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Tobacco ‘Deeming’ Regs Go Into Effect Aug. 8

Aug 1st, 2016
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http://www.cspdailynews.com/category-news/tobacco/articles/tobacco-deeming-regs-go-effect-aug-8

WASHINGTON — As of next Monday, Aug. 8, it will have been 90 days since the U.S. Food and Drug Administration (FDA) announced its final “deeming” regulations for cigars, pipe and hookah tobacco and electronic cigarettes. Aug. 8 also marks the date when the regulations officially go into effect.

A press release from the FDA’s Center for Tobacco Products (CTP) outlines which provisions affecting retailers will go into effect next Monday. As of that date, retailers:

• Must not sell e-cigarettes, hookah or pipe tobacco, or cigars to people under 18 years of age; also must check photo ID of everyone under age 27 who is attempting to purchase such products.
• Must not sell tobacco products covered under the rule in a vending machine (except in a facility where people under age 18 are not allowed on the premises).
• Must not give away free samples of any newly regulated tobacco products. (This provision also applies to manufacturers, importers, and distributors.)

Also, as of Aug. 8, manufacturers are prohibited from marketing “modified-risk tobacco products” without an FDA order in place. A modified-risk tobacco product includes a product with label, labeling or advertising that claims:

• It presents a lower risk of tobacco-related disease or is less harmful;
• The product or its smoke contains a reduced level of/presents a reduced exposure to a substance; or
• The product or its smoke does not contain/is free of a substance.

The FDA said modified-risk tobacco products using descriptors such as “low,” “light” or “mild” will be provided additional time to comply.

Aug. 8 also marks the deadline for manufacturers of newly deemed products to introduce new products without first obtaining FDA approval. Products on the market as of Aug. 8 will be provided additional time to comply with certain submission requirements, such as ingredient listing, health document submission and premarket tobacco applications.

The press release acknowledged that additional requirements for retailers and manufacturers will become effective at the end of the month, the end of 2016 and in the years that follow. A chart of compliance dates can be found here.

Think e-cigs are safe for kids? You’ll think twice after reading this

Jul 21st, 2016
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A study found 75 percent of flavored e-cigarettes contain a chemical linked to severe respiratory disease

The teenage brain is particularly vulnerable to addiction

“Popcorn lung’’ can develop

http://www.miamiherald.com/living/health-fitness/article91033197.html

Electronic cigarettes, or e-cigarettes, have become so popular that they surpassed conventional cigarettes as the most commonly used tobacco product among youth in 2014, according to the Centers for Disease Control and Prevention.

E-cigarette use among youth has soared — from 1.5 percent in 2011 to 13.4 percent in 2014 among high school students, and from 0.6 percent in 2011 to 3.9 percent in 2014 among middle school students, according to the CDC.

E-cigarettes, battery-powered devices that provide doses of nicotine and other additives to the user in an aerosol, are often falsely viewed as a harmless alternative to conventional cigarettes because e-cigarettes do not contain tar, which can lead to tobacco-related diseases.

But, there are real dangers for users of e-cigarettes, especially for youth, medical experts say.

An adolescent brain is particularly vulnerable to addiction because it is still developing, said Dr. Judy Schaechter, chair of the department of pediatrics at UHealth — University of Miami Health System. Nicotine addiction can then become more severe and difficult to break.

Nicotine addiction can also become a gateway to conventional cigarettes and other substances, said Dr. Loretta Duggan, an adolescent medicine fellow at Nicklaus Children’s Hospital. A person with a family history of addiction or an addictive personality can also be very vulnerable.

“It can make it easier to lead to illicit drug use,” Duggan said.

Nicotine can increase heart rate and blood pressure as well as contribute to cardiovascular and heart disease, Duggan said. E-cigarettes can cause strokes and cancer because nicotine can negatively affect blood vessels.

“Even though e-cigarettes seem harmless, a real risk exists,” Duggan said.

There is very little research about other effects that e-cigarettes, which include other additives, can have on the body, Schaechter said. But, e-cigarettes can have a negative effect on the brain, causing inflammation to the lungs and developing tissue.

Schaechter noted reports of e-cigarette users suffering from “popcorn lung” or bronchiolitis obliterans. That is an irreversible life-threatening disease that causes scarring within small air sacs in the lungs, resulting in a severe cough and shortness of breath that gets progressively worse over time.

According to a study released by the Harvard School of Public Health, 75 percent of flavored e-cigarettes and their refill liquids were found to contain diacetyl, a flavoring chemical linked to cases of severe respiratory disease such as “popcorn lung.”

E-cigarettes are often attractive to adolescents because of their kid-friendly flavors, packaging and advertisements.

According to a CDC study released in April, there is a link between exposure to e-cigarette advertisements and the use of e-cigarettes by middle and high school students. Spending on e-cigarette advertising rose from $6.4 million in 2011 to an estimated $115 million in 2014.

