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FDA unveils plans to restrict electronic cigarette flavorings to tobacco, menthol; enforcement projected to begin early February

The Trump administration made official Thursday its plans to implement heightened — and controversial — restrictions on most flavored electronic cigarettes by early February.

The Food and Drug Administration confirmed the regulatory change that was cited anonymously Tuesday by administration officials and hinted at by President Donald Trump.

The agency would eliminate all cartridge electronic-cigarette flavorings except for tobacco and menthol — those that are legal in traditional cigarettes.

The FDA is providing manufacturers of cartridge-based e-cigarettes, such as Juul Labs Inc., R.J. Reynolds Vapor Co., NJoy and Fontem Ventures, with just 30 days to stop making, distributing and selling “unauthorized flavorings” or risk enforcement actions.

“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes,” HHS Secretary Alex Azar said in a statement.

“HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally.”

The FDA said these products have been available at retail since August 2016 “as an exercise of its enforcement discretion.”

FDA Commissioner Dr. Stephen Hahn said federal regulators will review the use of tobacco and menthol flavorings by underage individuals — those under age 21 since Dec. 20 — and will be prepared “to take additional restrictive actions.”

The 30-day countdown goes into effect once the FDA’s notice is published in the Federal Register, likely early next week.

The countdown appears to affect tobacco and vape shops that make their own nicotine liquids for open-pod e-cigarettes. Some vaping advocates have said the premarket application process is too costly and too cumbersome for most vape shops.

“A vape shop that is in the business of manufacturing, by mixing nicotine and flavors, has a decision that it has to make about what business it wants to be in going forward,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

“If they are involved in the manufacturing process, they are subject to the law.”

Lyle Beckwith, senior vice president of government relations for the National Association of Convenience Stores, said that “our initial feeling is that while the open-pod flavors will not be a priority enforcement, any vape shop that mixes flavors will have to apply by May 12” or go out of business.

The FDA said for manufacturers and vape shops that submit premarket applications for their e-cigarette and vaping products by a court-ordered May 12 deadline, those products would be allowed to stay on the market for what is projected to be a 12-month review process from the time of submission.

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.

“Importantly, the FDA’s enforcement priorities are not a ‘ban’ on flavored or cartridge-based ENDS,” the FDA said. If a product meets the premarket stands, “then the FDA could authorize that product for sale.”

The original Vuse version by R.J. Reynolds Vapor Co. is the No. 2 selling e-cigarette. Its current flavors are tobacco, menthol, mint, rich tobacco, chai, crema, fusion, tropical, mixed berry, melon and nectar.

Unlike Juul, which limited itself to menthol and tobacco flavors in November, Reynolds has not voluntarily removed any of its flavors.

Reynolds Vapor entered the FDA’s regulatory gauntlet Oct. 11 with its submission for premarket approval of multiple Vuse e-cigarette products. The FDA said Nov. 30 it would review whether Vuse can claim it is a lower-risk tobacco product.

It is not clear whether a flavored e-cigarette other than menthol and tobacco can remain in the marketplace past early February if it is already part of a premarket application, or it would have to removed and then return once it is included in a premarket application submission.

Reynolds spokeswoman Kaelan Hollon said Thursday the company “is well positioned to submit applications for the remaining Vuse portfolio ahead of the deadline of May 12.”

“We have submitted a (premarket application) for multiple Vuse products, which includes several flavors. The FDA guidance provided today is clear that flavors can return to the entire marketplace once they have been cleared through the (premarket) process.”

Jack Bowles. chief executive of British American Tobacco Plc, said in a statement that "we have long said it is not the marketing of these products per se that is the concern; it is the irresponsible marketing of them that should be robustly addressed.

"For us, smart regulatory frameworks partnered with responsible marketing and appropriate enforcement will ensure the sustainability of adult consumer choice across all categories.”

"We are confident that, as required by the (premarket) process, all Vuse products will be shown to be appropriate for the protection of public health," Bowles said.

