Tag: regulation

  • Romania Restricts Advertising of Vaping Products

    Romania Restricts Advertising of Vaping Products

    Photo: cristianbalate

    Romania has tightened advertising restriction on electronic nicotine devices and modern oral products, reports Xinhua.

    Under new legislation signed into law by President Klaus Iohannis on July 19, the rules cover e-cigarettes, heat-not-burn (HNB) products and nicotine pouches.

    Explicit advertising for these products is now banned on radio and television broadcasts and on public transportation tickets.

    Furthermore, the legislation prohibits advertising for these products within educational and healthcare institutions or within 200 meters of their entrances.

    The law also restricts advertising in publications primarily targeting minors and in theaters before, during, and after performances intended for children.

  • Critics Blast UK’s Focus on Generational Tobacco Ban

    Critics Blast UK’s Focus on Generational Tobacco Ban

    Image: Benjaminet

    The new U.K. government’s intention to progressively increase the age at which people can buy cigarettes will not achieve its objectives, according to the smoker’s group Forest.

    Responding to an announcement in today’s King’s Speech, the annual ceremony in which the British monarch sets out the policies of and proposed legislation that the government plans to introduce, Forest Director Simon Clark said the measure would fail to stop people smoking. Instead, he warned, it would drive more people to the black market and make smoking cool again.

    SImon Clark

    Originally proposed by former Prime Minister Rishi Sunak, the generational tobacco ban would make it illegal for anyone born on or after Jan. 1, 2009, to ever legally buy cigarettes, effectively raising the legal age of purchase by one year, every year.

    The measure passed its first parliamentary hurdle in April but was put on hold after Sunak, a conservative, called a national election, which was won by the Labour party.

    While vowing to ditch many Tory policies, Labour reiterated its commitment to the generational tobacco ban, prompting criticism from smoker rights activists.

    “Labour, like the previous Conservative government, is addicted to the nanny state,” said Clark.

    “It’s ironic that Labour wants to reduce the voting age to 16 whilst denying adults the freedom to legally purchase cigarettes.

    “If you are old enough to drive a car, join the army and buy alcohol, you are old enough to buy cigarettes and other tobacco products.”

  • King Confirms UK Generational Ban Moving Ahead

    King Confirms UK Generational Ban Moving Ahead

    Credit: Michael

    The new Labour government will propose a bill to gradually raise the legal age for purchasing cigarettes and impose restrictions on the sales and promotion of vaping products, as confirmed by the UK’s King Charles III in a speech.

    Under the proposed Tobacco and Vapes bill, children born on or after Jan. 1, 2009 will never be able to legally be sold cigarettes.

    The bill will also stop vapes and other consumer nicotine products from being deliberately branded and advertised to appeal to children.

    The Tobacco and Vapes bill was proposed under the previous Conservative government and was voted through the House of Commons in April, according to media reports.

    It has also passed the Committee stage but must still pass a third reading in the House of Commons, three readings in the House of Lords, amendments, and Royal Assent before becoming legislation.

  • Court Bans Soul Vapor From Selling Illegal Vapes

    Court Bans Soul Vapor From Selling Illegal Vapes

    Credit: Yelp

    The United States District Court for the Southern District of West Virginia enjoined Soul Vapor LLC, a West Virginia-based company, and the company’s owner, Aurelius Jeffrey, from “directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product” that has not received marketing authorization from FDA.

    The court also ordered Soul Vapor and Jeffrey to destroy e-cigarette products that were manufactured by Soul Vapor and are in their custody, control, or possession.

    “FDA vigorously enforces the law and will continue to work with the U.S. Department of Justice to take enforcement actions, such as pursuing permanent injunctions, against those who defy the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “This injunction is another reminder that FDA will use the full scope of its enforcement tools to protect public health.”

    According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, the defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products by failing to first obtain marketing authorization from FDA. The complaint also alleged that the defendants submitted materially false information to FDA.

    “The court’s order is yet another example of how FDA – in coordination with federal partners – is successfully ramping up enforcement to combat unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “We will continue to work with our federal partners to identify and bring enforcement actions against bad actors, while continuing to educate stakeholders about the need for additional resources to best support these efforts.”

    CTP’s ability to pursue enforcement actions, including injunctions, is solely dependent on user fees. CTP is 100 percent funded by user fees, which the FD&C Act authorizes FDA to collect from manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars, and pipe tobacco. However, this authority has not been updated to reflect the realities of the tobacco product marketplace, including the emergence of e-cigarettes over a decade ago, according to a release.

