Recommendations for Scott Gottlieb

[Cas002]

As most of you know, the FDA led by Scott Gottlieb, has created a mandate for reducing the amount of tobacco consumption, particularly by American youth. The goal is to save lives and the best way to do that is to minimize the use of combustible products which we know kill almost 500,000 Americans annually. There is NO proof that e-cigs kill people, although a few deaths have occurred from nicotine poisoning - mostly infants that got into the parents e-juice stash. We also know there is a widespread "Juuling" phenomenon occuring in America with our youth and that needs to stop - I know because my 14 year-old son tells me about it weekly. The current approach, based on the published notices with intent of nicotine reduction and regulating flavors, will NOT achieve their goals. With that said, I have created 5 key changes that I believe would help the FDA achieve their goals without negatively impacting the already declining rate of combustible tobacco use and adults that have already converted to alternate forms of nicotine consumption. These ideas are far from perfect, and there's plenty of room for criticism (i.e. I loathe taxes but the $ needs to come from somewhere) but with some feedback from this community, maybe we can construct alternative approaches that may one day be reviewed and considered by the FDA. One thing I believe most everyone on ECF can agree with: reducing combustion as a means to consume nicotine by adults and completely eliminating access to any nicotine products for our youth, is highly desirable and needed.

1. Significantly Increase the Current Penalties for Selling Nicotine Products to Minors
a. Raise the current fine cap of $1,000 to $10,000 per event
b. Change “possible up to 90 days jail” to mandatory 30 days for each event

2. Require Proof of Identity/Age at PoS for All Retailers
a. Offline retailers (traditional brick & mortar) must request proof of identity such as driver’s license or state ID card for sale to anyone that could be a minor. It’s not clear that this is being done today with the necessary level of rigor and the higher fines will help.
b. Online retailers must validate purchaser’s age. Several options can be used including a signature by adult upon receipt of a package (a la Amazon for alcohol) or a multiple authentication option with 3rd party risk services to validate identity once per transaction for any nicotine product. The 3rd party services costs could be as low as $0.50 per transaction (IDology, LexisNexis, etc.) plus the cost of API development (system services integration). Identity validation inputs could include one or more of these options, as needed:

• Require secret question at account registration and request for every nicotine-based transaction (no 3rd party required - cheapest option)
• Driver’s License # or Image Scan
• Last 4 SSN
• DoB
• Identity Questionnaire

3. Require Child-Proof Caps on All E-Juice Products That Contain Nicotine
a. Not much more needs to be said - this is a no-brainer change that should have happened already. This would add pennies to the cost of each bottle.

4. Set New Safety Guidelines & Education Campaign for E-Cig Users
a. These Guidelines would be for benefit of e-cig users, and smokers considering a change, and not a mandate to the industry on how the build devices. With an effective campaign, they are likely to drive demand for safer products with better disclosures, and in turn, drive innovation in the industry that will yield safer products.
b. The Guidelines would outline best practices to maximize safety, based on the limited research we have available, possibly including:

• Use regulated devices
• Maintain coil temperatures under 450F using temperature control if possible
• Maximize airflow to reduce coil temps
• Ensure proper wicking to reduce coil temps and prevent dry hits that can potentially generate combustion-like chemicals, especially when not using temp control
• Ensure all e-juice and flavor products you purchase disclose presence of harmful chemicals
• Proper battery and device handling and management tips

c. Allocate Funding for Continued Research on Health Impact of E-cig Devices

• Scope should cover materials, hardware, e-juice, bases and flavors
• Adjust guidelines as new findings are published to ensure the public and industry can make appropriate adjustments quickly
• Hire @mikepetro and give him $500M to figure this stuff out

5. Increase the Federal Cigarette Tax for Combustible Products Only

• The current federal excise tax of $1.01 per pack is bringing in about $13B annually. An increase of just $0.10 per pack would generate an additional $1.3B which would be allocated exclusively towards helping vape users and retailers and this is more than enough $.
• Utilize a portion of the funds to provide a one-time tax write-off for any cigarette smoking tax filer who has converted to e-cigs if they have receipts of purchases on e-cigarette supplies up to $1,000.
• Provide a recurring tax write-off for online retailers to offset the increased costs of validating identity and age for each purchase. The amount should be based on the number of transactions and $1 per transaction should cover costs of the one-time technology integration with the 3rd party services, the recurring per transaction fees, or increased costs of shipping with signature upon receipt, and child-proof packaging.