The high rate of e-cigarette use among adolescents suggests that adolescents who would not have otherwise used tobacco products are picking up the habit, according to a study released this summer by the American Academy of Pediatrics.

Parents can guard against these dangers. Talk to children as young as 6, before they are influenced by their peers, Duggan said.

Parents should also not indulge in e-cigarette use, Schaechter said.

“We know children of smokers are more likely to smoke,” Schaechter said. “If parents don’t want their children to pick up addictive habits, they shouldn’t do it.”

Also, monitor their social media, TV and cellphone usage, where adolescents can view e-cigarette advertisements.

The Food and Drug Administration (FDA) issued new rules in May that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them.

The new rules also require manufacturers to register with the FDA, disclose detailed reports of their products’ ingredients and obtain permission to sell their products.

“We can work with teens to break addiction, unlike with our parents and grandparents, who didn’t have the type of knowledge that we have today,” Duggan said.

 

Testing on Animals Is Shameful, Says Tobacco Industry Editor

Jul 19th, 2016
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http://www.peta.org/blog/testing-animals-shameful-says-tobacco-industry-insider/

Countless animals will suffer and die now that newer tobacco products, such as e-cigarettes, will be required to have Food and Drug Administration (FDA) approval in order to enter or remain on the market—and one tobacco industry expert isn’t pleased one bit.

In a scathing op-ed, George Gay, an editor for industry publication Tobacco Reporter, writes of the inherent deficiencies of experimenting on animals:

Have you ever tried to get a puppy to sit down with a cup of coffee and vape? No, the puppy will be tested under hugely stressful circumstances that, in respect of inhalation studies, will see her constrained, with a mask covering her mouth and nose through which vapor will be delivered, probably in ludicrous quantities and for periods that, in the case of a cancer study, might last her whole life.

Gay writes that it is “shameful” to test on animals in order to demonstrate the health risks of tobacco to humans and that those who find it acceptable “have a ridiculously inflated view of their own importance.”

Why should countless nonhuman animals be subjected to barbaric experiments so that we can snuggle under a totally threadbare security blanket as we take up what, with all due respect, is a fairly dumb habit.

This dumb habit is also not one that other animals take up freely. In laboratories, experimenters force rats into tiny canisters so that cigarette smoke can be pumped directly into their noses for hours on end. When the experiment is over, the animals are killed and dissected.

Rats squeezed into inhalation tubes

Rats squeezed into inhalation tubes

“[M]umbo-jumbo,” Gay asserts. Different animals have different reactions to toxins, and, as the rat experiment shows, animals in laboratories aren’t exposed to cigarette smoke in the same manner or time frame as human smokers are. “These experiments are ancient vestiges of a primitive body scientific and should be cut off.”

But what’s the alternative? Paraphrasing PETA’s own Joseph Manuppello, Gay points to the recent successes of cutting-edge technology:

[S]tudies that use in vitro methods have the ability to assess potential modified-risk tobacco products more quickly and to provide more specific, actionable and human-relevant data than do animal studies. In vitro models could also better reflect genetic and environmental differences within the human population.

In addition to in vitro technology, manufacturers can also effectively use human-based research methods and the existing body of knowledge from human epidemiological and clinical studies to ascertain health concerns associated with tobacco. These non-animal methods are humane, more relevant to humans, and usually take less time and money to complete.

What You Can Do

Testing tobacco products on animals has already been banned in Belgium, Estonia, Germany, Slovakia, and the United Kingdom. Write to the FDA to request that it follow the lead of agencies in these progressive countries by banning tobacco tests on animals:

Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave.
Document Control Center
Bldg. 71, Rm. G335
Silver Spring, MD 20993-0002
AskCTP@fda.hhs.gov

E-Cigarettes May Be Getting More Kids to Smoke

Jul 11th, 2016
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Including teens who may have avoided tobacco products entirely.

http://fortune.com/2016/07/11/e-cigarettes-teen-use-growing/

Cigarette smoking among American teens is on the decline. But adolescents who may have never tried cigarettes are now vaping with e-cigarettes, new research suggests.

E-cigarettes’ popularity has soared in the past five years and ballooned into a $3.5 billion market. But while manufacturers claim that the products are healthier alternatives to traditional tobacco, public health officials have questioned their safety and pushed for regulations.

Much of the concern has centered on younger Americans who may be drawn to the high-tech smoking devices which often come with flavored nicotine. The Centers for Disease Control (CDC) recently found that an alarming 5.3% of middle school students and 16% of high school students reported using e-cigarettes in 2015—sharp rises from the figures reported at the beginning of the decade.

The new study by the American Academy of Pediatrics (AAP) tracked nearly 5,500 Southern California teens over the course of 20 years (1995-2014) and measured their smoking habits. In 2004, before vaping technology was around, 9% of 11th and 12th grade students were “current smokers,” meaning they’d smoked in the past 30 days.