Federal health officials have said they view the nicotine liquids in open-pod vaping systems as a lower regulatory priority in part because those products have been of limited appeal to date to underage individuals, and in part because those outlets have been viewed as being better at enforcing age restrictions than other retail outlets, including convenience stores.

“This move will allow thousands of small businesses to remain open, but short-term exemptions will mean little without long-term reforms at the FDA,” said Gregory Conley, president of American Vaping Association. “We are now 130 days away from the exact class of vaping products President Trump exempted from his ban — open tank systems — being banned because of the sky-high costs associated with Obama-era rules the FDA is retroactively enforcing on vaping companies.”

The 30-day deadline also affects all electronic nicotine delivery products where manufacturers have failed to adequately put into place measures to prevent underage use, or products determined to target underage users or promote use of these products by those underage.

Azer said the regulatory changes serve to strike a balance “by prioritizing enforcement against the products that are most widely used by children and by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth.”

Fontem Ventures, maker of blu eCigs brand, continues to sell sweeter flavors, including honeymoon, neon dream, blue ice and melon time.

Juul, maker of the controversial top-selling e-cigarette, said Nov. 7 that it had reduced its flavorings to Virginia tobacco, classic tobacco and menthol flavorings — the same flavors allowed for traditional cigarettes. It ceased online sales of its mint pod products and halted orders from retailers and wholesalers.

In November 2018, Juul stopped selling its creme, cucumber, fruit and mango flavorings at retail outlets, but kept them available via age-verification requirements on its website.

“The evidence indicates that if menthol e-cigarettes are left on the market, kids will shift to them,” Myers said. “Decades of experience with menthol cigarettes demonstrate that menthol appeals to kids — in fact, over half of current youth smokers smoke menthol cigarettes.”

Myers claimed Juul would “exploit this menthol loophole by reclassifying its popular mint products as menthol.”

FDA officials said they would monitor any attempts to sell current mint flavors as menthol.


Z-no-digital
Duke Energy and challengers reach settlement in 'historic' coal ash cleanup that includes Belews Creek Steam Station

Duke Energy, state regulators, and environmental and community groups have reached a massive settlement agreement requiring that most of the utility’s submerged coal ash be disposed of in lined landfills.

The agreement means more than 76 million tons of coal ash now stored under water in basins will be excavated and buried in landfills, state officials said.

The settlement directly affects Belews Creek Steam Station in Stokes County, and five other active and former coal-fired plants in other parts of North Carolina where disposal methods had been in dispute.

State environmental officials hailed the pact as securing “the nation’s largest coal ash excavation of nearly 80 million tons.”

“North Carolina communities have lived with the threat of coal ash pollution for too long,” said Michael Regan, secretary of the state Department of Environmental Quality. “They can now be certain that the cleanup of the last coal ash impoundments in our state will begin this year.”

The decision does not affect the former, now-demolished Dan River Steam Station near Eden, where Duke Energy already has largely completed previously agreed-upon landfill disposal of long submerged ash.

Duke Energy had filed an appeal with the state Office of Administrative Hearings last year after DEQ regulators rejected the utility’s proposal to use a “cap-in-place” technique that would have left some of the ash in place at Belews Creek and several other North Carolina sites.

The utility had sought to cover stored ash at those sites under impervious caps the utility contended were just as safe as landfill disposal.

The agreement also promises to settle separate lawsuits by environmental and community groups that were under way in state Superior and federal court systems.

Environmental and community groups that signed onto the agreement included Appalachian Voices, the Stokes County Branch of the NAACP, Catawba Riverkeeper Foundation, the Sierra Club, the Waterkeeper Alliance and the Roanoke River Basin Association.

They were represented by the nonprofit Southern Environmental Law Center, which praised the agreement for its “historic” potential.

“The agreement is a historic cleanup of coal ash pollution in North Carolina, and the Department of Environmental Quality and community groups throughout the state have provided essential leadership in obtaining it,” said Frank Holleman, senior SELC attorney based in Chapel Hill.

