The expansion of JUUL’s product line onto the international market may face serious obstacles in south asia, where India’s Health Ministry has put forward a desire to block the entry of the vapor manufacturer from that country’s market.
JUUL has already hired executives for a planned subsidiary in India, but Health Secretary Preeti Sudan has sent a letter voicing objection to the entry of the company:
“Novel products such as ‘JUUL’ are harmful and addictive and could potentially undermine our tobacco control efforts. It is felt that the young generation would be particularly vulnerable to such products and gimmicks.”
Preeti Sudan, India Health Secretay
Asked for comment on Sudan’s letter, JUUL spokeswoman Victoria Davis signaled that the company is eager to work with Indian lawmakers and authorities to secure approval of their products in the Indian market, saying that JUUL remains, “open to dialogue with lawmakers and regulators in order to help switch” India’s smokers to the less harmful products.
India, however, may be a hard sell, as the country has already outright banned vapor products in one third of its 26 states.
*This article is reprinted from VAPE News Magazine.
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FDA Commissioner Scott Gottlieb resigned yesterday after less than two years on the job, and will leave office next month. In January, Gottlieb denied that he was quitting the job, telling his Twitter followers, “I want to be very clear – I’m not leaving. We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon.”
Gottlieb is well known to vapers, both for postponing the 2018 deadline for FDA marketing approval — which saved the industry from certain death — and later for legitimizing the coordinated attacks on JUUL that have led to a nationwide moral panic over teenage vaping.
Gottlieb announced in July 2017 that the FDA would launch an initiative that would reduce the nicotine in cigarettes below addictive levels, and at the same time encourage smokers to switch to e-cigarettes and other safer nicotine products. For the first time, Americans heard an FDA commissioner admit that vapor products could have a public health benefit.
But Gottlieb denied the rumors and instead cited personal reasons. He has commuted weekly between his Washington, D.C.-area office and his home in Westport, CT for two years, and has had little time to spend with his wife and three young children. He did not explain why he announced six weeks ago that he would not quit.
He told the Times he will remain in office long enough to advance his c-store flavor ban, and other tobacco regulatory initiatives that are in the pipeline. That could include e-liquid flavor regulations, which the FDA has been considering for about seven months. Prohibition of most flavors could kill the independent vaping industry.
Unnamed sources in the Trump administration told the Washington Post that Gottlieb was not fired. Two White House officials said that Trump doesn’t want Gottlieb to leave the FDA, and that he might even be asked to take another job.
President Trump reacted on Twitter: “Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month. Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!”
No successor has been named. Vaping industry stakeholders who are tempted to throw parties should probably consider that the next commissioner may not be an improvement by their standards. Previous FDA commissioners have left much of the vaping regulatory decisions to the FDA Center for Tobacco Products and that office’s director Mitch Zeller. It was Zeller that led the creation of the Deeming Rule.
Scott Gottlieb, 46, had worked at the FDA previously, during the George W. Bush administration. Since then he has worked as a venture capitalist, a fellow at the conservative American Enterprise Institute, and an assistant professor and practicing M.D. at New York University School of Medicine. He also owned stock in many pharmaceutical and biotech companies, and was on the board of vape shop franchiser Kure. (He divested all his stocks after he was approved.)
Because of his libertarian politics and industry ties, he got some pointed questions from skeptical Democrats during his confirmation hearing, but once approved by the Senate he set about becoming one of the most active and hands-on FDA commissioners in history, taking actions that were generally applauded by both sides in the hyperpartisan Congress.
In his resignation letter, sent to Department of Health and Human Services Secretary Alex Azar, Gottlieb ticked off the FDA’s accomplishments during his watch:
Dear Mr. Secretary:
With this letter, I hereby tender my resignation as Commissioner of Food and Drugs, effective in one month.
Over the past 23 months, I’ve been privileged to work with an outstanding team at the Food and Drug Administration, and to collaborate with the professional staff on the implementation of many meaningful initiatives that have advanced the public health. I’m fortunate for the opportunity that the President of the United States afforded me to lead this outstanding team, at this time, in this period of wonderful scientific advances. I’m deeply grateful for your support and the support of the President and his team in advancing many critical public health goals.
In the last two years, the FDA set out to advance major new policies to reduce the morbidity associated with tobacco use; to confront teen use of e-cigarettes; to decrease the rate of new opioid addiction; to improve access to affordable generic drugs; to modernize the development process for novel medical technologies like gene therapy and targeted medicines; to implement measures to improve food safety and our ability to identify and track outbreaks of foodborne illness; and to reduce the burden of chronic disease through better information and diets.
Working together, my colleagues and I achieved all of these goals, and much more.
We approved a record number of generic medicines, novel drugs, and novel devices in 2017 and then topped our own achievements with new records we set in 2018. We set in motion a historic modernization of the Office of New Drugs and of the Office of the Commissioner.