Fast-forward to 2014 and 13.7% of those students currently smoke cigarettes or e-cigarettes. That sharp spike in the combined smoking data, the researchers wrote, “suggests that e-cigarettes are not merely substituting for cigarettes and indicates that e-cigarette use is occurring in adolescents who would not otherwise have used tobacco products.”

Trends like these, as well as research showing that some vaping products contain high amounts of carcinogens like formaldehyde and acetaldehye, have spurred federal officials to crack down on the industry.

In May, the Food and Drug Administration (FDA) finalized new regulations treating e-cigarettes, hookah, and cigars like traditional cigarettes. That means that any e-cigarette manufacturer whose products weren’t already on the market by February 15, 2007 will have to seek marketing approval from the FDA. They’ll also have to put labels on the devices’ packaging warning about nicotine’s addictive properties, and states will be strictly prohibited from allowing e-cigarette sales to minors (a practice that was previously permitted in several places).

But the rules have drawn sharp rebukes from the industry. Smaller e-cigarette manufacturers say that the types of studies required to pass the FDA’s regulatory muster will favor Big Tobacco companies like Imperial Tobacco and Reynolds American, which also make popular vaping brands like blu and VUSE.

A final resolution over the rules, as The Hill notes, may be determined in the courts. A compendium of e-cigarette companies and trade organizations including Nicopure Labs, the American Vaping Association, and the Right to be Smoke-Free Coalition, among others, have recently filed complaints against the FDA and the Department of Health and Human Services (HHS) calling the regulations “unreasonable” since vaping products contain just nicotine and not tobacco.

The FDA’s Deeming Rule On Vapor Products Must Be Challenged

Jun 30th, 2016
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http://www.forbes.com/sites/realspin/2016/06/30/the-fdas-deeming-rule-on-vapor-products-must-be-challenged/#58f5a11f3e0e

Legal challenges to the U.S. Food and Drug Administration’s (FDA) final deeming rule on vapor products are mounting, with lawsuits focusing on various aspects of the regulations, including claims ranging from violations of the Regulatory Flexibility Act and Administrative Procedure Act, to infringement of freedom of speech under the First Amendment and encroachment of the Fifth Amendment’s due process clause.

It is likely that more lawsuits will follow. In fact, the Smoke-Free Alternatives Trade Association (SFATA) supports the Right to Be Smoke-Free Coalition (RSF) who have filed a suit of their own challenging the FDA’s industry-crushing rule.

One of our fundamental objections to the deeming rule is that the FDA lacks the authority to regulate vapor products in the absence of therapeutic claims. Many legal experts agree that the Tobacco Control Act was never intended to apply to vapor products.

FDA is trying to extend its jurisdiction over e-cigarettes

The courts have been vigilant in policing the FDA’s over assertion of jurisdiction. The Supreme Court rejected the agency’s attempt to regulate nicotine as a “drug” and cigarettes and smokeless tobacco as “devices” in FDA v. Brown & Williamson Tobacco Corporation. Likewise, in Sottera Inc. v. FDA, the U.S. Court of Appeals for the D.C. Circuit rejected the FDA’s attempt to regulate e-cigs as unregulated medical devices, holding that unless a vapor product is marketed for therapeutic purposes, the agency may not regulate them as drugs, devices or combination products.

At the time the D.C. Circuit issued its ruling in Sottera, the FDA had not yet deemed e-cigs to be subject to its authority. Thus, the question presented in Sottera was not whether e-cigs are tobacco products, but whether they were, as FDA then asserted, “drugs” or “devices.” The D.C. Circuit rejected the FDA’s position, noting that the agency had frequently expressed the view that “cigarettes are beyond the scope of the Food, Drug and Cosmetic Act (FDCA) absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor.”

The FDA’s final regulations purport to address the jurisdictional lines established by Sottera by deeming vapor products as tobacco products subject to the FDCA. However, vapor products do not meet the definition of a “tobacco product.” As defined in Section 201 of the FDCA, as amended by the Tobacco Control Act, a “tobacco product” is “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

E-cigarettes and Lung Health

Jun 2nd, 2016
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http://www.lung.org/stop-smoking/smoking-facts/e-cigarettes-and-lung-health.html

On May 5, the Food and Drug Administration (FDA) announced it will be extending its authority to include e-cigarettes and other tobacco products. Starting in August 2016, FDA will begin to apply and enforce key provisions of the Family Smoking Prevention and Tobacco Control Act as it relates to the sales, marketing and manufacturing of e-cigarettes.

The American Lung Association had long called for FDA to bring e-cigarettes and other unregulated tobacco products under its authority. This action was especially important given the rapid rise in youth use of e-cigarettes in the U.S. over the past several years.

How Will FDA Oversee E-cigarettes?

A 2010 ruling from a federal court in a case filed by an e-cigarette manufacturer against the FDA determined that e-cigarettes which do not make therapeutic claims will be regulated as tobacco products.

If a manufacturer does make a therapeutic claim (such as that an e-cigarette can help you quit smoking), then the manufacturer must first prove through a series of clinical trials that their product is safe and effective.