The agreement will save Duke Energy about $1.5 billion particularly by allowing the utility to leave in place some of the ash that had been buried at coal-fired plants in Catawba and Person counties.

“This agreement significantly reduced the cost to close our coal ash basins in the Carolinas for our customers, while delivering the same environmental benefits as full excavation,” said Stephen De May, Duke Energy’s North Carolina president.

The utility now expects to spend a total of more than $8 billion cleaning up roughly 124 million tons that had been kept at one time in storage ponds near current and former coal-fired plants in North Carolina, company officials said.

Of that amount, Duke Energy said Thursday that it already had spent about $2.4 billion in preliminary work and actual closure efforts at Dan River and other North Carolina sites.

In addition to Belews Creek, other active coal-fired plants with ash basins covered by the settlement include the Allen Steam Station in Gaston County; the Mayo and Roxboro plants in Person County; the Rogers Energy Complex in Rutherford and Cleveland counties; and the Marshall Steam Station in Catawba County.

The 33-page agreement among Duke Energy, state regulators and seven environmental or civic groups specifically addresses each of the six plants where ash disposal had remained at issue.

At Belews Creek near Walnut Cove, the agreement acknowledges that Duke Energy estimates it will take until late 2031 to excavate and take to a lined, on-site landfill all 11.9 million tons of ash stored there in a 270-acre basin.

That’s two years past the closure deadline currently set by state Coal Ash Management Act, but the agreement forecasts that Duke Energy would have the right to seek deadline extensions by petitioning regulators for additional time.

No such petition would be granted to push the mandatory completion date at Belews Creek past Dec. 31, 2034, according to the agreement.

“This paragraph does not constitute a variance for the CAMA deadline for completion of closure,” the agreement says, referring to the Dec. 31, 2029 endpoint set for closing all coal ash basins by the state Coal Ash Management Act that is widely known by its CAMA acronym.

Rather, the utility could petition state DEQ for any such delay and the environmental agency could approve or disapprove as it saw fit, according to the settlement agreement.

The N.C. General Assembly adopted CAMA after a February 2014 coal ash spill from a storage basin at the former Dan River Steam Station in Rockingham County spewed contamination for miles downstream.

That incident occurred after a storm water pipe failed under a storage basin that no longer exists, sending an estimated 39,000 tons of waste into the neighboring river.

At Belews Creek, the new agreement requires Duke Energy to “remove or permanently close all pipes currently running through or beneath the ash basin.”

As an alternative to on-site disposal in a lined landfill, the settlement allows Duke Energy to recycle its Belews Creek ash as an ingredient in cement or any other “industrial process at least as environmentally protective.”

The agreement also requires Duke Energy to build a wall or other such structure if needed at Belews Creek to “prevent lateral movement” of submerged ash or that which is already stored in its Pine Hall Road Landfill nearby.

The agreement would enable Duke Energy to leave in place about 100,000 tons of ash buried in that landfill, “which is capped with a geosynthetic cap and has been closed pursuant to (a state permit) and stopped receiving coal ash in 2014.”

The utility also agreed to do additional, extensive monitoring of groundwater and surface water near the Belews Creek plant to ensure neither is being contaminated by any of its activities.

Coal ash contains trace elements of various metals and other constituents that can be harmful to human health when encountered in heavy enough concentrations.

As part of the agreement, Duke Energy sent DEQ detailed closure plans Monday for Belews Creek and the other disputed plants that include “corrective action” plans for each site.

“The public will have an opportunity to comment on the closure plans at public hearings near each of the six sites in February,” DEQ said Thursday in a news release.

Under CAMA, state regulators have four months to take final action on such plans. After getting the go-ahead from DEQ for each plant, the utility would have 60 days to begin work.

At all six sites, the agreement requires Duke Energy to meet water-quality standards within 500 feet of storage areas or before it reaches the next property owner’s land, if that is closer.

