Category: Regulation

  • Uncertain future for ‘small vapor’

    Uncertain future for ‘small vapor’

    Vapor industry representatives are worried about the future of small- and mid-size vapor companies in the wake of the U.S. Food and Drug Administration’s recently announced new rules.

    The e-cigarette industry has been concerned with one proposed FDA regulation in particular—a rule that would require all e-cigarette and vapor products that came on the market after February 2007 to undergo a Pre-Market Tobacco Applications (PMTA) process.

    The provision is problematic for the vapor business because many vapor products were introduced after that date. What’s more, the PMTA is a costly and time-consuming process and likely out of reach for many small- and mid-sized vapor companies.

    “The FDA refused to change the predicate date knowing that their “pathways” are not available to 99 percent of the companies in the market,” says Arnaud Dumas de Rauly, president of Gaïatrend USA and treasurer of the Vapor Technology Association, an American trade association that represents the manufacturers, wholesalers, small business owners and entrepreneurs in the vaping industry.

    “The FDA says it has only identified one product that may “possibly be able to serve as a valid predicate for purposes of the substantial-equivalence pathway,” which makes it clear that the pathway is closed.

    “The FDA’s suggestion that they are using a sliding timeframe for applications is nothing more than them re-arranging chairs on the deck of the titanic.

    “Small and mid-sized companies have been shown the end and will stop producing product. Worse, the regulations will freeze all real innovation in the segment, choice will be eradicated, and product safety will be compromised.

    “But the Cole-Bishop Amendment is a real path forward; it presents a common sense and bipartisan approach to protect the public while regulating vapor products for what they are—technology products, not tobacco products.

    Approved by the U.S. House Committee on Appropriations on April 19, the amendment would modify the predicate date for vapor products.

    However, during an FDA press conference announcing the regulations, Mitch Zeller, director of the agency’s Center for Tobacco products, said Zeller said Congressional passage of the Cole-Bishop amendment would have an adverse impact on public health and the FDA’s ability to do its job.

    For this reason, he added, the administration opposes the amendment.

     

  • ’Rules promote cigarettes’

    ’Rules promote cigarettes’

    Michael Siegel of Boston University called the FDA’s final deeming regulations “a disaster for public health.”

    According to him, the legislation should be called  “The cigarette smoking promotion regulations of 2016,” because it regulates e-cigarettess much more stringently than it does combustible cigarettes.

    The rule, he said, essentially decimates the vaping industry, stifles innovation, and prevent the “much safer products from competing with cigarettes.”

  • Regs raise concerns about health, jobs

    Regs raise concerns about health, jobs

    The U.S Food and Drug Administration (FDA) today announced its long-anticipated deeming regulations, extending its authority to e-cigarettes, cigars, hookah tobacco and pipe tobacco, among other tobacco-related products.

    The FDA will stick to its position that hitherto unregulated tobacco products that hit stores after Feb. 15, 2007, would have to be approved by the FDA.

    The grandfather date has caused considerable concern within the young vapor industry, which introduced most of its products after 2007. Many vapor companies say they lack the resources to comply with the FDA’s expensive and time-consuming product-approval process.

    Gregory Conley, president of the American Vaping Association, says each review could cost more than a million dollars. “There are thousands of small businesses and tens of thousands of jobs on the line,” he said.

    During a press conference announcing the regulations, Mitch Zeller, director of FDA Center for Tobacco Products, put the average cost of an application at “several hundreds of thousands of dollars.”

    Established in the Tobacco Control Act of 2009, the grandfather date can be changed only by an act of Congress. An amendment currently working its way through the U.S. House would change the date so more e-cigarettes would be grandfathered in.

    The legislation would prevent the FDA from requiring retroactive safety reviews of e-cigarettes that are already on the market and exempt some premium and large cigars from those same regulations. E-cigarette products introduced in the future would still undergo the safety reviews.

    “While the FDA’s decision to use the Feb. 2007 predicate date was not a surprise, the agency considered itself bound by that date because of the Tobacco Control Act,” said Jeff Stier, director of risk analysis at The National Center for Public Policy Research.

    “The publication of the rule only gives more urgency to the Cole/Bishop amendment to change the predicate date. That bill is wending its way through the House appropriations process.”

    Zeller said passage of the amendments would have an adverse impact on public health and the FDA’s ability to do its job. For this reason, he added, the administration opposes the amendments.

    Bonnie Herzog, senior analyst at Wells Fargo Securities, expressed concern that the announced regulations would suppress innovation.

    “Our main concern is that these final deeming regs could realistically stifle innovation, which could dramatically slow industry growth by disincentivizing consumer conversion from combustible cigs,” she wrote.

    “This would ultimately have a net negative impact on public health, which is clearly in direct opposition to the FDA’s goal.”

    Asked about the impact of e-cigarettes on smoking cessation, Zeller said that the FDA was required by law to evaluate its policies at the population level. While the agency was aware of instances in which e-cigarettes had helped individual smokers quit tobacco, he said such anecdotal evidence was insufficient to build policy upon.

