or intended function(s)."
a. Who defines "any aspect" of the product's performance or intended function(s)? The manufacturer? The FDA?
b. Who defines the products "performance"? The manufacturer? The FDA?

[Note: The "intended function(s)" provision is not a problem since the intended function of a sunbed is to provide a means of facillitating the development of a cosmetic tan.]

4. "The manufacturer who performs such modification shall re-certify and re-identify the product in accordance with 21 CFR 1010.2 and 1010.3." This means that the salon owner must, if they have violated the provisions of "Amendment 3 - Definition of a Manufacturer", file the necessary papers to "re-certify" and "re-identify" the product in accordance with the appropriate FDA regulations which is AN IMPOSSIBLE TASK FOR ANY TANNING SALON OWNER!

Hopefully, you can now all see why "Amendment 3 - Definition of a Manufacturer" is so important for tanning salon owners! (And you can see why I have been so concerned about it for the past two years.)

Don

Max Recone

Don:

As you know i thoroughly enjoy your debates and the valuable information you provide to all of us.....

I am not an equipment manufacturer, but having made products for the better part of 24 years i have to say that i agree with the law in that if someone changes something outside the products specifications and compatible parts - it does in my mind shift the responsibility from the original supplier to the party that did the changes.

The best way to prevent these mis-understandings is to get the maintenance schedules and replacement parts cost(s) at the original time of purchase....All reputable suppliers will provide this and if they don't - the salon owner has the ultimate right not to buy their goods.

This also includes purchasing used equipment, it is the responsibility of the buyer to fully understand the transfer warranty policies from the manufactuer and to carefully review the maintenace records of the piece of equipment. The potential buyer should contact the manufacturer and get in writing what they will or will not cover.

The more you know, the better decisions you can make, remember you will live with this equipment for five to eight years, it is worth looking into more than just the price.

My two cents on this.


As far as lotions are concerned, California Tan products test, review and market out products to comply with all FDA and FTC guidelines and laws.....Basically they do what they say they will do.

We also, do not support tampering or modifying claims of product efficacy....

As always, i enjoy and value the information you provide.

Would love to hear from others on this.

Max

Don Smith

Max:

Here's a few questions for YOU (so that I can bring the problems involved with "Amendment 3 - Definition of a Manufacturer" issue "home" to you).

Let's say a customer buys a bottle of Cal Tan's "Heat Shock" AND a bottle of one of the "additives" that increase the "tingle" factor. The client mixes too much of the "additive" and, in conjunction with tanning, has a SEVERE reaction requiring EXPENSIVE medical treatment. Then, give the fact that ours is a litigious society, the client sues everyone in sight.

The "action" of adding the "additive" most certainly changed the "performance" of the Heat Shock according to the wording of the FDA "proposed" language but how does one "measure" the "performance of the "unmodified" Heat Shock? In other words, what "performance" claims does Cal Tan make (and that FDA approved) for Heat Shock?

Some questions:

1. Does your label strictly "prohibit" adding an "additive" to your products? Have you advised tanning salon owners IN WRITING that this practice is prohibited?

2. The tanning salon owner didn't mix the products together so she/he can't be construed to have become the "manufacturer of record" of the "modified" Heat Shock product.

3. Cal tan didn't mix the products together so you can't be contstrued to have become the "manufacturer of record" of the "modified" Heat Shock product.

4. The manufacturer of the "additive" didn't mix the products together so they can't be contstrued to have become the "manufacturer of record" of the "modified" Heat Shock product.

5. Finally, it appears that THE CLIENT who purchased the two products and mixed them together has, according to the FDA wording "ANY PERSON engaged in the business of manufacturing, assembling OR MODIFYING..." has, I believe, unintentionally become the "manufacturer of record" for the "modified" Heat Shock product ("any person" means just that!).

So, Max, WHO do you think is going to get sued? The client? No way, Jose because he/she is instigating the action! The tanning salon owner? Probably, but they have a plausible "defense" (nobody told me that they couldn't be mixed!) and won't have the "deep pockets" that the client's attorney is looking for. The "additive" company? Probably, but once again, no deep pockets. So who is left? You got it, Max, Cal Tan! And one more party will most certainly be sued! The FDA (if the attorney is smart) because of the "ambiguity" of the wording of "Amendment 3 - Definition of a Manufacturer" as it currently exists and because FDA cannot define "performance" for these products.

Now go back and read question 1 "Does your label strictly "prohibit" adding an "additive" to your product? Have you advised tanning salon owners IN WRITING that this practice is prohibited?" and perhaps now you will start to understand why "Amendment 3 - Definition of a Manufacturer" SHOULD NOT be approved UNLESS AND UNTIL the FDA can define the "performance" of the products involved.

It is, IMHO, a "time bomb" that will soon be "ticking away" for EVERYONE!

Amendment 3 - Definition of a Manufacturer will create far more problems that it will solve. Another case of "unintended consequences" for both FDA and the indoor tanning industry.

Your thoughts, Max?

Don

solarmeter

Don,

Well, for whatever parallels may exist between a car and a sunbed, a review of warranty book showed the following:

No prohibitions of market available maintenance parts are expressly made. It even says in an emergency they will reimburse for repairs made at a joe-blow's garage in timbucktoo (paraphrasing).

No distinctions between regular or safety-related repairs were noticed.

Wear & tear parts are identified, and excluded from warranty except for mfg defect.

Damage from abuse, acts of god, acid rain etc are excluded. So is neglect of routine maint (oil changes bla bla..).

Incidental/consequental damages/extra expenses are excluded (standard implied warranty language).

After all that there are two seemingly contradictive ditties:

1. This warranty does not cover any damage or failure resulting from modification or alteration to the vehicle's original equipment as manufactured or assembled by (name of car company). (ncc) below.

2. The emission control systems of your vehicle were designed, built and tested using genuine (ncc) parts and the vehicle is certified as being in conformity with applicable federal and CA emission requirements. Accordingly, it is recommended that any replacement parts used for maintenance or for repair of emission control systems be new, genuine (ncc) parts.
The warranty obligations are not dependent upon the use of any particular brand of replacement parts. The owner may elect to use non-genuine (ncc) parts for replacement purposes. Use of replacement parts which are not of equivalent quality may impair the effectiveness of emission control systems. If other than new genuine (ncc) parts are used for maintenance replacements or for the repair of parts affecting emission control, the owner should assure himself/herself that such parts are warranted by their manufacturer to be equivalent to genuine (ncc) parts in performance and durability.

I think 1. means don't put a Ford crankshaft in your Chrysler motor and expect free repair when the motor blows up.

BUT, 2. seems quite applicable to our amendment 3 concerns. Just add UVR before emission and you've practically got it. I should bring a copy to FDA meeting as talking point (and email it first).

For lamps "equivalent" means "compatible", even tho the science behind testing needs improvement.

Steve

Don Smith

Steve:

Your information is very helpful!

I had a long discussion with FDA regarding "Amendment 3 - Definition of a Manufacturer" today and I'll be posting some additional information about what we discussed later.

Don