FDA CDC News
FDA Outlines Steps to Strengthen Tobacco Program
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) outlined the steps it plans to take in response to an external evaluationExternal Link Disclaimer I commissioned last year from an independent panel of evaluators working through the Reagan-Udall Foundation. The evaluation was an important opportunity to take a critical look at the Tobacco Program’s regulatory processes and operations.
We have made tremendous progress preventing death and disability caused by tobacco use, but I am a strong believer that we can always benefit from examining how we can work most effectively and proactively to protect public health, support our staff, and be as responsive as possible to external stakeholders. When I started my career in intensive cardiac care, hospitals were full of relatively young people with sudden death, heart attacks, strokes and cancer attributable to tobacco use. The effectiveness of the public health and medical communities to reduce the toll of tobacco products was enhanced when the FDA was granted the authority to regulate tobacco.
As we enter this era of declining use of combustible tobacco and continued innovation in the e-cigarette industry, the societal concerns are not subtle. Our ability to keep pace with these changes will depend on immediate, short-term and long-term actions the center is taking that we believe will position the agency to more successfully implement our regulatory oversight of tobacco products.
CTP Director Brian King, Ph.D., M.P.H., has provided more detail about our approach to respond to the evaluation recommendations and our new plans, which will include the release of a 5-year strategic plan and comprehensive policy agenda by the end of the year. CTP has committed to providing regular updates on the progress of these activities, including some noted here.
Application Review
In the past several years in particular, CTP has made important progress in the review of applications for e-cigarette products – authorizing several tobacco-flavored e-cigarette products and devices and rejecting marketing applications for millions of products that did not meet the requirements in the law.
Given the ever-evolving tobacco marketplace, it is imperative that we optimize the framework for application reviews to ensure any products marketed meet the law’s public health and regulatory standards. This work will include, among other things:
- further streamlining of reviews when appropriate;
- increasing the use of the Tobacco Products Scientific Advisory Committee to discuss broader scientific matters central to premarket evaluation and individual product applications;
- posting current and future scientific policy memos and reviewer guides when appropriate; and
- working internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency. These critical efforts will be bolstered by a new director in CTP’s Office of Science, who will begin in late March.
To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco. Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products. The FDA also continues to explore ways, including engaging with the U.S. Department of Health and Human Services and the Office of Personnel Management, to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match CTP’s needs.
Compliance and Enforcement
As the agency continues to make progress on its review of new and pending applications for novel products like e-cigarettes, the FDA will take additional action to remove illegal products from the market—particularly ones that have led to e-cigarettes being the most commonly used tobacco product among youth.
Between January 2021 and February 17, 2023, the FDA has issued more than 550 warning letters to companies for continuing to sell e-cigarette products that lacked the required FDA marketing authorization. These companies had millions of products listed with the FDA. After receiving warning letters, a majority of these companies have complied and removed their products from the market. However, in cases where companies did not do so, the FDA can pursue further enforcement action. For example, the FDA recently worked with the Department of Justice (DOJ) to file the first complaints for permanent injunctions against six e-cigarette manufacturers. Additionally, for the first time, the FDA this week filed civil money penalty complaints against four tobacco product manufacturers for manufacturing and selling new e-liquids without marketing authorization. The agency will continue to work as expeditiously as possible to remove illegal products from the market while identifying new ways to strengthen compliance and enforcement.
As recommended by the external evaluation, effective immediately, the FDA will begin planning to convene a summit with senior officials from the HHS and DOJ related to enforcement. The agency will also continue to work with other government agencies, such as U.S. Customs and Border Protection, the U.S. Postal Service, the Federal Trade Commission, Bureau of Alcohol, Tobacco, Firearms and Explosives, as well as with our compliance and enforcement partners at the state/local/territorial/tribal levels. This work will maximize compliance and enforcement activities where there are shared interests. Additionally, the FDA will explore alternative approaches to achieve compliance outside of judicial enforcement actions.
The agency acknowledges that some unlawful e-cigarette products continue to be sold in the U.S. Many companies have challenged the agency’s marketing denial orders in courts around the country. In some cases, this has constrained our ability to remove these products from the market while the legal cases are pending. It is also important for the public to understand that the agency does not have the authority to independently bring legal cases seeking injunction or seizure against those who violate the law. Instead, the agency must rely on DOJ, who must evaluate the legal risks of pursuing particular enforcement actions and decide whether to dedicate its finite resources to litigate cases on our behalf. The FDA will continue to use all the tools at our disposal to hold companies accountable; however, the agency cannot be everywhere at all times. The agency needs additional resources to ensure that companies comply and that we have the ability to take action against those who break the law and tie up the system in court proceedings.