We advanced new approaches for the modern and efficient regulation of cell based regenerative medicine, complex generics, targeted cancer drugs, dietary supplements, digital health tools, and personal genetic tests. We forged a new breakthrough pathway for novel devices that promote safety, and undertook historic modernizations of the 510(k) process. We expanded opportunities for patients with terminal illness to access investigative medicines.
We’ve taken notable enforcement actions to confront bad actors that put Americans at risk. We cracked down on bogus stem cell therapies, on sham homeopathy, on unsafe medical device products, on tobacco sales to minors, on unsafe dietary supplements, and on kratom.
The agency helped support major legislative efforts to secure a more modern framework for the efficient regulation of diagnostic tests and over-the-counter drugs; to advance animal health through a new pathway that makes the development of drugs targeting unmet animal health needs more efficient; to support our efforts to address the opioid crisis with historic new authorities and resources; to more efficiently advance safe and effective medical priorities for our troops; and to sharply expand our interdiction work inside the International Mail Facilities.”
We were strong in moments of crisis.
We dedicated ourselves to the recovery of Puerto Rico and mitigated and averted drug and device shortages in its aftermath. We led a global investigation into impurities found in a class of critical medicines. We restored critical functions and protected the public during a historic government shutdown. We were transparent with the public in these and all our endeavors. All of these efforts were broad undertakings. They took the collective dedication of the professional staff of the FDA, whose commitment to the public health drove these and many other objectives on behalf of Americans.
All of these efforts will have palpable impacts on the health of patients and the safety of families. We did all this, and much more, through the hard work, scientific prowess, and public spiritedness of one of the most talented workforces in the Federal government. I’m grateful to have shared these opportunities with my FDA colleagues. I’m thankful for their support and commitment to our shared mission. And I’m thankful to my family for their support in enabling me to take on the privilege of serving in this role. I’m confident that the FDA will continue to advance all these efforts, and many other goals.
Scott Gottlieb, MD
Commissioner of Food and Drugs
*This article was reprinted from vaping360
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Last week the FDA sent 42 letters to vape manufacturers and importers asking for evidence that their products meet FDA’s marketing requirements. As mandated in the agency’s Deeming Rule, manufacturers or importers must have proof that products were marketed in the United States before Aug. 8, 2016.
Any product entering the market after that date must receive marketing approval from the FDA. No company has received such approval, and no vaping company has even applied.
Nicopure Labs, maker of industry leader Halo e-liquids, received a letter from the FDA, asking for proof that the company’s Ultra Nic Salts products follow FDA marketing requirements.
“Although FDA has extended the compliance deadlines for the premarketing requirements for deemed products, FDA’s compliance policy applies only to those deemed products that were on the market as of August 8, 2016,” says the FDA letter to Nicopure. “FDA has received complaints that Nicopure Labs LLC may have first commercially marketed Halo Nic Ultra Salts in the United States after August 8, 2016.”
Other major manufacturers receiving letters were Joyetech and Sigelei Vape (both Chinese companies with offices in the U.S.), and e-liquid maker Space Jam. All three received inquiries about pod devices. Two importers received letters about their marketing of three different SMOK pod devices (Fit, Infinix, and Rolo Badge). Because SMOK has no U.S. business presence, importers are responsible for following the rules that would apply to domestic manufacturers.
For unknown reasons, a letter was sent to the small manufacturer of extra doors and door accessories for high end mods like the Billet Box. The agency requests information about plugs that are used in the aluminum doors of these mods. Clearly, the FDA lawyers simply picked some things on the internet that struck their fancy — since no child has been “addicted to nicotine” by a fancy door (or a delrin plug) for a $200 mod.
Most of the other letters are aimed at pod vapes and nicotine salt e-liquid. Both kinds of products were popularized by the JUUL, which was brought to market more than a year before the marketing deadline. However, it is widely assumed that many or even most of the pod vapes and nic salt e-liquid that has come to market in the last two years is not compliant with the restrictions set forth in the Deeming Rule.
You can see a complete list of the vape companies that received letters, and the products the FDA cited, at the bottom of this article.
Vaping360 reported last year that the FDA has been training inspectors of retail “tobacco products” outlets to verify that products meet the 2016 deadline. The agency set aside $23 million for contracted inspections over five years. But many of the companies cited by the FDA last week required no research at all. The FDA simply copied and pasted the information from patent complaints filed last October and November by JUUL Labs. JUUL actually showed when some of these rival products came to market in their legal filings.
As he has done lately in interviews and on Twitter, FDA Commissioner Scott Gottlieb’s public statement on the enforcement actions included an implied threat to impose additional restrictions on vape products in the name of protecting children.
