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FDA to delay e-cigarette Regs | DIY E-Liquid Blog – E-Juice Makers


YES!!!!
https://www.washingtonpost.com/news/to-your-health/wp/2017/07/28/fda-to-delay-e-cigarette-rules-for-years-and-explore-reducing-nicotine-in-conventional-cigarettes/?utm_term=.8bf4b6f1b19f

FDA to delay e-cigarette reg for years and explore reducing nicotine in conventional cigarettes

The FDA will exploring reduce nicotine in cigarettes so that the products are no longer addictive.


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House To Exempt E-Cigs From FDA Rules | DIY E-Liquid Blog – E-Juice Makers


House Panel Says To Exempt E-Cigs From FDA Rules
Burdensome FDA Regulations came to be under the Obama era, but the Trump administration has delayed enforcement of the new FDA rules. During this delay, a house panel is once again trying to exempt e-cigs from the Food and Drug Administration rules. Legislation approved by the Republican-controlled Appropriations Committee prevents the FDA from requiring retroactive […] #vaping

House Panel Says To Exempt E-Cigs From FDA Rules

 


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Exempt from FDA rules? | DIY E-Liquid Blog – E-Juice Makers


Progress?

Should e-cigarettes be exempt from FDA rules? A House panel says yes

Legislation approved Wednesday by the Republican-controlled Appropriations Committee would prevent the FDA from requiring retroactive safety reviews of e-cigarettes already on the market. But most panel Democrats said the products are dangerous and are targeted at children.


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Cosmic Fog meets with FDA, prepares PMTA – Vaping360


Cosmic Fog meets with FDA, prepares PMTA

The first premarket tobacco application (PMTA) from the independent vapor industry may come from Cosmic Fog Vapors. The company announced Thursday that it has sent a briefing document to the FDA — “for the purpose of submitting Premarket Tobacco Applications (PMTAs) for their range of E-Liquid products.”

Cosmic Fog is located in Costa Mesa, CA. The company was founded in 2013, and is one of the oldest and largest premium e-liquid manufacturers in the country. They also sell their products in 60 countries around the world, including in all 28 European Union member states.

The company’s press release says Cosmic Fog’s compliance team will meet with the FDA on June 13 to discuss its “PMTA strategy, including product analysis, behavioral studies, non-clinical and clinical studies such as actual use, pharmacokinetic and pharmacodynamic studies.”

The bottom line is that a company submitting a vapor product for marketing approval must prove that the product will be beneficial for the overall public health.

The company will complete its studies by June 2018, according to an e-mail from company spokesperson Christine Lawrie. She says they intend to file the application with the FDA in September 2018, though it could be postponed if the deadline is changed by the agency. The FDA has delayed some deadlines already.

According to the press release, “The Cosmic Fog regulatory team includes strategic advisors with decades of experience in navigating regulated industries such as the medical device, tobacco and pharmaceutical industries.”

Does a vapor PMTA have a chance?

The requirements for approval of a PMTA are unknown, but the FDA’s deeming regulations do list some of the tests and studies they will require. Many vaping advocates believe the specific requirements are deliberately situated beyond the ability of small companies to meet, and are designed to prevent the independent industry from pursuing approval.

The bottom line is that a company submitting a vapor product for marketing approval must prove that the product will be beneficial for the overall public health. That means that the manufacturer must analyze how its presence in the marketplace will affect smokers and vapers, but also non-smokers. They must explain how it will affect youth uptake of vapor (and cigarettes), and prove that when weighing all costs and benefits that the product will be a net positive for public health.

People call the PMTA process a “million dollar lottery” because while preparing the application may cost a fortune, there is no guarantee of approval.

“The FDA has no idea what it is doing,” wrote Dr. Michael Siegel soon after the rule was announced. “And what it is doing is completely losing its perspective.” But things have changed since Siegel wrote those words.

Many in the vapor industry are pinning their hopes on new FDA Commissioner Scott Gottlieb. As recently as last year, he served on the board of a vape shop franchising company. More importantly, he has indicated a belief in harm reduction — reducing use of high-risk products (like cigarettes) by making attractive, low-risk ones (like e-cigs) widely available.

Fight or flight…or compliance

There are two paths to remaining on the market after November 8, 2018. Vape manufacturers who want to stay in business have to decide whether to fight or comply. People call the PMTA process a “million dollar lottery” because while preparing the application may cost a fortune, there is no guarantee of approval.

