Federal - Executive Branch
News releases, reports, statements and associated documents from the U.S. Executive Branch, covering all aspects of the Obama administration including cabinet departments, federal agencies, regulatory and independent agencies.
Featured Stories
Expanded Coverage of Phytocompounds by Mass Spectrometry Imaging Using On-Tissue Chemical Derivatization by 4-APEBA
WASHINGTON, Nov. 17 (TNSres) -- The U.S. Department of Energy's Pacific Northwest National Laboratory issued the following abstract of a journal article:
Probing the entirety of any species metabolome is an analytical grand challenge, especially at a cellular scale. Where spatial metabolomics, completed primarily by matrix-assisted laser desorption/ionization (MALDI), has limited molecular coverage for several reasons. To expand the scope of spatial metabolomics, we developed an on-tissue chemical derivatization (OTCD) workflow using 4-APEBA for confident identification of several dozen elusive
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WASHINGTON, Nov. 17 (TNSres) -- The U.S. Department of Energy's Pacific Northwest National Laboratory issued the following abstract of a journal article:
Probing the entirety of any species metabolome is an analytical grand challenge, especially at a cellular scale. Where spatial metabolomics, completed primarily by matrix-assisted laser desorption/ionization (MALDI), has limited molecular coverage for several reasons. To expand the scope of spatial metabolomics, we developed an on-tissue chemical derivatization (OTCD) workflow using 4-APEBA for confident identification of several dozen elusivephytocompounds, including several phytohormones, which have various roles within stress responses and cellular communication. Superiority of 4-APEBA is established in comparison to other derivatization agents with (1) broad specificity towards carbonyls, (2) low background, and (3) introduction of bromine isotopes, where the latter two facilitate confident bioinformatics. The outlined workflow trailblazes a path towards spatial hormonomics within plant samples, enhancing detection of carboxylates, aldehydes, ketones, and plausibly phenols.
***
Original text here: https://www.pnnl.gov/publications/expanded-coverage-phytocompounds-mass-spectrometry-imaging-using-tissue-chemical
baseflow: a MATLAB and GNU Octave package for baseflow recession analysis
WASHINGTON, Nov. 8 (TNSres) -- The U.S. Department of Energy's Pacific Northwest National Laboratory issued the following abstract of a journal article:
`baseflow` is a MATLAB(r) [@matlab_2020_] toolbox that facilitates baseflow recession analysis, a set of methods used in hydrologic science to infer aquifer properties that cannot be measured directly [@brutsaert_1977_WRR].
The widespread availability of streamflow measurements means that baseflow recession analysis can be used to estimate aquifer properties and their variations globally over the modern instrumental stream gage record.
This
... Show Full Article
WASHINGTON, Nov. 8 (TNSres) -- The U.S. Department of Energy's Pacific Northwest National Laboratory issued the following abstract of a journal article:
`baseflow` is a MATLAB(r) [@matlab_2020_] toolbox that facilitates baseflow recession analysis, a set of methods used in hydrologic science to infer aquifer properties that cannot be measured directly [@brutsaert_1977_WRR].
The widespread availability of streamflow measurements means that baseflow recession analysis can be used to estimate aquifer properties and their variations globally over the modern instrumental stream gage record.
Thistoolbox offers easy-to-use functions for baseflow recession analysis using measured values of streamflow recorded on a daily timestep.
***
Original text here: https://www.pnnl.gov/publications/baseflow-matlab-and-gnu-octave-package-baseflow-recession-analysis
Los Alamos Team Develops 'Game-Changing' Approach to Explosives Testing
WASHINGTON, Oct. 31 (TNSres) -- The U.S. Department of Energy's Los Alamos National Laboratory issued the following news:
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More modern method a fundamental leap forward in safety
* * *
An interdisciplinary team at Los Alamos National Laboratory developed a new method for testing explosives that provides more precise data, helping researchers determine whether an explosive is safe enough to handle. The findings were recently published in the Journal of the American Chemical Society.