With nearly 12 million tons of submerged ash, Belews Creek has the third largest amount to excavate at the six plants covered by the new agreement. Roxboro and Marshall have more at about 16.8 million tons each.

The agreement notes that Duke Energy expects that it can complete the closure process as soon as Dec. 31, 2028, at the Rogers and Mayo plants, but not until late 2035 at the Roxboro facility.


Local
City of Winston-Salem, others say court properly dismissed UDC Confederate statue lawsuit

The city of Winston-Salem says a lawsuit filed to force the return of a statue of an anonymous Confederate soldier to downtown is flawed because the United Daughters of the Confederacy cannot show that it has any rights over the placement of the statue and the memorial plinth it stood on.

As the UDC’s challenge of the Confederate monument’s removal from the southeast corner of West Fourth and North Liberty streets moves forward through the court system, legal briefs have been filed by the UDC, the city, Forsyth County and Winston Courthouse LLC, the entity that has owned the former county courthouse property since 2014. The monument was erected in 1905 on what was the courthouse grounds at the time.

The knotty — and essentially unresolved — question of who owns the statue is a thread that weaves through all the legal documents that the judges on the N.C. Court of Appeals will have to read in deciding the case.

It isn’t clear when the appellate might take up the case.

The UDC is appealing the decision by Judge Eric Morgan in Forsyth Superior Court on May 8 that dismissed the UDC’s lawsuit over the statue, and did so in a way that prevents the UDC from filing additional lawsuits in the case.

Morgan ruled that the UDC had no right to sue, in part because the group did not claim to own the statue, nor could it demonstrate the kind of concrete injury it would have to show to carry a lawsuit forward.

The UDC, in its legal brief by attorney James A. Davis, maintains that Forsyth County owns the statue because the group donated it to the county. At the same time, the UDC argues that it has the right to sue, in part, because the city identified the UDC as the owner of the statue and in late 2018 gave it a deadline to remove it.

“Putting the matter in a straightforward manner, one must ask the question: if the plaintiff (the UDC) does not have standing to contest the removal ... why has the city of Winston-Salem directed its efforts to remove it at the plaintiff, even to the point of threatening plaintiff with the imposition of sanctions if it were not removed?” Davis asks the court.

Citing public-safety concerns after pro and anti-statue demonstrations, the city removed it on March 12 and put it into storage. The city has offered to put the statue in a section on Salem Cemetery where Confederate veterans are buried.

The UDC is arguing that because the county owns the statue, it can’t be moved under the state’s public-monuments law.

The problem with that argument, attorneys on the other side say in their filings, is that the land the statue sits on is not publicly owned. Though Forsyth County exempted the statue from the sale of the courthouse property to Winston Courthouse LLC, it did not exclude the land under the statue.

In her filing, City Attorney Angela Carmon says that what the UDC wants the court to do is force Winston Courthouse to accept the statue “forever, even though (it) does not want it there and has granted no legally-protected property right to the UDC with regard to the statue’s presence on its property.”

While the UDC has claimed ownership of the statue outside of legal proceedings in the past, it has taken the position in the current controversy that the county owns the monument.

But Gordon Watkins, the county attorney, argues in his filing that the county gave permission to the local chapter of the UDC in 1905 to put the statue on county property, which means the UDC continues to own it. Watkins goes on to argue that Winston Courthouse was within its rights to tell the UDC in January 2019 that it wanted the UDC to remove the statue.

Both Watkins and the attorney for Winston Courthouse, Jodi Hildebran, argue that just because the county didn’t transfer ownership of the statue when the courthouse property was sold, it doesn’t mean the county claimed ownership. If the county doesn’t own the statue, they say, it had to exclude it from the sale because it couldn’t sell something it did not own.

Hildebran said that what the UDC wants the court to do is “create an easement for UDC’s benefit where one does not exist.”


