FDA FDA sends warning letters to 3 vendors for saying their e-cig products were made in FDA certified or registered lab

[Bill Godshall]

The FDA has sent warnings letters to 3 e-cig vendors (including one in the UK) for informing customers that their vapor products were made in a FDA certified or registered lab, which FDA attorneys determined violates of Section 301(tt) of the FD&C Act, which then Rep. Henry Waxman added to his FSPTCA bill in 2005 after I revealed (in letters to Congress) that (among many other things, that Waxman’s 2004 FSPTCA bill would encourage tobacco companies to market their cigarettes as “FDA approved”).
Warning Letters Issued to E-Cigarette Companies Illegally Making FDA-Related Claims
www.vaperz.co.uk 4/2/15
Knoxville Vapor LLC 4/2/15
Dr. K 4/2/15


In contrast to FDA's assertions, I don't think two of the three websites misled customers to believe their products were FDA approved (although the third website that posted a FDA certificate might mislead some clueless customers to believe their e-cigs were FDA approved). But my opinion is irrelevant, and it is doubtful that any of the 3 vendors will challenge FDA's assertions in court (as doing so will cost a lot of money, and the outcome is unknown).

Other e-cig vendors should take note.

 

[DC2]

So the vendors need to qualify the statement that their liquid was made in FDA certified labs?
Like maybe a disclaimer that "this does not mean the products are FDA approved" or something like that?

 

[Kent C]

Suggest blurb for vendors:

"If you're looking for FDA Approval, you've come to the wrong place. The FDA is an enemy to our industry and our customers. They would like to regulate the e-cigarette industry out of business. Our company is responsible for the quality of products we sell and we will stand by that, without any 'approval' from a government agency that cares nothing for your safety, but only seeks control over the choices you make as individuals."

 

[Bill Godshall]

DC2 inquired:

So the vendors need to qualify the statement that their liquid was made in FDA certified labs?

NO. FDA is basically claiming that any statement or imagery about FDA by any e-cig company that could potentially be perceived by even one consumer (or by even one FDA staffer) as a positive portrayal of the product(s) is a violation of the FSPTCA.


Then again, if an e-cig company had a statement on its website saying "FDA sucks" or "FDA lies", I suspect the FDA would similarly claim they also violate the FSPTCA.

 

[DC2]

NO. FDA is basically claiming that any statement or imagery about FDA by any e-cig company that could potentially be perceived by even one consumer (or by even one FDA staffer) as a positive portrayal of the product(s) is a violation of the FSPTCA.

Then again, if an e-cig company had a statement on its website saying "FDA sucks" or "FDA lies", I suspect the FDA would similarly claim they also violate the FSPTCA.

There doesn't seem to be any legal leg to stand on there.

And if there is, I'm taking my ball and going home.
:LaughWhileCrying:

 

[bigdancehawk]

The relevant language from the statute is as follows:

It prohibits:

(tt) Making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—

(1) the product is approved by the Food and Drug Administration;

(2) the Food and Drug Administration deems the product to be safe for use by consumers;

(3) the product is endorsed by the Food and Drug Administration for use by consumers; or

(4) the product is safe or less harmful by virtue of—

(A) its regulation or inspection by the Food and Drug Administration; or

(B) its compliance with regulatory requirements set by the Food and Drug Administration;

So, what do you think, fellow vapers? Does saying a product is made in an FDA approved lab mislead consumers into believing that the product "is safe or less harmful"? Given the fact that there is nothing in the statement to say that the product itself is regulated or inspected by the FDA or that the product itself complies with FDA regulations, it would be a stretch to conclude that anybody is being misled.

 

[DC2]

So, what do you think, fellow vapers? Does saying a product is made in an FDA approved lab mislead consumers into believing that the product "is safe or less harmful"? Given the fact that there is nothing in the statement to say that the product itself is regulated or inspected by the FDA or that the product itself complies with FDA regulations, it would be a stretch to conclude that anybody is being misled.

If I'm not using my manual forum filter, I would say it's a load of horse.....
I can't even begin to convey how absolutely absurd this is.

So you can't say you work in an FDA approved lab?
Is this the FDA saying that their approval of your lab is misleading?

What the ....?

I'm no longer happy, so I'm going to change my "mood" now.