Heated tobacco product

FDA Roundup: December 8, 2023

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금요일, 12월 8, 2023
Safety, Heated tobacco product, Food, PDF, Multimedia, FDA, Vaccine, Animal, Computer security, Cosmetics, Human services, Dietary supplement, CDC, Content, News, Public

SILVER SPRING, Md., Dec. 8, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Key Points: 
  • SILVER SPRING, Md., Dec. 8, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
    On Wednesday, the FDA announced that eSTAR is now available for voluntary use for certain PMA Submissions.
  • eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission.
  • eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review.
  • The FDA's update also includes updated adverse event report numbers for the FDA, as well as case count information reported by the CDC.

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

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금요일, 12월 8, 2023
Malignancy, VOC, DNA, Sickle cell disease, Abdominal pain, Headache, Patient, Research, Hemoglobin A, Cas9, CRISPR, Oxygen, Volatile organic compound, Recurrence, Fever, Mutation, Priority review, DSM-IV codes, Vomiting, Bone marrow, Hematology, China Biologic Products, Safety, Food, Multimedia, Rejection, HBF, Ronas Voe, Health, Person, Nausea, Throat, Mouth, Hispanic and Latino Americans, Public, Adolescence, Stomatitis, Risk, Tissue, Febrile neutropenia, History, End organ damage, Fetal hemoglobin, Animal, Pain, SCD, B cell, Regenerative medicine, Heated tobacco product, Disease, FDA, African Americans, Mouth ulcer, Vaccine, Cosmetics, Blood, Human services, Dietary supplement, Freedom, Pharmaceutical industry

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S.

Key Points: 
  • Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S.
  • The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body's tissues.
  • Casgevy, a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises.
  • In patients with sickle cell disease, increased levels of HbF prevent the sickling of red blood cells.

Truth Initiative Urges Swift Action to Prevent Delay in Removing Menthol and Cigar Flavors, Citing Serious Health Implications

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수요일, 12월 6, 2023
Smoker, Research, Heated tobacco product, White, Truth Initiative, Risk, Cancer Moonshot, African Americans, FDA, Science, Tobacco industry, Health, Big Tobacco, Menthol, Administration, Public, Smoking, Tobacco

WASHINGTON, Dec. 6, 2023 /PRNewswire/ -- Truth Initiative is deeply concerned over the Administration's delay in finalizing crucial rules aimed at removing menthol as a characterizing flavor in cigarettes and eliminating all characterizing flavors from cigars. The originally anticipated timeline for these rules, set for August 2023, has now been extended to March 2024. This delay not only puts the rules at risk of never being finalized but also represents a significant victory for Big Tobacco's well-documented exploitative practices, all at the expense of our nation's public health.

Key Points: 
  • The originally anticipated timeline for these rules, set for August 2023, has now been extended to March 2024.
  • The unjustifiable delay we are witnessing will inevitably result in more smokers and more lives lost.
  • Prohibiting menthol as a characterizing flavor in cigarettes can prevent an estimated 92,000 to 238,000 smoking-related deaths among Black Americans, as stated by the FDA.
  • We cannot afford to wait any longer for the menthol and flavored cigar rules to be enacted.

It's Time to End the Menthol Poisoning of Communities

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화요일, 12월 5, 2023
Smoker, Brain, Heated tobacco product, OMB, White, FDA, Nicotine, Tobacco industry, National Alliance, Menthol, Management, Death, Nation, Tobacco, Doctor of Philosophy, Life

WASHINGTON, Dec. 5, 2023 /PRNewswire/ -- "For decades, the tobacco industry has used menthol and flavored products to deliberately target and addict Hispanic and other targeted communities in a callous campaign to increase profit. The White House Office of Management and Budget (OMB) can stop it now. Sitting at OMB are proposed rules from the FDA, that have been decades in the making, to ban menthol in cigarettes and flavors in cigars. A ban on menthol this month would save over 15,000 lives next year. Action can simply no longer be delayed," said Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the Nation's leading Hispanic health advocacy group.

Key Points: 
  • WASHINGTON, Dec. 5, 2023 /PRNewswire/ -- "For decades, the tobacco industry has used menthol and flavored products to deliberately target and addict Hispanic and other targeted communities in a callous campaign to increase profit.
  • Sitting at OMB are proposed rules from the FDA, that have been decades in the making, to ban menthol in cigarettes and flavors in cigars.
  • A ban on menthol this month would save over 15,000 lives next year.
  • Ongoing delays in enactment of these rules is literally a matter of life and death," concluded Dr. Delgado.

Cigarette Inner Liner Market to Surge to $120 Million by 2034 as Health and Regulatory Landscape Shifts | Future Market Insights, Inc.

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목요일, 11월 16, 2023
Tobacco industry, Attention, Growth, Printing, Holography, Automation, Heated tobacco product, Internet, Environment, Global Expansion Summit, Digitalization, Drug

This comprehensive report explores the industry's critical shaping factors, challenges, and investment opportunities, providing valuable insights for businesses navigating this dynamic market landscape.

Key Points: 
  • This comprehensive report explores the industry's critical shaping factors, challenges, and investment opportunities, providing valuable insights for businesses navigating this dynamic market landscape.
  • Cigarette Inner Liner Market Forecast by Aluminium Foil and Printing Paper, Global Growth Opportunities, and Revenue Forecast, from 2024 to 2034
    The global cigarette inner liner market is anticipated to register a valuation of US$ 82.6 million in 2024 and reach up to US$ 120.0 million by 2034.
  • The global market is estimated to secure a CAGR of 3.80% during the forecast period.
  • Promote Security: The demand for cigarette inner liners to protect tobacco products with advanced technologies drives market growth.

