FDA FDA issues ANPRM for e-liquid and/or e-cig packaging and labeling

[Bill Godshall]

The FDA has just issued an Advanced Notice of Proposed Rulemaking (ANPRM) for e-liquid and/or e-cig packaging and labeling.
Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM453226.pdf

This same docket was exposed and discussed on another ECF thread at
Interesting new docket opened and withdrawn | E-Cigarette Forum

Although FDA doesn't have any legal authority to formally propose or impose any additional regulations on nicotine vapor products unless and until the Final Rule for the FDA deeming regulation is approved by OMB and printed in the Federal Register (which could take several more months), the agency issued this ANPRM to generate more fear mongering news stories about the negligible risks of e-liquid, to further lobby for the deeming regulation, and to further deceive the public and the news media to believe that the deeming regulation is a done deal.

Note that FDA's ANPRM is requesting comments about color graphic warnings for e-liquid and/or all e-cigs. But the FDA still hasn't proposed new regulations (that Congress mandated the FDA impose in 2009) for color graphic warnings on cigarette packs (since Judge Leon ruled that FDA's previous cigarette warnings were unconstitutional because they misrepresented some smoking risks, demonized smoking and stigmatized smokers, and included the phone number 1-800-Quit-Now that hawked FDA approved drugs as the only effective way to quit smoking).

 

[Kent C]

"Recent increases in calls and visits to both poison control centers (see, e.g., CDC’s Morbidity and Mortality Weekly Report, available at Notes from the Field: Calls to Poison Centers for Exposures to Electronic Cigarettes — United States, September 2010–February 2014 and emergency rooms in the United States involving liquid nicotine poisonings and exposures has increased the public health concerns of these exposure risks." (my emphasis)

Attempting a prophylactic side-step to the 'it's only calls' argument by adding 'and visits' (which is a minute and negligible fraction of the calls), and then the link to CDC is only about the 'increase in calls'

IOW, more deception.

 

[Lessifer]

We are still opposing the deeming as a whole, right?

 

[Kent C]

"Secretary must consider: (1) The risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products."

I can see (although don't agree with) #1. #2 is something that wasn't done well or wasn't reported fully on the lack of success for other products - gum, patches and totally discounted for the success of snus.

With #3 - it will again be totally discounted (giving credit to their own programs) that the decrease in smoking in teens is in any way connected to (caused by?) ecigs.

 

[Kent C]

We are still opposing the deeming as a whole, right?

Hmm.. no ellipses...

 

[Lessifer]

Hmm.. no ellipses...

Nope, no sarcasm in that one. I am honestly concerned that I don't hear anything, from anyone, about opposing the deeming regs. It's hard for me to imagine vaping in any recognizable form surviving the regs. The only hope I see is stopping them before being enacted, or fighting them in court, and I know I don't have the money for that.

 

[Lessifer]

Still reading and digesting but:
"FDA is considering whether, based on the acute toxicity of nicotine (up to and including nicotine poisoning), it would be appropriate for the protection of the public health to warn the public about the dangers of nicotine exposure, especially due to inadvertent nicotine exposure in infants and children, and/or require that some tobacco products be sold in child-resistant packaging."

So, are they going to start putting cigarettes in CRP? Last I read, cigarettes are responsible for four times as many pcc calls as vapor products.

 

[Bill Godshall]

Here AVA's press release


Contact: Gregory Conley
Tel: 609-947-8059
Email: gconley@vaping.info
FOR IMMEDIATE RELEASE
6/30/2015 at 2:10 pm EST

FDA Jumps the Gun on E-Cigarette Regulations
Deeming regulations have not been finalized, but agency still laying the groundwork for future regulations

WASHINGTON, D.C. - Today, the American Vaping Association, a leading advocate for the benefits of vapor products such as electronic cigarettes, reacted to the Food & Drug Administration's (FDA) Center for Tobacco Products' plan to publish an Advanced Notice of Proposed Rulemaking (ANPRM) with regard to vapor products in the Federal Register tomorrow, July 1st. This marks the first occasion that the FDA has formally signaled its intent to eventually set product standards for vapor products.

Through the ANPRM, the FDA is seeking comment on the possibility of requiring child-resistant packaging and nicotine exposure warnings for products containing liquid nicotine, such as bottled e-liquids. Importantly, while the FDA can seek out information, the agency has no power to issue any proposed rule until the 'deeming' regulation is finalized (and possibly litigated).

"The FDA is jumping the gun by moving on this issue before the deeming regulation has been finalized," said Gregory Conley, President of the American Vaping Association. Reflecting on the fact that the FDA had previously pledged to have the deeming regulation finalized in June 2015, only to issue this ANPRM on July 1st, Conley noted, "The timing indicates that this is more of a public relations strategy than it is the actions of a neutral regulator just collecting information."