Called the High Explosive Initiation Time (HEIT) experiment, the interdisciplinary team at Los Alamos used
... Show Full Article
WASHINGTON, Oct. 31 (TNSres) -- The U.S. Department of Energy's Los Alamos National Laboratory issued the following news:
* * *
More modern method a fundamental leap forward in safety
* * *
An interdisciplinary team at Los Alamos National Laboratory developed a new method for testing explosives that provides more precise data, helping researchers determine whether an explosive is safe enough to handle. The findings were recently published in the Journal of the American Chemical Society.
Called the High Explosive Initiation Time (HEIT) experiment, the interdisciplinary team at Los Alamos useda high-voltage source to very rapidly heat small explosive samples confined within narrow hypodermic needles. This enabled the team to learn exactly what temperatures were applied to the sample and how long it took for the sample to explode after the application of the voltage pulse. By applying different voltages, the team measured temperature's impact on the time to explosion.
"This method gives us reaction kinetics, which is something that researchers use to understand the safety characteristics of explosives," explains Virginia Manner, an explosives scientist at Los Alamos and leader of the project.
Prior to this experiment, the most widely used approach to testing new explosives was the so-called "drop weight impact test" -- dropping a weight onto an explosive material and measuring the reaction. While effective, this method is limited, Manner says.
"With a drop weight impact test, we can analyze the sound levels produced by the impact -- the loudness of the 'bang' -- to determine that a reaction has taken place with the explosive material. These sound levels provide a picture, but not a complete one," she says.
For example, this standard test tells researchers how to rank explosives in terms of handling safety, but it can't tell them what is physically happening during the explosion, what temperatures were achieved, or whether the explosive sample was fully or partially consumed. The Los Alamos team sought to fill in these holes with a more modern approach to explosive testing.
Los Alamos chemists, physicists, engineers, and theoreticians closely collaborated for three years to develop a test to provide greater fidelity for explosives testing than sound levels alone.
"The onset of thermal explosion in the test agrees surprisingly well with theoretical calculations of the reaction rates," said Marc Cawkwell, a materials scientist and co-leader of the project. "This effort transitions explosive safety testing from the crude, WW2-era drop weight impact test to the 21st century."
"This work is a game changer," adds Douglas Tasker, a physicist on the project who led the development of the experiment. "It links quantum molecular dynamic calculations of explosive reactions on a femtosecond timescale, to real-world explosive accident scenarios that occur in milliseconds -- a trillion times slower. We can now understand explosive accidents at a fundamental level."
Paper: "An Integrated Experimental and Modeling Approach for Assessing High-Temperature Decomposition Kinetics of Explosives" The Journal of the American Chemical Society.
Funding and Support: This research was funded by the Laboratory Directed Research and Development program at Los Alamos.
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JOURNAL: Journal of the American Chemical Society https://pubs.acs.org/doi/10.1021/jacs.4c08424
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Original text here: https://discover.lanl.gov/news/1030-explosives-testing/
Gross Domestic Product, Third Quarter 2024 (Advance Estimate)
WASHINGTON, Oct. 31 -- The U.S. Department of Commerce's Bureau of Economic Analysis issued the following news release:
Real gross domestic product (GDP) increased at an annual rate of 2.8 percent in the third quarter of 2024 (table 1), according to the "advance" estimate released by the U.S. Bureau of Economic Analysis. In the second quarter, real GDP increased 3.0 percent.
The GDP estimate released today is based on source data that are incomplete or subject to further revision by the source agency (refer to "Source Data for the Advance Estimate" on page 2). The "second" estimate for the third
... Show Full Article
WASHINGTON, Oct. 31 -- The U.S. Department of Commerce's Bureau of Economic Analysis issued the following news release:
Real gross domestic product (GDP) increased at an annual rate of 2.8 percent in the third quarter of 2024 (table 1), according to the "advance" estimate released by the U.S. Bureau of Economic Analysis. In the second quarter, real GDP increased 3.0 percent.
The GDP estimate released today is based on source data that are incomplete or subject to further revision by the source agency (refer to "Source Data for the Advance Estimate" on page 2). The "second" estimate for the thirdquarter, based on more complete source data, will be released on November 27, 2024.
The increase in real GDP primarily reflected increases in consumer spending, exports, and federal government spending (table 2). Imports, which are a subtraction in the calculation of GDP, increased.