I know some people will criticize these ideas, and that's good if they provide compelling reasons and an alternative, but the FDA is going to take action whether we like it or not, so providing alternative approaches from people that understand this industry better than people in Washington, will hopefully shed some light on other options. I believe vaping is here to stay and what we have today is only scraping the surface of how vaping can help society. I believe one day this will be the primary means of medicinal delivery since it's more effective through absorption in the lungs and takes action faster than pills. Looking forward to everyone's positive and negative feedback!

 

[CMD-Ky]

My recommendation to Gottlieb: Go away, we don't vape tobacco, just go away. We know that, like every governmental agency with rule writing power known to man (or woman), once you start writing your rules you will never never stop.

 

[1/2 fast]

Dear Scott. Go pound salt.................

 

[LyLyV]

The FDA doesn't even know a thing about nutrition, let alone can they advise on this topic. All these people are paid shills. That's my personal opinion and I'm sticking to it. Grrr.

 

[Eskie]

Dear Scott, please pass on the private jets and watch your travel expenses. And don't buy a $30,000 dining room set.

 

[stols001]

I find some of the recommendations interesting. I kind of think more "enforcement" as far as minors... I'm sorry, but no matter what is recommended, minors (some) will get their hands on whatever. And, I'm talking about the fact that many homeless persons will buy whatever for a minor.... For the right price. IDs can be faked, and etc. If the jail time is for the minor, for having possession, well, that might and could be interesting, although being "punitive" with such minors tends to worsen their behavior not lessen it.

"Dealing" with the kids is impossible, frankly. I've worked with a lot of teens, and they are infinitely creative in getting what they "want." For an example, I sent a kiddo to an RTC, she suddenly became interested in "girly" things like hairspray... Only she let me know, once she got out, exactly to what purpose she was "utilizing" it for, and it wasn't here hair. Etc. Sometimes confining minors to "wherever" doesn't do much, other than increase anti social behaviors. The second time she went, it was different. So, IDK. I'd recommend treatment over time in lockdown, that really doesn't do much for kids than to teach them more anti social behaviors.

Really, (and I hate to say it) ignoring the issue of minors is completely and entirely our best bet. There is no "win" with kids, and the anti's know this. It's why it's a hot button topic. I think we need to be focusing less on the kids and more on "relative" harm reduction in our society. Our society doesn't like to admit, however, that illicit teen use will happen no matter what. So, I'm uncertain if it's the most fruitful way to proceed, although I guess it couldn't hurt to offer up another opinion on how to keep kids safe.

Mainly I wish Gottleib got sent to work in a residential treatment center for teens. It was my first job out of SW school and any and all naivite I had left was firmly squashed. I am GLAD it was my first job and boy did I learn. Gottlieb would come out a different man, with a better understanding of teens, is all I'm saying.

But, I don't know how much "commenting" is going to change things. I pretty much commented my reasons and rationales for flavors, and for continued harm reduction but I doubt that it will make little difference.

The comments are for "show and tell" nothing less nothing more. It's kind of like my grandmother (whom I was not fond of) be all cheery and ask me and my little sister breakfast. "You can have anything you want!" she said.
"I'd like toast please..." said my sis.
"WHAT? You want me to toast this lovely fresh bread and turn it into toast? You can't have that!"

Oh, believe me I argued my sister's "cause" but all it got me (at age five) was a fit of distress so intense, I went upstairs and cut up my favorite dress. My mom did not understand, asking me why I had not cut up some of my "grandmother's clothes."
"Have you seen that lady? I think if I cut up her stuff she might kill me... " etc.

I approach the FDA like my grandmother now (well she is dead) but 1) I believe any future promise as "a possibility, not a fact."
"I make my own breakfast now (and my own eliquid)"
"I try not to literally tear my hair out when promises are broken, destroyed, and in a pile of rubble at my feet."

Of course, I'm a lot older. LOL. But the FDA is and will continue to be a lot like my granny, I've just got more options these days. So, I comment to the best of my ability where I can, then leave the area (not holding my breath).