Transparency and Communication
As part of the center’s work, the agency plans to enhance and increase its public communications to provide greater transparency about the agency’s approach to compliance and enforcement. By this spring, we plan to begin posting content to a new comprehensive webpage for all enforcement activities, which will include a searchable public database of all tobacco products that have an FDA marketing order to discourage the sale of illegal products. Additionally, the center plans to conduct additional public meetings and workshops, as well as provide more information regarding the application review process.
The center will also explore new ways for soliciting and considering public input on its public education campaigns, including input on formative research into messaging for adult smokers that nicotine – while highly addictive – is delivered through products that represent a continuum of risk.
The State of Tobacco Regulation in the U.S.
When Congress tasked the FDA with regulating tobacco products more than 13 years ago, the vision was to make tobacco-related disease and death part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every family.
We’ve made notable progress, but important opportunities and challenges lie ahead as we seek to regulate an evolving marketplace. Current cigarette smoking among U.S. adults declined from 20.6% of the population in 2009 to 11.5% in 2021. Despite this progress, nearly 500,000 Americans still die every year from cigarette smoking and continued youth vaping is producing another generation plagued with addiction to products with unknown long-term health consequences.
We’ve announced plans to prevent initiation and help people quitExternal Link Disclaimer the deadliest form of tobacco use – combustible tobacco products. The agency is working to finalize product standards that would ban menthol in cigarettes and characterizing flavors (including menthol) in cigars. We’ve also announced plans for future potential regulatory actions, including developing a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. These actions are key to achieving the Cancer Moonshot goal of cutting the cancer death rate in half over the next 25 years, a key pillar of President Biden’s Unity Agenda.
Additionally, we continue to make significant strides in our science-based review of more novel tobacco products, such as e-cigarettes. The FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The agency has also issued marketing denial orders for more than one million flavored e-cigarette products that lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health concerns posed by the well-documented, alarming levels of youth use of such products. While certain e-cigarettes may help adult smokers transition completely away from, or significantly reduce their use of more harmful combusted cigarettes, the law’s public health standard balances that potential with the known and substantial risk with regard to youth appeal, uptake, and use of these highly addictive products.
Unfortunately, the tobacco industry has fought the agency on many of the science-based actions we’ve taken – putting profits over public health. For example, despite being the only country with sweeping regulatory authority over the industry, unlike many other nations, legal challenges have twice prevented us thus far from implementing Congressionally mandated warnings on cigarette packs depicting the serious health risks of cigarette smoking. And, as noted earlier, many decisions about product applications have also been challenged in court, which has, among other things, required significant resources to defend.
The FDA will continue to undertake our critical work to improve public health. It’s imperative that we are able to meaningfully implement transformational regulations and make decisions based on the public health standard in the law, with the American public – not the interests of the tobacco industry – at the forefront. We’ve made progress, but there’s a lot more work to come.
Source: FDA
Food and Beverage
Nationwide Health Alert for E. coli Contaminated Ground Beef: What You Need to Know
“Nationwide health alert issued for E. coli-contaminated ground beef. Check FSIS website for affected products and disposal instructions.”
A recent national health alert has been issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) regarding Greater Omaha ground beef products potentially contaminated with E. coli O157:H7. This particular strain of E. coli can cause severe gastrointestinal infections in humans. In this article, we will provide you with all the information you need to know about this alert and how to stay safe.
Product Details:
The affected ground beef products were produced and packaged on March 28, 2024, with a “Use/Freeze by” date of April 22, 2024. The packaging will also have “EST.960A” inside the USDA mark of inspection. While the ground beef was distributed to various restaurants and retail locations nationwide, it is important to note that the impacted products are no longer available for sale.
