Deeming Regulations have been released!!!!

[Kent C]

It's simple, they don't want to do the March of Dimes. "Quick! They cured it, what are we going to ask them to donate money for now?!?!"

The March of Dimes has called me 5 times in the last three days - I have caller ID :- ) I think I'll take the next call and ask them some questions lol.... I might ask THEM for money for my cause.

 

[The Ocelot]

FDA Plans To Re-evaluate The Term "Healthy"

The term “healthy” can only currently be used on packaging when it meets certain nutrient criteria. Under this current criteria, some Kind fruit and nut bars would not be able to use the term “healthy,” according to the administration. The company later asked for a re-evaluation of the term saying the rule prevents avocados and salmon from being labeled “healthy.”

 

[YoursTruli]

They stopped FT from shipping 18650s about 2-3 years ago.....

and more recently you can no longer use Paypal to buy Aspire products from fasttech, so, they can effectively shut it down quite a bit, if not totally, by eliminating payment methods combined with customs and bans.

 

[zoiDman]

We need to create a Hall of Shame on ECF where each politician who is for these FDA regs are exposed.

We also should have a List of people coming up for Re-Election.

 

[Robert Cromwell]

The money goes into preparing your application not to the FDA.
Mike

THIS!

 

[StormFinch]

We interrupt this serious discussion to bring you a brief video intermission...

 

[Bronze]

We also should have a List of people coming up for Re-Election.

That would work too. Of course, every House representative is up for election/re-election so this would be relegated to senators which will be an easier list to come up with. Maybe I'll work on that tonight or tomorrow. Should be 34 senate seats. Good idea.

 

[markfm]

Here's the list of senators coming up for reelection:
2016 Senate Election Interactive Map

(No claim on the politics, this was just the first list I saw )

 

[Kent C]

Ultimate List of Anti-Vaping Politicians - VaporVanity.com

The 'no votes' on the House Appropriations Committee:


Congressional action on electronic cigarette regulations may save vapers

 

[Kent C]

Here's the list of senators coming up for reelection:
2016 Senate Election Interactive Map

(No claim on the politics, this was just the first list I saw )

Richard Burr NC should be considered a friend of vaping from his HELP committee comments, imo.

 

[tiburonfirst]

THIS!

creating jobs the american way!

 

[Tim Jenson]

and more recently you can no longer use Paypal to buy Aspire products from Fasttech, so, they can effectively shut it down quite a bit, if not totally, by eliminating payment methods combined with customs and bans.

They accept bitcoins, they can't shut that down.

 

[nicnik]

I had to laugh at a headline on my local news stations website, relating to food labeling guidelines:
FDA to reevaluate definition of 'healthy'
Seems to me they've already redefined the word.

LOL!

At least, what is being considered, is a change that would make part of it less strict, Also more consistent and fair.

 

[The Ocelot]

I'm curious as to how they handle OTCs, but not enough to give myself a headache by looking it up. Common sense would say they since most everything OTC was at one time a prescription, as long as there was no change in ingredients, there's really no PMTA needed. Then again, we know exactly how much common sense the FDA doesn't have. I do remember one member saying her husband works in OTC and it isn't as involved as scripts.

Needless to say, I really hope Congress looks at them and says that not only do we fund them but pharma already funds them as well, and they still can't get anything done...

To clarify, my comment was focused on the number of employees assigned to review OTC drugs.

"...unlike prescription drugs, which are regulated via new drug applications (NDAs), hundreds of thousands of OTC drugs are evaluated and approved via what are known as monographs. Sponsors of OTC drugs relying on monographs are not required to seek FDA approval prior to marketing a product under a monograph."

“The OTC monograph process is ingredient-based, as opposed to product-based, and is done through a multi-step public rulemaking process,” FDA notes. “The monograph allows industry to market a drug product that contains a monograph ingredient as long as the manufacturer complies with all applicable regulations, including the conditions of the monograph."

