FDA Head Vows to Keep E-Cigs Away from Kids .

E-cigarettes may pose less risks than combustible tobacco, and may provide a “viable alternative,” for adults, but adult access to such products will be reined in if the number of kids using e-cigarettes continues to climb, according to FDA Commissioner Scott Gottlieb, MD.

“We’re going to have to step in … We can’t just addict a whole generation of young people on nicotine with e-cigarettes and consider that a public health advance,” Gottlieb said Tuesday to a subcommittee of the House Committee on Appropriations. “We’ll be taking some very vigorous enforcement steps … starting in the coming weeks.”

During the hearing on the FDA budget, subcommittee members stressed that the agency must act quickly to stop kids and teenagers from using e-cigarettes.

Rep. Nita Lowey (D-N.Y.), the top Democrat for the full Committee on Appropriations, raised a small rectangular device in her hand and said “Commissioner Gottlieb, what does this look like to you?”

Gottlieb said he said he knew what the device was, but played along. “It looks like a USB key,” he said.

“This is a JUUL, which is now among the most popular e-cigarette on the market … One JUUL pod, like this, contains as much nicotine as an entire pack of cigarettes,” Lowey stated.

She applauded the FDA for its work in reducing nicotine levels in cigarettes, but criticized the agency for its “silence” on e-cigarettes, saying it could “open the gates to the next public health emergency.”

Lowey also argued that “kid-friendly” flavors of e-cigarettes, such as mango and cucumber, had been introduced in apparent violation of FDA’s deeming rule, which blocks new e-cigarettes from entering the market after Aug. 8, 2016, without a premarket review from the FDA.

Asked whether JUUL had submitted an application for the new flavors, Gottlieb did not directly answer, saying that he did not want to “telegraph coming enforcement action.”

The FDA does have authority over e-cigarettes to inspect the products, impose good manufacturing practice standards, and enforce age restrictions, he noted.

He reiterated that the agency would be “stepping into this fight in a vigorous way in the coming weeks.”

On Wednesday, six leading public health and medical organizations, including the American Academy of Pediatrics, sent a letter to the FDA urging the agency to take action against JUUL, which has a boxy-sleek design that resembles a flash drive.

But not all committee members took issue with how the FDA has handled e-cigarettes so far. Rep. Sanford Bishop (D-Ga.) thanked Gottlieb for delaying certain regulations for e-cigarettes until 2022, noting that many of his constituents are switching to e-cigarettes to help them stop smoking.

However, Bishop did convey his concerns about children’s access to e-cigarettes.

Cannabis for Pain Control

Members also discussed marijuana as an alternative treatment for pain control, and whether or not its $5.8 billion budget request was sufficient.

Rep. David Young (R-Iowa) suggested that moving marijuana to a different schedule might make it easier to study. Marijuana (cannabis) is currently classified as a schedule I drug by the Drug Enforcement Agency, meaning that its “defined as drugs with no currently accepted medical use and a high potential for abuse.” However, many states have legalized cannabis for medicinal and/or recreational use.

Gottlieb said that it is already possible to study schedule I drugs, and that a supply of botanical marijuana, and its derivatives, is currently available for research through the National Institute on Drug Abuse (NIDA) supply program.

Asked for his “general thoughts,” on marijuana use, Gottlieb said that the “best way to deliver an active pharmaceutical ingredient is in a measured dose, in a form where you can purify the ingredient and you know what you’re getting. Rolling something up in a piece of paper and lighting it on fire and smoking it is not the most efficient way to deliver an active pharmaceutical ingredient.”

“I can’t think of another drug that we deliver that way, at least therapeutically… because you want to make sure the patient is getting a reliable dose and a reliable effect with each administration,” he added. “Also, the lung itself isn’t a very efficient drug deliver platform. We generally would prefer not to deliver drugs through the lung unless we were treating the lung in some fashion.”

A Bold Request

Gottlieb highlighted agency initiatives that would be made possible if the $5.8 billion FY 2019 budget request is met. The request includes $473 million in budget authorities and $190 million for user fees, he noted.

Subcommittee Chair Robert Aderholt (R-Ala.) called the request the “boldest and largest funding request in recent memory” for the agency.