HOGP  

FILE — In this Sept. 18, 2016, file photo provided by an official website of the office of the Iranian supreme leader, Revolutionary Guard Gen. Qassem Soleimani, center, attends a meeting in Tehran, Iran. Iraqi TV and three Iraqi officials said Friday, Jan. 3, 2020, that Soleimani, the head of Iran’s elite Quds Force, has been killed in an airstrike at Baghdad’s international airport. (Office of the Iranian Supreme Leader via AP, File)


Local
AG: No appeal of judge's decision to block voter ID until after March primary elections

A federal judge’s decision to temporarily block North Carolina’s voter ID law won’t be appealed until after the March 3 primary, N.C. Attorney General Josh Stein announced in a statement late Thursday.

“In the federal litigation over North Carolina’s photo identification voting requirement, the North Carolina Department of Justice will appeal the district court’s recent decision to enjoin the law pending a trial,” Stein said in the statement.

Stein added that the appeal won’t be filed until after the March primary to avoid, among other things, voter confusion.

U.S. District Judge Loretta C. Biggs issued a decision Tuesday that officially blocked North Carolina’s voter ID law from going into effect during the March 3 primary. The ruling means voters will not have to show photo ID in order to cast a ballot in the primary elections.

Republican House Speaker Tim Moore and Senate leader Phil Berger had urged Stein to request a stay of Biggs’ decision and to seek an appeal.

They have also strongly condemned the ruling, particularly the part that said Republican leaders had discriminatory intent in passing it.

They have noted that a black Democrat, Joel Ford, was one of the legislation’s authors. Biggs noted in the opinion that Ford had admitted in a deposition that he was considering switching political parties at the time of the bill’s drafting.

Local Republicans, starting at the Forsyth County Government Center and ending at the federal courthouse, where Biggs has an office, held a protest Thursday over Biggs’ decision.

“I’m so mad, I could spit,” Lee Haywood said in a video posted on the Forsyth County Republican Party’s Facebook page. He added that he would not spit and urged people to get even at the polls.

The N.C. NAACP and several local chapters, including the Winston-Salem chapter, filed a federal lawsuit challenging the law, which was approved in December 2018.

Gov. Roy Cooper vetoed the legislation, but state Republican legislators, who still had super majorities in both the House and the Senate, overrode Cooper’s veto.

In her decision blocking the voter ID law, Biggs cited North Carolina’s “sordid history of racial discrimination and voter suppression stretching back to the days of slavery and Jim Crow.” She said that the state’s most recent history provides evidence on whether the voter ID law has racially discriminatory intent and whether it would have a disproportionate impact on minority voters.

North Carolina Republicans have tried several times, first in 2011 and again in 2013, to pass a photo ID law.

In 2013, a limited photo ID bill sat in committee for months until after the U.S. Supreme Court invalidated a section of the Voting Rights Act of 1965 that required certain states and counties to get prior approval before passing changes in election laws.

After that decision, state Republican leaders rapidly approved House Bill 589, which not only required photo IDs but also eliminated same-day voter registration, cut the number of days for early voting and prohibited county election officials from counting out-of-precinct ballots.

Opponents of the law said the very measures Republican legislators either curtailed or eliminated were disproportionately used by black voters. The law was challenged in federal court, and in 2016, the 4th U.S. Circuit Court of Appeals struck the law down, finding that Republican legislators had racially discriminatory intent in passing the law.

Biggs said in her ruling that racially discriminatory intent was at least one motivating factor for Republican legislators to pass the new voter ID law in 2018.

“The preliminary evidence demonstrates a clear likelihood that Plaintiffs will establish that discrimination was behind the law,” she said in her decision.”S.B. 824 (the voter ID law) was enacted against a backdrop of recurring state-sanctioned racial discrimination and voter suppression efforts — both in the far and more recent past — and the state’s polarized electorate presents the opportunity to exploit race for partisan gain.”

Stein said in his statement that the appeal will be filed with the 4th U.S. Circuit Court of Appeals. A trial on the federal lawsuit is still pending.