Since even the largest independent companies don’t have millions to gamble, most will be unlikely to attempt the PMTA path. For them, putting money into advocacy strategies is the only option. But Cosmic Fog says it intends to pursue both possibilities.

“Today is a bittersweet day,” CEO Robert Crossley said in the press release. “Since the announcement of the Deeming Rule last May, we have worked tirelessly on advocating for a fair and fact based regulatory system for the vapor product category. Today, we take the responsibility of finding those facts and delivering them to the FDA ourselves. Although we will continue to support advocacy based efforts,” he continued, “we have a responsibility to our customers to ensure our products are available and on their shelves no matter what may happen in the future.”

“We will continue to support advocacy at the same level as we have in the past.”

Cosmic Fog has been known as a financial supporter of vaping advocacy causes. The company was a founding member of the Right to be Smoke-Free Coalition, which led a lawsuit against the FDA last year. (The suit was later consolidated with the Nicopure Labs suit, and is still pending. The ruling could come any day.)

That won’t change, according to Christine Lawrie. “We will continue to support advocacy at the same level as we have in the past,” the company spokesperson said in an e-mail to Vaping360. “The purpose of that statement was to let the industry know that although we have started down this regulatory pathway, we have not given up the fight.”

That’s good, because while everyone in the vaping world is wishing luck to Cosmic Fog, very few other e-liquid companies can afford to play the compliance game. Most are counting on a legislative or administrative answer. But if no one takes the chance and puts their money behind a PMTA strategy, as Cosmic Fog is about to do, we’ll never know if the possibility of FDA approval exists.

The post Cosmic Fog meets with FDA, prepares PMTA appeared first on Vaping360.

Cosmic Fog meets with FDA, prepares PMTA – Vaping360

 


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FDA Commissioner Testifies to Senate About Premium Cigars – halfwheel


The thoughts of small business in his comments are a positive sign. http://halfwheel.com/fda-commissioner-testifies-senate-premium-cigars/156555

FDA Commissioner Testifies to Senate About Premium Cigars – halfwheel

Dr. Scott Gottlieb, the newly-appointed commissioner of the U.S. Food & Drug Administration (FDA), testified yesterday in front of a Senate Appropriations Subcommittee regarding the agency’s budget and was asked about the regulation of premium cigars. Specifically, Sen. Marco Rubio, R-Fla., asked Go…


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Pharma Industry insider and advocate of reduced regulation picked to head FDA but not even more pro-antiaging O’Neill


Pharma Industry insider and advocate of reduced regulation picked to head FDA but not even more pro-antiaging O’NeillPresident Trump as nominating Dr. Scott Gottlieb to be Commissioner of the Food and Drug Administration (FDA). Gottlieb is a medical doctor and former FDA deputy commissioner.
Gottlieb has advocated speeding up the approval complex generics — cheaper, copycat versions of products such as Mylan’s allergy jab, the EpiPen, and Copaxone, an injection for multiple sclerosis from Teva, which both command high prices.
Dr Gottlieb is a cancer survivor who survived cancer.
He advocates patient power and backs several reforms that would make it easier for some drugs to secure approval.
More medicines could be designated as “breakthrough” treatments to get faster approval.
He supports the conditional or “accelerated” approval of medicines based on early evidence gathered during smaller clinical trials, rather than waiting for the conclusion of longer studies that provide more definitive proof.Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive. But he is also likely to support one of the agency’s basic functions: to ensure that drugs are proven safe and effective before they are sold.
His selection is a victory for the mainstream pharmaceutical industry, which has little appetite for upending the FDA approval process. Even many Democratic critics of the drug industry, and of Gottlieb himself, privately indicated they strongly preferred him to another frequently mentioned contender, Jim O’Neill, an associate of Silicon Valley billionaire and Trump adviser Peter Thiel. In a 2014 speech, O’Neill called for allowing drugs to be marketed after they were proven safe, but before they were shown to be effective.Read more »

Pharma Industry insider and advocate of reduced regulation picked to head FDA but not even more pro-antiaging O’Neill

 


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Trump Poised to Nominate Scott Gottlieb to Head FDA: Sources

Trump Poised to Nominate Scott Gottlieb to Head FDA: Sources

The White House is expected as early as Friday to nominate Dr. Scott Gottlieb, a physician and conservative health policy expert, to lead the U.S. Food and Drug Administration, sources familiar with the matter said.