Anna

 

[Steve W Pedersen]

Everyone is assuming that this politician / bureaucrat actually wishes to do his job he does not all he truly is concerned with is increasing his personal grip on any kind of power over others he can get if getting that power involves screwing over millions of Americans so be it.

 

[VHRB2014]

I agree Scott. If the FDA really cared about people, they would simply get out of the way. Sadly self-righteous has become a false religion unto itself. And it's practitioners are growing daily.

 

[AzPlumber]

I suggest he take a long walk off a short pier.

 

[ENAUD]

NVM...

 

[stols001]

I understand wishing Gottleib harm (sorta), but if he leaves, whomever replaces him is going to have the same mandate, pretty much. The FDA loves to regulate what it can (bonus if more funding for staff). That's all the FDA does, is regulate and monitor, pretty much. I wish it were so simple... But, it's not. So, I don't bother with the "wishing harm" part, I just pray for the best, and continue to advocate.

Although, if it were to make much difference, I'd wish Gottlieb all the harm in the world, but it won't, sadly.

Anna

 

[ENAUD]

I understand wishing Gottleib harm (sorta), but if he leaves, whomever replaces him is going to have the same mandate, pretty much. The FDA loves to regulate what it can (bonus if more funding for staff). That's all the FDA does, is regulate and monitor, pretty much. I wish it were so simple... But, it's not. So, I don't bother with the "wishing harm" part, I just pray for the best, and continue to advocate.

Although, if it were to make much difference, I'd wish Gottlieb all the harm in the world, but it won't, sadly.

Anna

forgive my gallows humor, it missed the mark completely so I edited it out.
I agree he is probably just another cog in the gears of a mighty machine.

 

[stols001]

No, I get the gallows humor, @ENAUD, I just think you are wishing the wrong person off the pier. Who EXACTLY that is, well I won't comment, LOL. But, I imagine it would have to be a whole bunch who took that walk....

We could make it like a fantasy football league, of sorts.

Anna

 

[VHRB2014]

I have a solution for poorly performing politicians. It would involve the top ten worst performing polls. IE: Lois Lerner, Eric holder, ect, and a game called Hunger games. I think after a couple seasons our polls would shape up and the show could be temporarily put on hold. We The People!

 

[alvitae]

Whatever gives the government more control over what I can and can't do. And makes decisions for parents on how they are to raise their children I'm all for. After all, Our birth certificate is just a title and Bill of sale isn't it?

 

[stols001]

Well, my kid's Birth Certificate cost me ten bucks. LOL, this was back in the days of "good" insurance and I had "Cadillac" insurance, so one $10 copay at my first OBGYN visit, and that was it. The only thing I had to worry about was my (Jewish) doc's deep, deep desire to bill my insurance co like 2K to remove my son's foreskin. I told him the FIRST VISIT that would not be happening, but he tried to do it three times. More disturbingly the couple I shared a room (and doc) with consented "without understanding" but I had my "What to expect" book with me, and showed them pics... That dad went RACING down the hall to rescue his kid from a circumcision and I was like, "Win!" (Can you imagine?? They were from a culture where NO parent did this).

So, a) bet my obgyn "hated" me
b) 10 for the birth certificate.... It was not long therafter that things became quite a BIT more expensive, in a sort of ever increasing, lengthy spiral. A lot of stuff I "paid for" I did so out of the desire to not let the government "raise" my kid like private schools. But, not it's not exactly cheap either. LOL.

Anna

 

[Cas002]

I understand wishing Gottleib harm (sorta), but if he leaves, whomever replaces him is going to have the same mandate, pretty much. The FDA loves to regulate what it can (bonus if more funding for staff). That's all the FDA does, is regulate and monitor, pretty much. I wish it were so simple... But, it's not. So, I don't bother with the "wishing harm" part, I just pray for the best, and continue to advocate.

Anna

One of the points I made in my post was that we cannot stop the FDA - they are a regulations bureau. I wish they would go away too but they're not going to so let's help steer them in the right direction, assuming they're listening, which they probably aren't.

@stols001 response above is spot-on and I fear what his replacement would do is worse than what he might do. I believe Gottlieb is simply trying to implement recommendations from the Surgeon General's 2016 report on youth smoking and anyone replacing him will likely follow the same mandate. The best way for us to reduce their power is to vote people into office that will shrink government so they have fewer resources to tell us what to do. Meanwhile we're left waiting in limbo for either a lite rain, anvils, or something in-between to drop on vapers. In the end, the best way to prevent youth from getting nicotine is better parenting but unfortunately the FDA can't mandate that.