The increase in consumer spending reflected increases in both goods and services. Within goods, the leading contributors were other nondurable goods (led by prescription drugs) and motor vehicles and parts. Within services, the leading contributors were health care (led by outpatient services) as well as food services and accommodations. The increase in exports primarily reflected an increase in goods (led by capital goods, excluding automotive). The increase in federal government spending was led by defense spending. The increase in imports primarily reflected an increase in goods (led by capital goods, excluding automotive).
Compared to the second quarter, the deceleration in real GDP in the third quarter primarily reflected a downturn in private inventory investment and a larger decrease in residential fixed investment. These movements were partly offset by accelerations in exports, consumer spending, and federal government spending. Imports accelerated.
Current dollar GDP increased 4.7 percent at an annual rate, or $333.2 billion, in the third quarter to a level of $29.35 trillion. In the second quarter, GDP increased 5.6 percent, or $392.6 billion (tables 1 and 3).
The price index for gross domestic purchases increased 1.8 percent in the third quarter, compared with an increase of 2.4 percent in the second quarter (table 4). The personal consumption expenditures (PCE) price index increased 1.5 percent, compared with an increase of 2.5 percent. Excluding food and energy prices, the PCE price index increased 2.2 percent, compared with an increase of 2.8 percent.
Personal Income
Current-dollar personal income increased $221.3 billion in the third quarter, compared with an increase of $315.7 billion in the second quarter. The increase primarily reflected an increase in compensation (table 8).
Disposable personal income increased $166.0 billion, or 3.1 percent, in the third quarter, compared with an increase of $260.4 billion, or 5.0 percent, in the second quarter. Real disposable personal income increased 1.6 percent, compared with an increase of 2.4 percent.
Personal saving was $1.04 trillion in the third quarter, compared with $1.13 trillion in the second quarter. The personal saving rate--personal saving as a percentage of disposable personal income--was 4.8 percent in the third quarter, compared with 5.2 percent in the second quarter.
Source Data for the Advance Estimate
The GDP estimate released today is based on source data that are incomplete or subject to further revision by the source agency. Information on the source data and key assumptions used in the advance estimate is provided in a Technical Note and a detailed "Key Source Data and Assumptions" file posted with the release. The "second" estimate for the third quarter, based on more complete data, will be released on November 27, 2024. For information on updates to GDP, refer to the "Additional Information" section that follows.
Next release, November 27, 2024, at 8:30 a.m. EST
Gross Domestic Product (Second Estimate)
Corporate Profits (Preliminary Estimate)
Third Quarter 2024
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Table:Release Dates in 2025
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Original text here: https://www.bea.gov/news/2024/gross-domestic-product-third-quarter-2024-advance-estimate
FDA Issues Warning Letter to Vapes and Such
WASHINGTON, Oct. 31 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Vapes and Such:
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To: Vapes and Such, United States, suppor@vapesandsuch.com
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://vapesandsuch.com and determined that electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to customers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic
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WASHINGTON, Oct. 31 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Vapes and Such:
* * *
To: Vapes and Such, United States, suppor@vapesandsuch.com
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://vapesandsuch.com and determined that electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to customers in the United States.
Under section 201(rr) of the Federal Food, Drug, and CosmeticAct (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including ENDS products are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. Sec. 387a(b)) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act.
Please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA's jurisdiction to products "containing nicotine from any source," not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of "tobacco product" under section 201(rr) of the FD&C Act (21 U.S.C. Sec. 321(rr)) to include products containing nicotine from any source. Tobacco products, including ENDS products containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
Generally, to be legally marketed in the United States, the FD&C Act requires "new tobacco products" to have a premarket authorization order in effect. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. Sec. 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. Sec. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. Sec. 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. Sec. 387e(j)(3)).
New Tobacco Products Without Required Marketing Authorization are Adulterated and Misbranded
FDA has determined that you offer for sale or distribution to customers in the United States ENDS products that lack a marketing authorization order: Swype 30K Disposable Vape Blue Razz Ice, Posh Xtron 30000 Disposable Vape Grape Blow Pop, V-Play 20000 Disposable Vape Pineapple Punch, and Posh Pro Max 30000 Berry Breeze.
