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Fun fact, if you claim to be a smoking cessation product you get the FDA at your door going "oh, so this is a medical product" and you're now obligated to prove

Fun fact, if you claim to be a smoking cessation product you get the FDA at your door going "oh, so this is a medical product" and you're now obligated to prove that your product works as a medical cessation product, and requires a doctor's note to pick up. You can't market yourself as a smoking cessation product without getting the hounds of hell being unleashed on you by the regulators.

egeozcan 5y ago
Getting licensed for vaping is easier? (really asking)
- CodeWriter23 5y ago
  No. The only companies eligible in the PMTA License process for vape had to have been manufacturing in 2015 or 2016 when the FDA began its moratorium on new players entering the market.
- Red_Leaves_Flyy 5y ago
  They’re both incredibly expensive and laborious. Like millions of dollars per sku expensive. The fda has put all the good vape shops out of business and extortionate taxes are killing the rest as people revert back to cigarettes. The fda is actively hurting Americans by shifting these costs onto retailers which was a Coup d'état for big tobacco who had been completely blindsided by the success of startup vape companies.
  - OptionX 5y ago
    Several "Citation needed" in that comment.
    - Red_Leaves_Flyy 5y ago
      Here’s a good primer. I was a bit off, it’s not millions per sku, more like hundreds of thousands, but all the combinations of products also need to be accounted for and approved at great cost. https://vaping360.com/vape-news/105656/how-will-the-pmta-deadline-affect-vapers-and-the-industry/ https://vaping360.com/vape-news/105656/how-will-the-pmta-dea... If that’s not enough detail let me know, I’m happy to dig up other old articles for you. This small business destroying charade by the fda has been well documented and publicized. Though not as well as the fear mongering about children juuling.
      - TedDoesntTalk 5y ago
        > fear mongering about children juuling. Why is that fear-mongering? My anecdotal evidence is that it's rampant with teens. Do you have any stats that are not anecdotal so I can educate myself?
        markzzerella 5y ago
        When I was growing up all the teens were smoking and drinking. Considering how bad we know alcohol and cigarettes are for a developing brain, I'm inclined to not panic over the newest trend.
        tekknik 5y ago
        Don’t forget marijuana, it reduces blood flow to the brain. Absolutely horrible for a developing brain.
        markzzerella 5y ago
        I don't know how I forgot that. It was more popular than alcohol and cigarettes at my school.
        Red_Leaves_Flyy 5y ago
        Because the stories are pushing an agenda and ignoring the broader scope of the issue that is children using addictive substances. Conversations about children vaping should be had, but in comparison to the rate of other tobacco and nicotine use. If it’s really about the kids shouldn’t we also be looking at alcohol and other drugs like marijuana too as reference? I don’t see articles about the high school kids that start drinking, taking opiates, or smoking cigarettes and marijuana every year. These are expected behaviors, vaping is new, and the preponderance of evidence says is far less dangerous than smoking, so a lot of ignorant and easily frightened people got caught up in the rhetoric and forgot how to rationalize about new risks. The fear mongering about juul was little more than a perfect excuse to quash outcry over the ridiculous legislation against vaping products on the state and National level.
    - pope_meat 5y ago
