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For years, the FDA has moved in slow motion on tobacco rules. Now, a dramatic acceleration on new restrictions.

When Donald Trump was elected president in November 2016, an era of federal deregulation was projected for many industry sectors, particularly tobacco.

The Trump administration Food and Drug Administration was expected to shift into lower gear, if not halt, its already slow-walking of asserting the regulatory authority given to it by a Democratic Congress in the 2009 Tobacco Control Act.

Instead, in a stunning 13-day turn of events, the FDA accomplished two once-improbable goals sought by public-health and anti-tobacco advocacy groups:

  • Getting Congress and Trump to approve raising the federal minimum age for buying and consuming tobacco products from 18 to 21. Trump signed the new minimum age language into law Dec. 20 as part of a federal spending bill.
  • Establishing a ban — potentially temporarily — on flavored closed/cartridge electronic-cigarette products outside menthol and tobacco. Thursday’s ban is set to go into effect in early February.

The FDA also determined that makers of nicotine liquids are manufacturers, and thus required to submit a premarket application by a federal court-mandated May 12 deadline in order to be included in a 12-month FDA review process.

The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users, particularly as it compares with traditional cigarettes.

If e-liquid manufacturers don’t apply, their products would be deemed as illegal to sell. However, being in the process allows their product to stay in the marketplace.

Analysts, industry officials and advocates have said for years it could cost millions of dollars for each product to go through the premarket regulatory pipeline.

The FDA, meanwhile, has estimated it would cost about $500,000 per product. FDA officials said Thursday they would offer application assistance to small manufacturers of vaping liquids.

Finding a balance

For a Trump administration trying to revive so-called “clean coal,” lower automobile emission standards, and rescind, if not eliminate, Affordable Care Act health regulations, the willingness to expand tobacco restrictions appears out of character.

But analysts say the national outcry, or some would say histrionics, over the vaping crisis in 2019 may have forced Trump and the FDA’s hands with the public.

The FDA was given the authority in June 2009 to: remove ingredients considered as hazardous; restrict the marketing and distribution of cigarettes and smokeless tobacco; focus on limiting the impact of advertising on youth; expand warning labels; and stop the use of such characterizations as “light” or “low tar.”

At that time, e-cigarettes were in their infancy, mostly made in China with little popularity with smokers.

The FDA’s dilemma has been that there are no safe-for-consumers tobacco products, even with the potential for reduced risk with e-cigarettes and snus.

The risk with an FDA “seal of approval” for tobacco products is that it would be perceived as a symbol that they are appropriate to consume, rather than just less harmful than traditional-cigarette products that contribute annually to more than 400,000 premature deaths in the U.S. alone.

There have been only four tobacco products to have gained a form of FDA authorization: iQOS heat-not-burn traditional cigarette by Philip Morris USA; the very-low-nicotine traditional cigarettes Moonlight and Moonlight Menthol by 22nd Century Group Inc.; and the General Snus style of Swedish Match.

They all carry the caveat that it does not mean “these products are safe or FDA approved.”

R.J. Reynolds Tobacco Co. said in July 2018 that its heat-not-burn traditional cigarette, Eclipse and Eclipse Menthol, had received market authorization from the FDA. Reynolds has not announced a test market for the Eclipse styles after initially projecting it would begin such an effort by July 2019.

Thom Golab, president of the American Council of Science and Health, a health-care think tank, said the FDA’s challenge remains “finding a balance on tobacco and public health to eliminate as much exposure to underage users as possible, while also expanding the potential for electronic cigarettes to be a public-health benefit for those trying to stop smoking.”

“Flavors are necessary for enticing people to buy your product, whether it’s candy, soft drinks, fast food or tobacco.”

That’s why Golab said he is hopeful the FDA will accelerate its review process of innovative tobacco products, particularly the premarket application process, so that flavored e-cigarettes can be returned to retail outlets if determined to have an overall public-health benefit.

Warning labels

When the Tobacco Control Act was enacted in June 2009, the FDA provided a guideline for implementing new restrictions expected to be fully in place by 2012.

