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FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

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Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. The FDA and NIH have selected the Critical Path InstituteExternal Link Disclaimer (C-Path) as the convener of this partnership.

“There is a crucial need to develop new treatments that can improve and extend the lives of people diagnosed with rare neurodegenerative diseases, including ALS. Collaboration across public and private sectors can accelerate the progress to address this urgent need,” said FDA Chief Medical Officer, Hilary Marston, M.D., M.P.H. “The partnership we are announcing today will leverage the shared expertise of all participants to create a path towards new breakthroughs in treating these diseases. We look forward to working with NIH, C-Path, and other public and private partners to carry out this important effort.”

“This public-private partnership will convene the entire ALS community to develop novel strategies and approaches to therapy development and clinical testing with the goal to finally produce a treatment that stops the tragic progression of ALS,” said Walter Koroshetz, M.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH. 

C-Path will convene the partnership, bringing together experts in rare neurodegenerative diseases, including, but not limited to, patient communities, advocacy organizations, and private entities. The direction and priorities for the effort will be determined with input from the partners. Areas of focus will include patient-focused drug development, and utilization of the FDA-funded Rare Disease Cures Accelerator-Data and Analytics PlatformExternal Link Disclaimer (RDCA-DAP) to bring together scientific data on rare neurodegenerative diseases to facilitate the characterization of neurodegenerative diseases and their natural history, the identification of molecular targets for neurodegenerative disease, and increased efficiency, predictability, and productivity of clinical development of therapies.

Building on and leveraging the shared expertise of the participants, the goal of this partnership is to generate actionable solutions that can tangibly accelerate drug development for rare neurodegenerative diseases. 

The Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (Act for ALS) was signed into law on December 23, 2021 by President Biden and requires HHS, through FDA and NIH, to establish and implement a public-private partnership not later than one year after enactment. This partnership is a key component of the FDA’s Action Plan announced in June. 

To learn more about the Critical Path for Rare Neurodegenerative Diseases, contact the C-Path team at cp-rnd@c-path.org.

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Health Alert: Classic Delight Sandwiches May Pose a Risk of Contamination

Potential contamination alert: Classic Delight sandwiches recalled due to Listeria monocytogenes risk. Take necessary precautions.

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Classic Delight sandwich recall due to Listeria monocytogenes contamination risk
Fresh sub sandwich on white and wheat hoagies.(Adobe Stock)


In a recent public health alert, Classic Delight LLC, a food company based in St. Mary’s, Ohio, has announced a voluntary recall of certain individually wrapped sandwiches due to potential contamination with Listeria monocytogenes. This organism can result in severe infections, especially among vulnerable individuals. While no illness or adverse reactions have been reported thus far, the company is taking proactive measures to ensure consumer safety.

Details of the Recall:
The affected products, produced between May 11, 2023, and June 6, 2024, were distributed to several states, including Arkansas, California, Maryland, Missouri, Ohio, Pennsylvania, and Texas. These sandwiches may have made their way into food service distribution, convenience stores, and vending machines. To assist in identifying the recalled items, here is a list of the specific products:

  • 7060 Classic Delight Twin Chili Cheese Dog
  • 514713 Wakefield Charbroiled Cheeseburger
  • 311 Classic Delight Turkey Ham and Cheese Sub
  • 551697 Wakefield Ham Cheddar Pretzel Croissant
  • 314 Classic Delight Turkey Cheese Sub
  • 648899 Wakefield Chorizo Egg Ciabatta
  • 6731 Classic Delight Turkey Cheese Round
  • 806604 Wakefield Ham Egg Cheese Muffin
  • 6757 Classic Delight Twin Breaded Chicken Sliders
  • 806612 Wakefield Ham Egg Cheese Croissant
  • 7626 Classic Delight Breaded Chicken Waffle
  • 806620 Wakefield Bacon Egg and Cheese Bagel
  • 73131 Nutrisystem Turkey Sausage and Egg Muffin
  • 806638 Wakefield Sausage Egg and Cheese Biscuit
  • 176586 Wakefield Pretzel Bacon Angus Cheeseburger
  • 806646 Wakefield Sausage Egg and Cheese Muffin
  • 176594 Wakefield Southern Chicken Biscuit
  • 806653 Wakefield Bacon Cheeseburger
  • 195263 Wakefield Spicy Hawaiian Sliders
  • 806661 Wakefield Blazin Chicken
  • 514711 Wakefield Bacon Egg and Cheese Bagel
  • 806679 Wakefield Charbroiled Cheeseburger
  • 514712 Wakefield Sausage Egg and Cheese Biscuit
  • 806687 Wakefield Chicken and Cheese
  • 942821 Wakefield Sausage Egg Pancake

Reasons for Recall:
Classic Delight initiated the recall after routine environmental testing revealed the presence of Listeria monocytogenes. The company is actively collaborating with the U.S. Food & Drug Administration (FDA) to investigate the origin of the issue. As a precautionary measure, production of the affected products has been halted until the source of contamination is identified and resolved.