Cigarette Inner Liner Market to Surge to $120 Million by 2034 as Health and Regulatory Landscape Shifts | Future Market Insights, Inc.

Retrieved on: 
목요일, 11월 16, 2023
Tobacco industry, Attention, Growth, Printing, Holography, Automation, Heated tobacco product, Internet, Environment, Global Expansion Summit, Digitalization, Drug

This comprehensive report explores the industry's critical shaping factors, challenges, and investment opportunities, providing valuable insights for businesses navigating this dynamic market landscape.

Key Points: 
  • This comprehensive report explores the industry's critical shaping factors, challenges, and investment opportunities, providing valuable insights for businesses navigating this dynamic market landscape.
  • Cigarette Inner Liner Market Forecast by Aluminium Foil and Printing Paper, Global Growth Opportunities, and Revenue Forecast, from 2024 to 2034
    The global cigarette inner liner market is anticipated to register a valuation of US$ 82.6 million in 2024 and reach up to US$ 120.0 million by 2034.
  • The global market is estimated to secure a CAGR of 3.80% during the forecast period.
  • Promote Security: The demand for cigarette inner liners to protect tobacco products with advanced technologies drives market growth.

Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products

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목요일, 11월 16, 2023
CGMP, China Biologic Products, Safety, Heated tobacco product, Regulatory affairs, Food, Justice, Justice minister, Risk, Multimedia, FDA, Animal, Vaccine, Balance, Cirrhosis, COVID-19, Health, Cosmetics, District court, Human services, Dietary supplement, Cancer, Balance of nature, Diabetes, Walmart, Asthma, Public, Amazon

Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs.

Key Points: 
  • Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs.
  • In addition, Evig LLC violated current good manufacturing practice (CGMP) requirements, which rendered its products adulterated dietary supplements.
  • Evig distributes Balance of Nature dietary supplement products through Amazon, Walmart, and its own online store at www.balanceofnature.com .
  • The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

FDA Announces Federal Court Enters Consent Decree Against Arizona-Based Company for Distribution of Unapproved Contraceptive Drugs

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수요일, 11월 15, 2023
China Biologic Products, Safety, Heated tobacco product, Justice, Complaint, Choice, Multimedia, Research, FDA, Animal, Vaccine, Social media, Cosmetics, District court, Human services, Dietary supplement, Person, Food, FD, Public, Pharmaceutical industry

According to the complaint, which was filed with the consent decree by the U.S. Department of Justice, Smart Women's Choice and Richard unlawfully distributed unapproved new drugs within the U.S. marketplace.

Key Points: 
  • According to the complaint, which was filed with the consent decree by the U.S. Department of Justice, Smart Women's Choice and Richard unlawfully distributed unapproved new drugs within the U.S. marketplace.
  • "The FDA remains fully committed to taking enforcement action against companies and executives responsible for marketing unapproved drugs in violation of federal law."
  • The FDA has not approved Smart Women's Choice's drug, a vaginal cream the company has marketed as a safe and effective contraceptive.
  • Smart Women's Choice has disseminated these claims on its website and social media accounts, among other sources.

National PTA Awards Over $700K in Funding to Support Local Efforts for Students, Families and Communities

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수요일, 11월 15, 2023
CAE, Safety, Heated tobacco product, Learning, Campaign, Student, PTAS, Science, Campaign for Tobacco-Free Kids, Health, Caregiver, Ready, School, Huntington Ingalls Industries, Mental health, Family, Parent, Walmart, Knowledge, PTA, Education, AT&T, Life insurance, Nursing, Mobile phone, Tourism, Belong, STEM, Discord

ALEXANDRIA, Va., Nov. 15, 2023 /PRNewswire/ -- National PTA announced today the recipients of over $700K in funding to support local PTAs across the country as they engage families and support student success through PTA programs.

Key Points: 
  • ALEXANDRIA, Va., Nov. 15, 2023 /PRNewswire/ -- National PTA announced today the recipients of over $700K in funding to support local PTAs across the country as they engage families and support student success through PTA programs.
  • Following are the funding recipients:
    200 local PTAs have been selected to receive $1,250 each, supported by AT&T , to host an interactive PTA Connected: Ready, Tech, Go!
  • For example, we were able to jump from funding 150 to 200 recipients for our PTA Connected: Ready, Tech, Go!
  • Funding is not needed to run National PTA programs, and PTAs are encouraged to visit PTA.org/Programs to learn how they can implement the programs in their school communities.

IMPERIAL TOBACCO CANADA STANDS BY ZONNIC AS A TOBACCO HARM REDUCTION TOOL

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수요일, 11월 15, 2023
Sale, Health Canada, Smoker, Heated tobacco product, Foreign policy, Imperial Tobacco Canada, Nicotine, Advertising, NRT, Smoking, Pharmacy, Tobacco

MONTREAL, Nov. 15, 2023 /CNW/ - Despite the criticism from health groups, Imperial Tobacco Canada (ITCAN) believes that ZONNIC, a Nicotine Replacement Therapy (NRT) product authorized for sale by Health Canada, will help adult Canadians smokers quit.

Key Points: 
  • MONTREAL, Nov. 15, 2023 /CNW/ - Despite the criticism from health groups, Imperial Tobacco Canada (ITCAN) believes that ZONNIC, a Nicotine Replacement Therapy (NRT) product authorized for sale by Health Canada, will help adult Canadians smokers quit.
  • "I want to be absolutely clear, ZONNIC is not a tobacco product.
  • "It is licensed, regulated and advertised in the same way as any other smoking cessation product on the market.
  • ZONNIC is not promoted any differently than any other competing smoking cessation product in Canada.