Awww.
...I would have cried leaving that one behind too.
Uh, not me. I couldn't get that critter off to his new home fast enough. The new people had a big pasture, so he wouldn't be in their way all the time.
Deeming Regulations have been released!!!!
- Thread starter Oliver
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Uh, not me. I couldn't get that critter off to his new home fast enough. The new people had a big pasture, so he wouldn't be in their way all the time.
That's one thing I really don't get. If I'm a vendor, why should I have to prove what my "Flavored Glycerine" is FOR??? Maybe my customers like to bathe in it. I don't know. As long as I don't tell them "Add nicotine, then vape it" - I'd imagine I might have an argument.
But still - I think the "easy targets" are e-liquid vendors and vape shops.
But still - I think the "easy targets" are e-liquid vendors and vape shops.
This is a tough one. i believe the correct answer is.
"No you silly rabbit,Trix are for kids."
Mike
"narrow'? MOST vapers, probably by a landslide, use ready-made e-juice.
I mean like 98% of vapers are buying juice, and 2% of us are making our own.
The other huge impact is against the NEW vaper.
A shop can't recommend anything to get them off cigarettes - not without risking an FDA violation. That's what the FDA will do, too - walk into a shop and wait for someone to be sold an e-cig to quit smoking. That's a violation...intent to use with nic...
Insane, I know...
I mean like 98% of vapers are buying juice, and 2% of us are making our own.
The other huge impact is against the NEW vaper.
A shop can't recommend anything to get them off cigarettes - not without risking an FDA violation. That's what the FDA will do, too - walk into a shop and wait for someone to be sold an e-cig to quit smoking. That's a violation...intent to use with nic...
Insane, I know...
A lot of damage will be done just because many will not want to deal with all of this.
Also, everyone is too wrapped up in workarounds and loopholes, IMO.
Big takeaway so far; Demetri says Cole-Bishop is the main thing we should focus on. The HR 2058 support might even hurt us since the bill is stalled. He gives more details. About 24 minutes in for those that want to just see his explanation.
And wow- they spent 2.7million to infiltrate social media and collect data on how we alter and modify.
I truely believe alot if not most of fda's deeming regulations will end up being thrown out but not before alot of damage is done. The fda will NEVER back down it will take the courts to get anything reversed. This is going to take years in the mean time a whole lot of vendors will be long gone
I have to say that I agree with them and really hope that CASAA will soon issue a new CTA in support of the Cole/Bishop amendment.
The last thing we need now is a war between different advocacy groups--and I already see some signs of this very thing beginning to happen. God help us.
I agree 100% with that.... it's bound to happen never going to please everyone.. Not that I count as I am just 1 vapor... I think we need another classification ... vaping is not tobacco..it's not medical...it's not food... It's a recreational device
IMO there are valid reasons to prefer HR 2058 over the amendment, HOWEVER, at this point in time, we need ANYTHING we can get.
Not only is it stalled, it's a partisan bill, and even if, by some miracle, it should pass the House and the Senate, it will most certainly be vetoed by the President.
The FDA won't be swayed by anything we say or do. We need to strip them of their power. IDK what the best plan of attack would be for that. Take vaping out of their jurisdiction? Work to get the FSPTCA amended?
Would it be wishful thinking that the groups fighting fda on our behalf are following this thread. I mean its the largest ecig forum in the world maybe we are giving them ideas how to move forward. I mean we know the fda will not listen I would hope the groups fighting for us are listening
Not so narrow perhaps, this is not about me, I will be fine, the smokers whom have now been denied the easiest way to stop killing themselves will be screwed.
Dear Mr. Guster,
Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “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” (Deeming rule).
FDA anticipates that newly regulated businesses may have many questions and compiled this e-mail as a resource to help you better understand the Deeming rule and the potential impact to your business. We encourage you to review this information and keep checking our website for new information such as compliance training webinars and updates based on questions FDA receives.
The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer.
