FDA Publishes Final Rule To Reduce Ambiguity For Products Made Or Derived From Tobacco

The FDA on Jan. 9th published a final rule entitled Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” to clarify that products made or derived from tobacco will be regulated as drugs, devices or combination products rather than tobacco products if they “are intended to 1) diagnose, cure, mitigate, treat or prevent disease, including use in smoking cessation, or 2) affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco prior to March 21, 2000.”

Source:

Food and Drug Administration

Source Date:

January 10, 2017

https://www.tma.org/article/2017/clarification-when-products-made-or-derived-tobacco-are-regulated-drugs-devices-or-0?utm_source=TMA+Publications&utm_campaign=11d472ef4d-EMAIL_CAMPAIGN_2017_01_12&utm_medium=email&utm_term=0_f85a4ca640-11d472ef4d-72141293

Fontem, Nu Mark End E-Cig Patent Fight With Settlement

Law360, New York (January 6, 2017, 4:40 PM EST) — Fontem Ventures BV has reached a settlement with Nu Mark LLC in a fight over electronic cigarette patents, ending an infringement lawsuit as well as challenges that Nu Mark had launched attacking the validity of the patents. 
Fontem, a unit of U.K tobacco company Imperial Brands PLC, and Nu Mark filed papers Wednesday in North Carolina federal court to dismiss the lawsuit. The companies have also agreed to resolve cases at the Patent Trial and Appeal Board.

Terms of the agreement were not disclosed in court documents. A spokesman for Altria Group Inc., the parent of Nu Mark, said the company was pleased the issue had been resolved but declined to disclose details of the settlement.

Representatives for Fontem did not immediately respond to a request for comment.

The company sued Nu Mark in the spring of 2016, alleging its MarkTen and GreenSmoke products infringed eight patents. The suit was one of several that Fontem has filed against e-cigarette manufacturers in recent years.

It has also gone after the likes of R.J. Reynolds Vapor Co., maker of the top-selling Vuse; Spark Industries LLC; and Logic Technology Development LLC, among others.

Not long after the suit was filed, Nu Mark challenged each of the patents it was accused of infringing at the PTAB. It requested the board examine the patents in inter partes review, arguing that claims in each were invalid.

While some of Nu Mark’s petitions were still pending, the PTAB had declined to institute review in a handful of those cases, including one last month, when it said Nu Mark’s arguments about parts of a patent being obvious relied on evidence that had already been considered by a patent examiner.

The board said Nu Mark was, in effect, asking it to “second guess” the U.S. Patent and Trademark Office examiner.

“We are not persuaded that adjudicating a dispute on an already considered issue is an efficient use of the board or party resources,” the board wrote in its Dec. 15 decision.

Fontem in November 2013 paid $75 million to acquire e-cigarette technologies from Dragonite International Ltd. Hon Lik, a Chinese pharmacist who founded Dragonite and is widely recognized as being the inventor of the e-cigarette, also joined the company.

In addition to this week’s settlement with Nu Mark, Fontem has reached deals with companies including NJOY Inc., Vapor Corp. and Electronic Cigarettes International Group Ltd. to end patent litigation. Each of those three publicly announced deals included license agreements.

Fontem and R.J. Reynolds recently told the judge overseeing their case that the companies are working to identify a mediator that they can agree on.

The patents at issue are U.S. Patent Numbers 8,365,742; 8,375,957; 8,393,331; 8,689,805; 8,490,628; 8,863,752; 8,893,726; and 8,899,239.

Fontem is represented in the Nu Mark case in district court by Michael J. Wise, Joseph P. Hamilton, Lara J. Dueppen and Courtney M. Prochnow of Perkins Coie LLP, and Stuart H. Russell and G. Gray Wilson of Wilson Helms LLP.

Nu Mark is represented by Gregory P. Stone, Peter A. Detre, Peter E. Gratzinger and Zachary M. Briers of Munger Tolles & Olson LLP, Anish Desai, Elizabeth S. Weiswasser and Stephen Bosco of Weil Gotshal & Manges LLP, and Gregory C. Holland and Whit D. Pierce of Smith Moore Leatherwood LLP.

The case is Fontem Ventures BV et al. v. Nu Mark LLC, case number 16-cv-01261, in the U.S. District Court for the Middle District of North Carolina.

–Editing by Aaron Pelc.

https://www.law360.com/articles/878255/fontem-nu-mark-end-e-cig-patent-fight-with-settlement

Donald John Bores – November 21, 1934 – December 1, 2016

With sadness I pass on this information. Don helped me greatly and I will miss him greatly.

