Latest news with #FDA-authorised
TimesLIVE
6 hours ago
- Business
- TimesLIVE
USPS blocks shipping of illicit vapes in boost for Big Tobacco
The US Postal Service (USPS) has cracked down on distributors of unregulated vapes using its services for business shipments, letters reviewed by Reuters show, in a blow to a multibillion dollar industry that has dented Big Tobacco's sales. The letters, previously unreported, show the USPS wrote to major New York-based distributor Demand Vape, blocking it from using its services after New York City's (NYC) law department, which represents the city's government and officials in legal matters, provided evidence that its shipments broke laws. The USPS' action stands to benefit tobacco giants including Altria and British American Tobacco (BAT), which have for years battled against unregulated vapes, mostly from China. Unregulated vapes lack authorisation from the US Food and Drug Administration (DFA) required for them to be legally sold in the US, the world's largest market for smoking alternatives. The USPS revoked Demand Vape's mailing exception last month after it received evidence the company shipped vapes lacking FDA authorisation and that violated a local flavour ban, a letter from the USPS to the company, dated July 15, showed. 'Your local Buffalo business mail entry office will not accept any packages from Demand Vape that contain ENDS products,' the letter read, referring to electronic nicotine delivery systems, another term for vapes. Demand Vape said it complied with relevant laws and was contesting the revocation, adding the industry operates in a 'regulatory grey zone' with only a small number of FDA-authorised products that do not meet consumer demand. 'We reject any characterisation that paints Demand Vape as anything other than a transparent, lawful and reputable business,' it said. The USPS did not respond to a request for comment. So far, the FDA has authorised only 39 e-cigarette products. But unauthorised devices are widely available as authorities struggle to contain them. Under a 2021 law, the USPS is restricted from mailing vapes directly to consumers, internationally and in most other circumstances. The limited exceptions include domestic shipments between businesses, which need a 'mailing exception' and their shipments must comply with relevant laws. Some other large carriers, including FedEx, refuse to ship vapes. DHL only offers carriage for business shipments with prior approval. The USPS has provided NYC's law department with a list of other vape firms it has granted mailing exceptions so it can assess whether they should be challenged, in line with legal requirements, Eric Proshansky, deputy chief of the city's division of affirmative litigation, told Reuters. This could further limit the number of carriers available to the unauthorised vape industry. Other options, such as using smaller carriers or handling freight directly, tend to be more costly. BAT estimated the unauthorised vape market was worth about $8.05bn (R142.6bn) last year. It is, however, increasingly under pressure. This year's US import tariffs and seizures at ports have reduced unauthorised vape imports. The FDA also wrote letters to 24 US-based middlemen, including distributors crucial to the unauthorised vape market, as part of a crackdown in May. This has led to empty shelves in vape shops, said Tony Abboud, executive director of the Vapor Technology Association, which represents firms including Demand Vape. The USPS revocations will further damage US vape businesses, he said. One of the largest US e-cigarette distributors, Demand Vape sells to about 5,000 retailers in 49 states, according to 2024 filings in a NYC lawsuit against the company. The evidence city attorneys provided to the USPS included copies of invoices showing Demand Vape's sales of unauthorised e-cigarettes. Brands the FDA has specifically flagged as illegal to sell were among them, a separate letter reviewed by Reuters showed.