      I'm a living citation. Was a small business owner, retail vape shop. Did fine for 5 years. Then the regulations to save the children and hit pieces in the news. All the small independent shops went under and now you can only buy the vuse, and juul, both owned by...you guessed it, the same folks who sold cigarettes. Basically, the wrong people were making money, and the regulators fixed that. Now the money is flowing to the right people and no one gives a shit that teen smoking rates went back to higher than they were before vaping. Harm reduced, a slow clap to our regulators.
  - mullingitover 5y ago
    > The fda has put all the good vape shops out of business and extortionate taxes are killing the rest as people revert back to cigarettes I'm not a conspiracy theorist, but I'll just point out the observation that there are a lot of perverse incentives to keep the tobacco money flowing, public health be damned. Hell, remember back 2019 public health officials were running made-up 'e-cigarettes are causing lung injury' scare which turned out to be entirely caused by contaminated black market THC cartriges? SF still hasn't walked back their e-cigarette ban that led to a doubling of tobacco use by high schoolers[1]. To give an idea of where priorities are, the state of California does 10x the number of checks to make sure stores are paying their cigarette taxes as they do to make sure stores aren't selling to minors. [1] https://jamanetwork.com/journals/jamapediatrics/fullarticle/2780248 https://jamanetwork.com/journals/jamapediatrics/fullarticle/...
  - soperj 5y ago
    Philip Morris owns 35% of Juul.
jasonhansel 5y ago
> you're now obligated to prove that your product works And that's a bad thing?
- rmellow 5y ago
  For business? Absolutely
  - qwerty456127 5y ago
    Also bad for the people who might benefit from the product even though it didn't help a statistically significant portion of people in an expensive clinical trial.
    - tekknik 5y ago
      I wonder how many non smokers we have in this thread making decisions for others. If only we’d think of the children! Screw the adults struggling with nicotine addiction, they should go back to cigarettes or just quit (like they’ve been trying to for years). Why do people have to stick their noses in things that don’t affect them?
- deleted 5y ago
  [deleted]
- theli0nheart 5y ago
  > And that's a bad thing? If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval. It will also greatly affect access to the product, as not everyone has access to good doctors, and most items that are FDA-regulated requires prescriptions. For a product which is a superior, healthier option to cigarettes, it's a massive regulatory burden that could kill the business. I can't imagine anyone would defend that as preferable to the status quo.
  - acituan 5y ago
    > If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval Question stands, is that a bad thing? Besides not everything FDA approved becomes a prescription medication. On topic; nicotine gums and patches as smoke cessation products are widely available as OTC.
ouid 5y ago
Working as intended: moved to won't fix.
Spooky23 5y ago
But… you get to charge 10x more and make the insurance companies or government pay.
prepend 5y ago
> requires a doctor's note to pick up. I don’t think this is true. I can buy Nicolette all over the place without a doctors note. In the US at least.
- pope_meat 5y ago
  That's the case now, initially the product was prescription only. Oh and it tastes like shit, to save the children.
tw04 5y ago
*these statements have not been validated by the FDA There are countless products from weight loss to joint pain to "improve your memory" that sidestep the issue with those 9 simple words. I don't see why it would be any different for Juul.
- billh 5y ago
  Because that language is for dietary supplements which have a specific legislative carve out from falling under FDA regulation.
- folli 5y ago
  These products can do that because they contain no substances that need approval in any way, so they are likely just food supplements without any active ingredients. Nicotine will count as an active ingredient, you can't just slap these 9 words to any random drug and just sell it over the counter.