Lou

Donald John Bores

November 21, 1934 ~ December 1, 2016

Just 10 days after celebrating his 82nd birthday at home in Apopka, Florida, Don, ‘Pops’ Bores

received an opportunity for yet another venture that he could not pass up. This one came with a

great sign-on bonus of meeting his Creator and being reunited with his friends and loved ones

that have gone before him. He has accepted this new opportunity and has left us, not to return,

while he beings this new journey. He will be missed beyond measure.

Don began his first venture in Brecksville, Ohio, the oldest son of Kazmer and Wanda Bores.

His entrance was followed by his brother, Ken and many years later by another brother, Jack.

He spent his early years in Ohio, playing first string quarterback at and graduating from

Brecksville High School before entering Kent State University where he graduated with a

business degree in 1957. He served in the United States Marine Corp & Reserves from 1957 to

1963.

Don met Patricia Morin on a blind date in 1960 and they were married in 1961 in a beautiful

church in Nashua, New Hampshire. Together they had three children, Michelle, Linda and DJ.

Don began his career at Norwich Eaton Pharmaceuticals, where he spent 25 years and held

several positions cumulating with the Director of Sales and Marketing. His positions took him

and his growing family to live in several states including Ohio, New York, & Illinois. When Don

felt he’d shared enough of his talent at Norwich Eaton, he joined Brown and Williamson in 1980

in Louisville Kentucky, as the Director of Trade Marketing.

Don was married to Patricia for 25 years and although their marriage ended, their friendship

never did. From 1985 to 1992 Don was married Shirley Engelmeier, and they had one son,

John Michael Bores, who gave Don a second chance at fatherhood at 55 years old, one that he

took very seriously and as a result he had an extra special connection with John.

After 7 years at B & W he felt the need to go out on his own so he started CTI, (Consultant to

Industry) in 1987. His success there and cumulative experience in the industry encouraged him

to establish Tobacco Trade Magazine in 1998, and one year later a successful candle business

in 1999. Although that would be an impressive career for most, Don was just beginning. He

continued on to establish the NATO (North American Trade Organization) trade show in 2004,

(and was just recently honored by them in 2015) while he continued to consult with MSA

(Management Science Associates) for almost 25 years and with American Tobacco for almost

10. Although he officially retired at least twice, (retirement parties included) he continued

actively working, obtaining patents and direction for his newest venture which holds great

promise, until his last days on earth while still consulting and directing his other businesses.

Don was recently perfectly described as ‘Gritty and Generous’. He was never afraid to color

outside of the lines, take risks or keep going until he got a ‘Yes’.

Don had a fondness for Fox News, talking politics, beautiful cars & homes, sports, golf, travel, a

good (or not so good) Pinot Grigio and an Outlaws cigar. He was an avid golfer until age 75 (4

hole in ones!) and played regularly with his two best friends Stu and Steve until they left this

earth to pursue their own adventures. It was rare for him to say anything negative, unless it had

to do with California or Democrats. But, without a doubt Don’s biggest passion was his family.

His children have blessed him with 8 amazing grandchildren: Cristen, Ryan, Christian,

(Gabriella) Matthew, Patrick, Katie, Justin & Nolan. He was the driving force in keeping his kids

and grand kids together & connected despite their geographic distance. He was generous to

everyone he met whether it be a neighbor, friend, (or friend of a friend) or a local church or

business. His generosity to his family was extra ordinary and he was responsible for so much,

including but not limited to: annual family vacations, home improvements, education, braces,

cars, washer/dryers, or any other need they might have.

Pops worked hard to build a family that he was proud of and he has left a great legacy. He led

by example (and by lots of direction and advice…both solicited and not) He taught about

honesty, integrity, unconditional love, hard work, making time to enjoy life, kindness, loving and

accepting everyone for who they are (unless they are a Democrat), generosity, humor, faith in

ourselves, confidence, getting the job done right, and success. He was proud of all of his

children and grandchildren, and they were proud of him. He made sure his family remained

very close to each other and that may be one of his biggest gifts that lives on with them. We are

better people because of him.

Don Bores was a great example of a life well lived. He lived life on his terms and yet he was the

ROCK to so many and made an impact on all he met. His departure has left a hole that will

never be filled but also a memory and example that will never be forgotten. He was a true

legend. In addition to his 4 children and their families, and 8 grandchildren, he leaves behind

his two brothers Ken and Jack and their families, his Aunt Jane Martin, sister in law Priscilla

Morin and very special neighbor, best pal and partner Linda Lipham, and her family, their dog

Gracie and so many friends, family and business connections.