For example, traditional cigarette flavorings outside menthol were to be banned by September 2009 — not a major task given most manufacturers already had abandoned candy and fruit flavors.

The law required FDA premarket approval for new products, those introduced after Feb. 15, 2007. There was an exemption for new products if they were substantially equivalent health-wise to existing products.

Camel Snus, the top-selling snus in the U.S., was introduced by Reynolds before February 2007, and there were similar snus products in existence as well.

Litigation from U.S. tobacco manufacturers successfully bogged down some of the FDA’s roll-out initiatives.

One example is the FDA’s efforts to put new graphic warnings labels still have not reached cigarette packaging.

The FDA said in August 2019 that it has released a new set of 13 graphic warning labels for traditional cigarettes that are toned down considerably from its first attempt in 2012. They include images of diseased lungs, a man with surgical stitches from heart or lung surgery and a child with an oxygen mask.

The warnings have been mandated by a federal judge to be in place by March 2020 for cigarette packaging and marketing. The ruling does not affect other tobacco products, such as electronic cigarettes.

By July 2021, the labels would be required to cover the top 50% of the front and rear panels of cigarette packages, as well as at least 20% of the top of cigarette advertisements.

“The FDA needs to stop focusing on the flavorings and for once, focus on the nicotine, which is the problem,” said Michael Siegel, a professor in the Boston University School of Public Health.

“The epidemic we have is not one of youth flavor use, but of youth addiction to the Juul device ... because Juul has more than 50 milligrams/milliliters of nicotine salts.”

“If policy makers were interested in protecting the health of Americans, the first thing they would do is to get the nicotine out of combustible cigarettes and restrict their sale to tobacco shops that are only open to adults.

“The second thing they would do is limit the level of nicotine salts in electronic cigarettes, especially Juul.”

Regulations

Four months after the Trump administration took office, it chose in May 2017 to give federal health officials more time to evaluate Obama administration-era guidelines on e-cigarettes, vaporizers and other innovative nicotine and tobacco products.

As a result, rules that were supposed to go into effect were put on hold, supposedly for just three months.

Those guidelines include: manufacturer submission of cigar warning label plans; registration and listing; ingredient listing; health documents; substantial equivalence exemption requests; substantial equivalence applications; premarket tobacco product applications; and harmful and potentially harmful constituent reports.

Meanwhile, Sen. Ron Johnson, R-Wis., sent a letter to the FDA commissioner warning that a Republican-controlled Congress and White House would take aim at the August 2016 regulations.

Johnson said part of his motivation is that the costs of adhering to the new regulations “are so needlessly high that the very existence of the vapor products industry is being threatened.”

For example, a bill sponsored by Rep. Duncan Hunter, R-Calif., would require that e-cigs no longer be classified as tobacco products.

Gregory Conley, president of the American Vaping Association, said the fact that President Trump “is also a teetotaler who has never drank or smoked” likely influenced his decision in September to support a more extensive banning of flavored tobacco products.

“The only voices President Trump was hearing from the morning he announced the ban were pro-ban advocates like HHS Secretary Alex Azar and Kellyanne Conway,” Conley said.

David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cig studies, said that “since the time of initial regulation of nicotine-replacement therapy products, there has been the seemingly absurd position that the least hazardous nicotine products are subject to the greatest regulatory constraints.”

Some studies, including one by the Royal College of Physicians, have claimed e-cigs and vaporizers are up to 95% less harmful than traditional cigarettes. The Royal College’s study on traditional cigarettes played a key role in the landmark 1964 surgeon general’s determination.

“The public positioning on vaping has been overwhelming focused on risks rather than benefits,” Sweanor said.

“To the extent that the use of a low-risk form of nicotine is now widely seen as a bigger problem than the 500,000 annual U.S. deaths from cigarette smoking.

“Fears often outweigh facts, and politicians are responding to the public mood,” Sweanor said.


Local
2019 in Review: The Arts -- Changes, challenges and crowd pleasers abound in the world of Winston-Salem arts

Any year that includes a National Black Theatre Festival, the birth of a new performance space and a new music director for the Winston-Salem Symphony can be counted as a good year for the arts in Winston-Salem.