    As a result of this inequity, e-cigarette manufacturers are currently paying no fees while continuing to profit off unauthorized products. In order to enhance the CTP’s enforcement actions, including pursuit of injunctions, the agency has requested updated authority from Congress to modernize the tobacco user fee framework to apply to all tobacco products regulated by the agency.

    The injunction against Soul Vapor highlights the successful cooperation between FDA and the DOJ to enjoin bad actors from manufacturing, selling, and distributing unauthorized e-cigarette products. FDA has taken numerous judicial enforcement actions as a part of its comprehensive approach to enforcing the law, including eight injunctions in coordination with DOJ since 2022, according to the FDA.

    Additionally, on June 10, 2024, FDA and DOJ announced the creation of an interagency task force focused on using an all-government approach to combat the illegal distribution and sale of unauthorized e-cigarettes in the U.S.

  • FDA Issues Warning Letters for Delta-8 THC Foods

    FDA Issues Warning Letters for Delta-8 THC Foods

    Credit: FDA

    The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling copycat food products containing delta-8 THC and introducing them into the marketplace in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

    The warning letters were issued to: Hippy Mood, Earthly Hemps, Shamrockshrooms.com, Mary Janes Bakery Co. LLC and Life Leaf Medical CBD Center. The FDA also issued a warning letter independently to the company GrowGod LLC for the same FD&C Act violations. 

    These warnings are part of the FDA and FTC’s ongoing joint effort to take action against companies selling illegal copycat food products containing delta-8 THC. In June 2023, the two agencies worked together to warn six other companies about selling edible food products containing delta-8 THC in packaging that could easily be confused for foods sold by popular national brands.

    All six of those companies no longer have such products in stock.

    “Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” said FDA Principal Deputy Commissioner Namandjé Bumpus. “As accidental ingestion and/or overconsumption of delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.

    “The FDA will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”

    In June 2022, the FDA warned consumers about children accidentally ingesting food products containing delta-8 THC. From Jan. 1, 2021, to Dec. 31, 2023, the FDA received over 300 adverse event reports involving children and adults who consumed delta-8 THC products.

    Nearly half of these reports involved hospitalization or emergency department visits, and approximately two-thirds of these adverse events followed ingestion of delta-8 THC-containing food products such as candy or brownies. Adverse events included, but were not limited to, hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness.

  • Health Groups Contest IQOS Quit-Rate Data

    Health Groups Contest IQOS Quit-Rate Data

    Photo: Arkadiusz Fajer

    Anti-tobacco activists are questioning Philip Morris International’s figures on the number of people who have quit smoking using the company’s bestselling heat-not-burn device, IQOS, reports Reuters.

    The move comes as the U.S. Food and Drug Administration is considering PMI’s application for renewal of its IQOS3 exposure modification order, along with the company’s premarket tobacco product applications for IQOS Iluma and request for permission to make reduced exposure claims for that product.

    In a joint letter to the U.S. Food and Drug Administration, dated June 27, six health groups, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics and the American Lung Association, cited yet-to-be published independent studies contradicting PMI’s findings about how many IQOS users completely switch to the device from cigarettes.

    According to letter writers, the International Tobacco Control Project (ITC) at Canada’s University of Waterloo found a far lower rate of IQOS users had quit smoking in Japan and Korea than estimates from PMI.

    PMI estimates more than seven out of 10 of its registered IQOS customers globally have quit cigarettes. A 2023 PMI application to the FDA emphasized that the majority of IQOS users were using IQOS exclusively.

    However, the ITC’s researchers put the percentage of all IQOS users that had quit smoking at just 15 percent in Japan and 30 percent in Korea in 2021.

    Users most commonly used IQOS and cigarettes simultaneously, often leading to an overall increase in tobacco consumption, the ITC researchers found.

    PMI pointed to a 2019 Japanese government health survey, where 75 percent of respondents who reported using heated tobacco said they did not smoke.

    However, a paper published this year, led by researchers from Georgetown University, highlighted flaws in the government’s survey, including changes to the question format that can lead to under-reporting of smoking.

    Other surveys have also found higher rates of dual use than the government, it said.

    In addition to questioning the smoking cessation rates quoted by PMI, the health groups accused the multinational of making deceptive statements wrongly suggesting that the FDA has found IQOS reduced the risk of disease, citing examples of such statements in the U.S., Kazakhstan, the Philippines and Mexico.

    A PMI spokesperson told Reuters the language flagged by campaigners was, in the company’s view, compatible with the FDA’s orders.