Long live the beauty and strength that comes down from you and into all of us Pops. You will

remain forever in our hearts.

Services to be held:

Funeral Visitation/Wake

Monday, December 5th from 6-8pm

Baldwin Fairchild Funeral Home

601 North Park Ave

Apopka, FL 32712

Funeral Service

Tuesday, December 6th from 10:30am

St. Francis of Assisi Catholic Church

834 S Orange Blossom Trail

Apopka, FL 32703

There will be an open house at Don’s home immediately following the funeral service (1792

Cranberry Isles Way, Apopka, FL 32712).

Should you wish to honor Don, please make a donation to your favorite charity in his name.

 

NJOY Files for Bankruptcy

The e-cigarette manufacturer files for relief under Chapter 11 after its Kings 2.0 fails to perform.

NJOY Inc., the electronic cigarette manufacturer, filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code late Friday, Sept. 16, in Delaware.

The failure of NJOY’s Kings 2.0 device was behind the bankruptcy filing, according to Law360, which pointed to court filings in which NJOY President Jeffrey Weiss noted that NJOY sustained significant losses after it rolled out Kings 2.0, which was an updated version of its Kings disposable e-cigarette. Kings 2.0 rolled out near the end of 2013, but the product did not perform as expected.

The Debtor’s case was assigned case no. 16-12076 and is pending before the Honorable Christopher Sontchi in the U.S. Bankruptcy Court for the District of Delaware. The hearing is set for Sept. 20 at 9:30 a.m. EST.

FDA Inspects Retailers for Tobacco Regulation Violations

The fines for tobacco regulation violations have been increased for all fines issued after Aug. 1, 2016.

A new report from the National Association of Tobacco Outlets (NATO) has revealed that 55 retailers have received warnings from the U.S. Food and Drug Administration (FDA) for selling tobacco products to a minor decoy. No fines were issued with these warnings, but the FDA has stated that the stores in question will be re-inspected to determine if further violations occur.

NATO has released a statement encouraging its member stores to remind their staff about complying with federal law, which prohibits the sale of tobacco products, including cigarettes, RYO, smokeless tobacco, cigars, pipe tobacco, e-cigarettes/vapor products and hookah tobacco, to underage youth.

In addition to performing inspections on retail stores that sell tobacco products, the FDA has announced that it has increased the monetary fines that are charged to retailers who violate the federal tobacco regulations, NATO reported. The Federal Civil Penalties Inflation Adjustment Act of 2015 allows federal agencies to adjust monetary fines for inflation once a year, and this increase was made in accordance with this legislation.

The adjusted fine amounts apply to retailers who were fined after Aug. 1, 2016.

According to the report from NATO, the adjustments to the fines are as follows:

  • One Violation: The fine of $0 with a warning letter remained the same.
  • Two Violations within a 12-Month Period: Increased from $250 to $275
  • Three Violations within a 24-Month Period: Increased from $500 to $550
  • Four Violations within a 24-Month Period: Increased from $2,000 to $2,200
  • Five Violations within a 36-Month Period: Increased from $5,000 to $5,501
  • Six Violations within a 48-Month Period: Increased from $10,000 to $11,002

September 16, 2016

FDA Inspects Retailers for Tobacco Regulation Violations

The Value of BARS Reporting

Build Both External & Internal Value Using BARS Reports

The value of incorporating the BARS Reporting Program into company culture when it comes to the sale of age-sensitive products such as alcohol and tobacco is both external and internal.  Sharing each and every result from the store visits provided by the BARS Program with the store manager, district supervisor and regional manager will reinforce a culture of using best practices when it comes to carding individuals purchasing these products.  By consistently sharing this message, all employees will become accustomed to carding on each visit, lessening the chances of being caught in a sting.

Externally, using the BARS reporting program can provide value by allowing clients to expand their business by voluntarily implementing our program.  A restaurant chain currently utilizing the BARS program was recently able to expand their liquor licenses in new locations by providing the liquor licensing board with the BARS reports, as well as a letter outlining the program and its implementation.  Many of their competitors are currently on hold for expanding liquor licensing.

When it comes to reporting, our system is unparalleled, and we encourage everyone selling age-sensitive products to implement a strong culture of carding everyone as soon as possible.  Not only can a sting and fines be avoided, it can help propel a business to the next level.  Contact us today at 1-877-540-5500 for a complimentary consultation. Ask for David or Richard. Please reference the Tobacco Today blog when speaking to David or Richard at the Bars Program.