Although the Arts Council of Winston-Salem and Forsyth County fell short of its annual fundraising goal, it redeemed itself by rolling out a 200-seat theater, complete with an inviting combination lobby and art gallery, and local-artisan gift shop just in time for the opening of the 15th biennial Black Theatre Festival.

The Reynolds Place Theatre is now the resident theater for the Little Theatre, other performing arts organizations and the N.C. Black Repertory Co. that produces the Black Theatre Festival and other shows year-round, including fully produced plays, commissions and intimate “living room theater.”

The focal point of the Rhodes Center lobby is the ArtisTree, which features eight different-length tree branches with a 60-foot span.

The renovation, which included sound improvements to the Mountcastle Forum black box theater, cost $2.7 million.

Theater space in Winston-Salem had shrunk by nearly 1,200 seats in 2018 when the arts council sold the Arts Council Theatre on Coliseum Drive (540) to a church, and Performance Place (647) on the UNC School of the Arts campus closed for renovations.

Reynolds Place Theatre made a little dent in that, and Performance Place reopened this summer after getting a few minor improvements. Its largest theater space, the Freedman Theatre, seats 368; Catawba Theatre seats 179, and the Patrons Theatre holds up to 100.

The Milton Rhodes Center has two other theaters: Hanesbrands Theatre, which seats about 228; Mountcastle Forum seats about 120.

The current seating capacity of the Stevens Center, which belongs to UNCSA, is 1,366. A plan to renovate it, initiated by former Chancellor Lindsay Bierman, would reduce seating to 1,024 but increase two levels of seating to three, providing more leg room and street-level access to orchestra-level seating.

To pique the public’s interest, Bierman hired a facilities director Wiley Hausam who has begun programming intriguing concerts, including Kathy Mattea, Steve Earle and an all-female mariachi band, Flor De Toloache.

Hausam also programmed Winston-Salem’s first touring Broadway show in many years, “Kinky Boots,” which sold out, and several more musicals are planned, including “The Color Purple” in May.

Music man

If the arts council is the administrative backbone of the arts community, the symphony orchestra is its artistic heart.

In July, the organization announced that Timothy Redmond, a Londoner, would be the symphony’s fifth music director.

He was the last of five finalists who interviewed and auditioned for the job in 2018 and 2019, vetted down from 121 applicants.

David Levy, a professor of music at Wake Forest University and a former symphony musician who writes the program notes for the symphony’s concerts, was on the search committee.

“Overall, Tim was the strongest candidate,” Levy said. “As a conductor, he got the musicians excited to play, and he got the audience excited. In some ways, he’s the most experienced of the conductors.”

Redmond said that he found the team at the symphony and the city of Winston-Salem to be inspiring. “It seems like everybody wants to do more and better,” he said. “And you don’t get that vibe everywhere.”

He conducted his first concerts as music director Oct. 27 and 29, featuring Stravinsky’s “The Rite of Spring.” His next concerts will feature Béla Fleck playing his “Juno” banjo concerto on Jan. 11 and 12, and “John Williams: Star Wars and Beyond” in February.

Black theater holy ground

Performers, celebrities and audience members once again declared Winston-Salem “black theater holy ground” when they took their songs and celebrations into venues, restaurants and streets downtown and beyond.

The brainchild of the late Larry Leon Hamlin exceeded expectations artistically and financially in 2019.

“From a tourism perspective, the economic impact of the visitors that are staying in our hotels are generating approximately $8 million,” said Marcheta Cole Keefer, director of marketing and communications at Visit Winston-Salem.

Besides dozens of performances, a film festival, vendors and the international colloquium, the 2019 festival boasted appearances by such celebrities as the honorary co-chairs Chester Gregory and Margaret Avery; Ted Lange of “Loveboat Fame” who directed the festival’s first Shakespeare at Sunset, “Twelfth Night”; and a visit from actor André De Shields, who took his one day a week off to attend the festival.