Time of India
7 hours ago
- Business
- Time of India
USPS blocks shipping of illicit vapes in boost for Big Tobacco
London: The U.S. Postal Service has cracked down on distributors of unregulated vapes using its services for business shipments, letters reviewed by Reuters show, in a blow to a multi-billion dollar industry that has dented Big Tobacco 's sales. The letters, previously unreported, show that USPS wrote to major New York-based distributor Demand Vape , blocking it from using its services after New York City's Law Department, which represents the city's government and officials in legal matters, provided evidence that its shipments broke laws. USPS' action stands to benefit tobacco giants including Altria and British American Tobacco, which have for years battled against unregulated vapes, mostly from China. Unregulated vapes lack the authorisation from the U.S. Food and Drug Administration that is required for them to be legally sold in the United States, the world's largest market for smoking alternatives. USPS revoked Demand Vape's mailing exception last month after it received evidence the company shipped vapes lacking FDA authorisation and that violated a local flavour ban, a letter from USPS to the company, dated July 15, showed. "Your local Buffalo BME Office will not accept any packages from... Demand Vape that contain ENDS products," the letter read, referring to electronic nicotine delivery systems, another term for vapes. Demand Vape said it complied with relevant laws and was contesting the revocation, adding the industry operates in a "regulatory grey zone" with only a small number of FDA-authorised products that do not meet consumer demand. "We reject any characterisation that paints Demand Vape as anything other than a transparent, lawful and reputable business," it said in a statement. USPS did not respond to a request for comment. LIMITED EXCEPTIONS So far, the U.S. Food and Drug Administration has authorised only 39 e-cigarette products. But unauthorised devices are widely available as authorities struggle to contain them. Under a 2021 law, USPS is restricted from mailing vapes directly to consumers, internationally and in most other circumstances. The limited exceptions include domestic shipments between businesses, which need a "mailing exception" and their shipments must comply with relevant laws. Some other large carriers, including FedEx, refuse to ship vapes. DHL only offers carriage for business shipments with prior approval. USPS has provided NYC's Law Department with a list of other vape firms it has granted mailing exceptions so it can assess whether they should be challenged, in line with legal requirements, Eric Proshansky, deputy chief of the city's division of affirmative litigation, told Reuters. This could further limit the number of carriers available to the unauthorised vape industry. Other options, such as using smaller carriers or handling freight directly, tend to be more costly. MOUNTING PRESSURE BAT estimated the unauthorised vape market was worth around 6 billion pounds ($8.05 billion) last year. It is, however, increasingly under pressure. This year's U.S. import tariffs and seizures at ports have reduced unauthorised vape imports. The FDA also wrote letters to 24 U.S.-based middlemen, including distributors that are crucial to the unauthorised vape market, as part of a crackdown in May. This has led to empty shelves in vape stores, said Tony Abboud, executive director of the Vapor Technology Association , which represents firms including Demand Vape. USPS revocations will further damage U.S. vape businesses, he said. One of the largest U.S. e-cigarette distributors, Demand Vape sells to some 5,000 retailers in 49 states, according to 2024 filings in a NYC lawsuit against the company. The evidence city attorneys provided to USPS included copies of invoices showing Demand Vape's sales of unauthorised e-cigarettes. Brands the FDA has specifically flagged as illegal to sell were among them, a separate letter reviewed by Reuters showed. ($1 = 0.7452 pounds)
Straits Times
10 hours ago
- Business
- Straits Times
US Postal Service blocks shipping of illicit vapes in boost for Big Tobacco
Sign up now: Get ST's newsletters delivered to your inbox The US Food and Drug Administration has authorised only 39 e-cigarette products. LONDON - The US Postal Service (USPS) has cracked down on distributors of unregulated vapes using its services for business shipments, letters reviewed by Reuters show, in a blow to a multi-billion dollar industry that has dented Big Tobacco's sales. The letters, previously unreported, show that USPS wrote to major New York-based distributor Demand Vape, blocking it from using its services after New York City's Law Department, which represents the city's government and officials in legal matters, provided evidence that its shipments broke laws. USPS' action stands to benefit tobacco giants including Altria and British American Tobacco (BAT), which have for years battled against unregulated vapes, mostly from China. Unregulated vapes lack the authorisation from the US Food and Drug Administration (FDA) that is required for them to be legally sold in the United States, the world's largest market for smoking alternatives. USPS revoked Demand Vape's mailing exception in July after it received evidence the company shipped vapes lacking FDA authorisation and that violated a local flavour ban, a letter from USPS to the company, dated July 15, showed. 