Gottlieb touted plans to build a new “knowledge management system” for storing the “collected experience” of medical product review teams, identifying “scientific precedence,” and “bring[ing] more consistency to decision-making.”

The FDA will also open a policy office inside the Office of New Drugs to “promote policy, transparency, and consistency,” he said. Information culled from the new system could then be used to create hundreds of disease-focused guidance documents, he added, which would make drug development more efficient.

A portion of the budget, about $58 million, would be used to fund the transition to more modern manufacturing methods, such as continuous manufacturing.

Such a system would allow flu vaccines to be developed more quickly in a cell-based environment, rather than in eggs — the current process — and in a period of weeks, not months.

“You could scale up much more quickly and you could convert to different kinds of vaccine, if you saw changes in the contours of the resistant patterns over the course of a season,” he said

In other budget issues, Lowey noted that FY2019 budget represents a $372 million increase over the FY 2018 budget, but cautioned that the food safety budget, which saw a $10 million increase, was “insufficient” and barely enough to keep up with inflation.

She also pointed to the absence of a “vision” for how the agency would address the opioid epidemic.

“Every level of government must do all it can to combat the opioid epidemic,” she said.

E-cigs Contain A Million Times More Cancer-causing Chemicals Than Polluted Air

The research, carried out by the Baptist University, also found a type of flame retardant in the devices that affected the reproductive system and could also lead to cancer. Thirteen random electronic cigarettes available on the Chinese market were analyzed and returned worrying results: the level of polycyclic aromatic hydrocarbons (PAHs), a by-product of burning petroleum also found in polluted roadside air, ranged from 2.9 to 504.5 nanograms per milliliter. That’s “at least one million times more than roadside air in Hong Kong,” according to Dr Chung Shan-shan, assistant professor in the Baptist University’s biology department. Another substance of concern found in abundance is Polybrominated diphenyl ethers (PBDEs).

E-cigarettes Chung Milliliter Nanograms

These are flame retardants that are widely used in the manufacturing of furniture and electronic products. With an average 5 nanograms per milliliter in a conventional cigarette, the number of PBDEs in e-cigarettes range from 1.7 to 1,490 nanograms per milliliter. PBDEs are added to e-cigarettes to reduce the risk of burning in the devices’ plastic combustible components. According to Dr Chung Shan-shan, inhalation of PBDEs has been associated with thyroid hormone disruption and reduction of fertility; it affects fetal development and can cause cancers.

“Even though we don’t know the exact number of e-cigarettes one should take, not to mention that many of the carcinogenic effects are cumulative, I don’t think there is a safe margin,” Chung said. At least 16 countries have imposed a total ban on e-cigarettes, including Singapore, Thailand and Brazil, while the World Health Organization (WHO) admits that there is insufficient information so far on health implications caused by e-cigarettes. “Some research programmes are already under way but given that e-cigarettes have been popular in the last four or five years, research has barely started and it’s early days yet. It would take about five or 10 years before we have evidence that could change the current picture.” Armando Peruga, Programme Manager of WHO’s Tobacco Free Initiative, said in a 2014 interview .

You can get e-cigs on the NHS – but the government tried to keep it a secret | Metro News

You can get e-cigs on the NHS - but the government tried to keep it a secret
Coming to a pharmacy near you 

Quitting smoking in the new year?

You’ll soon be able to get e-cigarettes on the NHS – but ssshhhhhhh, don’t spread it it around.

The government wants to keep it on the DL so that doctors aren’t overrun by raging nicotine addicts.

Last month the NHS licensed e-Voke, which means doctors will be able to offer it on prescription.

But a Whitehall source said they ‘didn’t want to make a song and dance about it because GPs would be overrun by people demanding it,’ the Sunday People reported.

You can get e-cigs on the NHS - but the government tried to keep it a secret
‘Enjoy your vaping, madam’

Public health minister Jane Ellison bigged up e-cigarettes when Labour MP Steve McCabe asked her about it directly.

She told him: ‘The Government believes vaping is ­significantly less harmful than smoking. We encourage ­medicinal license applications.’

The move is likely to cost the NHS £20 per kit and £10 a week for each patient’s cartridges, saving money in the longterm as e-cigarettes are much less harmful.

As people currently pay £8.20 for a prescription in England, they could make a saving as vaping starter kits often come in at around £20.