What Are E-cigarettes?

Electronic cigarettes, or e-cigarettes, include e-pens, e-pipes, e-hookah, and e-cigars are known collectively as ENDS – electronic nicotine delivery systems. According to the FDA, e-cigarettes are devices that allow users to inhale an aerosol (vapor) containing nicotine or other substances.

Unlike traditional cigarettes, e-cigarettes are generally battery-operated and use a heating element to heat e-liquid from a refillable cartridge, releasing a chemical-filled aerosol.

What Are in E-cigarettes?

The main component of e-cigarettes is the e-liquid contained in cartridges. To create an e-liquid, nicotine is extracted from tobacco and mixed with a base (usually propylene glycol), and may also include flavorings, colorings and other chemicals.

Following the 2016 announcement allowing FDA oversight of tobacco products, e-cigarette manufacturers must register with FDA by August 8, 2016, and then will have two additional years to submit an application to remain in the marketplace. Until that time, the nearly 500 brands and 7,700 flavors of e-cigarettes will remain on the market – before FDA is able to fully evaluate them. Until FDA’s evaluation is done, there are very few ways for anyone other than the manufacturers to know what chemicals are contained in e-liquids, or how e-cigarette use might affect health, whether in the short term or in the long run.

Initial studies show that e-cigarettes contain nicotine and also may add in other harmful chemicals, including carcinogens and lung irritants.

Nicotine

Nicotine is an addictive substance, and almost all e-cigarettes contain nicotine. Even some products that claim not to have any nicotine in them may still contain it. For instance, initial FDA lab tests conducted in 2009 found that cartridges labeled as nicotine-free had traceable levels of nicotine. A 2014 study found little consistency in the amount of nicotine delivered by e-cigarettes of the same brand and strength.1 Similarly, another 2014 study found that the amount of nicotine in e-liquid refills is often substantially different from the amount listed on the package.2 Experienced users learn how to use e-cigarettes in a way that increases their exposure to nicotine. Newer e-cigarette devices, especially “tank” styles, with higher voltage also deliver a greater concentration of nicotine. This matters because the more nicotine used, the greater the potential for addiction.

Nicotine is not safe. The U.S. Surgeon General has found exposure to nicotine during pregnancy harms the developing fetus, and causes lasting consequences for the developing brain and lung function in newborns. Nicotine exposure also affects maternal and fetal health during pregnancy, and can result in low birth weights, preterm delivery and stillbirth.

Nicotine also has a negative impact on adolescent brain development. Human brain development continues far longer than was previously realized, and nicotine use during adolescence and young adulthood has been associated with lasting cognitive and behavioral impairments, including effects on working memory and attention.3

Other chemicals

We don’t presently know what is in e-cigarettes. However, in initial lab tests conducted in 2009 the FDA found detectable levels of toxic cancer-causing chemicals, including an ingredient used in anti-freeze, in two leading brands of e-cigarettes and 18 various cartridges. A review of studies found that levels of toxins in e-cigarette aerosol varied considerably within and between brands. A 2014 study found that aerosol from e-cigarettes with a higher voltage level contains more formaldehyde, another carcinogen with the potential to cause cancer. The findings are alarming, and underscores why the American Lung Association called so urgently for FDA oversight of these products.

Flavors in e-cigarettes are also a cause for concern. Not only are flavors used to target kids, but they may be harmful on their own. E-cigarette and flavor manufacturers and marketers may suggest that the flavor ingredients used in e-cigarettes are safe because they have FEMA GRASTM status for use in food, but such statements are false and misleading. The reality is that FEMA GRASTM status only applies to food, meaning it’s safe to eat, and does not apply to inhaling through e-cigarettes.

Diacetyl, a buttery flavored chemical often added to food products such as popcorn, caramel, and dairy products, has also been found in some e-cigarettes with flavors. Diacetyl can cause a serious and irreversible lung disease commonly known as “popcorn lung.”4

Poisoning concern

Aside from concerns about e-cigarette use and emissions alone, data released by the Centers for Disease Control and Prevention (CDC) shows that calls to the nation’s poison centers for e-cigarette exposure poisonings are rapidly increasing. One study found that while most calls involving e-cigarette liquid poisoning came from accidental ingestion of the e-cigarette or its liquid, about one-sixth of the calls related to someone inhaling these items. Exposure through the eye and the skin were also reported.

Large doses of nicotine have a potential for poisoning, with symptoms beginning with nausea and vomiting in cases of acute toxicity and progressing to seizures and respiratory depression in cases of severe nicotine poisoning. This is particularly true in children as calls to poison control centers have increased nationwide. Tragically, one child died from acute e-cigarette poisoning in 2014, attributed to the ingestion of liquid nicotine from an e-cigarette.

Secondhand Emissions from E-cigarettes?

As public spaces increasingly become smokefree, anecdotal reports show some people are attempting to use e-cigarettes indoors and in public spaces which are smokefree, like bars, restaurants and even public transit.