'Your local Buffalo BME Office will not accept any packages from... Demand Vape that contain ENDS products,' the letter read, referring to electronic nicotine delivery systems, another term for vapes. Demand Vape said it complied with relevant laws and was contesting the revocation, adding the industry operates in a 'regulatory grey zone' with only a small number of FDA-authorised products that do not meet consumer demand. Top stories Swipe. Select. Stay informed. Business Keppel to sell M1's telco business to Simba for $1.43b, says deal expected to benefit consumers Business Singtel, StarHub shares fall after announcement of Keppel's M1 sale Opinion Anwar's government: Full house but plenty of empty offices Singapore S'pore Govt asks inactive political parties including Barisan Sosialis for proof of existence Singapore 79 arrested, over 3kg of heroin seized in 5-day drug blitz Singapore Man's claim amid divorce that his mother is true owner of 3 properties cuts no ice with judge Asia Tourist spots in South Korea face complaints over rude service, price gouging during peak season Singapore Healthy lifestyle changes could save Singapore $650 million in healthcare costs by 2050: Study 'We reject any characterisation that paints Demand Vape as anything other than a transparent, lawful and reputable business,' it said in a statement. USPS did not respond to a request for comment. Limited exceptions So far, the US FDA has authorised only 39 e-cigarette products. But unauthorised devices are widely available as authorities struggle to contain them. Under a 2021 law, USPS is restricted from mailing vapes directly to consumers, internationally and in most other circumstances. The limited exceptions include domestic shipments between businesses, which need a 'mailing exception' and their shipments must comply with relevant laws. Some other large carriers, including FedEx, refuse to ship vapes. DHL only offers carriage for business shipments with prior approval. USPS has provided NYC's Law Department with a list of other vape firms it has granted mailing exceptions so it can assess whether they should be challenged, in line with legal requirements, Mr Eric Proshansky, deputy chief of the city's division of affirmative litigation, told Reuters. This could further limit the number of carriers available to the unauthorised vape industry. Other options, such as using smaller carriers or handling freight directly, tend to be more costly. Mounting pressure BAT estimated the unauthorised vape market was worth around £6 billion pounds (S$10 billion) in 2024 . It is, however, increasingly under pressure. US import tariffs and seizures at ports in 2025 have reduced unauthorised vape imports. The FDA also wrote letters to 24 US-based middlemen, including distributors that are crucial to the unauthorised vape market, as part of a crackdown in May. This has led to empty shelves in vape stores, said Mr Tony Abboud, executive director of the Vapor Technology Association, which represents firms including Demand Vape. USPS revocations will further damage US vape businesses, he said. One of the largest US e-cigarette distributors, Demand Vape sells to some 5,000 retailers in 49 states, according to 2024 filings in a NYC lawsuit against the company. The evidence city attorneys provided to USPS included copies of invoices showing Demand Vape's sales of unauthorised e-cigarettes. Brands the FDA has specifically flagged as illegal to sell were among them, a separate letter reviewed by Reuters showed. REUTERS
Yahoo
19-05-2025
- Health
- Yahoo
FDA grants 510(k) clearance to Fujirebio's blood-based test for Alzheimer's
The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio's Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid pathology in individuals under assessment for Alzheimer's disease and other cognitive decline causes. The test claims to be the first blood-based IVD test in the country cleared by the regulator to help detect those with amyloid pathology associated with the illness. According to the company, this test offers a minimally invasive and accessible pTau 217 and β-Amyloid 1-42 concentration measurement in plasma, serving as an indicator of β-Amyloid plaque pathology presence in the brain. Intended for use in adults aged ≥ 50 years presenting with cognitive decline symptoms, the test was evaluated in a clinical trial of 499 subjects, reflecting US demographics, and using a dual cut point. In the trial, it showed positive and negative predictive values of 92% and 97%, respectively, with 20% of subjects needing further testing for amyloid pathology. It operates using the company's fully automated LUMIPULSE G1200 instrument system. The new ratio test reportedly complements the previously FDA-authorised Lumipulse G β-Amyloid Ratio (1-42/1-40) for use in cerebrospinal fluid (CSF), in May 2022. The agency noted that the test measures the levels of two proteins, pTau217 and β-amyloid 1-42, in human plasma and calculates their ratio. This ratio correlates with the presence or absence of amyloid plaques in the patient's brain, potentially minimising the requirement of a positron emission tomography (PET) scan. Fujirebio Diagnostics CEO and president Monte Wiltse said: 'The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an Alzheimer's diagnosis in early stages of the disease, when interventions are more effective. 'As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.' Last July, Fujirebio introduced the Lumipulse G GFAP assay in the US, a neurological research tool tailored for measuring glial fibrillary acidic protein (GFAP). "FDA grants 510(k) clearance to Fujirebio's blood-based test for Alzheimer's" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
