It seems like solid advice. A new commentary posted on the National Review website calls for the U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) to “decline to defend” pending litigation related to the deeming rule for vapor products.
Authors Jeff Stier, a senior fellow at the National Center for Public Policy Research in Washington, D.C., and Henry Miller, a physician, molecular biologist and the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution, say newly appointed FDA Commissioner Scott Gottlieb and Attorney General Jeff Sessions could help save thousands of lives by not defending current lawsuits by the several cigar and vapor industry manufacturers.
“Attorney General Sessions, in consultation with Commissioner Gottlieb, can act right now by announcing the administration’s decision not to further defend the myriad cases,” the opinion states. “Not only would doing so remove a politically charged issue from Gottlieb’s already very full plate, but it would help to restore the FDA’s credibility. It would also prevent the DOJ from being forced to make untenable legal arguments.”
Stier first presented his decline-to-defend argument during a tobacco industry conference held in Washington D.C. last week. He said at that time that declining to defend the lawsuits could also save taxpayers millions of dollars in legal fees.
Japan Tobacco Inc’s domestic cigarette volume sales during the three months to the end of March, at 23.0 billion, were 15.3 percent down on those of the three months to the end of March 2016, 27.2 billion.
JT reported today that the volume reduction was down mainly to the overall industry decline, which was partly caused by an increase in the vapor-product category.
‘Core revenue declined 10.4 percent [from ¥160.6 billion to ¥143.9 billion] due to the impact from the sales volume decline partially offset by the benefit from the retail price amendment of Mevius last year,’ the company reported.
‘Adjusted operating profit declined 13.0 percent [from ¥65.7 billion to ¥57.2 billion] due to lower core revenue and despite benefits from cost reduction initiatives.’
Meanwhile, Japan Tobacco International’s shipment volume during the three months to the end of March, at 91.7 billion, was down by 2.9 percent on that of the three months to the end of March 2016, 94.4 billion. At the same time GFB (global focus brands) volume fell by 0.5 percent from 66.4 billion to 66.0 billion.
JT said that JTI’s volume decline had been caused by industry-wide contractions in some markets, market share loss in the face of competitor-driven price discounting in the Commonwealth of Independent States, and unfavorable trade inventory adjustments when compared with the situation during the first quarter of last year.
‘GFB shipment volume was stable but grew excluding inventory adjustments, supported by strong performance in Iran and Taiwan,’ the company said. ‘Year-on-year total and GFB market shares increased in several key markets.
In US dollars, JTI’s core revenue at constant currency was said to have been stable at US$2,469 million [in Yen it was down 3.1 percent from ¥284.7 billion to ¥276.0 billion] as price/mix gains in several key markets offset the volume decline impact.
‘Adjusted operating profit at constant currency grew 1.5 percent [in Yen it was down 7.6 percent from ¥99.5 billion to ¥92.0 billion] driven by price/mix gains and cost reduction benefits including contribution from the manufacturing footprint optimization; while investments in emerging markets and emerging products continued.
‘On a reported basis, core revenue and adjusted operating profit declined 1.6 percent and 6.1 percent, respectively, due to unfavorable currency movements.’
“We are making good progress towards achieving our full year profit target,” said Mitsuomi Koizumi, JT’s president and CEO in presenting the company’s consolidated results.
“This quarter was impacted by unfavorable comparisons due to one-off specific factors in the previous year, but our underlying business performance and financial results were in line with our expectations.
“The international tobacco business delivered steady profit growth at constant currency, in a challenging operating environment.
“At the same time, we reaffirmed our robust operating base in the Japanese domestic tobacco business as assumed.
“It is encouraging that the pharmaceutical and the processed food businesses continued to contribute to the Group.
“I’m confident that we can achieve our full year target while continuing to invest for future sustainable growth amid a continuously challenging business environment.”
The US Food and Drug Administration has issued its guidance on the Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule. The extension applies only to dates set for May 10 or later.
In a press note, the FDA’s Center for Tobacco Products said the extension was first communicated in legal filings in federal court on May 1, and was then shared with stakeholders. It was announced also that the FDA intended to issue the latest guidance document.
‘As announced, and under the guidance being released today, all provisions with compliance dates that have already occurred – such as mandatory age and photo-ID checks to prevent illegal sales to minors – will remain in effect,’ the note said. ‘The FDA will continue to enforce such requirements.
‘For all future compliance dates related to the final deeming rule, the FDA is deferring its enforcement for an additional three months. Provisions for which this extension will apply include, but are not limited to:
Submission of cigar rotational warning plans
Registration and listing
Ingredient listing
Health documents
Substantial Equivalence (SE) exemption requests
Substantial Equivalence (SE) applications
Premarket tobacco product applications (PMTAs)
Harmful and potentially harmful constituent (HPHC) reports.’
The UK Vaping Industry Association (UKVIA) has said that it is delighted with the results of a survey showing that more than half of Great Britain’s 2.9 million vapers no longer smoke.