egeozcan 5y ago

Getting licensed for vaping is easier? (really asking)

CodeWriter23 5y ago
No. The only companies eligible in the PMTA License process for vape had to have been manufacturing in 2015 or 2016 when the FDA began its moratorium on new players entering the market.
Red_Leaves_Flyy 5y ago
They’re both incredibly expensive and laborious. Like millions of dollars per sku expensive. The fda has put all the good vape shops out of business and extortionate taxes are killing the rest as people revert back to cigarettes. The fda is actively hurting Americans by shifting these costs onto retailers which was a Coup d'état for big tobacco who had been completely blindsided by the success of startup vape companies.
- OptionX 5y ago
  Several "Citation needed" in that comment.
  - Red_Leaves_Flyy 5y ago
    Here’s a good primer. I was a bit off, it’s not millions per sku, more like hundreds of thousands, but all the combinations of products also need to be accounted for and approved at great cost. https://vaping360.com/vape-news/105656/how-will-the-pmta-deadline-affect-vapers-and-the-industry/ https://vaping360.com/vape-news/105656/how-will-the-pmta-dea... If that’s not enough detail let me know, I’m happy to dig up other old articles for you. This small business destroying charade by the fda has been well documented and publicized. Though not as well as the fear mongering about children juuling.
    - TedDoesntTalk 5y ago
      > fear mongering about children juuling. Why is that fear-mongering? My anecdotal evidence is that it's rampant with teens. Do you have any stats that are not anecdotal so I can educate myself?
      - markzzerella 5y ago
        When I was growing up all the teens were smoking and drinking. Considering how bad we know alcohol and cigarettes are for a developing brain, I'm inclined to not panic over the newest trend.
        tekknik 5y ago
        Don’t forget marijuana, it reduces blood flow to the brain. Absolutely horrible for a developing brain.
        markzzerella 5y ago
        I don't know how I forgot that. It was more popular than alcohol and cigarettes at my school.
      - Red_Leaves_Flyy 5y ago
        Because the stories are pushing an agenda and ignoring the broader scope of the issue that is children using addictive substances. Conversations about children vaping should be had, but in comparison to the rate of other tobacco and nicotine use. If it’s really about the kids shouldn’t we also be looking at alcohol and other drugs like marijuana too as reference? I don’t see articles about the high school kids that start drinking, taking opiates, or smoking cigarettes and marijuana every year. These are expected behaviors, vaping is new, and the preponderance of evidence says is far less dangerous than smoking, so a lot of ignorant and easily frightened people got caught up in the rhetoric and forgot how to rationalize about new risks. The fear mongering about juul was little more than a perfect excuse to quash outcry over the ridiculous legislation against vaping products on the state and National level.
  - pope_meat 5y ago
    I'm a living citation. Was a small business owner, retail vape shop. Did fine for 5 years. Then the regulations to save the children and hit pieces in the news. All the small independent shops went under and now you can only buy the vuse, and juul, both owned by...you guessed it, the same folks who sold cigarettes. Basically, the wrong people were making money, and the regulators fixed that. Now the money is flowing to the right people and no one gives a shit that teen smoking rates went back to higher than they were before vaping. Harm reduced, a slow clap to our regulators.
- mullingitover 5y ago
  > The fda has put all the good vape shops out of business and extortionate taxes are killing the rest as people revert back to cigarettes I'm not a conspiracy theorist, but I'll just point out the observation that there are a lot of perverse incentives to keep the tobacco money flowing, public health be damned. Hell, remember back 2019 public health officials were running made-up 'e-cigarettes are causing lung injury' scare which turned out to be entirely caused by contaminated black market THC cartriges? SF still hasn't walked back their e-cigarette ban that led to a doubling of tobacco use by high schoolers[1]. To give an idea of where priorities are, the state of California does 10x the number of checks to make sure stores are paying their cigarette taxes as they do to make sure stores aren't selling to minors. [1] https://jamanetwork.com/journals/jamapediatrics/fullarticle/2780248 https://jamanetwork.com/journals/jamapediatrics/fullarticle/...
- soperj 5y ago
  Philip Morris owns 35% of Juul.

jasonhansel 5y ago

> you're now obligated to prove that your product works And that's a bad thing?

rmellow 5y ago
For business? Absolutely
- qwerty456127 5y ago
  Also bad for the people who might benefit from the product even though it didn't help a statistically significant portion of people in an expensive clinical trial.
  - tekknik 5y ago
    I wonder how many non smokers we have in this thread making decisions for others. If only we’d think of the children! Screw the adults struggling with nicotine addiction, they should go back to cigarettes or just quit (like they’ve been trying to for years). Why do people have to stick their noses in things that don’t affect them?
deleted 5y ago
[deleted]
theli0nheart 5y ago
> And that's a bad thing? If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval. It will also greatly affect access to the product, as not everyone has access to good doctors, and most items that are FDA-regulated requires prescriptions. For a product which is a superior, healthier option to cigarettes, it's a massive regulatory burden that could kill the business. I can't imagine anyone would defend that as preferable to the status quo.
- acituan 5y ago
  > If your product causes harm in any way—regardless of the benefits—you're going to have a difficult time getting regulatory approval Question stands, is that a bad thing? Besides not everything FDA approved becomes a prescription medication. On topic; nicotine gums and patches as smoke cessation products are widely available as OTC.

ouid 5y ago

Working as intended: moved to won't fix.

Spooky23 5y ago

But… you get to charge 10x more and make the insurance companies or government pay.

prepend 5y ago

> requires a doctor's note to pick up. I don’t think this is true. I can buy Nicolette all over the place without a doctors note. In the US at least.

pope_meat 5y ago
That's the case now, initially the product was prescription only. Oh and it tastes like shit, to save the children.

tw04 5y ago

*these statements have not been validated by the FDA There are countless products from weight loss to joint pain to "improve your memory" that sidestep the issue with those 9 simple words. I don't see why it would be any different for Juul.

billh 5y ago
Because that language is for dietary supplements which have a specific legislative carve out from falling under FDA regulation.
folli 5y ago
These products can do that because they contain no substances that need approval in any way, so they are likely just food supplements without any active ingredients. Nicotine will count as an active ingredient, you can't just slap these 9 words to any random drug and just sell it over the counter.