While e-cigarettes do not contain smoke, they do expose others to secondhand emissions. Little is known about these emissions or the potential harm they can cause. Two studies have found formaldehyde, benzene and tobacco-specific nitrosamines (all carcinogens) coming from those secondhand emissions. Other studies have shown that chemicals in the vapor contain formaldehyde, acetaldehyde and other potential toxins. There is no evidence that shows e-cigarettes emissions (secondhand aerosol) are safe for non-users to inhale.

The American Lung Association supports prohibiting the use of e‐cigarettes in worksites and public places, and including e-cigarettes under smokefree laws with other tobacco products. Currently, nine states and hundreds of communities have prohibited e-cigarette use in the same places where smoking is already prohibited.

Can E-cigarettes Help Someone Quit Smoking?

Many e-cigarette companies market their product as a tool to help smokers quit. However, the FDA’s Center for Drug Evaluation and Research has not approved any e-cigarette as a safe or effective method to help smokers quit.

Instead of quitting, many e-cigarette users are continuing to use e-cigarettes while still using conventional cigarettes. In 2013, 76.8 percent of the people who recently used e-cigarettes also currently smoked conventional cigarettes. The U.S. Surgeon General has found that even smoking a few cigarettes a day is dangerous to your health.

The U.S. Public Health Service has found that the seven therapies approved by the U.S. Food and Drug Administration in combination with individual, group or phone cessation counseling are the most effective way to help smokers quit. Until and unless the FDA approves a specific electronic nicotine delivery system or e-cigarette as safe and effective for use as a tobacco cessation aid, the American Lung Association does not support their use for cessation or any direct or implied claims that e-cigarettes help smokers quit.

Youth and E-cigarettes

Youth are using e-cigarettes at increasing and alarming rates. Between 2014 and 2015, CDC studies found e-cigarette use among high school students increased by 19 percent, with more teens now using e-cigarettes than cigarettes.

The tobacco industry aggressively markets e-cigarettes to youth, glamorizing e-cigarette use in advertisements and offering e-cigarettes in candy flavors like bubble gum and gummy bears. Kids can also easily buy e-cigarettes online, according to a March 2015 study published in JAMA Pediatrics. Learn more about youth e-cigarette use. Basic FDA oversight, which would include youth access restrictions, is needed to protect kids from becoming the next generation hooked on nicotine.

Bottom Line

E-cigarettes are a tobacco product. The American Lung Association remains concerned about their impact on the public health, as they are now the most commonly used tobacco product by youth. As FDA begins its oversight of these products, we will learn more about them and more safeguards will be put in place to protect the public health.

Smokers who wish to quit can learn more about ways that have been proven safe and effective in helping smokers quit at Lung.org/smoke-free.

Learn more: Read the American Lung Association’s statement on e-cigarettes.

Updated: June 2, 2016

Sources

Goniewicz ML, Hajek P, McRobbie H. Nicotine Content of Electronic Cigarettes, its Release in Vapour and its Consistency Across Batches: Regulatory Implications. Addiction. 2014;109:500-7.
Cameron JM, Howell DN, White JR, Andrenyak DM, Layton ME, Roll JM. Variable and Potentially Fatal Amounts of Nicotine in E-Cigarette Nicotine Solutions. Tobbaco Control. 2014;23:77-8.
U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. 2014.
Farsalinos KE, Kistler KA, Gillman G, Voudris V. Evaluation of electronic cigarette liquids and aerosol for the presence of selected inhalation toxins. Nicotine Tob Res, 2014; 17:168-74.
Centers for Disease Control and Prevention. Tobacco Use Among Middle and High School Students – United States, 2011–2014. Morbidity and Mortality Weekly Report April 17, 2015; 64(14):381-5

FDA seizes Rs 124-crore worth cigarette packs for flouting pictorial warning norms

May 28th, 2016
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Manufacturers to be issued warnings to cover 85% of packet surface with visuals on adverse health effects.

http://indianexpress.com/article/entertainment/regional/fda-cigarette-packs-flouting-pictorial-warning-2822567/

According to the Food and Drug Administration, cigarette packets and other tobacco products, which should display pictorial warnings on 85 per cent of the packet surface about the adverse health effects as per the new law, are clearly flouting the rules in Pune district.

The FDA team conducted a massive operation beginning April this year and seized cigarette packets worth a whopping Rs 124.53 crore from 14 places across Pune district.

Joint Commissioner (FDA) Shashikant Kekare told The Indian Express that they have seized the packets worth Rs 124.53 crore from April till date. “We have decided to re-send the packets to the manufacturing companies, mainly ITC and Godfrey Phillips, and issue a warning to them to cover 85 per cent of the packet surface with large visual warnings within two months,” said Assistant Commissioner FDA Dilip Sangat.

