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The Law on Labels

Noah Steinsapir, general counsel for Kretek International, offers a legal look at what the FDA’s new warning label requirements mean for manufacturers and retailers.

http://tobaccobusiness.com/fda-law-on-warning-labels/

The FDA’s Deeming Regulations are now in full swing, and several deadlines have come and gone since its implementation on August 8, 2016. Currently, the tobacco industry is working hard to comply with the imminent deadlines in connection to the FDA’s new labeling requirements. Manufacturers/importers of cigars are required to submit a rotational warning plan in compliance with FDA regulations by May 10, 2017, and the new labels must be implemented and in commerce no later than May 10, 2018.

The material aspects of the new FDA warning plan are fairly straightforward. Manufacturers and importers of cigars must rotate six warnings:

  1. WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale;
  2. WARNING: Cigar smoking can cause lung cancer and heart disease;
  3. WARNING: Cigars are not a safe alternative to cigarettes;
  4. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers;
  5. WARNING: Cigar use while pregnant can harm you and your baby; or SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth, and Low Birth Weight; and
  6. WARNING: This product contains nicotine. Nicotine is an addictive chemical.

These rotated warnings must be permanently affixed to the cigar packaging and advertisements. For packaging, the warning must encompass no less than 30 percent of the two principal display panels of the product’s packaging (a principal display panel being defined by the Deeming Regulations as the panels of the package that are most likely to be displayed, presented, shown or examined by the consumer) and no less than 20 percent of the total display area of the advertisement, with the caveat that the warning on advertisements appear in the upper portion of the advertisement within the trim area of the advertisement. The warnings have some other requirements such as font size, capitalization and color.

Although the rule is relatively straightforward, the industry still remains confused in connection with two looming issues: First, how will this warning coalesce with California’s current Proposition 65 warning requirements? Second, how will the timing of selling through products with older warnings on them work?

Prop 65 vs. FDA Warning

For Prop 65, certain industry groups are working to devise a plan. The purpose of California’s Proposition 65 is to warn the consumer and the public at large that tobacco products contain toxic chemicals. The new FDA warning plan achieves California’s objective and does so in a meaningful manner such that 30 percent of the principal display panels of the product’s packaging will notify the consumer of the health warnings of the tobacco product. In terms of size and visibility, the FDA’s rule goes above and beyond what is required by California’s Proposition 65. Therefore, a proposed and reasonable outcome is that California determines that the additional Prop 65 warning is unnecessary, duplicative and may cause customer confusion in light of the new federal guidelines that require such a clear and conspicuous warning. In either event, hopefully the State of California will provide clarity in connection with this issue.

Products Already in the Retail Pipeline
Another common concern is that the May 10, 2018 deadline for implementing the new warning scheme may create challenges in light of the fact that product can sit in a warehouse or on a retail shelf for extended periods of time. This may result in the sale of product without the adequate warning to the consumer after the May 10, 2018 deadline, which would not be the fault of the manufacturer/importer or the retailer. While the answer is not crystal clear yet, the Deeming Regulations appear to have considered this issue and provide a safe harbor to both the manufacturer/importer, as well as to the retailer. The manufacturer and importer appear to be allowed to introduce product without the current warning requirements into commerce up until May 10, 2018. They then have an additional 30 days after this deadline as a safe harbor to continue selling the last of the product.

In addition, retailers appear to be provided a safe harbor as long as the retailer purchased the product from a licensed manufacturer, the packaging contains some type of health warning, and the retailer has not altered the packaging. Both the FDA and the industry want to provide clear and conspicuous warnings so that consenting adults may make informed decisions. With time, the new FDA warning plan will be further clarified.