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Will Trump’s new FDA commissioner help save vaping? – Vaping360


Will Trump’s new FDA commissioner help save vaping?

President Trump will nominate Scott Gottlieb to be the next commissioner of the Food and Drug Administration (FDA). The appointment requires approval by the Senate, after confirmation hearings are held.

The FDA commissioner oversees more than a dozen sub-agencies, including the Center for Tobacco Products (CTP), which last year imposed regulations that deemed e-cigarettes and some other nicotine-containing products to be under their control.

It would be within the control of the new commissioner to fire CTP director Mitch Zeller, and to replace his staff. He could also decide to take a new direction in regulating vaping, or to not regulate it at all.

Is Gottlieb good for vaping?

Will Dr. Gottlieb change the FDA’s course on regulating e-cigarettes? It’s impossible to know, but there may be some encouraging signs.

First, he understands some of the issues — or at least he did in 2013. That was when he wrote an article for Forbes that correctly identified some of the issues at the CTP. He described the FDA tobacco center — and the Family Smoking Prevention and Tobacco Control Act (TCA) that created it — as being precariously balanced between fulfilling its mandate to encourage the production of reduced-harm products and satisfying the anti-tobacco zealots whose influence has grown since the TCA passed.

The success of the CTP “was dependent on FDA being able to establish – and maintain – a regulatory path that let tobacco get approval for new products that posed a ‘reduced harm’ over traditional smoked cigarettes,” he wrote. “It always seemed a naïve aspiration — that FDA would ever sanction such products – and even more uncertain that the anti-tobacco crowd would let this paradigm advance.”

It’s encouraging to hear a health policy expert who isn’t a wild-eyed anti-nicotine true believer.

He repeatedly refers to the “anti-tobacco crowd” and even calls them “activists,” which is exactly correct. These are the same people deadset against allowing vaping to gain a toehold in the market. “Activists have managed to infiltrate the middle ranks of the agency’s center,” wrote Gottlieb, referring to the CTP. It’s encouraging to hear a health policy expert who isn’t a wild-eyed anti-nicotine true believer.

Dr. Gottlieb works for the American Enterprise Institute (AEI), a conservative think tank that has been generally pro-vaping (and other tobacco harm reduction products). AEI is also the home of Dr. Sally Satel, the Yale psychiatrist who has been one of vaping’s most visible defenders recently.

Or will it be more of the same?

On the other hand, Gottlieb has close ties to the pharmaceutical industry, which has been an opponent of consumer nicotine products in general, and vaping specifically. Gottlieb is a partner in a venture capital firm, where he is involved with health-related investments.

He has also served as a consultant or board member for several pharma company, including GlaxoSmithKline, maker of Nicorette gum and NicoDerm nicotine patches. He received more than $400,000 from pharma companies from 2013 to 2015, according to the New York Times.

According to Reuters, a recent survey of 53 pharmaceutical executives found that 72 percent preferred Gottlieb over other candidates who had been in the running. Pharma bosses seem relieved that Gottlieb was chosen.

Gottlieb has served at the FDA before, doing several jobs at the agency during the George W. Bush administration, including deputy commissioner for medical and scientific affairs. Gottlieb seems to be respected even by those who disagree with his conservative stances on some health care issues. Former FDA lawyer John Taylor told the Times that Gottlieb was open minded and showed great attention to detail. “Scott and I have different ideological backgrounds, but I recognize that he does have a record of doing things that are for the benefit of the consumers.”

The post Will Trump’s new FDA commissioner help save vaping? appeared first on Vaping360.

Will Trump’s new FDA commissioner help save vaping? – Vaping360

 


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Taste Your Juice | BIG NEWS: Cole and Bishop Introduce The FDA Deeming Authority Clarification Act of 2017 & The VTA Explains it


BIG NEWS: Cole and Bishop Introduce The FDA Deeming Authority Clarification Act of 2017 & The VTA Explains it
Cole and Bishop Introduce The FDA Deeming Authority Clarification Act of 2017

“While there is disagreement about whether certain tobacco products should be regulated or not, there should be agreement that new regulations should apply to products moving forward, and not retroactively,” said Cole. “Inconsistent authority like this will be detrimental and unfair to many manufacturers and businesses. This legislation preserves the FDA’s ability to regulate these products on part with cigarettes, grandfathers currently available products and then requires the FDA’s approval before any new product is introduced.”