 

[stols001]

I don't think the FDA (or any government organization) actually wants to mandate better parenting. Also, I do think from a genetics standpoint, it's really easy to say parents who "let" their kids get their hands on addictive substances also ignore the power of other teens, and also, I do actually believe that addiction (in some cases) or a tendency to risk take or whatever else you'd LIKE, has a certain amount of genetic predisposition and I'm not sure it's fair to blame a parent for all of a kiddo's woes and decisions. Part of parenting is letting go and whatnot, and that often includes some bad decisions along the way, and parents need to do that, as well. Also, parents often just don't have as much time for their kids (although, good parents somehow make time) as when a single earner household was the norm (although, I'm fairly certain youthful smoking was routine, then, too.)

The bottom line is, we don't try to "behaviorally stamp out" say, the Flu. We don't put the flu in time out and tell it, "You are not allowed to behave this way," and with enough consequences, the flu "gets worn out/submits/agrees to not infect you and etc." The flu doesn't behave that way.

The best model for an addictive illness (if cold turkey, the 12 steps, whatever) is a harm reduction model. I was distinctly unshocked that my kid started smoking. When he told me, he was able to quit, fairly easily, and move to vaping, which he eventually gave up as well. He got to where he got at the ages he did because our household (me, my ex, and his stepdad) didn't freak out. (Over any of his youthful angsty need to experiment).

The only sane method is harm reduction. I should point out that 100% of my parents kids smoked cigarettes. My older brother quit the earliest and wasn't really into smoking. Same with my little sister (only her cold turkey was more "awful" as it were, and she smoked for longer. My little brother is still intermittently smoking, but goes cold turkey when/if he quits. I was the holdout-- smoked the most, for the longest, right up to "health red line" and I am grateful for vaping being there when it was, as I don't have the ability to cold turkey cigarettes (I have cold turkeyed other stuff, but never cigarettes.) I have a brain particularly vulnerable to tobacco, not to mention many other things.

The reason for harm reduction is that bar every other method, it has, societally the most impact. Not age limits, not judgement, but look at Sweden! Look at Britain! Countries who choose harm reduction, not judgement, fines, "look at the parents" and everything else, THEY are having success with "harmful substances" because they have mechanisms for harm reduction that are available to all, /promoted over MORE harmful things, etc., etc.

We can look at almost any European country and we could emulate that. The endless "whose fault is it?" could stop.

Of course, that would also mean overregulation, taxation, sin taxes, and everything else would stop, too.

It's a false economy to look at "who is to blame." When an entire society has been smoking cigarettes freely LONG AFTER harm was found, and for it to be taxed and demonized, rather than approached sanely and with forethought, NO ONE is to blame, including the addicted person.

Our government is to blame, setting up false economies where the "fortunate" (read, healthy) are pit against the "bad" (read, addicted, unhealthy, etc).

The only person benefitting are the politicians. I don't demonize my .parents for my smoking. My dad was a smoker, and I was a rebellious teen. I have a "high" genetic and modeling "preference" for tobacco. I'm not a bad teen with a bad parent because we both smoked. Etc.

Anna

 

[Beamslider]

Uh! don't think so. I have no intention of buying from an online store that requires the upload of a driver's license image. It is used by the IRS to sign tax forms filed online among other things. The info on the card such as number, issue date and expire date. No reason to hand hackers more info to use to steal identities.

This won't stop kids anyway. They still find it easy to get beer, smokes and the other unmentionable item on here.

Don't you remember when you were a teen?

 

[Cas002]

Boy do I remember being a teen. You're right - nothing we do will STOP teens from gaining access to things that hurt them but making it harder will help. Identity validation online, including driver's license numbers and images, is becoming more prevalent but until there's more progress made in protecting our data there's risk for sure. When breaches occur there isn't enough punishment - look at Equifax...no punishment yet...waiting on Washington - that needs to change. All personally identifiable info (PII) MUST be encrypted in transit, at rest and hashed in the database. This costs more $, resources, and impacts the performance of the tech stack so few companies are making the commitment to do it the right way. This HAS to change in the future but until then we should all be cautious about submitting PII online.