In Pune district in the last four years, the FDA has also collected fines amounting to Rs 50,000 from 350 people, who were found smoking at public places and Rs 11,400 from 77 people who were found selling tobacco and related products within 100 metre distance of schools. The gutkha collected, however, has been phenomenal and packets worth Rs 8.68 crore have been seized from 638 places in the district.

As per the Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules, 2014, the size of the pictorial warning was increased and were to come into effect from 2015 onwards. However, the Centre had on April 1, 2016 brought in the 85% pictorial warning rule. The Supreme Court too directed the tobacco manufacturing companies to comply with the rules to display the pictorial warnings across 85% of the surface of packets of cigarettes.

This year, the World Health Organisation (WHO) has stressed upon plain packaging of cigarettes and tobacco products on No Tobacco Day (May 31).

PACE team to reach out to more students, train medical interns

About one million people die each year from tobacco-related diseases. By 2020, that number is expected to touch 1.5 million, according to the World Health Organisation (WHO). May 31 is observed as No Tobacco Day to spread awareness on the harmful effects of tobacco consumption. The Association of Hospital (AOH) urges people to control and gradually reduce tobacco usage.

In Pune, the team of doctors at the Prevention of Addiction through Children’s Education (PACE) has actively reached out to more than one lakh students in the city and Mumbai. Dr Vandana Joshi, ENT surgeon, who heads PACE and is supported by a team of activists including Dr Neeta Ghate, Anuya Chabukswar and others, have now decided to focus on private schools this year. “We also want to train students of medical and dental courses so that they can take up the campaign to prevent gutka and smoking,” Joshi said.

Pictorial warnings welcome, but poor implementation: Docs

Cancer surgeons have welcomed the move to display pictorial warnings on cigarette packs but say it is poorly implemented. Dr Kamalesh Bokil, who is flooded with oral cancer patients at Ruby Hall Clinic, said the visual warnings really work.

“We need to sustain this movement. No firm can sell tobacco without displaying 85 per cent warning visuals on packs,” said Dr Pankaj Chaturvedi, head and neck cancer surgeon from Tata Memorial Hospital.

Ex-FDA Commissioner faces RICO charges, helped form e-cig regulations

May 19th, 2016
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Current FDA head Califf also has ties with Johnson & Johnson, corruption may be inevitable.

http://us.blastingnews.com/opinion/2016/05/ex-fda-commissioner-faces-rico-charges-helped-form-e-cig-regulations-00921737.html

You wouldn’t think of “corruption” in any form when you think of the Food and Drug Administration (FDA). Certainly, you wouldn’t think of conspiracy and intent to conceal detrimental information to the public. Certainly, you’d be wrong. Those employed by the government have the responsibility and duty to “protect” the public. They are supposed to be in the care and custody of information and decisions that may endanger or save lives via regulations. They’re not doing a very good job of it.

Racketeering and corrupt organizations

Margaret Hamburg, former FDA Commissioner (May 2009 to March 2015) is facing charges under the “Racketeer Influenced and Corrupt Organizations” (RICO) act for concealing deadly consequences of the drug Levaquin made by Johnson & Johnson. Along with her abuse of power, her husband Peter Brown was a hedge-fund manager at Renaissance Technologies and is also facing RICO charges along with drug giant, Johnson & Johnson. According to the Alliance for Human Research Protection (AHRP) report, Brown’s reported income was “$10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012″ due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.”

Corruption by design or default

While Hamburg was acting Commissioner, she was instrumental in forming e-cigarette regulations before she left the FDA. Her replacement, Dr. Robert Califf also has financial ties to pharmaceutical giants AstraZeneca, Johnson & Johnson, GlaxoSmithKline and more. While he was the director of the Duke Translational Medicine Institute (DTMI) he received a consulting payment from Johnson & Johnson of $87,500. Taking over where Hamburg left off, Califf released the FDA e-cigarette regulations, and litigation is already pending on the rule. Regulations, by design or default, may be heavily strewn with conflict of interest. With the makers of nicotine reduction therapies and drugs like Johnson & Johnson having an FDA Commissioner and former commissioners ear, corruption may be inevitable.

Are decisions based on health?

Senator Ron Johnson (R-Wis.) wants answers from the FDA about regulations. In a letter, the chairman of the Senate Homeland Security and Governmental Affairs Committee asked Commissioner Califf a few specific questions. Burdensome expenses related to the application and approval costs and public health were of importance in his letter. As he stated, “the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences.” Another observation made by Senator Johnson stated:

“The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.”

Then Senator Johnson asked, in part:

“How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health”?

The Committee on Homeland Security and Governmental Affairs is authorized to investigate “the efficiency and economy of operations of all branches of the Government.”

Senator Johnson stated he wanted all material “no later than 5:00 p.m. on May 31, 2016.”

Exploding e-cigs will soon be subject to regulatory oversight

May 18th, 2016
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The booming e-cig market has been largely unregulated

http://www.local10.com/consumer/call-christina/exploding-e-cigs-will-soon-be-subject-to-regulatory-oversight

PEMBROKE PARK, Fla. – As the e-cigarette market grew in popularity, so did calls for oversight and regulation following reports from across the country of e-cigs exploding or catching fire.