The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. Sec. 387c(a)(6)) because a notice or other information respecting these products was not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Additional Considerations
FDA finds these products particularly concerning because the product labeling and/or advertising for Swype 30K Disposable Vape, Posh Xtron 30000 Disposable Vape, and Posh Pro Max 30000 (see Exhibit A) may be attractive to youth by imitating a smartphone or other smart technology (see Exhibit B), and the product labeling and/or advertising for V-Play 20000 Disposable Vape (see Exhibit C) may be attractive to youth by imitating gaming products (see Exhibit D).
In particular, youth and young adults may be attracted to the products' design and functionalities imitating smart phones and other smart technology, including:
Swype 30K Disposable Vape
* "It's not just a vape, it's an entertainment hub!"
* "Touch Screen & Bluetooth: Navigate features and connect to your devices with ease."
* "Beyond Vaping: Stay connected with call/text notifications, play games, personalize your vape, and even check the weather - all on your Swype 3K! [sic]"
* "The Swype 30K Disposable Vape allows you to personalize your device with custom wallpaper options."
* "The Swype 30K Disposable Vape features a calculator function for quick and convenient calculations on the go."
Posh Xtron 30000 Disposable Vape
* "Advanced Touchscreen: Includes call and text notifications, built-in games, and a calculator for added utility."
* "Customizable Options: Allows for personalized wallpapers and real-time weather updates to tailor your experience."
* "User-Friendly Design: Adjustable airflow, a built-in entertainment system, and a Type-C rechargeable battery for convenience."
* "The Posh XTRON 30000 Disposable Vape offers more than just a vaping device; it provides a comprehensive, customizable experience with cutting-edge features and a wide range of flavors to enhance your vaping journey."
Posh Pro Max 30000
* "Bluetooth Connectivity: Sync with your smartphone for weather updates, time display, and calendar management."
* "All-in-One Functionality: Customize wallpapers, locate your phone, or play games directly from your vape."
V-Play 20000 Disposable Vape
* "Your Ultimate Vape & Play Companion"
* "This groundbreaking disposable vape offers a blend of enduring flavor and gaming excitement, ensuring endless enjoyment wherever you go."
* "Gaming Thrills: Take a vaping break and immerse yourself in retro gaming fun on the vibrant 1.77 inch HD display. Conquer high scores in classic fighter jet, Pac-Man inspired, and Tetris-like games."
* "The V-Play 20000 caters to: Gaming enthusiasts seeking a seamless vape and play experience" and "Anyone craving a distinctive and entertaining vaping adventure."
Further, the products' design may be attractive to youth because the design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the products are tobacco products. FDA is concerned about the youth appeal and widespread youth use of ENDS products, which are the most common tobacco products used by students reporting current tobacco use. Any efforts to entice youth to use tobacco products are of concern to FDA. Sales of such unauthorized products are prohibited, and FDA is concerned that your actions likely encourage unlawful sales, maintain or increase youth use, and contribute to the public health and safety concerns associated with ENDS products.
Conclusion and Requested Actions
FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA's discretion.
For a list of products that received marketing granted orders, please visit our website: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-products-marketing-orders#PMTAView%20all%20marketing%20granted.
It is your responsibility to ensure that all tobacco products you sell and/or distribute in the United States and all related labeling and/or advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to adequately address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute "written notice" for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, and take any necessary actions to bring these tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.
Please note your reference number, RW2402229, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ John E. Verbeten, Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC, abuse@godaddy.com
Bigcommerce Inc., abuse@bigcommerce.com
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vapes-and-such-695524-10292024
FDA Issues Warning Letter to North Disposable
WASHINGTON, Oct. 31 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to North Disposable:
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To: North Disposable, 21746 73rd Place, Vero Beach, FL 32966, United States, marketing@northdisposable.com
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://northdisposable.com and determined that electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to customers in the United States.
Under section
... Show Full Article
WASHINGTON, Oct. 31 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to North Disposable:
* * *
To: North Disposable, 21746 73rd Place, Vero Beach, FL 32966, United States, marketing@northdisposable.com
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://northdisposable.com and determined that electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to customers in the United States.
Under section201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source and intended for human consumption. Certain tobacco products, including ENDS products, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. Sec. 387a(b)) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act.