  • Disputed grandfather date stays

    Disputed grandfather date stays

    Today, the U.S. Food and Drug Administration finalized its rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco.

    This rule helps implement the Family Smoking Prevention and Tobacco Control Act of 2009.

    “Today’s announcement is an important step in the fight for a tobacco-free generation—it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” said HHS Secretary Sylvia Burwell.

    The new rules include provisions aimed at restricting youth access to e-cigarettes, hookah tobacco and cigars, which will go into effect in 90 days.  The new rules include:

    • A ban on sales to persons under the age of 18 (both in person and online)
    • Requiring age verification by photo ID
    • A ban on the sale of covered tobacco products in vending machines (unless in an adult-only facility)
    • A ban on the distribution of free samples.

    Today’s rule also requires manufacturers of all newly regulated products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

    Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit–and an additional year while the FDA reviews—a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

    The new rules will subject all manufacturers, importers and/or retailers of newly regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

    These requirements include:

    • Registering manufacturing establishments and providing product listings to the FDA;
    • Reporting ingredients, and harmful and potentially harmful constituents;
    • Requiring premarket review and authorization of new tobacco products by the FDA;
    • Placing health warnings on product packages and advertisements; and
    • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

    FDA’s document with the rules is available here: deeming regs final.

  • Totally Wicked to challenge TPD

    British e-cig manufacturer Totally Wicked said it received permission from the U.K.’s Administrative Court to seek a judicial review by the EU Court of Justice of the revised Tobacco Products Directive (TPD), specifically Article 20 pertaining to e-cigarettes.
    The company claims that the TPD article “represents a disproportionate impediment to the free movement of goods and the free provision of services, places electronic cigarettes at an unjustified competitive disadvantage to tobacco products, fails to comply with the general EU principle of equality, and breaches the fundamental rights of electronic cigarette manufacturers.” 
    A hearing is scheduled for October 6th in the Administrative Court to determine if the matter is to be referred to the EU court, a hearing is likely to take place in 2015.

  • Coming soon: FDA to announce e-cig regulations proposal

    It is quite literally “any day now” that the U.S. Food and Drug Administration (FDA) says it will release its proposal for the regulation of e-cigarettes, according to a spokesperson for the FDA. The rules could change the landscape of the tobacco and vapor industries.

    The FDA will most likely ban sales to those under 18, set product standards, require companies to disclose e-juice ingredients and place health warnings on packaging and advertisements. The FDA will also decide whether there will be a grandfather date for products that are currently on the market and what it might be, in addition to proposing rules on advertising, sponsorships, Internet sales limitations and child-proof packaging requirements.

    Last Friday, a trade-industry group was set to post a leaked copy of the impending FDA draft regulation for e-cigarettes on its website, but in a classy move, the Tobacco Vapor Electronic Cigarette Association (TVECA) changed pace on its plans to release the full report today, stating that it decided not to go ahead with formally releasing the document following informal discussions with the FDA on Friday. “[W]e all decided that [it would be] in the best interest of the regulatory process, as well as the industry and the public, not to post the document on Tuesday,” TVECA explained in a brief note on its website.

    The posted title document on the TVECA homepage indicated that the FDA will classify e-cigs as “Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.”

    The FDA Center for Tobacco Products—which completed a three-day meeting Friday with its scientific advisory committee on topics of nicotine addiction, population modeling and evaluating proposed modified-risk tobacco products—was quick to respond.

    “The FDA has not issued its proposed rule regarding what additional tobacco products should be regulated by the agency,” it reaffirmed in a statement. “We are aware that the Tobacco Vapor Electronic Cigarette Association has indicated publicly that they have a copy of our proposal. The proposal is still in draft form and under review. As a matter of policy, the FDA does not share draft rules with outside groups while a rule is still under review.”

    The agency has had e-cigarettes on its agenda for years, but finally sent its draft proposal of rules to the Office of Management and Budget (OMB) last fall; action was further delayed by the partial government shutdown. The document was still with the OMB as of last month.

  • Bhutan says tobacco ban must end

    Bhutan’s Upper House resolved that the country’s ban on the import of tobacco must end. In a majority resolution on February 3 the house said the ban on import and sale of tobacco products must end to control the black market, reports the Bhutan News Network.

    Bhutan had gained fame for being the first country to completely ban on manufacturing, import and sale of any tobacco products. However, the government also received harsh criticism for sending a monk behind bar for years on charge of carrying tobacco products.

    After public outcry over the harshness of the law, the first elected parliament of the country showed some leniency towards tobacco consumers. Many send to jail for selling tobacco were subsequently released on king’s order.

    The country recently lifted its ban on the import of furniture and alcohol.

    Now, the National Council comes with proposal that the tobacco import ban must end, though the resolution says the ban must continue on production of tobacco products within the country.

    The resolution should pass through the National Assembly before it becomes the law.