This story first appeared in the May/June 2017 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

Cigarette Filter Ventilation and its Relationship to Increasing Rates of Lung Adenocarcinoma

https://academic.oup.com/jnci/article-abstract/109/12/djx075/3836090/Cigarette-Filter-Ventilation-and-its-Relationship?redirectedFrom=fulltext

The 2014 Surgeon General’s Report on smoking and health concluded that changing cigarette designs have caused an increase in lung adenocarcinomas, implicating cigarette filter ventilation that lowers smoking machine tar yields. The Food and Drug Administration (FDA) now has the authority to regulate cigarette design if doing so would improve public health. To support a potential regulatory action, two weight-of-evidence reviews were applied for causally relating filter ventilation to lung adenocarcinoma. Published scientific literature (3284 citations) and internal tobacco company documents contributed to causation analysis evidence blocks and the identification of research gaps. Filter ventilation was adopted in the mid-1960s and was initially equated with making a cigarette safer. Since then, lung adenocarcinoma rates paradoxically increased relative to other lung cancer subtypes. Filter ventilation 1) alters tobacco combustion, increasing smoke toxicants; 2) allows for elasticity of use so that smokers inhale more smoke to maintain their nicotine intake; and 3) causes a false perception of lower health risk from “lighter” smoke. Seemingly not supportive of a causal relationship is that human exposure biomarker studies indicate no reduction in exposure, but these do not measure exposure in the lung or utilize known biomarkers of harm. Altered puffing and inhalation may make smoke available to lung cells prone to adenocarcinomas. The analysis strongly suggests that filter ventilation has contributed to the rise in lung adenocarcinomas among smokers. Thus, the FDA should consider regulating its use, up to and including a ban. Herein, we propose a research agenda to support such an effort.

Big Tobacco Attacks Sensible F.D.A. Rules on Vaping

As smokers turned to electronic cigarettes to reduce the health risks of smoking, big tobacco companies started buying e-cigarette makers and producing and selling their own. Now those companies are lobbying Congress to prevent the Food and Drug Administration from regulating electronic cigarettes and cigars, as it does conventional cigarettes. If they succeed, they will be able to sell and market addictive nicotine products to young people with few restrictions.

https://www.nytimes.com/2017/04/19/opinion/big-tobacco-attacks-sensible-fda-rules-on-vaping.html?_r=1

While promoters of e-cigarettes and e-cigars, which provide nicotine in vapor form, say they can help people quit conventional tobacco products containing harmful tar, there is not a lot of evidence for that claim. In addition, the devices are dangerous to young people because the nicotine they provide “can cause addiction and can harm the developing adolescent brain,” according to a 2016 report by the surgeon general, Vivek Murthy. Health experts also say that the vapor those devices produce can contain carcinogens and metal particles.

Another government report found that 16 percent of high-school students said they had used e-cigarettes in 2015, up from just 1.5 percent in 2011. The industry sells these products in a broad array of flavors, like gummy bear and cotton candy, designed to appeal to young people when they are more susceptible to becoming dependent or addicted to nicotine.

After years of deliberation, the F.D.A. said last May that it would begin regulating the manufacturing, sale, packaging and advertising of e-cigarettes, and all tobacco products, under a 2009 federal law that authorized it to do so. Specifically, the agency said it would begin reviewing the health risks of e-cigarettes introduced since early 2007, and potentially ban specific flavors and products that it deemed harmful. The tobacco lobby wants Republicans to amend a vital appropriations bill to exempt products that were introduced before May 2016 from F.D.A. review.

The push to undermine the F.D.A.’s authority began even before the agency had finished its rule. One Republican lawmaker, Representative Tom Cole of Oklahoma, introduced a bill in 2015 that was identical to a draft circulated by the Altria Group, the country’s biggest tobacco company and a marketer of vaping products. In addition to its legislative effort, the industry has also filed several lawsuits in federal courts challenging the rule.

Tobacco companies complain that the F.D.A.’s rule amounts to “retroactive” regulation because many of the e-cigarettes and e-cigars it will regulate have been on the market for years. But the industry has known for years that government officials were developing this rule. Large bipartisan majorities in Congress voted in 2009 to hand the agency the authority to evaluate and approve new tobacco products introduced on or after Feb. 15, 2007. The F.D.A. is simply doing its job by protecting public health.

Justice Ministry says iQOS product will be treated as ordinary tobacco

Previously, the company asked the US Food and Drug Administration to recognize iQOS as “modified-risk product.”

http://www.jpost.com/Business-and-Innovation/Health-and-Science/Justice-Ministry-says-iQOS-product-will-be-treated-as-ordinary-tobacco-485912

The world’s largest tobacco company, Philip Morris International, faced an obstacle in Israel that has apparently influenced its position toward its heated-tobacco product iQOS.