“We’ll also be sharing additional planned policy changes and actions soon,” said Gottlieb. “I still believe that e-cigarettes present an important opportunity for currently addicted adult smokers to transition off combustible products and onto nicotine delivery products that may not have the same level of risks associated with them. But if these trends of youth e-cigarette use persist, we’ll be forced to consider regulatory steps that could constrain or even foreclose some of the opportunities for currently addicted adult smokers to have the same level of access to these products in order to protect youth.”
The FDA goes after Walgreens too
The FDA also announced that Commissioner Gottlieb has sent a letter requesting Walgreens executives meet with FDA to explain the company’s sales of tobacco products to underage buyers. Walgreens has been specifically called out by the commissioner for having a high failure rate on compliance inspections.
The huge pharmacy chain has also been the subject of a pressure campaign aimed at forcing Walgreens to stop selling tobacco products. That effort has been led by the Truth Initiative and other tobacco control organizations, many of whom receive funding from CVS, which would be the biggest winner if its largest competitor Walgreens no longer sold tobacco. CVS stopped selling tobacco products in 2014, and would clearly prefer Walgreens not maintain that competitive advantage.
In some areas, Walgreens may be the only outlet for low-risk vapor products. This is especially true and poor and minority communities, where vape shops are uncommon. If Walgreens were to stop selling e-cigarettes, these customers may not be able to find them near their homes.
Complete list of vape companies receiving FDA letters:
7 Daze, LLC – ZOOR
Access Vapor, LLC – Cali Pods and Delicious Pods
Al Khalifa Group, LLC (MK Vape) – SMOK INFINIX and SMOK FIT
All Access Vapor LLC – All Access Vapor E-liquids
American Vapor Group – Airbender Pods
Blue Dot Vapors – Nic Salts
Cool Pods, LLC – COOL pods
DripTip Vapes LLC – ATOM PODS and mngo PODs
ECBlend, LLC – MATE1
Eparticles.Co. – Salteez Pods
ePuffer International Inc. – XPOD
Ethos Vapors, LLC – Ethos Vapor Candy Treats
Fuma Vapor Inc. – FUMA Pods
Ghost Pods LLC – Ghost Pods
GRIPUM LLC – Skippermilk Pie
Hold Fast Vapors Inc. – Air Factory E-liquids
Holy Smokes – Holy Smokes Pods
Ikrusher Inc. – ALD POD Systems
Joyetech USA Inc. – TEROS
Kilo E-Liquids, Inc. – Kilo E-Liquid 1K Device
Lan & Mike International Trading Inc.(Vapor DNA) – Vapor Storm Stalker
LCF Labs, Inc. – Zalt Pods
Limitless Accessories, Inc. – Unique Pods and NicoTech Pods
Maduro Distributors Inc. (The Loon) – Loon Pods and Loon Pod Starter Kit
Madvapes Holdings, LLC – Madvapes E-Liquids
Midwest Distribution Illinois US – Edge Pods, J-fit Pods, and Mr. Fog Pods
MK Distributors, Inc. – SMOK Rolo Badge
Modern Vapor Co. – Caesar Pods
Mums Fantasy Factory, LLC – G10 PLUG and DELRIN PLUG
Nicopure Labs LLC – Halo Nic Ultra Salts
Parallel Direct LLC (The Magic Mist) – Magic Mist PODS
Vapor 4 Life Holdings, Inc. – Viv Pods and BOMBZ Pods
Vaportronix, LLC – VQ Pods
*This article was reprinted from vaping360
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The Post and Courier reports that a study will be done on the positive impact of nicotine on brain function.
The two year review project currently includes 29 national research sites, who are looking for participants for the study on memory improvement through nicotine dosing – or MIND study. “We know it’s likely to affect memory and attention,” said Dr. Jacobo Minzter, chief research and innovation officer at Roper St. Francis, which is one of the 29 research sites where the MIND study will be held.
In a 2004 study, researchers found that people with mental disorders such as adult ADHD and schizophrenia tended to smoke cigarettes heavily due to it being potentially soothing to some of their disorder symptoms.
With difficulty in maintaining attention or concentration being one of those symptoms, researchers have found that nicotine activates specific areas in the brain that call for concentration and attention during specific tasks.
With the MIND study, researchers want to see if controlled nicotine usage could take brain research a step further, specifically with a condition known as Mild Cognitive Impairment or MCI. “The goal is to completely understand how the nicotine patch can improve the memory of people with MCI,” Minzter said.
MCI often appears as an early indication of Alzheimer’s disease. Not everyone who has MCI will have it progress to Alzheimer’s, but MCI does involve mild memory loss, difficulty with language and decision making.
Mintzer explained that while aging often involves memory loss, the memory loss with MCI is a little more intense. Still, it may be overlooked if not properly diagnosed by an expert. “It’s something that they may not notice in their everyday life,” Minzter said.
MIND study participants will first be extensively examined to determine if they have MCI. Once that is established, then participants will be given either nicotine or placebo patches to be taken daily while also coming in every three months for a total of 12 visits over the next two years.
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