Please be aware that, on March 15, 2022, the President signed legislation to amend the FD&C Act to extend FDA's jurisdiction to products "containing nicotine from any source," not just nicotine derived from tobacco. See Consolidated Appropriations Act, 2022, Public Law 117-103, Division P, Title I, Subtitle B. Specifically, this legislation expanded the definition of "tobacco product" under section 201(rr) of the FD&C Act (21 U.S.C. Sec. 321(rr)) to include products containing nicotine from any source. Tobacco products, including ENDS products, containing nicotine from any source, must be in compliance with the FD&C Act and its implementing regulations. For more information, please see https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
Generally, to be legally marketed in the United States, the FD&C Act requires "new tobacco products" to have a premarket authorization order in effect. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007 (section 910(a) of the FD&C Act; 21 U.S.C. Sec. 387j(a)). Generally, a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. Sec. 387j(c)(1)(A)(i)) is required for a new tobacco product unless (1) the manufacturer of the product submitted a report under section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)) and FDA issues an order finding the product substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act (21 U.S.C. Sec. 387e(j)(1)(A)(ii)) and all modifications are covered by exemptions from the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act (21 U.S.C. Sec. 387e(j)(3)).
New Tobacco Products Without Required Marketing Authorization Are Adulterated and Misbranded
FDA has determined that you offer for sale or distribution to customers in the United States ENDS products that lack a marketing authorization order: V-Touch 30K Disposable - Jolly Rancher, Halo Vapor Synix 30K Bluetooth Vape - Black Cherry, and South Connect 35K Disposable - Grape Blow Pop.
The tobacco products listed above are new tobacco products because they were not commercially marketed in the United States as of February 15, 2007. These products do not have FDA marketing authorization orders in effect under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt from the marketing authorization requirement. Therefore, these products are adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. Sec. 387b(6)(A)). In addition, they are misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. Sec. 387c(a)(6)) because a notice or other information respecting these products were not provided as required by section 905(j) of the FD&C Act (21 U.S.C. Sec. 387e(j)).
Additional Considerations
FDA finds these products particularly concerning because the product labeling and/or advertising for V-Touch 30K Disposable, Halo Vapor Synix 30K Bluetooth Vape, and South Connect 35K Disposable (see Exhibit A) may be attractive to youth by imitating a smartphone or other smart technology (see Exhibit B).
695211-Watch and Cellphone
In particular, youth and young adults may be attracted to the products' design and functionalities imitating smart phones and other smart technology, including:
V-Touch 30K Disposable
* "Bluetooth Connectivity: Sync effortlessly with your smartphone"
* "Call Functionality: Make and receive calls directly from your vape"
* "Built-in Audio Player: Enjoy music on the go"
* "Find My Phone: Never lose your phone again"
* "Interactive Touch Screen: Easy navigation and control"
* "Social Media & Text Integration: Stay connected with friends"
Halo Vapor Synix 30K Bluetooth Vape
* "Bluetooth Connectivity: Stay seamlessly connected with built-in Bluetooth, enabling pairing with your smartphone for additional convenience and control."
* "AI Chat: Revolutionize your vaping experience with AI chat functionality, adding an interactive and engaging element to your sessions."
South Connect 35K Disposable
* "Downloadable App: Customize settings and access additional features."
* "Built-in Games: Three built-in games for entertainment."
* "Upload Wallpapers: Personalize with custom wallpapers."
* "Speaker: Enjoy music and audio during sessions."
Further, the products' design may be attractive to youth because the design helps conceal the nature of the product as a tobacco product from parents, teachers, or other adults, and therefore could be openly carried without revealing to parents, teachers, or other adults that the products are tobacco products. FDA is concerned about the youth appeal and widespread youth use of ENDS products, which are the most common tobacco products used by students reporting current tobacco use. Any efforts to entice youth to use tobacco products are of concern to FDA. Sales of such unauthorized products are prohibited, and FDA is concerned that your actions likely encourage unlawful sales, maintain or increase youth use, and contribute to the public health and safety concerns associated with ENDS products.
Conclusion and Requested Actions
FDA has determined that your firm markets new tobacco products in the United States that lack premarket authorization. All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA's discretion.
