FDA Letters Read them and don't panic!

[paise]

I agree completely. My husband has been eating Cheerios for years yet he has high cholesterol that has to be managed by prescription medication not to mention the fact he had 2 heart attacks (mild then massive) and a stroke in Jan 2009, which required a quadruple bypass. His cholesterol was still high then despite the fact he's only eat Cheerios cereal for years now. Why is the FDA picking on E-cigs, which is geared toward tobacco smokers/former tobacco smokers whom they don't care about to start with yet they won't go after a company like Kellogg? Could it be due to some backroom palm greasing?

Then there are all these infomercials on cures for acne, weight loss, calcium supplements, creams for everything under the sun yet NONE of these items meet FDA approval yet they are plastered all over the television between specific hours every day of the weekend all year long... Why not go after them? Now there are some lawsuits worth chasing... The Proactiv acne medicine is bunk. One of my cousins tried it even after I pleaded with her to go to the doctor and have the doctor prescribe something for it that does work. Both my girls have been on specific acne medicine to prevent scarring. The prescriptions work especially when they were/are (as one is currently in puberty as she is only 13), used in conjunction with the original Prell Shampoo as it pulls oil from hair like Dawn dish liquid, which I have actually used when I was a teen because I suffered from severely oily hair. Then there was a product that came out in my days as a teen called FOHO (For Oily Hair Only), which worked wonders but ultimately the company must have gone out of business because I haven't seen it since I outgrew that phase.

It's as if they don't have enough to worry about, real problems actually, that they would rather come after the E-cig community than do work that would actually make a damn change that is worthy of the time and money not to mention the aggravation this case is causing. We are all adults and as adults, we don't need the FDA playing Mommy and Daddy telling us what to do. My own parents didn't tell me what to do when I was at home living with them and my younger brother. I actually WAS the parent to my brother, the only one he ever knew! I raised him after leaving home and becoming emancipated then gained legal guardianship over him while he was in his pre-teen years and continued through high school and graduation and to be truthful, even now I am considered his mother versus his sister.

It's like the FDA or someone within the FDA is purposefully looking a reason to piss off the public, the smoking/vaping public. That needs to stop because IMHO, that boils down to nothing more than harassment. And, if memory serves me right (I know my lupus causes brain fog but I'm sure I'm right but giving a slice of doubt here....) I'm pretty sure that harassment is illegal... I did temp work with an attorney's firm for a time in my past and back then harassment was illegal. This feels like harassment and nothing less...

Just my 2 cents worth...


BTW, my cousin was actually allergic to the Proactiv and had to go to the doctor anyhow where he helped clear the infection from the allergic reaction then put her on a real regimen to clear her face. It didn't stop the scarring she ultimately wound up with but it did remove the acne, the prescription medicine vs the Proactiv... For most people; however, cleaning one's face well each morning, noon, and night works but for some reason, many in my family are more prone to acne, even in adulthood but especially during the puberty... I don't normally include my age anywhere b/c it's rather depressing when I think about but I'm 40 years old, a few months shy of 41. I still get the occasional breakout of acne. Most women my age don't have problems with acne; however, my cause could have something to do with the lupus (SLE) and Sjogren's disease. I don't get the butterfly rash on my face, heavily associated with people who have lupus of any type though I do get the rash and raised bumps that are almost acne-like but more so like a breakout of hives so to speak but those I get just above the hairline at the base of my neck and on my calves. It lasts a few months and with cortisone treatment, it goes away then comes back again for a few months or so. It's a cycle. So why hasn't the FDA gone after Proactiv? People are ALWAYS giving testimonials on that infomercial yet it's legal??????

What makes it so? Greased FDA palms or does the FDA simply not care? This whole ordeal with going after a "safer" tobacco alternative just pisses me off. I have never felt better in my life and I was a 28+ year smoker of 1-2 packs a day for most of those years. My doctor is ecstatic! He hopes more of his smoking patients would make the switch after treating me every month for well over a year now as I have been using the E-cigs. He is overjoyed at the increase in my health especially as it relates to the problems I have with lupus and Sjogren's. I feel better despite autoimmune diseases and that's saying a lot. Ask anyone you know with lupus and/or Sjogren's how they feel every day. They will be the first to tell you these diseases are a ..... to live with so when something comes along that has a positive effect despite living in your own private hell that happens to be your own body, you don't want to lose it, especially over a government official on a power trip!

 

[HeatherC]

I think both have very good points, my 2 cents is that the FDA is looking for support in the upcoming case. They are looking for evidence to bring that says "Look, even those in the industry agree it is a drug delivery, here we have them complying with FDCA regulations." I think the companies in question need to hold off any action or cease and desist until after the appeals process this month. Legally the question is still unanswered, or stated they are tobacco products at any rate, not under FDCA guidelines. It's shrewd to try to circumvent Jdg. Leon in this way.

I agree... I also think that it is a huge slap in the face of our judicial system in general.