From January 2015 to January 2016, scientists from the FDA’s Center for Tobacco Products have identified 66 reports of e-cigs overheating, catching fire or exploding.

Dr. Carl Schulman of the University of Miami/Jackson Memorial Burn Center said those numbers are probably only scratching the surface of what has become a new phenomenon.

“Locally we’ve seen several patients in the last couple of months who have had burns from electronic cigarettes, particularly exploding and catching fire in their clothing,” said Shulman. “If it is just in their clothing, and they are not using it, then their clothing is catching fire and they are get a bad flame burn where that is, and our two patients actually needed surgery for their burns and if they are actually using it at the time it explodes there have been some reports of actual explosions so they get a blast injury and they catch fire.”

The stories are harrowing. There’s a woman in New York who suffered third-degree burns to her leg after an e-cig caught fire in her pocket while driving; and dramatic surveillance video at a Kentucky gas station caught the moment an e-cig sparked and burst into flames in a customer’s pocket.

In the case of Florida resident Evan Spahlinger, the e-cig he was using exploded. His Fort Lauderdale-based attorney, John Uustal said it burst “into flames in his face, causing him to inhale flames, smoke, and scorching hot air,” and forced him into a medically-induced coma, Uustal filed a product liability lawsuit against Vaping American Made Products LLC, a foreign limited liability company; and Naples, Florida-based Vaping Station LLC.

Company owners and representatives never responded to repeated requests from Local 10 News for a statement about the pending lawsuit.

Uustal said for his client, the explosion and subsequent injuries were like “a nightmare”.

Spahlinger suffered from severe burns on his face and neck with severe internal injuries to his lungs, esophagus and mouth. Luckily Spahlinger survived and is now recovering from his injuries. “I was shocked knowing how burned he was, how good he looks,” said Uustal. “It is a miracle.”

He believes manufacturers and retailers have failed to adequately warn consumers of the potential safety risks and product design defects, “when you buy an e-cigarette nobody says you might be blowing your face off so you must be very careful.”

What is causing e-cig batteries to explode?

According to a 2014 U.S. Fire Administration report most incidents of e-cigs exploding or catching fire occurred while the battery was charging.

“The shape and construction of e-cigarettes can make them more likely than other products with lithium-ion batteries to behave like “flaming rockets” when a battery fails,” explained the report. “Using power sources not approved by the manufacturer to recharge a lithium-ion battery can result in an explosion and fire.”

“It is a relatively new phenomenon. I guess it is in the same trend as all the lithium-ion battery-type devices that are sometimes catching fire and exploding and we are seeing that with e-cigarettes as well,” said Dr. Schulman. “Don’t interchange the devices. Some of these injuries have occurred because people are using different batteries and different chargers and that is causing electrical problems and they are catching fire and exploding.”

“The device has no ventilation,” explained Uustal. “You think about a hoverboard catching fire that’s not great, it is a bad situation, but if you put that in a small cylinder that has only two weak ends, one of those ends is going to blow off if the battery explodes and one of those ends is pointed at someone’s face.”

The 2014 U.S. Fire Administration report goes on to say the devices’ lithium-ion batteries can fail, and noted a need for continued improvements in battery safety designs.

“If the person designing this e-cigarette cared at all for the safety of the user,” said Uustal; “there would be ventilation in the battery compartment, there would be a weak spot on the end that’s facing away from the user so that if something went wrong it would explode out.”

The 2014 report also noted that, “no regulation, code or law applies to the safety of the electronics or batteries in e-cigarettes. While many consumer products are required to be tested by a nationally recognized test laboratory, such as UL, there are no requirements that e-cigarettes be subjected to product safety testing.”

In the vacuum of that regulatory oversight, sales of e-cigs soared.

NEW FEDERAL OVERSIGHT:

In May of 2016, the FDA finalized a rule to extend its regulatory power over e-cigs.

They will be looking at the ingredients, marketing and product design.

A recent FDA/CDC survey found e-cig use by high school kids is up a whopping 900% since 2011.

FDA/CDC Recent Survey

E-cig use amount high school students up 900% since 2011.

2015: 16%
2011: 1.5%

Before this month’s move by the FDA, there was no federal law prohibiting retailers from selling e-cigs to minors.

Now you will have to be 18 years old and prove it with a photo ID in order to buy an e-cigarette.

An FDA spokesman tells Local 10 News that new rule takes effect this August.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell.

While Uustal thinks the new regulations are a step in the right direction, he believes those who make and sell e-cigs should have done more to warn consumers of the potential safety risks and should be held accountable for failures in product safety testing.