Conley and the AVA expressed support for child-resistant packaging that is in line with already existing federal law, but urged caution in formulating warning labels.

"Child-resistant packaging is already in use by the vast majority of e-liquid manufacturers," said Conley. "Measures should be taken to keep all nicotine-containing products, including pharmaceutical products like the nicotine gum, out of the hands of children."

Conley warned, however, that warning labels present distinctly different issues than child-resistant packaging. "Poorly designed warning labels have the capacity to mislead adult smokers on the relative risks of vaping versus tobacco smoking," said Conley. "Any proposed warning must be thoroughly tested to ensure that it only imparts factual information."

Equally concerning to the AVA is the FDA's inaction on cigarette warning labels, which were mandated by Congress in 2009. "Why is the FDA even inquiring about placing color warnings on vapor products when they haven't even fulfilled their duty to Congress to require graphic warnings on deadly combustible cigarettes?" asked Conley. "With each passing month, it seems that the FDA is doing less and less to combat the most lethal products on the market."

Currently fourteen states have laws requiring child-resistant packaging for nicotine-containing e-liquid products.* These states have almost universally mirrored language from the federal Poison Prevention Packaging Act, which provides clear language and allows for consistency between states.

The AVA continues to support proposals in the U.S. Congress that would prevent the FDA from retroactively requiring vapor products already on the market to undergo a potentially multimillion dollar "pre-market" approval process.

* Minnesota, Vermont, New York, Connecticut, Arkansas, Indiana, North Dakota, New Mexico, Nevada, Oregon, Tennessee, Texas, Virginia, and Wyoming have enacted child-resistant packaging laws. Not all laws have gone into effect. Bills in Missouri and North Carolina are awaiting action their respective Governors.

The image below represents calls to U.S. Poison Control Centers regarding exposures to different products.

For further analysis of data regarding calls to Poison Control Centers from vapor products, we recommend this article by Clive Bates, former head of the UK's largest anti-smoking group Action on Smoking & Health.

You can learn more about AVA and vaping by visiting the AVA website. You can also find us onFacebook and Twitter.


About the American Vaping Association:

The American Vaping Association is a nonprofit organization that advocates for small- and medium-sized businesses in the rapidly growing vaping and electronic cigarette industry. We are dedicated to educating the public and government officials about financial and public health benefits offered by vapor products, which are battery-powered devices that heat a liquid nicotine or nicotine-free solution and create an inhalable vapor.

 

[Bill Godshall]

Here is the e-mail FDA just sent with the deceptive fear mongering headline:

FDA Issues Nicotine Exposure Warnings and Child-Resistant Packaging ANPRM

FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research, and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels, and drinks.

FDA has evaluated data and science related to the risks, especially to infants and children, from accidental exposure to nicotine, including exposure to liquid nicotine and nicotine-containing e-liquid (s). The continuing rise in popularity of electronic nicotine devices (ENDS), such as e-cigarettes, which often use liquid nicotine and nicotine-containing e-liquids, has coincided with an increase in calls to poison control centers and visits to emergency rooms related to liquid nicotine poisoning and other nicotine exposure risks. FDA’s assessment of these recent trends has led the agency to seek additional information on whether, based on the acute toxicity of nicotine (up to and including nicotine poisoning), it would be appropriate for the protection of the public health to:

• warn the public about the dangers of nicotine exposure (especially due to inadvertent nicotine exposure in infants and children); and/or
• require some tobacco products be sold in child-resistant packaging.

FDA values the public’s input through the comment process and will consider all input, data, research, and other information submitted to the docket to help the agency make the best decisions about possible regulatory actions. If FDA decides to issue a rule, the first step in that process would be to issue a Notice of Proposed Rulemaking in the Federal Register, which would give the public an opportunity to comment on the proposal.



This ANPRM will be available for comment for 60 days, beginning tomorrow, July 1, 2015.

 

[caramel]

Still reading and digesting but:
"FDA is considering whether, based on the acute toxicity of nicotine (up to and including nicotine poisoning), it would be appropriate for the protection of the public health to warn the public about the dangers of nicotine exposure, especially due to inadvertent nicotine exposure in infants and children, and/or require that some tobacco products be sold in child-resistant packaging."

So, are they going to start putting cigarettes in CRP? Last I read, cigarettes are responsible for four times as many pcc calls as vapor products.

I can see how they would like to stick a label like this on eliquid:

 

[Placebo Effect]

AVA press release -- FDA Jumps the Gun on E-Cigarette Regulations - The American Vaping Association

AVA quoted in the AP report -- FDA Weighs New Restrictions on Liquid Nicotine Products - ABC News

 

[Jingles]

I heard on the radio last week that one child every day is hospitalized for exposure to laundry detergent pods. Not sure of the source...