 

[Vocalek]

​

I agree with you about the diet/...... vapes. A little common sense . . .
As for JC, I'm waiting for them to weigh in here or elsewhere. According to the letter the FDA sent JC, that "failed inspection" wasn't particularly recent; it took place a year ago.

From the FDA:

Additionally, during our September 1-25, 2009, inspection of your manufacturing facility, . . . investigator(s) from the FDA identified significant violations of Current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals . . .​

Hard to believe the FDA would sit on that information for a year before sending them a formal warning. Must be more to the story?

Blessings and peace to you tomorrow

Andi

Wow, Andi! Good catch! We will have to bring this fact out as we write about the situation. It went straight over my head! A million thanks!

 

[lonercom]

EDIT..... Sorry about the delay, lots of new posts while I was writing this one.... I'm still at work.


Hi Kristin and thanks for weighing in and you are correct. They are maintaining their position that e-cigs are a drug/device and acting accordingly.

The point that I made at the beginning of the post is that this action is not the end of vaping as we know it. I agree that the FDA's timing is not a coincidence given the date of the action and the press that this will generate over the next few weeks. Appeals court judges do read the papers afterall.

After reading the letters, I still believe that their actions are consistent with other actions that they have taken with other groups and other products. The more I read, the less I see any conspiracy on the part of the FDA. Those warnings are just that, warnings. Those companies have been given specific issues and 3 weeks to let them know what corrective action they plan to take.

The warning letters were from the director of new drugs and labeling compliance and are primarily about marketing materials. Johnson Creek's inspection failures ae a result of their registering with the FDA and continuing to state in promotional materials (implied or explicitly) that their products help people to quit smoking or alleviate the nicotine withdrawal symptoms.

It is still my theory that resolving the specific issues related to the marketing will stop the FDA issues. We simply will not know until one of the vendors tries. Set aside the tobacco vs drug fight that NJOY is running and take a different approach. I've been saying this for 9 months and I will continue to believe that this might be an effective alternative.

But back to the original point of the post... No Need to Panic here; Read the letters, read them 2 or 3 times and draw your own conclusions instead of reacting to to someone elses knee jerk reaction.

I know Kristin, Vocalek and the leaders at CASA have and I trust that cooler heads will prevail.

I continue to picture Sandra Bullock in "Demolition Man" saying "Enhance your caln, John Spartan"

Of course there is this conversation from the same movie:

Lenina Huxley: Anything not good for you is bad, hence, illegal. Alcohol, caffeine, contact sports, meat . . .
John Spartan: Are you sh**ing me?
A computer: John Spartan, you are fined one credit for a violation of the verbal morality statute.
John Spartan: What the Hell is that?
A computer: John Spartan, you are fined one credit . . .
Lenina Huxley: Bad language, child play, gasoline, uneducational toys, and anything spicy. Abortion is also illegal. But, then again so is pregnancy, if you don't have a license.

Finally let me quote Simon Phoenix from the same movie

You can't take away people's right to be a**holes.

And thanks for the welcome distraction this weekend

 

[grimmer255]

Here is the fact about nicotine. It is a drug period. It alters the bodies chemistry in a way that makes it hard to give it up. The FDA has every right to intervene on behalf of those who sell these because nicotine has been labeled a drug. And ecigs delivers that nicotine. Now should the FDA out right banned them?...... hell no. But its there job to make sure that these devices are manufactured to standard and have a low risk of causing harm to anyone. Are these safer than cigs, I believe so 99% sure they are better than analogs. Do I enjoy using ecigs? you bet I've been smoke free since April of 2009 because of them. I think the FDA should label them as a cigarette and regulate them as such. This might cause the manufactures and users some pain because the eliquid flavors and strengths will be regulated.... this is way better than an out right ban and then cause a black market. And if this happens any eliquid we get could be tainted with loads of crap.

I love my ecigs and I would love to continue to use them.... get the damn manufactures to test them to standard for the FDA to verify the safety, so we can continue to use them. If not the ecigs may most likely be banned.

 

[thephoenix]

I also think that it is a huge slap in the face of our judicial system in general.

Indeed it is, Heather...Kind of surprising to me as if they're posturing is this aggressivly pre-trial either they know something we don't about the outcome...or they're just flipping the bird to the courts...

Mind you, save Johnson's Creek - those other suppliers were simply acting irresponsibly and not paying any attention to the current legal climate surrounding eCigs in the US...not smart and they deserve to be corrected...IMO if they act this irresponsibly with serious consequences at stake - imagine how they must treat their customers...

although actions like what the FDA has just done do add up in court decisions even if not technically admissible - often times a plantiff/defendants actions are taken into account...the FDA may be thinking - well if we act like we're doing the right thing, maybe the judge will agree due to our convictions & actions...they're all just people at the end of the day with their own personal biases and can be influenced...

where as if the FDA didn't do anything, the judge could say, "Well if you think this is a violation - why haven't you done anything." And in my opinion they're not exactly going to court with any sort of viable argument...so all they can do is beat their chests like the gorilla in the china shop they are...