Previously, the company asked the US Food and Drug Administration to recognize iQOS as “modified-risk product.”

Last week, Israel’s Justice Ministry notified the company that it accepted the position of three voluntary organizations in Israel that the product is actually a “tobacco product,” and all the restrictions that apply to tobacco products should apply to iQOS.

In parallel, Philip Morris reversed its previous position towards the FDA and now wants iQOS to first be recognized as a “tobacco product.”

The small Society for Progressive Democracy thus “made history,” as the new position will set the definition of the product for deliberations by the FDA.

The Israel Medical Association, the Israel Cancer Association and the small Society for Progressive Democracy thus “made history,” as the new position will set the definition of the product for deliberations by the FDA.

While the Israel Cancer Association and the Israel Medical Association sent letters to the authorities to protest against Health Minister Ya’acov Litzman for preventing restrictions on the sale and marketing of iQOS in Israel, the Society for Progressive Democracy headed by lawyer Shabi Gatenio actually applied to the High Court of Justice and asked for an Injunction againt him.

“It is a story of the little David toppling Goliath, Philip Morris,” commented lawyer Amos Hausner, the chairman of the Israel Council for the Prevention of Smoking.

The limitations that now apply to all tobacco products will include iQOS, such as prohibiting its sale to minors, prohibiting smoking it in all public places where conventional cigarettes may not be smoked, excluding it from advertising in the electronic media and media for children and teens, and other restrictions for which violators are fined.

Under the rules of administrative law, the position of Justice Ministry professionals is binding upon all governmental agencies in Israel, and their position supersedes the one expressed by any political figure – in this case, the health minister.

Attorney-General Avichai Mandelblit has yet to decide on a petition by Avir Naki, a voluntary organization that aims to fight smoking, to prohibit Litzman from having any involvement in decisions on tobacco matters.

Dubek, the Israel tobacco producer and importer, has also filed an application in the High Court against Litzman, arguing that he was giving Philip Morris benefits that Dubek did not enjoy.

Hausner said that Philip Morris “officially changed its position here while its application was pending in the FDA, as a negative consequence in Israel might have negatively influenced the company’s position in its deliberations with the US over iQOS. We clearly learn from this case that politicians cannot determine policy on major public health issues like this; they must leave it to ministry professionals to set policy.

It turned out that Litzman was more protective of Philip Morris than the company itself demanded. As to Philip Morris, Hausner said that their products should meet the requirements of professionals and not only of the politicians.”

Commenting on the Justice Ministry decision, Philip Morris Ltd.’s spokesman in Israel said that it would “continue to market iQOS in Israel in a responsible way according to law so that adult smokers would have better alternatives than continuing to smoke cigarettes.”

The ministry said in a statement after the court decision was announced that “while waiting for the FDA’s position, we plan at this stage to place on the product all restrictions on tobacco products regarding marketing, advertising and smoking in public places.”

FDA delays ‘other use’ rule for tobacco-derived products

The Food and Drug Administration (FDA) pushed back by one year a rule to clarify when products derived from tobacco face regulation as drugs or combination products.

http://www.tobaccojournal.com/FDA_delays_other_use_rule_for_tobacco-derived_products.54153.0.html

Initially set to take effect in February, the FDA first delayed implementation by one month and now intends for it to take effect on 19 March 2018. An additional comment period will expire on 19 May 2017. Additional information is available at: https://goo.gl/BrQooq

FDA’s New Database on Grandfathered Tobacco Products

Industry group offers additional clarity on resource

Thomas A. Briant

MINNEAPOLIS — Feb. 15, 2007, is an important date in the Family Smoking Prevention and Tobacco Control Act, the law that Congress passed to authorize the U.S. Food and Drug Administration (FDA) to regulate tobacco products. That date is known as the “predicate date” or “grandfather date.” Every tobacco product that was on the market as of Feb. 15, 2007, is grandfathered, which means that special applications do not need to be filed with the FDA to keep those products on the market.