Action on Smoking and Health (ASH) has today published the findings from its annual Smokefree GB survey into the use of electronic cigarettes and vaporisers in Great Britain, a survey that is conducted by YouGov on behalf of ASH.
The survey data show that an estimated 2.9 million adults in Great Britain currently use electronic cigarettes and that, for the first time, more ex-smokers (1.5 million) than current smokers are using e-cigarettes.
“We are delighted that ASH and YouGov have confirmed that the British people are voting with their feet and switching from smoking to significantly less harmful vaping products,” said Doug Mutter of the UKVIA in a press note.
“Public Health England is clear that vaping is at least 95 percent less harmful than smoking.
“If we can now convince the UK’s nine million remaining smokers to switch to vaping, this will produce huge benefits for our nation’s health and the NHS’ [National Health Service’s] finances.
“Unfortunately, the public are still receiving a barrage of mixed messages about vaping. This, coupled with excessive tobacco-style regulation coming from the EU, puts at risk the seismic public health prize that vaping represents.
“It is time for the government to seize the public health opportunity on offer, and the chance presented by Brexit, to finally address one of our society’s most intransigent public health problems – smoking related diseases.”
The vapor industry has been given the gift of time from the cigar industry. Yesterday, the U.S. Food and Drug Administration (FDA) announced that it is extending and deferring enforcement of all future compliance deadlines under its controversial deeming rule for 90 days.
The three-month extension applies only to deadlines set for May 10, 2017, or later, and includes all newly regulated tobacco products, including vapor. The extension is a result of a lawsuit against the FDA by three cigar industry lobbying groups: the Cigar Association of America, the Cigar Rights of America, and the International Premium Cigars and Pipe Retailers Association.
The June 30 deadline for manufacturers to register with the FDA has been moved to Sept. 29. The deadline for submitting labeling and ingredients has moved from Aug. 8 to Nov. 6.
British American Tobacco has published what it calls the first practical guide to the allergy-safe use of ingredients, such as flavorings, in e-liquids.
In a press note issued yesterday, the company said that, as with the use of many flavouring or fragrance-containing consumer products, ‘vaping’ e-liquid had the potential for causing an allergic reaction.
‘An allergic reaction is an overreaction by the body’s immune system to compounds that a person is ‘allergic’ to,’ the press note said. ‘Even if a compound has the potential to cause such a reaction (i.e. it is an allergen), that doesn’t mean it will. Whether an allergic reaction is likely, will depend on the person’s immune system and the amount of the compound used in a product.’
However, some substances were more likely than were others to cause allergic reactions, said BAT.
Flavourings were an important part of the vaping experience and some flavourings were known allergens. But currently, there were no specific allergy-related regulatory restrictions under either the Tobacco Products Directive in Europe or regulations administered by the Food and Drug Administration in the US.
Researchers at BAT had therefore devised a practical approach to assessing and managing the allergy risk associated with e-liquid flavourings and other ingredients (Regulatory Pharmacology and Toxicology http://dx.doi.org/10.1016/j.yrtph.2017.04.003). The guide is said to be a follow-up to the company’s blueprint for the safe use of flavourings in e-cigs, which was published in Regulatory Pharmacology and Toxicology in 2015 (https://doi.org/10.1016/j.yrtph.2015.05.018).
The most common allergy was contact sensitization arising when, for example, nickel jewellery touched the skin. Much less common was respiratory allergy, or ‘chemical asthma’.
“Although respiratory allergy is much less common than skin allergy, the potential adverse effects are much more severe,” said Dr. Sandra Costigan, principal toxicologist at BAT. “Chronic inhalation of respiratory allergens can lead to symptoms ranging from mild breathing difficulties to fatal anaphylaxis.”
‘For skin allergens, the researchers propose a method for estimating the exposures to e-liquid ingredients and quantitatively assessing the risk,’ the press note said. ‘This has then allowed them to work out a concentration of an allergen that is not expected to cause allergy in the person vaping the e-liquid.
‘For skin allergens, putting this into practice is relatively straightforward, as an approach to prevent contact sensitization is well established: The stronger the allergen, the lower the supportable concentration in e-liquid.
‘Additionally, the researchers say any known allergen should be labelled as an ingredient if it is present at 0.1 percent concentration or higher, even if it is established that it can be used safely at a higher concentration. This will help those consumers who already know themselves to be sensitive to certain ingredients to make product choices.’
For respiratory allergens, the authors used a cocoa extract as a case study, because cocoa is used quite commonly in e-liquids. The case study showed the tolerable levels identified for the cocoa extract were not sufficiently high to allow it to perform as an effective flavouring in e-liquid. In the guide, the researchers discuss why this is likely to be an issue for other respiratory allergens as well. And they recommend that respiratory allergens are not used at all.