Affected Products:
- 10-lb. ground beef chub: GROUND BEEF 85 FINE GRIND 10#/6 (Lot codes: 25, 28, 29, 30, 31, 32, and 33; Case code: 263085)
- 5-lb. ground beef chub: GROUND BEEF GOHERF GB RIB BRISKET CHUCK CRAFT BURGER 5LB (Lot code: 26; Case code: 66500)
- 5-lb. ground beef chub: Greater Omaha 100% ALL NATURAL 5 LBS. GOURMET BLEND RIB BRISKET CHUCK
- 5-lb. ground beef chub: GROUND BEEF GOHERF GB 81 FINE GRIND 5#/12 EXACT WEIGHT (Lot code: 26; Case code: 663581)
- 4-pack 8-oz ground beef patties: GROUND BEEF GOANG GB Patty 8OZ Homestyle Rib/Brisket/CH (Lot code: 34; Case code: 716800)
- 4-pack 8-oz ground beef patties: LOT 34 Ground Beef GB GOANG 75 PATTY PUCK 8 OZ (Lot code: 34; Case code: 728075)
- 4-pack 7-oz ground beef patties: LOT 34 GROUND BEEF GOANG Rib/Brisket/Chuck 7OZ HOMESTYLE (Lot code: 34; Case code: 716700)
- 6-oz ground beef patties: LOT 34 GROUND BEEF GOANG GB PATTY 6 OZ HOMESTYLE RIB/BRISKET/CHUCK (Lot code: 34; Case code: 716600)
- 5-lb. ground beef chub: GROUND BEEF GOHERF GB 81 FINE GRIND 5LB EXACT WEIGHT (Lot code: 26; Case code: 63581)
- 6-pack 5.33-oz ground beef patties: Ground Beef GOHERF RIB BRISKET CHUCK 5.33oz HOMESTYLE (Lot code: 27; Case code: 616500)
- 4-pack 8-oz ground beef patties: LOT 27 Ground Beef GOHERF Homestyle GB PATTY RIB/BRISKET/CHUCK 8 OZ (Lot code: 27; Case code: 616800)
- 10-lb. ground beef chub: GROUND BEEF 73 FINE GRIND 10#/6 (Lot code: 37; Case code: 263073)
- 4-pack 8-oz ground beef patties: LOT 51 Ground Beef GB GOANG 75 PATTY PUCK 8OZ (Lot code: 51; Case code: 728075)
Recommendations:
If you have any of the above-mentioned ground beef products stored in your freezer, the FSIS advises against consuming them. Instead, it is important to either throw them away or return them to the place of purchase. Doing so will help prevent potential health risks.
Moreover, it is essential to note that no confirmed illness cases have been reported thus far in connection with this specific health alert. However, if you have consumed the ground beef and are experiencing any symptoms of illness, it is recommended to reach out to a healthcare provider immediately.
Ensuring the safety and well-being of consumers is a priority, and that is precisely why this nationwide health alert has been issued concerning E. coli contamination in specific Greater Omaha ground beef products. By taking the necessary precautions and following the FSIS recommendations, we can collectively prevent any potential health risks associated with this incident.
Remember, staying informed and proactive during such situations is crucial for ensuring the health and safety of yourself and your loved ones. Keep up to date with any further developments by visiting the FSIS website or seeking information from reliable sources. Stay safe and healthy!
Check out the article on The Hill regarding the E. Coli warning. https://thehill.com/changing-america/well-being/prevention-cures/4610002-nationwide-health-alert-issued-for-ground-beef-over-potential-e-coli-risk/
What is E. Coli?
-Escherichia coli is a gram-negative, facultative anaerobic, rod-shaped coliform bacterium. – It is commonly found in the lower intestine of warm-blooded organisms. – Most E. coli strains are harmless, but some can cause food poisoning and contamination incidents. – Some strains of E. coli are beneficial to humans by producing vitamin or preventing the colonization of pathogenic bacteria. – E. coli is expelled through fecal matter and grows rapidly for three days before declining.
E. coli and other bacteria make up only a small part of the gut microbiota, but can cause disease through fecal-oral transmission. They can be used as indicators to test for fecal contamination in the environment, and some strains can survive for days outside a host.
E. coli is a bacterium that has been extensively studied for over 60 years and can be easily and inexpensively grown in a lab. It is a chemoheterotroph and requires carbon and energy. E. coli is the most widely studied prokaryotic model organism and is significant in biotechnology and microbiology. It reproduces quickly, taking as little as 20 minutes under favorable conditions. (Wikipedia)
FDA CDC News
FDA Approval of Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Breaking news! FDA approves Duvyzat for Duchenne Muscular Dystrophy, a nonsteroidal treatment providing hope for patients and families. #DMD #FDAApproval
Breaking news in the medical world! The U.S. Food and Drug Administration has just approved Duvyzat (givinostat), an oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is making history as the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. This is a significant milestone in the treatment of this devastating disease.
DMD, being the most common childhood form of muscular dystrophy, primarily affects males. It is a neurological disorder that leads to progressive muscle weakness due to a lack of dystrophin, a muscle protein. Over time, the muscles deteriorate, causing difficulties with walking, muscle strength, and eventually leading to breathing problems and early death. However, with advancements in treatment, the life expectancy for individuals with DMD has been steadily increasing, with some patients surviving beyond 30 years.
Duvyzat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle in patients with DMD. Its efficacy for the treatment of DMD was evaluated in an 18-month phase 3 study involving a randomized, double-blind, placebo-controlled trial. The primary endpoint of the study was the change in muscle function, measured by the time it took patients to climb four stairs. Patients treated with Duvyzat showed a statistically significant reduction in the decline of muscle function compared to placebo.