These requirements include:
Under the new Deeming Rule, FDA now regulates any product that meets the definition of a tobacco product, except accessories (e.g., ashtrays, humidors, carrying cases). This includes any component of a tobacco product that is intended to alter the tobacco product’s performance, composition, constituents or characteristics or intended to be used with or for the consumption of a tobacco product. Some examples of components include cigar wrappers, cigar tobacco filler, coils, flavor cartridges, and liquid nicotine cartridges that are used in e-cigarettes.
All manufacturers of components of tobacco products that are sealed in final packaging intended for consumer use have to comply with certain provisions of the law. Some examples of these requirements include: establishment registration and product listing, premarket review, reporting of Harmful or Potentially Harmful Constituents (HPHCs), submission of tobacco health documents and ingredient listing, and compliance with the free sample ban.
Only those manufacturers of components of tobacco products that are sealed in final packaging intended for consumer use and are made or derived from tobacco must comply with the nicotine warning statements required on package labels and advertisements. And only those manufacturers of components of cigars that are sealed in final packaging intended for consumer use and are made or derived from tobacco must comply with the health warning statements required on the package labels and advertisements and submission of a rotational warning plan to FDA.
The following are a few examples for illustration:
Company A manufactures many liquid nicotine cartridges in different strengths that are packaged and intended to be sold to consumers to be used in an e-cigarette. Company A is required to comply with establishment registration and product listing, premarket review, reporting of HPHCs, submission of tobacco health documents and ingredient listing, and compliance with the free sample ban. Also, because the liquid nicotine is made or derived from tobacco, it also must bear the required nicotine statement on its packaging and advertisements.
Company B manufactures liquid flavor cartridges intended for use in flavored e-cigarettes. Company B sells their product to Company C who assembles a flavored e-cigarette closed system device. Company C sells their flavored e-cigarettes to Company D who packages and labels the flavored e-cigarette for sale to consumers. FDA will not require Company B or C to comply with any of the regulatory requirements listed above. Company D, however, is required to comply with the establishment registration and product listing, premarket review, reporting of Harmful or Potentially Harmful Constituents (HPHCs), submission of tobacco health documents and ingredient listing, and compliance with the free sample ban.
Company E manufactures many different flavors in different cartridges that are packaged and intended to be sold to consumers to be used in e-cigarettes. Company E is required to comply with establishment registration and product listing, premarket review, reporting of HPHCs, submission of tobacco health documents and ingredient listing, and compliance with the free sample ban. However, Company E does not have to comply with the nicotine warning on its packaging and advertisement because the component is not made or derived from tobacco.
Please see Deeming Rule and Small Entity Compliance Guide for further information.
FDA does not assess fees associated with the requirements identified above. The costs associated with compliance with these requirements may vary based on the type and complexity of the product, and, as a result, FDA is not able to provide an individualized estimate of costs that you may incur. However, FDA has included in the preamble to the Deeming rule its estimates of the quantified costs associated with the Rule over 20 years, as well as estimated hourly burdens on impacted entities (such as tobacco product manufacturers) for the requirements described above. Please see the link provided below for more information.
Final Rule and Accompanying Documents
FDA continues to update its Deeming webpage to provide information designed to help industry understand the Deeming rule. We plan to soon add a chart that may help you determine which provisions apply to you and the timeframes for complying. In addition, FDA plans to post Tobacco Compliance Webinars.
We also encourage you to subscribe to FDA’s “This Week in CTP.” By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.
Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:
Email:
SmallBiz.Tobacco@fda.hhs.gov
Phone:
1-877-287-1373
Mail:
Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
IM0978383
Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “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” (Deeming rule).
FDA anticipates that newly regulated businesses may have many questions and compiled this e-mail as a resource to help you better understand the Deeming rule and the potential impact to your business. We encourage you to review this information and keep checking our website for new information such as compliance training webinars and updates based on questions FDA receives.
The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer.