Just last week, the FDA announced that it has included on its website a searchable database to determine whether a tobacco product is grandfathered. Click here to access that database. To use it, type in the tobacco product name, the name of the manufacturer, select the product category from the drop-down list and then click the search button. The search results will inform you if the product is grandfathered.

However, there is some confusion about the completeness and accuracy of the FDA’s grandfathered database. The Coalition of Independent Tobacco Manufacturers of America (CITMA), Richmond, Va., has issued a letter to its members outlining the issues with the FDA grandfathered database and allowed NATO to disseminate the letter.

Specifically, the CITMA letter indicates that a FDA grandfather determination is not required to sell a grandfathered tobacco product and this has resulted in some grandfathered tobacco products not being included in the database. This means the FDA database only includes those tobacco products that were the subject of a voluntary grandfather-determination request submitted to the agency by a manufacturer. In other words, the database does not include those grandfathered tobacco products for which a voluntary grandfather-status application was not submitted. Also, CITMA indicates that the grandfathered database does not include those tobacco products that receive grandfather status through a substantial-equivalency application submitted to the FDA by a manufacturer.

In its letter, CITMA reports that the coalition has requested the FDA to issue a statement clarifying that the grandfathered database does not include all legally marketed, grandfathered tobacco products.

Download (PDF, 1.15MB)

Cole-Bishop Bill Reintroduced in Congress

http://tobaccobusiness.com/cole-bishop-bill-reintroduced-congress/

By Tobacco Business –

FDA Congress

U.S. Representatives Tom Cole (R-Oklahoma) and Cole Bishop (D-Georgia) reintroduced legislation in Congress in an effort to change the FDA predicate date under the FDA tobacco regulations. Known as the FDA Deeming Clarification Act of 2017 (HR 1136), this legislation would also adopt new regulations relating to e-cigarette and vapor products. HR 1136 is an updated version of HR 2058 and the Cole/Bishop amendment.

The re-introduced bill would change the predicate date from Feb. 15, 2007 to Aug. 8, 2016, the date when the FDA deeming regulations took effect.

This move would allow newly deemed tobacco products that were on the market as of Aug. 8, 2016-including e-cigarettes, vapor, cigars, pipe tobacco, hookah tobacco, nicotine gels and dissolvable nicotine products-would not need a special Substantial Equivalency Application or Pre-Market Tobacco Application to be filed with the FDA in order to remain on store shelves and in the market. These products would still be required to comply with the other FDA tobacco regulations, however.

Specifically for vapor products, the bill would also establish a product standard for vapor product batteries. The product standard would include technical characteristics that batteries for vapor products would need to meet in order to be used in an e-cigarette or vapor product. Vapor product manufacturers, wholesalers, and retailers would not be allowed to advertise a vapor product in a newspaper, magazine, periodical or other publication except an adult publication whose readers younger than 18 years old constitute no more than 15 percent of the total readership and fewer than 2 million people younger than 18 years older.

This bill would have a major impact on various part of the tobacco industry. First, it would relieve some of the burden placed on manufacturers of varying ages and sizes. Companies founded after Feb. 15, 2007 would be able to continue operating with their products readily available in the market. As is, compliance costs could drive many newer manufacturers out of business. Second, changing the predicate date would give many manufacturers more product on the market. This also could drastically change the course of the vapor industry, much of which was established long after 2007. The vapor industry is also greatly founded in technology and the ongoing improvement and development of said technology. Anything that was on the market prior to the 2007 predicate date, which is very little, would likely not be promoted or used by vapor consumers today. There are also a great deal of questions and concerns regarding the FDA approval process for tobacco products like cigars, pipe tobacco and vapor products, which is likely to be a very long, costly and confusing process.

Many in the vapor industry view HR 1136 as the first necessary step in developing appropriate regulation for the vapor industry. On its website, the Consumer Advocates for Smoke Free Alternative Association (CASAA) commented, “Different efforts and strategies are required to keep moving the ball forward. Looking to the future, fair regulatory treatment of vapor products is part of the larger campaign to change the tobacco control culture int he United States. Ultimately, policy makers, regulators, and public health advocates must change their abstinence-only approach to one of the comprehensive harm reduction in order to humanely reduce the morbidity and mortality associated with smoking cigarettes.”

