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April, 2014:

FDA deeming requirement for e-cigs

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

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm

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, waterpipe (or hookah) tobacco, and dissolvables 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.

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.

No Exclusions! Why Carveouts Would Weaken the Trans-Pacific Partnership

https://www.uschamber.com/above-the-fold/no-exclusions-why-carveouts-would-weaken-the-trans-pacific-partnership

The goal of the Trans-Pacific Partnership (TPP) is to craft a high-standard free trade agreement for the 21st Century that will create jobs and economic growth by reducing tariffs and trade barriers on all goods and services.

In an op-ed in the Singapore Straits Times [subscription required], Wan Saiful Wan Jan, head of the Institute for Democracy and Economic Affairs, explains why excluding even politically unpopular products like tobacco would prevent that goal from being achieved:

There is no debating that cigarettes are harmful. But if this exemption becomes law, it would establish a frightening precedent for other types of exemptions.

The TPP agreement is supposed to represent a trade framework suitable to the hyper-integrated, fluid global economy of the 21st century.

Singling out tobacco is unnecessary because TPP, like other trade agreements, won’t limit the ability of member countries from crafting public health regulations.

Furthermore, singling out one product will open a Pandora’s Box as other governments go after their particular bête noirs. Under the guise of public health regulations, countries could erect protectionist barriers to alcoholic beverages, sugary soft drinks, genetically-modified foods, and other products.

Wan Jan writes:

If a nation is charged with violating a free-trade pact by sheltering a favoured industry, it could then cite the tobacco exemption to legally justify targeted protectionism. Special interests would be fully empowered to warp global trade channels.

Instead of a trade agreement fit for a modern, global economy, we’d end up with something that will impede trade, Wan Jan notes:

A warped TPP that arbitrarily diminishes trade protection for one specific product category would reset the international trading system back to the 19th century, when global trade was plagued with costly and inefficient barriers to commerce.

Because TPP will set the standard for free trade agreements in the decades ahead, it’s crucial that it be a comprehensive, high-standard agreement.

COSH Funding

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E-Cigarette Gateway to Addiction

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Study finds cancer risk in e-cig vapors

Changes in cells exposed to vapor are similar to those in cells exposed to tobacco smoke

https://www.consumeraffairs.com/e-cigarette-warnings-and-lawsuits

Promoters of electronic cigarettes have been claiming that inhaling the vapor from e-cigs is less harmful than smoking traditional cigarettes made from tobacco.

It sounds good but is it true? Maybe not.

A new study published in the academic journal Clinical Cancer Research finds that the vapor from e-cigarettes damages human cells in much the same way as the smoke from traditional cigarettes.

Scientists at Boston University grew a batch of human bronchial cells in the presence of e-cig vapor and another batch in the presence of tobacco smoke. The result: the two batches of cells showed similar patterns of gene expression, which can cause the mutations that lead to cancer.

Lead researcher Avrum Spira, M.D., said that while e-cigs may be safer than tobacco, “our preliminary studies suggest that they may not be benign.” He said more research is needed.

“New route to … addiction”

It’s hardly the study to find potential problems with e-cigs. In March, a University of California San Francisco study found that e-cigs may be a new route to conventional smoking and nicotine addiction.

UCSF researchers found that adolescents who used the devices were more likely to smoke cigarettes and less likely to quit smoking. The study of nearly 40,000 youth around the country also found that e-cigarette use among middle and high school students doubled between 2011 and 2012, from 3.1 percent to 6.5 percent.

“Despite claims that e-cigarettes are helping people quit smoking, we found that e-cigarettes were associated with more, not less, cigarette smoking among adolescents,” said lead author Lauren Dutra, a postdoctoral fellow at the UCSF Center for Tobacco Control Research and Education.

“E-cigarettes are likely to be gateway devices for nicotine addiction among youth, opening up a whole new market for tobacco,” she said.

Poison control

Earlier this month, the Centers for Disease Control and Prevention (CDC) report finding a huge increase in the number of calls to poison centers involving e-cigarette liquids containing nicotine.

A CDC study published in the agency’s Morbidity and Mortality Weekly Report says calls shot up from 1 per month in September 2010 to 215 per month this past February. And, the report says, the number of calls per month involving conventional cigarettes did not show a similar increase during the same time period.

Sen. Barbara Boxer (D-Calif.) called the increase in poisoning cases “alarming” and said the report “should serve as a wake-up call to the American people that it is time for the FTC and the FDA to regulate these products to help prevent more tragedies.”

“I am particularly concerned that many e-cigarettes are packaged in bright colors and flavored to smell like candy or fruit, which puts children at higher risk of poisoning,” Boxer said.

Availability of illicit tobacco in small retail outlets before and after the implementation of Australian plain packaging legislation

http://tobaccocontrol.bmj.com/content/early/2014/04/10/tobaccocontrol-2013-051353.abstract

Abstract

Objective

We aimed to assess change in the availability of illicit tobacco in small mixed business retail outlets following the December 2012 introduction of plain packaging in Australia.