These requirements include:
- Register domestic manufacturing establishment(s) and submit product listings to FDA by December 31, 2016;
- Reporting ingredients, and harmful and potentially harmful constituents;
- Requiring premarket review and authorization of new tobacco products by the FDA;
- Placing health warnings on product packages and advertisements; and
- Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Under the new Deeming Rule, FDA now regulates any product that meets the definition of a tobacco product, except accessories (e.g., ashtrays, humidors, carrying cases). This includes any component of a tobacco product that is intended to alter the tobacco product’s performance, composition, constituents or characteristics or intended to be used with or for the consumption of a tobacco product. Some examples of components include cigar wrappers, cigar tobacco filler, coils, flavor cartridges, and liquid nicotine cartridges that are used in e-cigarettes.
All manufacturers of components of tobacco products that are sealed in final packaging intended for consumer use have to comply with certain provisions of the law. Some examples of these requirements include: establishment registration and product listing, premarket review, reporting of Harmful or Potentially Harmful Constituents (HPHCs), submission of tobacco health documents and ingredient listing, and compliance with the free sample ban.
Only those manufacturers of components of tobacco products that are sealed in final packaging intended for consumer use and are made or derived from tobacco must comply with the nicotine warning statements required on package labels and advertisements. And only those manufacturers of components of cigars that are sealed in final packaging intended for consumer use and are made or derived from tobacco must comply with the health warning statements required on the package labels and advertisements and submission of a rotational warning plan to FDA.
The following are a few examples for illustration:
Company A manufactures many liquid nicotine cartridges in different strengths that are packaged and intended to be sold to consumers to be used in an e-cigarette. Company A is required to comply with establishment registration and product listing, premarket review, reporting of HPHCs, submission of tobacco health documents and ingredient listing, and compliance with the free sample ban. Also, because the liquid nicotine is made or derived from tobacco, it also must bear the required nicotine statement on its packaging and advertisements.
Company B manufactures liquid flavor cartridges intended for use in flavored e-cigarettes. Company B sells their product to Company C who assembles a flavored e-cigarette closed system device. Company C sells their flavored e-cigarettes to Company D who packages and labels the flavored e-cigarette for sale to consumers. FDA will not require Company B or C to comply with any of the regulatory requirements listed above. Company D, however, is required to comply with the establishment registration and product listing, premarket review, reporting of Harmful or Potentially Harmful Constituents (HPHCs), submission of tobacco health documents and ingredient listing, and compliance with the free sample ban.
Company E manufactures many different flavors in different cartridges that are packaged and intended to be sold to consumers to be used in e-cigarettes. Company E is required to comply with establishment registration and product listing, premarket review, reporting of HPHCs, submission of tobacco health documents and ingredient listing, and compliance with the free sample ban. However, Company E does not have to comply with the nicotine warning on its packaging and advertisement because the component is not made or derived from tobacco.
Please see Deeming Rule and Small Entity Compliance Guide for further information.
FDA does not assess fees associated with the requirements identified above. The costs associated with compliance with these requirements may vary based on the type and complexity of the product, and, as a result, FDA is not able to provide an individualized estimate of costs that you may incur. However, FDA has included in the preamble to the Deeming rule its estimates of the quantified costs associated with the Rule over 20 years, as well as estimated hourly burdens on impacted entities (such as tobacco product manufacturers) for the requirements described above. Please see the link provided below for more information.
Final Rule and Accompanying Documents
- Final Rule: 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
- Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
- Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS); Draft Guidance for Industry
- Tobacco Product Master Files; Guidance for Industry
FDA continues to update its Deeming webpage to provide information designed to help industry understand the Deeming rule. We plan to soon add a chart that may help you determine which provisions apply to you and the timeframes for complying. In addition, FDA plans to post Tobacco Compliance Webinars.
We also encourage you to subscribe to FDA’s “This Week in CTP.” By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.
Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:
Email:
SmallBiz.Tobacco@fda.hhs.gov
Phone:
1-877-287-1373
Mail:
Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
IM0978383
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