Alternatives to 'Latex Free' Labelling

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M

MIREGMGR

#2
As the linked article says, and as FDA has said in the relevant guidance and in other communications, replace your "no latex" statement with "not made with natural rubber latex".
 
#3
As the linked article says, and as FDA has said in the relevant guidance and in other communications, replace your "no latex" statement with "not made with natural rubber latex".
Thanks, I am aware of this suggestion but I'm looking for other alternatives; especially shorter and ones.
 

Edward Reesor

Trusted Information Resource
#4
Unfortunately in their great wisdom, the "Guidance" document offers little guidance. In a combined but conflicting effort to increase the use of symbols, they have strongly suggested we add more words and let us decide which symbol to use at a later date.
 
M

MIREGMGR

#6
When an FDA reg / "guidance" is obviously written to be narrowly prescriptive, my experience has been that ignoring FDA's direction and getting creative is volunteering for trouble.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
This is apparently an act of :ca: on FDA's part.

As far as polymer manufacturing is concerned, "latex" and "natural rubber" are synonymous. The important bit is replacing the plain "No" (as in doesn't contain) with "Not made with..." which says "hey, we tried our best, but we can't guarantee we've succeeded".

Practically, it is a statement that says nothing while looking nice to the lay person. Did anyone say "misleading"...? :lol:

If looking for a shortened version of the :ca:, I would go for "Not made with latex". Natural rubber is included. I'm not sure though that no official bureaucrat would object.
 

GStough

Staff member
Super Moderator
#8
In a previous life, I worked for a company that manufactures medical exam gloves from a patented (their own patent) artificial latex ("nitrile"). The product packaging labeling used the term "artificial latex" or "nitrile" to indicate that it was not a product made from natural rubber latex.

This was acceptable to the FDA at the time I left the company.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
In a previous life, I worked for a company that manufactures medical exam gloves from a patented (their own patent) artificial latex ("nitrile"). The product packaging labeling used the term "artificial latex" or "nitrile" to indicate that it was not a product made from natural rubber latex.

This was acceptable to the FDA at the time I left the company.
That's where you would venture into the intricacies of clinical evaluation.

Nitrile is a well-known type of rubber (at least today). "Artificial latex" could stand for many things... I never heard that expression before (man-made equivalents of natural latex are commonly referred to as "synthetic latex"). Basically "latex" indirectly comes from the Latin word for milk, and it relates to the nature of the suspension (emulsion) harvested from plants, from which natural rubber is made. So technically the term "latex" could be attached to many things, depending on the creative mind of the user :)

There is a certain, specific clinical / FDA concern over sensitivity to natural rubber (latex, in lay terms) in some individuals. It has to do with its chemical nature. An "artificial latex" might or might not present similar issues, depending on what its chemical nature actually is. Since it was patented it's hard to say, and I'm not sure how wide an exposure this issue has had at the time. I understand that it was a long time ago, so maybe it even predated FDA's current concerns (which don't go back so far).

Today, a development of this kind would have had to go through some sort of clinical evaluation / investigation (trial) to establish safety, otherwise I assume that a conservative approach would have been followed (i.e. if the chemical nature indicated resemblance to natural rubber, similar restrictions would have been applied). On the other hand, today nitrile rubber gloves are considered "non-latex" gloves so I assume there would have been little concern; regardless, I guess that the FDA would have insisted on the "Not made with..." statement because no one could guarantee that none of the latex antigens are present (albeit in untraceable quantities) and thus its a "better safe than sorry" scenario...
 
M

MIREGMGR

#10
My understanding is that the direct basis for the FDA prescription is that someone asked a sufficiently large sample of end users, most of whom have basically no education in chemistry, and they were confused as to what "latex" is, how where it comes from is key to its allergic behavior, and particularly how latex in gloves and similar devices is related to "latex paint", the other common usage of that five-letter word.

So my guess would be that anyone using wording other than FDA's prescriptive direction should be prepared to show that it's not confusing.
 
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