Follow the money

In September, officials at UNC School of the Arts announced the institution’s first capital campaign in 20 years.

With a goal of $65 million, the campaign, nicknamed “Powering Creativity: The Campaign for UNCSA,” is also the largest in the school’s 50-plus year history. It had a quiet start in 2016 with a $5 million gift from former Chancellor Alex Ewing, who died in 2017. Since then, the school has raised more than $54 million, leaving less than $11 million to raise by June 2021.

Money from the campaign is earmarked for five main initiatives: scholarships, $25 million; faculty support, $8 million; innovation, $18 million; facilities improvements, $12 million; and community engagement, $2 million.

“ ‘Powering Creativity’ describes what we do better than anything else,” said Brian Cole, UNCSA’s interim chancellor. “The arts power our lives, society, our minds.”

On a smaller scale but in a big move for a community theater, Winston-Salem Theatre Alliance in April bought a 16,484-square-foot building on .92 acres at 650 W. Sixth St. In November, officials kicked off the first public capital campaign in the theater’s 36-year history. They aim to pay for (about $2.5 million) and complete renovations on the building by 2021.

The first floor will include a mainstage theater with 200 seats, box office, lobby, restrooms, a scene shop for set construction and the actors’ dressing rooms. Their current theater on Northwest Boulevard seats 120.

In the second phase, on the second floor, they aim to build a costume shop, prop storage, restrooms, rehearsal space, a meeting room and a black box theater with 50 seats.

Although the Arts Council of Winston-Salem and Forsyth County announced in October that it had missed its annual fundraising target by $250,000, Randy Eaddy, president and chief executive, said that he would not lower his sights.

“I’m not going to aim low to improve our odds of success,” Eaddy said. “We can live with the fact that we set a high goal and didn’t reach it.

“We set our 2020 goal for $2.5 million, and we will raise as much as we can, because the organizations that we serve deserve it.”

Awards, honors, kudos

Familiarity can lull us into forgetting how awesome an organization or person right under our noses really is.

Last January, USA Today named RiverRun International Film Festival in Winston-Salem one of the “10 amazing film festivals worth traveling for.”

RiverRun is an Academy Award-qualifying festival in two categories: Documentary Short and Animated Short. It is held annually in April.

In February, Gov. Roy Cooper and first lady Kristin Cooper honored African American artists and musicians from the Triad — and throughout North Carolina — at a reception in the Executive Mansion in Raleigh.

Locally, the late Larry Leon Hamlin and his widow, Sylvia Sprinkle Hamlin, were cited for their contributions to theater arts.

Jackie Alexander, N.C. Black Rep’s current artistic director, was cited for his theatrical contributions to the state.

Simona Atkins Allen was honored for helping found Delta Fine Arts, the Southeast’s first gallery and arts organization established by black women. Her contributions have helped bring the work of internationally known African-American artists to the city, including permanent murals by John Biggers at Winston-Salem State University.

Endia Beale, an internationally renowned photographer who is the director of Diggs Gallery at Winston-Salem State, was born and reared in Winston-Salem.

Patrick Denard Douthit, aka 9th Wonder, a Winston-Salem native and a producer, record executive, DJ, rapper and educator, was honored.

In June, long-time Winston-Salem resident Rosemary Harris received a Special Tony Award for Lifetime Achievement in the Theatre.

New hires

William J. “Bill” Carpenter, an educator with an English degree, became the new executive director of the Southeastern Center for Contemporary Art in June.

Carpenter, 46, came to SECCA from High Point University, where he had been a professor of English and director of the Honors Scholars Program.

Carpenter grew up in New Jersey and has a doctorate degree in English from the University of Kansas.

Also in June, Sawtooth School for Visual Art appointed Amy Jordan to the role of executive director.

Jordan had served as interim executive director since the departure in January of former president and chief executive Geoff Corbin.

Before that, she was the vice president of Arts and Innovation and had filled various roles at Sawtooth for the past seven years.

She first became acquainted with Sawtooth in high school, when she participated in the Summer Arts Honors Program, which she credits as being a turning point in her lifelong arts journey.

