FDA FDA regulations and the impact on small juice vendors | another side

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Kent C

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Big warning on label: Do Not, under any circumstances, combine the contents of this bottle of 'Pablo's Refried Beans' Flavored Water Enhancer with a 27ml bottle of 7 mg/ml nicotine solution to attempt to create 30ml of 6mg/ml 'Pablo's Refried Beans' eliquid.

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Kent C

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Regulations.gov

2. Alternative Statement for Products Without Nicotine
The products for which FDA is proposing health warnings under this rule all contain nicotine. FDA is not aware of any currently marketed tobacco product that does not contain nicotine. However, in the event that such products are developed, FDA proposes that manufacturers of such products submit a certification of that fact (and the fact that they have the data to support this assertion) to FDA. Products for which such a certification has been submitted would not contain any warning that would clearly indicate that it is a tobacco product. Accordingly, FDA is proposing that such products include the following alternative statement on their product packages and in their advertisements: “This product is derived from tobacco.” FDA believes it is important to alert consumers and retailers as to which items are tobacco products. Even if a tobacco product does not contain nicotine, it can still contain other addictive chemicals (like anabasine or nornicotine, discussed in the preamble) or dangerous toxicants. Therefore, FDA believes consumers should be aware that the product is, in fact, a tobacco product. In addition, the statement would alert consumers as to which products would require identification for purchase and increase retailer awareness of the products for which they must verify the age of consumers. FDA requests comments on this alternative statement.
 

Jman8

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Or put another way (using same wording)

FDA said:
FDA is not aware of any currently marketed tobacco product that does not contain nicotine.

FDA is proposing that such products include the following alternative statement on their product packages and in their advertisements: “This product is derived from tobacco.”

Even if a tobacco product does not contain nicotine

FDA believes consumers should be aware that the product is, in fact, a tobacco product.

FDA requests comments on this alternative statement.

Comment: Really FDA? Really?
 

goalie

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I was looking at it like a tobacconist that creates his own tobacco blends.. he uses FDA approved tobaccos, then blends them together. He doesn't need FDA approval for the blend he just made. I still occasionally smoke a pipe and use a blend made by a local tobacconist. He gets FDA inspections every now and then and they check to see that he's using approved products to make his blends. I don't see why this wouldn't apply to eliquids.

I will add some of the pipe community is getting upset by these rules.. based on some of the wording, they could consider regulating pipes as they are used to consume tobacco, which could kill off any new pipe production if every single pipe has to be approved..
 

Kent C

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I was looking at it like a tobacconist that creates his own tobacco blends.. he uses FDA approved tobaccos, then blends them together. He doesn't need FDA approval for the blend he just made. I still occasionally smoke a pipe and use a blend made by a local tobacconist. He gets FDA inspections every now and then and they check to see that he's using approved products to make his blends. I don't see why this wouldn't apply to eliquids.

I will add some of the pipe community is getting upset by these rules.. based on some of the wording, they could consider regulating pipes as they are used to consume tobacco, which could kill off any new pipe production if every single pipe has to be approved..

Frequently Asked Questions on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) Updated October, 2010

"Does the legislation impact tobacco products for pipe smoking?
Pipe tobacco is considered a tobacco product under the Tobacco Control Act. However, the Act does not automatically apply to pipe tobacco. FDA must issue a regulation deeming pipe tobacco to be subject to the law."

Sounds like they'd need a separate 'deeming' for pipe tobacco. Although there is some wording for pipes in the link in my earlier post. If interested, search 'pipe' in the pdf.
 
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DC2

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Frequently Asked Questions on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) Updated October, 2010

Does the legislation impact tobacco products for pipe smoking?
Pipe tobacco is considered a tobacco product under the Tobacco Control Act. However, the Act does not automatically apply to pipe tobacco. FDA must issue a regulation deeming pipe tobacco to be subject to the law.

Sounds like they'd need a separate 'deeming' for pipe tobacco. Although there is some wording for pipes in the link in my earlier post. If interested, search 'pipe' in the pdf.
I believe they are deeming pipe tobacco under the current proposed regulations, but I could be wrong.
My understanding is that pipes will in fact now possibly be subject to the concerns the previous poster was expressing.

But that is only based on some of the things I've read, and I'm not 100% sure of that as I don't study the pipe issues.
 

Kent C

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I believe they are deeming pipe tobacco under the current proposed regulations, but I could be wrong.
My understanding is that pipes will in fact now possibly be subject to the concerns the previous poster was expressing.

But that is only based on some of the things I've read, and I'm not 100% sure of that as I don't study the pipe issues.

Just scanning the deeming doc, I think you're right. That link above was a 2010 publication.... but the deeming doc says: pg 131

"The meaning of "covered tobacco product" would depend on whether FDA selects Option 1 or Option 2 for any final rule. For purposes of this part, FDA considers any loose tobacco, including pipe tobacco, and the
nicotine in e-cigarette cartridges to be within the definition of "covered tobacco product."

and:
"(See Sottera, Inc. v. FDA, No. 10-5032 (D.C.
Cir. Jan. 24, 2011) (per curiam).) This case affirms that FDA cannot regulate "customarily
marketed" tobacco products, including pipe tobacco, small and large cigars, e-cigarettes, and
hookah tobacco, until a regulation that deems them to be subject to the FD&C Act is finalized."

...but :) perhaps the pipe smokers are in with the premium cigar smokers:

"The International Premium Cigar and Pipe Retailers Association (IPCPRA), in its citizen
petition seeking to exempt large and premium cigars from FDA regulation..."

.. although it just mentions the premium cigars.
 

Kent C

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Is it just me, it seems every time someone reads through the deeming doc another tidbit pops up that is unclear in it's ultimate purpose.

Some would say that legislation is purposefully written as ambiguous so regulators can translate it any way they want. And that the regulations are ambiguous for the same reason. The end result isn't objective law but subjective whims.
 
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