FDA FDA battery concerns workshop
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And this is how they finally kill off all ecigs even if we get the predicate date changed. Simply deem all battery systems as dangerous. Everything current would fail to pass (making a date change moot) and any changes to the battery system would be a PMTA.
Paranoid? Maybe but sometimes they really are out to get you.
Paranoid? Maybe but sometimes they really are out to get you.
It was Nice to see 2 e-Cigarette Retailers (Stakeholder) participating by submitting a Comment to be included into the Public Record.
Regulations.gov
It was though kinda Discouraging to see only 2 Retailers doing so. If Retailers (or OEM's) do Not Submit any Comments, then I guess they are Happy to just let the FDA Decide what type of Battery Should or Shouldn't power an "e-Cigarette".
And do Not Care if the Public Record contains any Pertinent Information that could be used in any Future Litigation.
Regulations.gov
It was though kinda Discouraging to see only 2 Retailers doing so. If Retailers (or OEM's) do Not Submit any Comments, then I guess they are Happy to just let the FDA Decide what type of Battery Should or Shouldn't power an "e-Cigarette".
And do Not Care if the Public Record contains any Pertinent Information that could be used in any Future Litigation.
Flashlight explodes in Colo. man's mouth
Yep. I had to read that title twice too.
With "life" being as dangerous as it is... it's probably best if we all just stay inside. Under our beds. Until we die.
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I read every new ecig injury accident story I come across. Virtually all of them involve loose batteries with unprotected terminals or mishandled mech mods. The purpose of the workshop is to spread fear and make political points and reach no conclusions while people continue to get hurt. Then they can say drastic action is necessary because the problem is so intractable. Warning the public is sufficient. They'll never do that because it might work.
From the original post link: (red emphasis mine)
"Topics to be addressed include, for example: (1) Factors that contribute to failure of rechargeable and non-rechargeable ENDS batteries resulting in overheating, fire, explosion, or other modes of failure (this may include factors relating to batteries, charging equipment, components and parts such as voltage and temperature controllers or other circuitry, other ENDS design features, user modification of ENDS, and e-liquids), and what influence these factors have on the mode of failure (e.g., battery overheating versus explosion); (2) safety features (e.g., circuit protection, charging safety features) and battery standards that may be applied to ENDS batteries to limit their potential for overheating, fire, explosion, or other mode of failure; (3) changes, improvements, and innovations to battery and ENDS design that would limit the potential for overheating, fire, explosion, or other mode of failure; (4) other public health risks associated with ENDS batteries (e.g., leakage); (5) ENDS design changes that could mitigate public health risks upon battery failure; (6) battery safety information that is communicated to ENDS consumers and the general public; and (7) best practices to effectively communicate potential risks associated with ENDS batteries to consumers and the general public (e.g., via labeling, instructions for use, warnings)."
Sounds to me like a prelude to non modifiable closed system ecigs only.
"Topics to be addressed include, for example: (1) Factors that contribute to failure of rechargeable and non-rechargeable ENDS batteries resulting in overheating, fire, explosion, or other modes of failure (this may include factors relating to batteries, charging equipment, components and parts such as voltage and temperature controllers or other circuitry, other ENDS design features, user modification of ENDS, and e-liquids), and what influence these factors have on the mode of failure (e.g., battery overheating versus explosion); (2) safety features (e.g., circuit protection, charging safety features) and battery standards that may be applied to ENDS batteries to limit their potential for overheating, fire, explosion, or other mode of failure; (3) changes, improvements, and innovations to battery and ENDS design that would limit the potential for overheating, fire, explosion, or other mode of failure; (4) other public health risks associated with ENDS batteries (e.g., leakage); (5) ENDS design changes that could mitigate public health risks upon battery failure; (6) battery safety information that is communicated to ENDS consumers and the general public; and (7) best practices to effectively communicate potential risks associated with ENDS batteries to consumers and the general public (e.g., via labeling, instructions for use, warnings)."
Sounds to me like a prelude to non modifiable closed system ecigs only.
Everything I can find on it says 2170(0).. Have you measured the diameter of you cells?
Yep. Seems like they are seeking further "justification" to refuse to approve PMTAs to any open system components -- assuming anyone is actually willing to submit them.
I am speechless. I went right to my Chinese knock-off and looked to see if a dead short could happen even with the wrap removed. And they did it right. It is all plastic surrounding the positive contact. There are 21 pictures of the flashlight on 'USA Today.' Flashlight explodes in Colo. man's mouth
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Yes those of us that already have gear to put the batterys in would find a way to carry on. The issue is that If they deem all current ecig batterys too dangerous all existing systems could no longer be sold without a change to the batterys. Any change to the batterys would require a new PMTA. SO in essence even if we got the grandfather date changed everything would still need a PMTA since it would have been deemed unsafe due to the battery. Game over ecigs off the market. No new people stopping smoking via ecigs.
Edit: I am not worried for me. I am set for life. I am worried about the people who come after who will not have access to these life saving devices.
These days I'm a single issue voter. If congress or the courts or trump doesn't help us out I'll be looking to replace them all with any huminoid that wants the work.
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