The passing of HR 1136 would be a major breakthrough for those hit by the FDA deeming ruling. You are encouraged to reach out to your state representatives and voice your support for the bill, either through email, phone or attending a town hall meeting.

Trump’s Administration on the FDA Regulating Cigars

http://www.counselheal.com/articles/31659/20170128/trump-administration-on-the-fda-regulating-cigars.htm

President Donald Trump and his administration are about to get busy in the coming months. The present administration is expected to review the regulatory powers of the Food and Drug Administration of the United States over tobacco products.

The Daily Caller reports that organizations like the Campaign for Tobacco Free Kids and the Robert Wood Johnson Foundation are petitioning the FDA with its programs to discourage young people from smoking pipes and cigars. The group sees the idea of the government arm of paying up to $25 per cigar as absurd.

Last year, the FDA announced that its plans to regulate tobacco products and e-cigarettes did not push through in August because of injunctions filed by tobacco organizations against the FDA and the Department of Health and Human Services in July 2016. The additional regulations aim to prohibit walk-in humidors in stores, ban colorful and artistic labels on cigars and cigar boxes and will require pipe shop owners to secure a manufacturer’s license prior to taking bulk tobacco orders.

The H.R. 563, known as the Traditional Cigar Manufacturing and Small Business Preservation Act of 2017, when taken into effect will override the FDA’s regulations for cigars and was originally sponsored by Congressman Bill Posey and Florida Democrat Kathy Castor.

Forbes reports that Trump’s views against regulations and how they hamper the U.S. economy is backed up in his First 100 Days of Action Plan where is plans on cutting the red tape at the FDA. The Family Smoking Prevention and Tobacco Control Act that was signed by former U.S President Barack Obama gave the FDA the regulatory powers over tobacco products.

The new President’s move against or in favor of new and existing policies in the administration is now creating speculations not only in the FDA issue but as well as in healthcare. Trump has been very expressive against the Affordable Care Act and has pledged that an appeal to Congress will be in the works once he is elected.

Modifications of his stance on these issues and how far he will deconstruct existing policies is what the nation awaits.

Anti-Tobacco Groups Worried About Trump, Congress

Lawmakers considering efforts to weaken FDA’s regulatory power

http://www.medpagetoday.com/pulmonology/smoking/62788

The federal government and most states continued to receive mostly failing grades from the American Lung Association (ALA) for efforts to reduce tobacco use among adults and teens during 2016, despite the enactment of the long-awaited “deeming” rule giving FDA regulatory authority over all tobacco products, including e-cigarettes and cigars.

The failure to require graphic warning labels on cigarette packaging and to move toward banning menthol cigarettes earned federal administrators and lawmakers an “F” grade from the ALA for tobacco regulation, according to the group’s annual State of Tobacco Control report, released late this week.

But despite these shortcomings, anti-tobacco advocates who spoke to MedPage Today say there is no question that regulatory and other actions taken at the state and federal level during the Obama administration’s 8-year tenure helped spur the record decline in tobacco use among adults and teens.

And they expressed concern that many of these hard-fought gains will be rolled back by the new administration and Congress.

“There is no question that what government does makes a big difference,” Matthew L. Myers of Campaign for Tobacco-Free Kids told MedPage Today.

“During the last eight years we have seen tobacco advertising restricted through the FDA, there have been sustained (anti-tobacco) mass media campaigns, tobacco taxes have increased and internet sales have been curtailed. All of these things contributed to the dramatic decline in tobacco consumption,” Myers asserted.

Speaking with a group of corporate leaders on Monday, President Trump vowed to do away with 75% or more of government regulations and he repeated his campaign promise of massive tax cuts.

Myers said Trump’s views on specific tobacco regulations and taxes are not known.

“President Trump has not spoken about this, so it is still unclear what position he will personally take,” Myers said. “To date, the physical manifestation of our concern comes from the cigarette and e-cigarette industries urging Congress to curtail funding for successful mass media campaigns and critical regulatory measures.”