See the entire press release HERE.

The VTA goes on to further explain what this means:

WASHINGTON, DC – Today, the Vapor Technology Association (VTA) issued the following
statement in support of bipartisan legislation introduced by Representatives Tom Cole (ROK)
and Sanford Bishop (D-GA) that would modify the predicate date for e-cigarettes and
provide much needed regulation of vapor products as the technology that they are rather
than the tobacco products that they are not.

See the entire press release HERE.

Taste Your Juice | BIG NEWS: Cole and Bishop Introduce The FDA Deeming Authority Clarification Act of 2017 & The VTA Explains it

 


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Regulation Cutting Impact on FDA and AdComms | Eye on FDA


Regulation Cutting Impact on FDA and AdComms
During the campaign, candidate Donald Trump made several statements referring to the fact that he would be cutting regulation in this country by 70-80 percent. Since the election, that sentiment has been repeatedly affirmed.

Now in office, this week he signed an Executive Order that would require that federal agencies seeking to implement a new regulation must first do away with two. The Executive Order also set an annual financial cap on the cost of new regulation and that stated for the rest of 2017, the cost of new regulation must be offset by the undoing of old regulations.

How might that impact FDA? Especially in the wake of the passage of the 21st Century Cures Act, there will be a number of regulations that will have to be devised and go into effect and the agency is still constructing the regulatory pathway for biosimilars. But the executive order issued by the Administration exempts rules and regulations that are being mandated by legislation.

Also this week in a meeting with PhRMA, Trump specifically indicated not only that FDA was included in the mix for regulation-cutting, but also that the approval process would be streamlined to shave significant amounts of time from the approval process.

The drive for fewer regulations has a potential for impact on a number of fronts. At least one of the persons being considered for FDA commissioner has stated that drugs should be approved once safety is established and that efficacy would be determined in the market place. In addition, it could mean that drugs that are under study have greater access for those patients who wish to try unapproved drugs, or “right to try” policies. Fewer regulations could also take the form of minimizing FDA’s role in conducting inspections of manufacturing facilities. Finally, when it comes to “streamlining the approval process” it could have a direct impact on the way drugs are currently evaluated for approval, specifically reform of the advisory committee structure and function.

A few days prior to his departure from FDA, Commissioner Robert Califf authored a posting on FDA’s blog (FDA Voice) entitled “FDA Advisory Committees: Independent, Informed, Essential and Evolving“- a title that tried to say it all – in which he outlined his thinking about the role of advisory committees. While the posting begins with a recognition that there is a common concern among medical leaders that the advisory committee system function be improved, the aspect that is discussed at length is process of evaluating advisers to serve and minimizing potential conflicts of interest.

But the advisory committee system has other issues, some of which are cumbersome. For starters, it is huge – just for human drugs alone there are 17 committees, each comprised of 10-15 people. Meeting logistics are involved, particularly if there is a joint meeting. The identifying, vetting and scheduling are enormous.

Then there is the burden of proof. A drug sponsor will have to compile an enormous amount of data and then have a very short amount of time to present it during a proceeding that may seem a combination of a scientific meeting and adversarial proceeding, examining both the safety and the efficacy of a compound. This may seem like a negative, but in fact (having witnessed scores of these meetings) they are very thorough which is something you the patient really want if you are staking your life on taking a medicine that is going to cure you of a serious illness or manage a chronic one. You want medicines held to a higher standard than supplements.

Needless to say, there are a good number of regulations associated with the delivery of a new medicine. The two-for-one rule is a very simple approach to a complex issue. Similarly cutting down on the scrutiny a drug candidate receives in order to get it to market faster may also seem like a simple approach to a complex issue. In both cases, in the end the outcome may not be what you were aiming for.

Ultimately the shape of advisory committees – and the faster speed of drug approvals – will not be determined for some time to come. The choice of an FDA commissioner will likely shed a good deal of light on the direction, if not the timing. In the meantime, we are left to ponder three important questions. First – if we were going to set aside 80 percent of FDA’s regulations – what would they be and where is the low hanging fruit? Second – is the means to getting rid of these regulations a sudden process, or the more gradual attrition by means of the two-for-one rule? And last, if we are not going to approve drugs by the system we have, what would a better system look like?

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Regulation Cutting Impact on FDA and AdComms | Eye on FDA

 


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