Sent from my iPhone using Tapatalk

 

[caramel]

I heard on the radio last week that one child every day is hospitalized for exposure to laundry detergent pods. Not sure of the source...


Sent from my iPhone using Tapatalk

21000 children die every day around the world. None of them from vaping.

Today, around 21,000 children died around the world — Global Issues

 

[Placebo Effect]

L.A. Times -- FDA considering warning labels for liquid nicotine - LA Times

Wall Street Journal / Dow Jones (with quotes from me that differ from the press release) -- FDA Proposes Warning Labels on Liquid Nicotine Bottles - NASDAQ.com

 

[Lessifer]

Seems like they're counting their chickens before they've hatched. One way to help fight this, would be to sign the petition linked in my signature, and share it. They may not care, but if we can get the word out to enough people how ludicrous the deeming regs are, maybe we can stop them.

 

[DrMA]

As you can imagine, the "warnings" FDA has in mind are the same as those on current smokeless tobacco products such as "not a safe alternative". These are not genuine warnings, but another propaganda tool to falsely disparage far safer options and further smoker demonization. Quite apart from the fact that FDA has no authority to impose any requirements whatsoever on vaping products, we should object to any and all labeling/packaging regs they propose.

 

[AndriaD]

Here is the e-mail FDA just sent with the deceptive fear mongering headline:

FDA Issues Nicotine Exposure Warnings and Child-Resistant Packaging ANPRM

FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research, and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels, and drinks.

FDA has evaluated data and science related to the risks, especially to infants and children, from accidental exposure to nicotine, including exposure to liquid nicotine and nicotine-containing e-liquid (s). The continuing rise in popularity of electronic nicotine devices (ENDS), such as e-cigarettes, which often use liquid nicotine and nicotine-containing e-liquids, has coincided with an increase in calls to poison control centers and visits to emergency rooms related to liquid nicotine poisoning and other nicotine exposure risks. FDA’s assessment of these recent trends has led the agency to seek additional information on whether, based on the acute toxicity of nicotine (up to and including nicotine poisoning), it would be appropriate for the protection of the public health to:

• warn the public about the dangers of nicotine exposure (especially due to inadvertent nicotine exposure in infants and children); and/or
• require some tobacco products be sold in child-resistant packaging.

FDA values the public’s input through the comment process and will consider all input, data, research, and other information submitted to the docket to help the agency make the best decisions about possible regulatory actions. If FDA decides to issue a rule, the first step in that process would be to issue a Notice of Proposed Rulemaking in the Federal Register, which would give the public an opportunity to comment on the proposal.



This ANPRM will be available for comment for 60 days, beginning tomorrow, July 1, 2015.

The most hilarious and deceptive line in all of that: "FDA values the public’s input" -- BS! They don't give a ratzass about what the public thinks!!!!!

Andria

 

[Kent C]

One scenario - one I think that is unlikely - is that the FDA thinks they've lost the battle on deeming (or on the grandfather date) and are pushing the minimal, near standard stuff on child proof packaging - for those few vendors that still don't have it.

And then the labeling idiocies - (similar to... and having the same effect as 'ignored stickies' on forums ) - that have been pushed by the nannystaters, and the activists who can't really stop a product they don't like, but want to 'make the company pay' through really stupid labels and finally, out of necessity, grudgingly accepted by the companies, who are more afraid of the trial lawyers than the FDA.

So because of parents who leave open bottles of nicotine or eliquid within a child's reach or idiots that stand on the top step of a step ladder, we get labels that either don't fit on the container or 16 warning labels that take up the full length of a 12 foot ladder - all unread and unheeded.

 

[Kent C]

The most hilarious and deceptive line in all of that: "FDA values the public’s input" -- BS! They don't give a ratzass about what the public thinks!!!!!

Andria

And they purposely restrict our guys at their seminars for a full hearing of the truth - allocating only 3 minutes or less for their comments. ... while Glantz and his crew get graphics, podium, charts, etc. etc.

 

[BuGlen]

As you can imagine, the "warnings" FDA has in mind are the same as those on current smokeless tobacco products such as "not a safe alternative". These are not genuine warnings, but another propaganda tool to falsely disparage far safer options and further smoker demonization. Quite apart from the fact that FDA has no authority to impose any requirements whatsoever on vaping products, we should object to any and all labeling/packaging regs they propose.

You're probably right. If they were actually to come out with labeling requirements that were reasonable, I might support them. For example: "Warning: Keep this product out of reach of small children and pets." However, I can't imagine that they'd start being reasonable at this point, so I'm not holding my breath.