***

Remember that the FDA’s new “deeming” regulations regarding the sale and manufacture of tobacco products such as e-cigarettes, cigars, hookah tobacco, and pipe tobacco—essentially extending the regulations already placed on cigarettes to most tobacco products—go into effect August 8! We will be touching base again in the early fall, but in the meantime, we welcome any questions you might have about ensuring your compliance.

 

Visit our Website

 

 

3 Simple Steps to Join The BARS Program

Rising Cig Taxes Force Pennsylvania Couple to Close C-store

Dollar hike went into effect Aug. 1.

SHARON, Pa. — August ushered in a $1 hike in Pennsylvania’s cigarette excise tax to $2.60 per pack. The move pushed Pennsylvania up the ladder to the 10th highest cigarette tax in the United States. It also pushed one local convenience store out of business.

“It really hurts because you’re trying to make a buck and they keep on penalizing you,” Toby Abrutz, owner of Korner News, told WYTV. “Every time you try to get ahead, the state puts another tax on something.”

Toby and Jaque Abrutz own the c-store and say the increased tax is more than they can take. Cigarettes were their main source of business; however, the owners just can’t keep up with the tax, they explained.

“There’s just not enough business. I mean, everyone is going to start going to Ohio now to buy their cigarettes,” said their daughter Lisa. “It’s been tough for a long time and it just really pushed us over the edge.”

Meanwhile, the Abrutz family is trying to figure out how to make ends meet. “My daughter’s putting in an order today and…we decided not to order cigarettes because we are going to wait and see what this does with the business all week,” Jaque Abrutz told the news outlet.

While the Korner News flagship location is closing, the Abrutz’s other location in uptown Sharon will remain open, the report added.

http://www.csnews.com/product-categories/tobacco/rising-cig-taxes-force-pennsylvania-couple-close-c-store?cc=3&utm_source=MV_CSNews+Daily&utm_medium=email&utm_content=HTMLLinkID%3a+14&utm_campaign=Sheetz+Finds+New+Sandbox+to+Play+In%3b+Fastrac+Revs+Up+With+Latest+Store+Opening

Prof. Glantz Says Vaping May Be 1/3 To 1/2 As Harmful As Cigarettes

Prof. Glantz Says Vaping May Be 1/3 To 1/2 As Harmful As Cigarettes

University of California, San Francisco Prof. Stanton Glantz said that even though eVapor products deliver fewer carcinogens than conventional cigarettes, agencies concerned about public health “should consider them at least 1/3 as bad as cigarettes and maybe as high as half as bad (or higher),” asserting that “the evidence that e-cigarettes substantially increase heart and lung disease keeps piling up” and “at least some of the short-term effects of e-cigarette use on [the cardiovascular system and lungs] are comparable to cigarettes,” citing separate studies by Aruni Bhatnagar of the University of Louisville, Nick Wilson of the University of Otago, and Elizabeth Martin of the University of North Carolina. Prof. Glantz cited a recent review, in which University of Louisville Prof. Aruni Bhatnagar notes that “even if the levels of acrolein in e-cigarettes are 10-fold lower than those present in conventional cigarettes, given the non-linear dose-response relationship between cigarette smoke and cardiovascular injury, it is not clear whether this would result in proportional harm reduction.” Prolonged (90 days) exposure to even low-dose (0.2 ppm) acrolein leads to non-specific inflammatory cardiac lesions, and therefore, the generation of acrolein and other aldehydes in e-cig aerosols, even in low concentrations, remains a cause for concern, according to Prof. Bhatnagar. Based on his review of the evidence, he concludes, among other things, that eVapor products “cannot be recommended as a safer alternative to smoking cigarettes.” Prof. Glantz also cited a review of studies on biological markers in vapers published by Prof. Nick Wilson and colleagues at Otago University in New Zealand, which found that vaping had smaller effects on the vascular system than smoking, but the effects were still substantial, and that smoking and vaping had the same effects on the physiological endpoint, or the ability of arteries to dilate. In another study, Elizabeth Martin and colleagues from the University of North Carolina School Of Medicine found that vaping results in the suppression of immune and inflammatory-response genes in nasal epithelial cells similar to cigarette smoke. Prof. Glantz contended that all of this accumulating evidence shows that the “evidence-free ‘expert opinion’ from group of e-cigarette enthusiasts that e-cigarettes are ‘95% safer’ than cigarettes, which was repeated uncritically by Public Health England and the Royal College of Physicians is wrong.” He said the “longer these organizations take to modify their positions on the emerging science the lower their credibility is becoming” (UC San Francisco 7/9).