In November, the Little Theatre of Winston-Salem named Philip Powell as its interim executive director, replacing Lane Fields.

Acting and directing professionally for more than 25 years, Powell has a bachelor’s degree in Communication and Theatre from Asbury University in Wilmore, Ky.


Local
Judge awards nearly $300,000 to man allegedly defrauded by Clemmons financial adviser

A Clemmons man indicted on multiple charges of investment fraud is now facing a $294,500 civil judgment awarded to one of his alleged victims.

Russell Joseph Mutter, 50, of Curraghmore Road in Clemmons, has 41 criminal counts, including investment adviser fraud, financial exploitation and obtaining property by false pretenses, that are all pending in Forsyth Superior Court. Indictments said that the alleged victims were clients of Mutter’s company, RJM Financial LLC, and that Mutter withdrew money from his clients’ accounts and deposited the money into his own accounts without his clients’ permission. He is also accused of falsifying documents to cover up the fraud.

One of the alleged victims is Mutter’s father, according to the indictments.

Another of his alleged victims, Phillip K. Edwards, won a $294,500 judgment in a lawsuit he filed against Mutter and Vanguard Fiduciary Trust Company. Vanguard was voluntarily dismissed from the lawsuit in June 2019, leaving Mutter as the remaining defendant. Although he was served with the lawsuit while he was in the Forsyth County Jail, Mutter never filed a written response.

Judge Michael L. Robinson of Forsyth Superior Court granted a default judgment on Dec. 19, 2019, awarding Edwards compensatory damages in the amount of $294,500. He also found that Mutter breached a contract. He did not find that Mutter committed a breach of fiduciary duty or that he committed constructive fraud. Robinson also denied a request for punitive damages.

Chris Beechler, who represents Mutter on his criminal charges, said Friday that he had not seen Robinson’s order. Mutter’s priority has been dealing with his criminal case, which could come to trial this coming fall, Beechler said.

“He’s not in any position to do anything with those cases,” Beechler said, referring to civil lawsuits that have been filed against Mutter. “It’s going to be some time before those orders can be addressed.”

James Faucher, Edwards’ attorney, said it is sad what Mutter is alleged to have done to Edwards and more than a dozen other people.

“I don’t expect that we will ever collect that amount of money from Mr. Mutter,” he said. “We were happy to obtain that amount of money as a measure of justice.”

Another judge, Stuart Albright, awarded another one of Mutter’s alleged victims, Phillip E. Boydston, a $900,000 civil judgment.

In Edwards’ case, Mutter acted as an agent of Vanguard and gained access to Edwards’ investment accounts in 2014, according to Robinson’s order. Mutter was able to transfer money out of Edwards’ account at Vanguard without Edwards’ consent or knowledge, Robinson said in his order.

As a result, Mutter withdrew $294,500 between October 2014 and January 2017. Then, Mutter deposited that money into his bank account at Allegacy Federal Credit Union, Robinson’s order said.

Robinson said that Mutter covered his tracks by providing Edwards with forged account statements. Edwards didn’t find out about the forgery until Dec. 7, 2017, and he didn’t discover that Mutter had been taking money out of his account until Jan. 2, 2018.

Mutter was initially indicted on allegations that he defrauded Edwards, Boydston and another man, Walter R. Whiteman. Mutter was accused of taking a total of $904,000 from the men’s retirement accounts.

At a hearing in May 2018 to set bond, Shannon O’Toole, a special agent with the N.C. Secretary of State, said Mutter made a bet that would pay off if the market collapsed. It didn’t work out that way, and he lost the men’s money, O’Toole and Forsyth County District Attorney Jim O’Neill said at the hearing. To cover his tracks, he created fake documents that he would send to the three men.

“I truly believe, in his mind, he thought the market would correct,” O’Toole said at the hearing. “He was swinging for the fences and he was waiting for that.”

Mutter is in the Forsyth County Jail with bond set at $5 million. The N.C. Secretary of State has a permanent order against him that prohibits Mutter and his company from conducting business and recruiting new clients.