Furthermore, quoting the low occupational exposure guidelines related to respiratory allergens (aimed at protecting workers against respiratory allergy from unintended exposure to allergens in the workplace), the researchers said it was prudent to exclude all known respiratory sensitizers from e-liquids. As an additional safeguard, if natural extracts were used as flavourings and there was no specific data on whether those extracts were respiratory sensitizers or not, only protein-free versions should be used. This was because most respiratory allergens from natural extracts came from the protein parts.
Food allergens were yet another type of allergen and the researchers recommended the presence of any potential food allergens (that are not already excluded for being respiratory allergens) should be labelled.
‘No two people have the same immune response, which is why it is important to tell people about allergens in a product even if all your data says most people shouldn’t experience a problem,’ said Costigan.
The Village of Hartland, Wisconsin, USA, is getting ready to bring the vapor battle to the U.S. capital. Leaders of the small village of 9,200 residents voted this evening to take on the U.S. Food and Drug Administration (FDA) for not coordinating with local governments before the regulatory agency enacted it’s deeming regulations for vapor products. If the FDA admits it failed to coordinate with Hartland prior to enacting the deeming rule, those regulations would become unconstitutional.
The next step will be to forward the findings to FDA Commissioner Stephen Ostroff and Secretary of Health and Human Services Tom Price, and the White House’s Council on Environmental Quality. Hartland officials said they plan on presenting their evidence later this week.
The Village Board conducted a public hearing related to “coordination and lack of coordination” by the FDA and other agencies last week. Today’s vote in favor of the measure to challenge the FDA was unanimous.
Federal and state statutes require administrative agencies to “coordinate” with local governments in developing and implementing plans, policies and management actions. These statutes create a process allowing local governments to have an equal voice in negotiations, especially on issues related to a community’s economic stability, and social and cultural cohesiveness. Hartland’s leaders say this just didn’t happen.
Several industry experts spoke during last week’s hearings, including Stephen Moore, a senior fellow with the Heritage Foundation, a political think tank. He estimates the loss of Hartland-based e-liquid manufacturer Johnson Creek Enterprises and its 50 jobs alone would cost the local community nearly $1.5 million in economic input per year if the company were forced to close due to burdensome FDA rules. Johnson Creek is just one of several vapor-related companies in Wisconsin that say they’d have to shutter their doors if current FDA regulations remain.
Fred Kelly Grant, who served as Hartland’s hearing officer, is no stranger to coordination. He has used the coordination hearing process to successfully push back regulatory efforts by the departments of Interior, Agriculture and Homeland Security, as well as the Bureau of Land Management, the Environmental Protection Agency and the U.S. Forestry Service, among others.
Village of Hartland leaders hear testimony concerning FDA regulations during hearings last week. Credit: EVCA
“It’s going to be a unanimous approval,” a source close to the situation told Vapor Voice. A vote on whether to move forward with a “coordination” complaint against the U.S. Food and Drug Administration (FDA) is expected today in Hartland, Wisconsin (see update soon on vaporvoicemagazine.com). Village officials conducted a public hearing related to “coordination and lack of coordination” by the FDA and other agencies regarding deeming regulations on vapor products last week.
Federal and state statutes require administrative agencies to “coordinate” with local governments in developing and implementing plans, policies and management actions. These statutes create a process allowing local governments to have an equal voice in negotiations, especially on issues related to a community’s economic stability, and social and cultural cohesiveness.
Village officials do not believe the FDA complied with the coordination statutes. Mark Block, founder and director of the Electronic Vaping Coalition of America, wrote in a statement today that he “expect[s] the Hartland Village Board will vote this evening to forward the findings to the FDA Commissioner, the Secretary of HHS, and to the Council on Environmental Quality, within the White House.”
Several industry experts spoke during the hearings.
One down, three to go. Without some radical, last-minute change, the Cole-Bishop amendment to curtail U.S. Food and Drug Administration (FDA) regulations for the vapor industry will not be included in the U.S. Government’s 2017 budget. U.S. Congressional leaders reached a deal on a more than $1 trillion spending bill that would fund the government at updated levels through the end of September. The bill is expected to pass both the Senate and House this week and would still need to be signed by President Trump.
There is still plenty of hope for the industry, however. There are still three possibilities that could change or invalidate the FDA’s deeming rule. A vote on whether to move forward with “coordination” is expected today in Hartland, Wisconsin (see update soon on vaporvoicemagazine.com). Federal and state statutes require administrative agencies to “coordinate” with local governments in developing and implementing plans, policies and management actions. These statutes create a process allowing local governments to have an equal voice in negotiations, especially on issues related to a community’s economic stability, and social and cultural cohesiveness.
Also, Nicopure Labs still has an ongoing lawsuit in federal court. In its original filing, Nicopure claimed the FDA’s rulemaking process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the United States Constitution.
Then there is Rep. Duncan Hunter’s Cigarette Smoking Reduction and Electronic Vapor Alternatives Act, which would weaken the FDA’s deeming rule and remove vapor from standards set by the Tobacco Control Act for traditional cigarettes. Any of the three options would represent a major victory for the $4.4 billion U.S. vaping industry.