"Currently, a number of pain-relievers, pediatric cough and cold medications, decongestants, upset stomach medicines and antiseptics can be marketed under an OTC monograph.

"However, because of a lack of resources, FDA says the finalization of such OTC monographs has been slow in many therapeutic areas, with the result that there are OTC drugs on the market with still-pending monographs and for which the FDA has not made a final determination on safety and effectiveness."

The are only 18 employees to review OTC monographs. The FDA is seeking "User Fees" from the OTC drug manufacturers to increase revenue, possibly (since they didn't actually say) to hire more employees to speed-up the process.

How many employees will be allotted to review new PMTA, SE and SE Exemption applications coming in? I imagine the FDA already gets User Fees from BT, but doesn't it stand to reason that they will need more funding? Where will it come from? Will the application fees be enough to cover it?

 

[Kent C]

LOL!

At least, what is being considered, is a change that would make part of it less strict, Also more consistent and fair.

Yep. Not only are they "deeming" what is a tobacco product, but also "deeming" what is healthy.

 

[wiredlove]

FDA Plans To Re-evaluate The Term "Healthy"

The term “healthy” can only currently be used on packaging when it meets certain nutrient criteria. Under this current criteria, some Kind fruit and nut bars would not be able to use the term “healthy,” according to the administration. The company later asked for a re-evaluation of the term saying the rule prevents avocados and salmon from being labeled “healthy.”

There goes my plans for releasing a Healthful "Healthy" Salmon Avocado eJuice line.

 

[Robert Cromwell]

of course BT has the labs and stuff to do the testing.

There goes my plans for releasing a Healthful "Healthy" Salmon Avocado eJuice line.

Salmon and Avacado's together might qualify for "Healthy"?
But I think would make a horrible ejuice.

 

[mikepetro]

of course BT has the labs and stuff to do the testing.

Salmon and Avacado's together might qualify for "Healthy"?
But I think would make a horrible ejuice.

No crazier than my Worcestershire ejuice, which is pretty damn good.

 

[Kent C]

Something noted to me by Zoidman - the actual publication of the Federal Registry of the deeming today:

Federal Register | Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

(Comment 53) Comments stated the NPRM is a “major rule” according to the Office of Information and Regulatory Affairs, 5 U.S.C. 804(2) (1996), and the Congressional Review Act mandates that the rule cannot take effect until 60 days after the final rule is published in the Federal Register (5 U.S.C. 801(a)(3) (1996)). Therefore, they requested that FDA change the effective date for this rule and the compliance periods for parts 1100 and 1140 to at least 60 days following publication of the final rule.

(Response) FDA is providing a 90-day effective date for parts 1100 and 1140 with this final rule.

----
There's speculation as to whether such a Congressional review will happen.

I also noticed something in reading this - and I'm not sure whether it was in the original doc posted earlier this week (and didn't take the time to look :- ) ... but:


Also I found this interesting, since the Nicopure suit mentions it having problems with the definition of "tobacco products":

XV. Description of the Final Rule—Part 1140 Back to Top
Currently, part 1140 generally applies to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. FDA proposed additional provisions to apply to “covered tobacco products” (namely, the requirement to prohibit the sale and distribution of products to individuals under 18 years of age and the prohibition on vending machine sales except in adult-only facilities). As stated elsewhere in this document, “covered tobacco product” means any tobacco product deemed to be subject to the FD&C Act pursuant to § 1100.2, but excludes any component or part that is not made or derived from tobacco. FDA is finalizing these requirements without substantive change.

further down

We have slightly modified the definition of “covered tobacco products” from the notice of proposed rulemaking (NPRM) to clarify that components or parts that are “covered tobacco products” include not only those that contain tobacco or nicotine, but also those that contain any tobacco derivative.

Again, not sure if the context is right or if this was something they changed today.... just pointing it out.

 

[Robert Cromwell]

No crazier than my Worcestershire ejuice, which is pretty damn good.

If you say so