FDA deeming rule could happen tomorrow

[skoony]

comment 41. Can the FDA streamline the process for e-cigarettes as the
cause substantially less harm. FDA,no!, the use of any "tobacco product"
causes harm you silly's.
Mike

 

[TVC70]

A momentous victory today for Big Government and Big tobacco, and a devastating defeat for common sense and individual liberty.

 

[RandyF]

UGH, how long will nicotine hold in the freezer....I need to make a (substantial) order.

 

[Mazinny]

Am i interpreting this correctly ;

- vendors have only 90 days from today to introduce new products to the market without a PMTA application !?
- products currently on the market are ok until at least Aug 2018 !? Does that include nicotine ?

 

[skoony]

Comment 42. Can the FDA give clear guidance to what scientific evidence is
needed? Why yes we have in the past and will continue to move the goal posts
in the future.
mike

 

[jwbnyc]

Thank God.

I can still smoke my premium cigars (with my other fat cat friends) in peace.

 

[Topwater Elvis]

The Feb 2007 date is the killer.
The costs associated with getting any product(s) considered substantially equivalent is too great for any non BT business to absorb.
Hardly matters what other idiocy is included in the regulations.

 

[skoony]

Comment 43. Due to the lack of any current evidence of harm shouldn't
the FDA refrain from restrictions?
The FDA absolutley not. That's why we are going to require you to prove
all over again they aren't. No fare using pre-existing studies.
"(Comment 43) One comment stated that, because there is a lack of scientific evidence to show the health impact of vapor products, applying the premarket requirements to this category of products is premature. Therefore, the comment suggested that FDA exercise enforcement discretion to delay implementation of this requirement until more evidence is available. 105 (Response) FDA has established a compliance policy regarding the premarket review requirements. This is described in section V.A. As discussed elsewhere in this document, we believe the compliance period is appropriate, and it takes into account the time for firms to generate and submit the information for a PMTA. The requirements and costs of a PMTA may vary based on the type and complexity of the product. For example, where there is limited understanding of a product’s potential impact on public health, nonclinical and clinical studies may be required for market authorization. In such case, the requirements and cost of the PMTA likely would be higher (and the review time longer) than for a product in which there is already substantial scientific data on the potential public health impact. This information provided as part of premarket review (design, ingredients, levels of HPHCs) will provide critical information on these products."
Mike

 

[skoony]

Thank God.

I can still smoke my premium cigars (with my other fat cat friends) in piece.

Nope,they got thrown under the bus too.
Mike

 

[jwbnyc]

Oh.

I thought I read an exemption in there.

 

[Jonner]

I don't think anyone was/is quite prepared for how bad this is going to be. The more I read, the more I see it as a complete ban, except for BT. Who else can afford to jump through all of these hoops. And I'm sure only BT will be given the instructions for how to jump and how high. Stockpiling to commence. Didn't realize it but I will need everything, mods, batteries, nicotine, flavoring. Looks like the only thing they couldn't ban was vg/pg.

 

[skoony]

Comment 45 is very interesting and telling of the mind set we face.
should the FDA help others develop products that are safer.
The FDA's response is that the PMTA, MRTP, and other regulatory provisions will help foster the development of tobacco products that pose less risk to human health.
This is for BP. The FDA is preparing the ground work for taking all the credit for
the health benefits of e-cigarettes and letting BP reap the profits there of.
In other words,these cigalikes don't help you quit,try this.(insert Provari look alike here)
"(Comment 45) Some comments stated that FDA regulations should support manufacturers' efforts to invest in alternative tobacco products with the potential to reduce harm. (Response) The Agency continues to support development of alternative tobacco products with the potential to reduce harm, and believes that the PMTA, MRTP, and other regulatory provisions will help foster the development of tobacco products that pose less risk to human health. In addition, as a practical effect of the Agency's compliance policy for premarket review of newly deemed tobacco products, FDA expects that many manufacturers, including those with alternative tobacco products, will continue to market their products during preparation of submissions and for the continued compliance period afterward. The time it takes to review premarket applications is dependent upon the type of application and the complexity of the product"
Mike

 

[Robino1]

UGH, how long will nicotine hold in the freezer....I need to make a (substantial) order.

Years. If stored correctly. There are sections in the DIY area that can help you with questions on how to store correctly.

Am i interpreting this correctly ;

- vendors have only 90 days from today to introduce new products to the market without a PMTA application !?
- products currently on the market are ok until at least Aug 2018 !? Does that include nicotine ?

Yes, that is the understanding I am getting also.

 

[skoony]

Oh.

I thought I read an exemption in there.

Comments 37 and 38 in the released regs.
mike

 

[markfm]

Thank God.

I can still smoke my premium cigars (with my other fat cat friends) in peace.

They were included.

 

[skoony]

comment 46. It doesn't mater that PG and VG or the nicotine is already
made to strict approved standards. I believe the flavorings from the
big makers would apply in most cases also. It isn't ok until the FDA says
its ok.
"(Comment 46) A few comments suggested that FDA review and authorize marketing of products at the ingredient level. For example, if a tobacco product contained only preauthorized ingredients, the product could be marketed, possibly through self-certification. If the product used unapproved ingredients, the manufacturer would be required to submit a PMTA containing information on only those ingredients or meet established testing guidelines. The comments suggested that standards that could be used to assess the ingredients may include the U.S. Pharmacopeial Convention (USP), FDA's Generally Recognized as Safe (GRAS) standards, the New Drug Products Q3B(R2) guidance; and the Food Chemicals Codex or FDA Redbook of Foods. (Response) FDA disagrees. Section 910 of the FD&C Act requires FDA to evaluate the new tobacco product as a whole to determine whether the authorization of marketing of the product is appropriate for the protection of the public health. In addition, we note that GRAS status for a food additive does not mean that the substance is GRAS when inhaled, since GRAS status does not take inhalation toxicity into account and applies only to intended uses that may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (section 201(s) of the FD&C Act.)."
Mike

 

[sparkky1]

Am i interpreting this correctly ;

- vendors have only 90 days from today to introduce new products to the market without a PMTA application !?
- products currently on the market are ok until at least Aug 2018 !? Does that include nicotine ?

It will take at least 2 - 3 years for ALL tobacco products BUT with that tobacco products deeming in August comes the hammer from the "states" to enforce sin taxes especially your state and no internet purchasing, they will be assessed just like cigarettes.But like I mentioned previously, The FDA has determined that there are no significant concerns with using NRT products like Nicorette at the same time as another nicotine-containing product like a cigarette
So maybe it's better to just use their "safer" nicotine ?

 

[skoony]

comment 47. there's no validated methodology for testing these products.
The FDA,yes there is and or we will know it when we see it.

 

[skoony]

comment 48. The application process takes to long for a response from the FDA.
The FDA,don't worry we have added steps to help you and streamline the process.
(Read: We are prepared to make it more complicated.)
Mike

 

[skoony]

Woe!, hold the presses comment 49 actually makes sense.
"(Comment 49) At least one comment suggested that FDA should require manufacturers that have not received their marketing authorizations within 1 year after the effective date of the final deeming to include a statement on their packaging and labeling indicating that the product is pending FDA evaluation under the Tobacco Control Act. (Response) FDA declines to issue such a labeling requirement at this time. We do not have evidence that the statement will be appropriate for the protection of the public health, as 111 determined with respect to the risks and benefits to the population as a whole (which is the standard for such a requirement under section 906(d) of the FD&C Act). FDA also is concerned about consumer confusion or misconceptions that could result from such a requirement."
Mike