The ALA’s Erika Seward said two specific attempts now before Congress to weaken FDA’s regulatory authority over tobacco are of particular concern.

On Jan. 13, Rep. Bill Posey (R-Fla.) reintroduced a bill in the House to exempt premium cigars from FDA regulation. The agency’s deeming rule announced last May extended its authority to cigars, e-cigarettes, pipe tobacco, and hookah. Posey first introduced the legislation in 2015, but it failed to pass under the previous Congress.

Congress is also considering legislation to grandfather flavored e-cigarettes and other non-traditional cigarette tobacco products, which would allow them to stay on the market.

“This is especially troubling because the Surgeon General has found that these flavors are particularly attractive to kids,” Seward said, noting that flavorings are believed to be a major driver of the more than 10-fold increase in e-cigarette use among high school-age kids between 2011 and 2015.

She added that there is “real concern about what lies ahead for reducing tobacco use and, specifically, whether the FDA’s existing authority will be weakened.”

While President Trump has not yet named a new FDA director, past actions by his pick for Health and Human Services (HHS) secretary have not lessened this fear.

Rep. Tom Price, MD (R-Ga.), was one of the few members of Congress to vote against giving FDA authority over tobacco, and he also voted against continuation of the Children’s Health Insurance Program (CHIP), which is largely funded by tobacco taxes.

As head of HHS, Price would have authority over the FDA, the CDC, the National Institutes of Health, and other major health agencies.

Myers said lobbyists from the e-cigarette industry are working to convince lawmakers to effectively prevent the FDA from regulating the products, as are groups that oppose government regulation on ideological grounds.

On Jan. 17, a coalition of a dozen free-market and anti-tax activist groups opposed to e-cigarette regulation, including FreedomWorks and Campaign for Liberty, sent a letter to Congress urging that all products on the market before the regulations went into effect last August be exempt from key provisions of FDA oversight, arguing that regulation “is depriving smokers of a demonstrably safer alternative (to traditional cigarettes).”

“While everyone’s focus seems to be on the White House, the tobacco industry has made it clear that it intends to urge Congress to dramatically curtail what has been working to reduce tobacco use,” Myers said.”It may feel like we’ve been back this year for a really long time, but it’s still early.”

There’s Nothing Sexy About An E-Cigarette Exploding In Your Face

http://www.forbes.com/sites/robwaters/2017/01/17/theres-not-much-sexy-about-an-e-cigarette-exploding-in-your-face/#2bab2377177e

Rob Waters ,

Contributor

I write about health, science and our crazy healthcare system.

Opinions expressed by Forbes Contributors are their own.

The last time I wrote about electronic cigarettes in this space, the post generated about as many comments as I’ve received from any piece (with the possible exception of the hate mail I got when I wrote about the need to permit federal funding for research looking at gun violence). The commenters called me a liar, an idiot and…well, you get the idea.

In that earlier post, I noted that e-cigarette marketers were peddling their products as cool and sexy. The ads are full of women with bare shoulders or in slinky blue satin who “smoke in style” (as an ad for blu e-cigarettes exclaims), while dangling their devices. Now, the continuing spate of news about e-cigs blowing up in the faces or pockets of users made me wonder what a new set of anti-e-cigarette commercials might look like. (Note to California Dept. of Public Health: there’s an idea for you here.)

E-cigarette devices have burst into flames in people’s pockets, blown up in their mouths or exploded while charging. Videos of them starting a fire from the pocket of a Fresno, California, bus rider or in a Leeds, England, market are now making the rounds on the Internet.

But this is no laughing matter.

Earlier this month, the Food and Drug Administration announced it is investigating the dangers of “battery-operated nicotine-delivery devices” as they clinically, but accurately, refer to e-cigarettes. The agency has documented 134 incidents of e-cigarette batteries overheating, exploding or catching fire.

The FDA will hold a two-day public workshop to discuss safety issues surrounding the batteries used in e-cigarettes on April 19 and April 20, 2017, that scientists and members of the public are invited to attend. Some wonder why it took so long.