It's merely posturing. Especially in the face of the negative publicity they've received...FDA has to appear as if they believe in what they're doing...

 

[thephoenix]

If not the ecigs may most likely be banned.

I dont' believe they will be banned. Not at this point...Not in the US - what they're doing is acting like a bully front man for Big Tobacco & Big Pharma.

They want to knock little guys like me and my other supplier brethren out so they can spend the countless dollars on clinical trials (which is a drop in the bucket to BT & BP)...then reap the massive monopoly profits once we're shut down...

It's almost a joke when the FDA is saying "Hey, just submit your products to our incredibly expensive clinical trials, spend millions, wait years - and they you're in business." It's anti-competitive tactics if I've ever seen it...

 

[lonercom]

...*Snip*
If someone comments that they quit smoking and use snus or Orbs instead, does that make those tobacco products a drug treatment for nicotine addiction? No. ...*snip*

Kristin, you are right and wrong here. If someone comments that they quit smoking using snus or orbs it does not affect their drug/device status. If the manufacturer or distributor publishes that statement in advertising or other promotional material it DOES affect their drug/device status as they are now saying or implying that snus or orbs can help you quit smoking. None of the therapies currently authorized by FDA are marketed as Nicotine addiction treatments, they are called smoking cessation aids.

Intent matters here as much as content.

 

[paise]

The major flaw in the FDA getting involved is that they have already showed their hand. They are not going after E-cigs to make them safer or ensure they are safe. That's just their cover story. The primary reason the FDA is going after the E-cig industry is worm a way inside to allow other Big Businesses with the helping of Big Brother to make $$$ off of them and as a result, off of us and it won't be pennies on the e-liquids or a dollar or two on the PV units. They will end up tripling if not quadrupling the price so that it is MORE expensive than buying analog cigarettes b/c they KNOW they are facing a product that will ultimately put the Big Tobacco companies out of business.

I've heard that we need entrepreneurship for the last 10 years or more. Well, how can people become entrepreneurs when the government is constantly in your face taking every dime you have making it so you can't own or operate your business b/c the government, thanks to the greasy palmed FDA, will make it so the average person can't afford the products anymore thus putting every entrepreneur out of business and hence, everyone working for them out of a job.

If we as consumers give the FDA an inch, they can and will take a few hundred to several thousand miles and that's not good for anybody especially us the ones who are giving up analog tobacco for the health benefits of e-cigs that still allow us to have the nicotine but without the cancer-causing agents. The FDA has many more important things they should be doing than going after the e-cig industry. They are in it for the Benjamins, nothing more and nothing less.

Why haven't they gone after booze? Alcohol kills are more people every year, innocent people too, than cigarettes or e-cigarettes or any other substance used. The day they go after the alcoholics and jack up the alcohol rates as they have analog cigarettes, I'll take them as a serious agency but they won't go after booze because the top 1% of the country's richest people don't want to pay through the nose for their liquor, which is expensive regardless but they won't stand for those prices to quadruple the way we have had to tolerate the constantly growing prices of tobacco analog cigarettes. The moment we find something safer and cheaper than analog tobacco cigarettes that gives us the same nicotine hit, they immediately jump into action yet they don't do that with booze. Why? The big boys with money control the FDA game and right now, Big Tobacco and Big Pharma are losing money because nobody wants their products anymore and that group that doesn't want it is growing like Kudzu every day.

Here is the fact about nicotine. It is a drug period. It alters the bodies chemistry in a way that makes it hard to give it up. The FDA has every right to intervene on behalf of those who sell these because nicotine has been labeled a drug. And ecigs delivers that nicotine. Now should the FDA out right banned them?...... hell no. But its there job to make sure that these devices are manufactured to standard and have a low risk of causing harm to anyone. Are these safer than cigs, I believe so 99% sure they are better than analogs. Do I enjoy using ecigs? you bet I've been smoke free since April of 2009 because of them. I think the FDA should label them as a cigarette and regulate them as such. This might cause the manufactures and users some pain because the eliquid flavors and strengths will be regulated.... this is way better than an out right ban and then cause a black market. And if this happens any eliquid we get could be tainted with loads of crap.

I love my ecigs and I would love to continue to use them.... get the damn manufactures to test them to standard for the FDA to verify the safety, so we can continue to use them. If not the ecigs may most likely be banned.

 

[paise]

The FDA didn't ban those little ear magnets that were plastered all over the place that was supposedly the best way to quit smoking.... why? Because it wasn't a threat to the Big Tobacco or Big Pharma money. The fact is, magnets on your ears won't stop anyone from craving nicotine yet nothing was said even when the advertisers clearly made that claim! It wasn't testimonials. It was there own words. Use this and you won't want to smoke again... Nothing said, nothing done. It was only when e-cig industry began taking money out of their moneybags did the sniping begin and the FDA step in.