For a list of products that received marketing granted orders, please visit our website: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-products-marketing-orders#PMTAView%20all%20marketing%20granted.
It is your responsibility to ensure that all tobacco products you sell and/or distribute in the United States and all related labeling and/or advertising on any websites or other media (such as e-commerce, social networking, or search engine websites), and in any retail establishments in which you advertise, comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to adequately address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., or its implementing regulations relating to tobacco products including the tobacco regulations in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. However, this Warning Letter does not constitute "written notice" for purposes of section 303(f)(9)(B)(i)(II) of the FD&C Act. Please note that tobacco products offered for import into the United States that appear to be adulterated and/or misbranded may be detained or refused admission.
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should take prompt action to address any violations that are referenced above, and take any necessary actions to bring these tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring these products into compliance, including the dates on which you discontinued the violative sale and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that these products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at http://www.fda.gov.
Please note your reference number, RW2402220, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
c/o Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ John E. Verbeten, Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC, abuse@godaddy.com
Shopify, Inc., abuse@shopify.com
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-disposable-695211-10292024
DHS S&T, USFA, and FDNY Collaborate on Lithium-Ion Battery Risks at Public Safety Workshop
WASHINGTON, Oct. 31 -- The U.S. Department of Homeland Security Science and Technology Directorate issued the following news:
NEW YORK - The Department of Homeland Security's (DHS) Science and Technology Directorate (S&T), in collaboration with the U.S. Fire Administration (USFA) and Fire Department of the City of New York (FDNY), hosted a comprehensive two-day workshop titled Charging Forward: Public Safety in Community Electrification. The workshop, led by DHS S&T's New York City-based National Urban Security Technology Laboratory (NUSTL), convened public safety leaders, first responders, and
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WASHINGTON, Oct. 31 -- The U.S. Department of Homeland Security Science and Technology Directorate issued the following news:
NEW YORK - The Department of Homeland Security's (DHS) Science and Technology Directorate (S&T), in collaboration with the U.S. Fire Administration (USFA) and Fire Department of the City of New York (FDNY), hosted a comprehensive two-day workshop titled Charging Forward: Public Safety in Community Electrification. The workshop, led by DHS S&T's New York City-based National Urban Security Technology Laboratory (NUSTL), convened public safety leaders, first responders, andsubject matter experts to address the growing public safety risks posed by lithium-ion batteries when they are improperly used, not safety certified, become damaged or fail.
"With the federal government making historic investments in renewable energy, lithium-ion batteries have rapidly emerged as a leading technology for energy storage," said Julie Brewer, DHS Deputy Under Secretary for Science and Technology. "However, the increasing number of battery-related fires demonstrates the need for us to know more about the risks to protect both first responders and the public."
USFA and FDNY leaders echoed the urgency to address the dangers posed by these new technologies. The workshop's goal is to identify research and development needs that will give public safety officials additional tools and resources as community battery electrification advances.
"Fire risks are evolving and so must our response," said Dr. Lori Moore-Merrell, U.S. Fire Administrator. "As we continue to prioritize renewable energy, we must also enable research to identify any associated fire risks and prioritize the safety of the men and women tasked with responding to fire emergencies that occur."
"Lithium-ion battery fires are one of the most dangerous threats our first responders face in the country's largest metro area," said Robert S. Tucker, FDNY Commissioner. "One fatality due to these fires is too many. The tragic loss of lives and property from these incidents underscores why these collaborative workshops are so vital to creating new strategies and tools to allow us to better protect our city and our members."
The workshop's discussions focused on understanding community risk considerations with the expansion of energy storage across residential and commercial sectors, potential solutions for complex response, and actionable next steps to support public safety in ensuring the safety and health of our communities.
The workshop is supported by the U.S. Department of Energy's (DOE) Pacific Northwest National Laboratory (PNNL). As a result of the workshop, PNNL will work with DHS S&T on producing a comprehensive report offering actionable insights and opportunities for future research, development, and test and evaluation to support public safety.
B-roll of lithium-ion battery fires, courtesy of FDNY.
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Original text here: https://www.dhs.gov/science-and-technology/news/2024/10/30/st-usfa-and-fdny-collaborate-lithium-ion-battery-risks-public-safety-workshop