Another measure of efficacy was the change in physical function assessed by the North Star Ambulatory Assessment (NSAA), a scale commonly used to rate motor function in boys with DMD who can still walk. Patients treated with Duvyzat experienced less worsening in their NSAA scores after 18 months, compared to those on placebo.
Like any medication, Duvyzat does come with some potential side effects. The most common ones reported were diarrhea, abdominal pain, a decrease in platelets, nausea/vomiting, an increase in triglycerides, and fever. It’s important for healthcare providers to evaluate a patient’s platelet counts and triglyceride levels before prescribing Duvyzat. Patients with low platelet counts should not take the drug. Monitoring of platelet counts and triglycerides throughout treatment will help determine if any dosage adjustments are needed.
Healthcare professionals should also be aware that Duvyzat may cause QTc prolongation, which can increase the risk of irregular heartbeats. It’s crucial for patients taking other medications known to cause QTc prolongation or with certain types of heart disease to avoid taking Duvyzat.
The recommended dosage of Duvyzat is determined by the patient’s body weight, and it should be taken orally twice daily with food.
The approval of Duvyzat was granted to Italfarmaco S.p.A., and it received priority review, fast-track designation, as well as orphan drug and rare pediatric disease designations from the FDA. This demonstrates the agency’s commitment to advancing the development of new therapies for DMD and its recognition of the urgent need for effective treatments.
This milestone approval represents hope and progress for individuals and families affected by DMD. It provides another treatment option to help reduce the burden of this progressive and debilitating disease, regardless of the specific genetic mutation. With continued advancements in medical research and the dedication of organizations like the FDA, we are moving closer to a future where individuals with DMD can lead healthier lives.
As always, it’s important to consult with healthcare professionals for more information and guidance regarding Duvyzat and its suitability for individual cases. Let’s celebrate this achievement in medical science and look forward to more groundbreaking developments in the treatment of Duchenne Muscular Dystrophy.
Source: FDA
Related Information
- Duchenne muscular dystrophy – About the Disease – Genetic and Rare Diseases Information Center
- The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://stmdailynews.com/category/lifestyle/
Daily News
Understanding RSV: Symptoms, Treatment, and Prevention
RSV: a viral respiratory infection affecting children and adults. Learn about symptoms, treatment, and prevention for a healthier future.
RSV, short for Respiratory Syncytial Virus, is a common viral infection that primarily affects the respiratory system, particularly young children. While RSV infections are usually mild, they can pose a greater risk to infants, older adults, and individuals with weakened immune systems. If you or a loved one are facing RSV, it can be overwhelming to know what to do next. That’s why it’s important to know the symptoms, treatment options, and preventative measures available to you. By being informed and taking action, you can give yourself and those around you hope and guidance during this difficult time. So let’s explore what you can do to fight RSV and emerge victorious.
Symptoms and Diagnosis:
RSV presents symptoms resembling a cold, including cough, runny nose, fever, and occasionally, difficulty breathing. Infants may exhibit irritability, decreased appetite, and lethargy. Diagnosing RSV usually involves a medical professional evaluating symptoms, conducting a physical examination, and, if necessary, performing laboratory tests to confirm the presence of the virus.
Treatment and Management:
In most cases, RSV infections can be managed at home with supportive care. This includes ensuring proper hydration, maintaining a comfortable environment, and using over-the-counter medications to alleviate symptoms under a doctor’s guidance. However, for high-risk individuals or severe cases, hospitalization may be required for closer monitoring and specialized treatment, such as oxygen therapy or intravenous fluids.
Prevention is Key:
Preventing the spread of RSV is crucial, especially for vulnerable populations. Practicing good hygiene, such as frequent handwashing, covering coughs and sneezes, and avoiding close contact with infected individuals, can significantly reduce the risk of transmission. Additionally, promoting a clean and sanitized environment, particularly in daycare centers and schools, can help curb the spread of the virus.
Hopeful Outlook:
While RSV can be concerning, it’s important to remember that most cases resolve on their own with time and supportive care. In fact, the majority of children infected with RSV recover fully without complications. By following preventive measures, seeking medical attention when needed, and staying informed about the latest developments in RSV research and treatment, we can approach this viral infection with hope and confidence.
Respiratory Syncytial Virus (RSV) is a common viral infection that primarily affects young children, causing cold-like symptoms and occasionally resulting in more severe respiratory distress. However, with proper care and attention, RSV can be managed effectively. By understanding the symptoms, seeking medical help when necessary, and adopting preventive measures, we can protect ourselves and our loved ones from the impact of RSV and look forward to brighter days ahead.
You can find more information about RSV, including its treatment and prevention, by visiting the CDC website. https://www.cdc.gov/rsv/index.html
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