Methods

303 small retail outlets were visited in June and September 2012 (baseline months), and in December 2012 and February, April and July 2013. Fieldworkers requested a particular low-cost brand of cigarettes and then pressed the retailer for an ‘even cheaper’ brand. The cheapest pack of cigarettes offered was purchased and later examined to assess any divergence from prescribed Australian packaging regulations. The price paid was compared with tax liability and recommended retail price for the particular brand and pack size. In a sub-set of 179 stores, fieldworkers then asked the retailer about availability of unbranded (chop-chop) tobacco.

Results

Thirteen (2.2%) of 598 packs purchased pre-plain packaging were either non-compliant with Australian health warnings and/or suspiciously priced. Four packs (1.3%) of 297 met either or both criteria in the December implementation month, and five (0.6%) of 878 did so in the three collection months following implementation. Chop-chop was offered upon enquiry on 0.6% (n=2) of 338 occasions prior to implementation, 0.6% (n=1) of 170 occasions in the December 2012 implementation month, and 0.6% (n=3) of 514 occasions postimplementation. The likelihood of a ‘positive’ response (either an offer to sell or information about where unbranded tobacco may be purchased) did not differ across preimplementation, during-implementation and postimplementation waves.

Conclusions

Overall, packs judged likely to be illicit were sold in response to requests for cheapest available packs on fewer than one percent of occasions. Offers to sell unbranded tobacco were rare. No change in availability of illicit tobacco was observed following implementation of plain packaging.

E-cigs linked to spike in calls to poison centers

CDC says more monitoring of nicotine exposure through e-cigarette liquid is needed

https://www.consumeraffairs.com/e-cigarette-warnings-and-lawsuits

There’s been a huge increase in the last few years in the number of calls to poison centers involving e-cigarette liquids containing nicotine.

A CDC study published in the agency’s Morbidity and Mortality Weekly Report says calls shot up from 1 per month in September 2010 to 215 per month this past February. And, the report says, the number of calls per month involving conventional cigarettes did not show a similar increase during the same time period.

Sen. Barbara Boxer (D-Calif.) called the increase in poisoning cases “alarming” and said the report “should serve as a wake-up call to the American people that it is time for the FTC and the FDA to regulate these products to help prevent more tragedies.”

“I am particularly concerned that many e-cigarettes are packaged in bright colors and flavored to smell like candy or fruit, which puts children at higher risk of poisoning,” Boxer said.

In February, Boxer introduced the Protecting Children from Electronic Cigarette Advertising Act to prohibit the marketing of e-cigarettes to children and teens.

The trade group for e-cigarette manufacturers, the Smoke Free Alternatives Trade Association (SFATA), said it supports stronger safety measures. In a statement, executive director Cynthia Cabrera said the manufacturers “support federal age restrictions on the purchase of vapor products, childproof caps and proper labeling to safeguard against accidental ingestion of e-liquid by minors or adults.”

Kids at risk

More than half (51.1%) of the calls to poison centers due to e-cigarettes involved young children 5 years and under, and about 42% of the poison calls involved people age 20 and older.

The analysis, which compared total monthly poison center calls involving e-cigarettes and conventional cigarettes, found the proportion of e-cigarette calls jumped from 0.3% in September 2010 to 41.7% in February 2014.

Poisoning from conventional cigarettes is generally due to young children eating them. Poisoning related to e-cigarettes involves the liquid containing nicotine used in the devices and can occur in three ways: by ingestion, inhalation or absorption through the skin or eyes.

“This report raises another red flag about e-cigarettes — the liquid nicotine used in e-cigarettes can be hazardous,” said CDC Director Tom Frieden, M.D., M.P.H. “Use of these products is skyrocketing and these poisonings will continue. E-cigarette liquids as currently sold are a threat to small children because they are not required to be childproof, and they come in candy and fruit flavors that are appealing to children.”

A sweeping study

Data for this study came from the poison centers that serve the 50 states, the District of Columbia, and U.S. Territories. The study examined all calls reporting exposure to conventional cigarettes, e-cigarettes, or nicotine liquid used in e-cigarettes.

Poison centers reported 2,405 e-cigarette and 16,248 cigarette exposure calls from September 2010 to February 2014. The total number of poisoning cases is likely higher than reflected in this study, CDC says, because not all exposures might have been reported to poison centers.

“The most recent National Youth Tobacco Survey showed e-cigarette use is growing fast, and now this report shows e-cigarette related poisonings are also increasing rapidly,” said Tim McAfee, M.D., M.P.H., Director of CDC’s Office on Smoking and Health. “Health care providers, e-cigarette companies and distributors, and the general public need to be aware of this potential health risk from e-cigarettes.”

The report shows that e-cigarette liquids containing nicotine have the potential to cause immediate adverse health effects and represent an emerging public health concern. That, according to CDC, makes developing strategies to monitor and prevent future poisonings critical.

Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach

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Official Journal of the European Union

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