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E-cigarettes
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Are e-cigarettes good for your mental health?

Patients with mental health problems are far more likely than others to become dependent on cigarettes. Can ‘vaping’ reduce symptoms without the risks?
In all the debate over electronic cigarettes and their health implications, one issue is largely neglected: the implications of e-cigarettes on mental health. Nicotine has a history of being used as treatment for mental health problems and studies have found that it can quell the symptoms of several conditions, including attention-deficit disorder, depression and schizophrenia. Nicotine fuses with nicotinic receptors, which trigger the release of several neurotransmitters – including serotonin and dopamine – which are both associated with positive side-effects, including elation and excitability.

Research has shown that people with mental health problems are more likely to smoke cigarettes, more likely to be dependent on nicotine and have a greater difficulty quitting smoking than those without mental health problems. Almost 90% of schizophrenics are smokers and the percentage of those with bipolar and panic disorders, depression, anxiety and post-traumatic stress disorder who are smokers is also very high. A study carried out by the Centers for Disease Control and Prevention in the US found that people with mental health problems accounted for 31% of cigarettes smoked the in the country.

Although cigarettes may relieve symptoms of mental disorders, they also increase mortality rates – a report from the National Association of State Mental Health Program Directors showed that patients in psychiatric hospitals will on average die 25 years earlier than the general population. Many factors contribute to this difference, but diseases caused by smoking may account for part of it.

Nicotine-replacement therapies and e-cigarettes may be a solution to this problem. There are many “smoking cessation therapies” – gums, patches and sprays – that reduce cravings for cigarettes, while allowing the smoker to avoid the adverse effects of tobacco. Because of the absence of tobacco and combustion, e-cigarette vapour is devoid of the carcinogens tobacco contains.

Professor Peter Hajek, director of the Tobacco Dependence Research Unit at Barts and the London School of Medicine and Dentistry, Queen Mary, thinks that e-cigarettes are a promising development. He said: “Some wards give out nicotine replacements, such as patches, so considering e-cigarettes in the same light would make sense. Giving psychiatric patients access to e-cigarettes, particularly on closed wards, is definitely something to consider.”

A 2013 study at the University of Catania, Italy, put this into practice. It showed that electronic cigarettes could cut down schizophrenic patients’ standard cigarette consumption without having an adverse effect on their schizophrenic symptoms – which implies that e-cigarettes may be just as effective as tobacco cigarettes at reducing the symptoms of schizophrenia.

But some mental health organisations are yet to be convinced. Bob Carolla, director of media relations at the US body National Alliance on Mental Illness (Nami), explains: “Nami doesn’t have a position on electronic cigarettes. We are studying the issue and consulting with experts in the field.”

It is clear that more research is needed to determine the effect of e-cigarettes on the symptoms of mental health problems. But if e-cigarettes do have positive benefits and are to be proved safe, there should be no reason why they cannot be used in psychiatric wards.

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Will FDA Regulation Preserve Or Destroy The E-Cigarette Industry?

The first time the Food and Drug Administration (FDA) moved to regulate electronic cigarettes, it tried to ban them. Last week it took a different approach that may ultimately have a similar effect. Much will depend on whether the FDA irrationally decides to treat e-cigarettes as a menace to public health or recognizes them as a lifesaving alternative to conventional cigarettes.

On the face of it, the proposed rule that the FDA published last week is much more accommodating than its 2009 attempt to ban e-cigarettes as unapproved “drug-device combination products,” which was blocked by the courts. This time the FDA is classifying e-cigarettes as “tobacco products.” That in itself is rather puzzling, since e-cigarettes do not contain any tobacco. They do, however, contain nicotine derived from tobacco, which is the court-endorsed legal pretext for FDA regulation.
By the same logic, nicotine gum, lozenges, patches, and inhalers are also tobacco products, except that the FDA already regulates them as pharmaceuticals. As tobacco products, e-cigarettes should have a much better chance of remaining on the market. After all, the FDA is not trying to ban conventional cigarettes, which are far more dangerous because they deliver nicotine in a cloud of tobacco combustion products rather than a propylene glycol aerosol.

But there’s a catch. All the familiar brands of conventional cigarettes were grandfathered by the Family Smoking Prevention and Tobacco Control Act, the 2009 law that gave the FDA authority over tobacco products. According to the FDA, so were e-cigarettes, as long as they were on the market as of February 15, 2007—the cutoff date set by the statute. Since the e-cigarette business was just getting started in the United States at that point, this grandfather clause does not cover much.

E-cigarette companies that did not exist in early 2007 can get permission to continue selling their products by demonstrating that they are “substantially equivalent” to the early models, which means they have “the same characteristics” or raise the same public health issues. Will they be able to meet this test? I asked three people who are familiar with the e-cigarette industry that question, and I got three different answers.

The most optimistic answer came from Chip Paul, founder of the Oklahoma-based e-cigarette franchise Palm Beach Vapors, which sells vaping equipment and store-blended fluids to go with them. “I think everybody will be able to make that argument, that they are just furthering the technology that existed in 2007,” Paul says. One major change has been the shift from disposable cartridges of e-cigarette fluid to refillable tanks, but the underlying technology remains the same. “We don’t think what’s on the market today is substantially different from what was on the market in 2007,” Paul says. “There have been improvements in the technology, and there have been some design changes, but the way the liquid is delivered to the user is fundamentally the same, and the liquid is fundamentally the same. I think everybody who is in business today will be able to [satisfy that test] and be OK.”

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FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes

As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, water-pipe (or hookah) tobacco, and dissolvable not already under the FDA’s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said HHS Secretary Kathleen Sebelius.

Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements:

Register with the FDA and report product and ingredient listings;
Only market new tobacco products after FDA review;
Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole; and
Not distribute free samples.
In addition, under the proposed rule, the following provisions would apply to newly “deemed” tobacco products:
Minimum age and identification restrictions to prevent sales to underage youth;
Requirements to include health warnings; and
Prohibition of vending machine sales, unless in a facility that never admits youth.
“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” said FDA Commissioner Margaret A. Hamburg, M.D. “Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”
“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”

The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.

Products that are marketed for therapeutic purposes will continue to be regulated as medical products under the FDA’s existing drug and device authorities in the Food, Drug &Cosmetic Act.

The proposed rule will be available for public comment for 75 days. While all comments, data, research, and other information submitted to the docket will be considered, the FDA is requesting comments in certain areas, including:

The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
The FDA seeks answers to the many public health questions posed by products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products. The FDA seeks comment in this proposed rule as to how such products should be regulated.
For more information:
Proposed rule: Tobacco Products Deemed to be Subject to the Food, Drug and Cosmetic Act (Deeming) disclaimer icon
FDA: Extending Authorities to Additional Tobacco Products
Consumer Update: Recognize Tobacco in Its Many Forms
FDA Voice Blog: Proposed Rule Would Expand FDA’s Tobacco Control Authority
En Espanol: La FDA propone ampliar su autoridad para regular otros productos de tabaco, incluyendo los cigarros electrónicos
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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