    “Wherever we discuss our science and our products, we do so in accordance with all applicable laws,” the spokesperson was quoted as saying.

  • FDA Officially Issues Notice of Better Web Portal

    FDA Officially Issues Notice of Better Web Portal

    Credit: Postmodern Studio

    According to a release, today, FDA’s Center for Tobacco Products (CTP) issued two notices in the Federal Register regarding its intention to launch CTP Portal Next Generation—an improved web portal for the submission of applications for certain new tobacco products—next year.

    The improvements are intended to:

    • Streamline electronic submission into one system for substantial equivalence (SE) reports and premarket tobacco product applications (PMTAs), amendments to previous submissions, and submission of general correspondence;
    • Introduce a more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, FDA’s eSubmitter Desktop Tool, and FDA’s CTP Portal Web application in one place;
    • Provide tools to expedite data entry, guide applicants to relevant sections, and verify that the applicant has provided all required data.

    No action is needed from current users of any CTP systems regarding these planned improvements. Existing CTP Portal accounts, along with any pending or in-process applications, will be automatically migrated to the new CTP Portal Next Generation.

    CTP is committed to ensuring a smooth transition to CTP Portal Next Generation and will provide additional communication and support, including resources on how to use the new system, leading up to the change. 

  • Federal Judge Provides Hope to Iowa Hemp Sellers

    Federal Judge Provides Hope to Iowa Hemp Sellers

    Credit: Zorbor

    A federal judge has given hope to 10 companies looking to block the enforcement of a new Iowa law, which they argue unfairly prevents them from selling products containing hemp-derived THC.

    During a hearing about their request for an injunction against the law, U.S. District Judge Stephanie Rose stated that their argument that the law is unconstitutional is unlikely to succeed. However, she acknowledged that there may be merit to their claim that the state is applying the law in a discriminatory manner.

    The Hemp Amendments, a law passed by the Iowa Legislature during this year’s session, became effective on July 1. Under this law, the sale of hemp products to individuals under the age of 21 is prohibited. It also mandates compliance with new regulations that restrict the amount of tetrahydrocannabinol (THC) allowed in a serving and requires specific labeling, according to media sources.

    Rose already turned down an injunction request by two of them: Field Day, a Johnson County maker of THC sparkling water, and Climbing Kites, a Des Moines-based joint venture of the Lua and Big Grove breweries, maker of a THC-containing seltzer. She rejected their argument that the law was unconstitutional because it failed to define a serving size but said at the time that she had “serious concerns” about how the law would be enforced.

  • Italy Again Labels CBD as Narcotic, Defies EU Law

    Italy Again Labels CBD as Narcotic, Defies EU Law

    Credit: Cloudy Design

    The Italian government has placed CBD on the country’s list of narcotic drugs in defiance of a regional administrative court ruling and in contravention of European Union law.

    The Ministry of Health said the designation is in line with Italian Presidential Decree 309/1990, the cornerstone of drug legislation in Italy. However, that contradicts a ruling by a regional court last year, which was based on a legally binding ruling applicable across the European Union.

    The attack on CBD is only the latest move by the Italian government. The Ministry of Health first classified CBD as a narcotic and banned the compound from the market in October 2020 – only to rescind the order shortly thereafter, according to media reports.

    Later, in a separate attempt in early 2022, the State-Regions Conference – a platform for dialogue and cooperation between the central and regional governments – updated language in a 2018 decree to classify hemp as strictly a medicinal plant.

    In that case, four cannabis associations filed suit, and one year later, the decree was annulled by the Regional Administrative Tribunal of Lazio, which ruled it violated European law.

  • Malaysia: Vending Machine Sales Ban Extends to Vapes

    Malaysia: Vending Machine Sales Ban Extends to Vapes

    Photo: evannovostro

    E-cigarettes may not be sold in vending machines, Malaysia’s health ministry confirmed, according to a New Straits Times report.

    According to the ministry, Section 10 of the Control of Tobacco Product Regulations for Public Health Act prohibits selling and displaying all “tobacco” products, including e-cigarettes. “Regulations regarding sales, including through vending machines, are under review and will be enforced alongside the act once approved,” the law states.

    Earlier this week, the Malaysia Crime Prevention Foundation criticized the sale of vapes through vending machines at a Kuala Lumper mall, describing the practice as “irresponsible.”

    The vending machine has been removed from the premises after an inspection by health ministry officials.

    The ministry has begun briefing authorities nationwide on the prohibitions under the Control of Tobacco Product Regulations for Public Health Act.