“These devices are prone to explode even if the user does everything right,” Uustal told the Call Christina team. “If you are designing a device that with a lithium-ion battery that might explode; and create a flaming rocket right into someone’s face you have a certain responsibility when you are making money off these products, to include safety measures. It is not a question of if they are going to get burned, and the day is coming when the first person is going to die and we can prevent that and so we should.”

The Department of Transportation recently banned the devices from carry-on luggage due to the potential safety risk.

“We know from recent incidents that e-cigarettes in checked bags can catch fire during transport,” said Transportation Secretary Anthony Foxx. “Fire hazards in flight are particularly dangerous. Banning e-cigarettes from checked bags is a prudent safety measure.”

The U.S. Department of Transportation banned e-cigarettes from checked baggage Thursday.

Passengers and crewmembers will also be prohibited “from charging these devices and their batteries on board the aircraft. However, these devices may continue to be carried in carry-on baggage.”

“Fire hazards in flight are particularly dangerous, and a number of recent incidents have shown that e-cigarettes in checked bags can catch fire during transport,” said U.S. Transportation Secretary Anthony Foxx. “Banning e-cigarettes from checked bags is a prudent and important safety measure.”

One industry trade publication states it has created a list of media reported e-cigarette explosions. To date eCig One states it has found 173 e-cig explosion reports.

According to their analysis: Of the 173 e-cigarette explosions:
•47 e-cigarette explosions happened during use.
•73 e-cigarette explosions happened during charging.
•30 e-cigarette explosions happened during transport, storage or unknown circumstances.
•23 e-cigarette explosions involved spare batteries for removable battery mods.

Anti-E-Cig Dems Took Hundreds Of Thousands From Big Pharma

May 17th, 2016
by Editor.
No comments yet

Pro industry publication makes certain points – it seems prima facie money talks within the Great Satan to preserve market share

http://dailycaller.com/2016/05/17/anti-e-cig-dems-took-hundreds-of-thousands-from-big-pharma/

Seven Senate Democrats who signed a letter applauding the Food and Drug Administration’s (FDA) crackdown on e-cigarettes took hundreds of thousands of dollars from the pharmaceutical industry.

They wrote to the FDA May 11 congratulating the agency on its almost 500-page rule book regulating e-cigarettes, cigars, and pipe tobacco.

“We commend the Food and Drug Administration (FDA) for finalizing the deeming rule that extends FDA regulatory authority to include all tobacco products, including e-cigarettes, cigars, and pipe tobacco, to protect the public’s health—and especially the health of the youngest Americans—from the harmful effects of tobacco,” the senators wrote.

Industry experts and independent vape shop owners fear the regulations will destroy the market, wreck innovation and ban almost all vapor products.

The rule that most concerns the e-cigarette industry is the so-called “predicate date” of Feb. 17, 2007. All vapor products that came on the market after this date, which is almost all of them, will have to go through the notoriously onerous and expensive Pre-Market Tobacco Application process (PMTA).

PMTAs can cost millions of dollars per product and around 1,700 hours of paperwork. Industry experts and the FDA’s own analysis from 2014 estimate 99 percent of products on the market won’t even be put through this process and will be taken off the market within two years.

One sector that might benefit disproportionately from this outcome is pharmaceuticals. Companies such as Pfizer and Teva Pharmaceutical Industries make smoking cessation products like nicotine gum and patches, which directly compete with e-cigarettes to get smokers off tobacco.

CVS Health, which sells nicotine replacement therapies but refuses to carry e-cigarettes could also benefit the removal of competition. The company’s twitter account once compared e-cigarettes to the light cigarettes marketed by the tobacco industry.

Seven Democrats who signed the congratulatory letter to the FDA have raked in substantial sums from these organizations’ PACs, lobbyists and employees.

Sen. Richard Blumenthal
Pfizer: $12,300, 2009-2012
$24,300, 2009-2014
$28,500, 2011-2016
Total: $65,100

Sen. Dianne Feinstein
Pfizer: $12,000, 2005-2010
$33,250, 2007-2012
$38,250, 2009-2014
$35,750, 2011-2016
Total: $119,250

Sen. Kirsten Gillibrand
Pfizer: $45,298, 2009-2010
$76,048, 2009-2012
$72,800, 2009-2014
$44,500, 2011-2016
Total: $238,646

Sen. Patrick Leahy
Teva Pharmaceutical Industries: $12,500, 2005-2010
$14,500, 2007-2012
$18,450, 2009-2014
$15,750, 2011-2016
Pfizer: $15,000
Total: $76,200

Sen. Jack Reed
CVS Health: $55,250, 2007-2012
$43,250, 2009-2014
$39,200, 2011-2016
Total: $137,700
Sen. Tom Udall
Pfizer: $16,000, 2009-2014
Total: $16,000

Sen. Sheldon Whitehouse
CVS Health: $20,500, 2005 -2010
$27,050, 2007-2012
$33,050, 2009-2014
$28,050, 2011-2016
Pfizer: $10,000, 2011-2016
Total: $118,650

All the data listed above was collected from OpenSecrets.org.

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