Action Steps for Consumers:
If you have purchased any of the recalled Classic Delight sandwiches, it is crucial to take immediate action to safeguard your health and well-being. Here’s what you need to do:

  1. Discard the affected products if they are still in your possession.
  2. For a full refund, return the recalled items to the place of purchase.
  3. Any concerns or queries can be directed to the Classic Delight Consumer Hotline at (419)-300-3202, Monday through Friday, 8:00 am to 3:00 pm Pacific Time. Alternatively, you may contact them via email at info@classicdelight.com.

Health and Safety Measures:
While there have been no reported cases of illness linked to these products thus far, it’s important to remain vigilant. Should you experience any symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, or diarrhea after consuming these sandwiches, contact your healthcare provider immediately.


Classic Delight’s voluntary recall underscores their commitment to ensuring the safety of consumers. By swiftly addressing the potential risk of Listeria monocytogenes contamination, Classic Delight is taking proactive steps to protect public health. Remember to check your refrigerators or storage areas for the listed products and follow the recommended actions to minimize any potential harm. Always prioritize your well-being and stay informed about food recalls to make educated choices about the food you consume.

Company Contact Information

Consumers:Classic Delight Consumer Hotline (419)-300-3202 info@classicdelight.com

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Press Release: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/classic-delight-llc-issues-public-health-alert-due-possible-health-risk

https://stmdailynews.com/category/lifestyle/health-and-wellness

About the FDA?

The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health by overseeing food safety, tobacco products, caffeine products, dietary supplements, pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed, and veterinary products.

The FDA primarily enforces the Federal Food, Drug, and Cosmetic Act (FD&C) but also enforces other laws like Section 361 of the Public Health Service Act. This includes regulating lasers, cellular phones, and condoms, and controlling diseases in household pets and human sperm for assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President and confirmed by the Senate, reporting to the Secretary of Health and Human Services. Robert Califf is the current Commissioner as of 17 February 2022.

The FDA’s headquarters is in White Oak, Maryland, with 223 field offices and 13 laboratories across the US, including the Virgin Islands and Puerto Rico. Since 2008, the FDA has posted employees to various foreign countries like China, India, Costa Rica, Chile, Belgium, and the United Kingdom. (Wikipedia)

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Soft Drinks Recall: Undeclared Ingredients Pose Health Hazards

Recalled soft drinks by Charles Boggini Company contain undeclared ingredients, posing health hazards. Stay informed for a safer choice!

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In a recent development, the Food and Drug Administration (FDA) has issued a recall on three soft drink products produced by Charles Boggini Company. The recall was initiated by the company due to undeclared ingredients in their Pink Lemonade, Cola Flavoring Base, and Yellow Lemonade and Yellow Lemonade X. These undisclosed components have now been classified by their risk level, helping consumers make informed decisions regarding their health and wellbeing.

Understanding the Risk Levels:
The FDA classifies health hazards into three levels: Class I, Class II, and Class III. Class I indicates the most severe risk, where the product has the potential to cause “serious adverse health consequences or death.” Class II signifies that exposure or use of the product might result in temporary or medically reversible adverse health consequences. Class III denotes a situation where the product is unlikely to cause adverse health consequences.

Recall Details:
The recalled soft drinks include 28 gallons of Pink Lemonade, 2,723 gallons of the Cola Flavoring Base, and 112 gallons of Yellow Lemonade and Yellow Lemonade X. The Pink Lemonade and Cola Flavoring Base were classified as Class II health hazards, while the Yellow Lemonade and Yellow Lemonade X products received a Class III categorization. It’s important to note that these recalls were voluntary and initiated by Charles Boggini Company in March this year.

Undisclosed Ingredients:
The Pink Lemonade was found to contain undeclared FD&C Red No. 40, the Cola Flavoring Base contained undisclosed sulfites, and the Yellow Lemonade and Yellow Lemonade X contained undeclared FD&C Yellow No. 5.

FD&C Red No. 40:
FD&C Red No. 40, also known as E129, is a red dye used in a wide range of products worldwide. While various organizations agree that dietary exposure to this dye is generally not a health concern, some studies have suggested potential links to allergies, migraines, and mental disorders, particularly ADHD in children. Consequently, the FDA mandates that any product containing this dye must declare it as an ingredient. Failure to comply can lead to product recalls.

Sulfites:
Sulfites, commonly used as preservatives in food products, were found in the Cola Flavoring Base. Although the FDA requires sulfites to be declared in food products with a level over 10 ppm (parts per million), some individuals may have sensitivities to sulfites. These sensitivities can manifest as skin reactions, digestive issues, or respiratory problems.

FD&C Yellow No. 5:
The Yellow Lemonade and Yellow Lemonade X were found to contain FD&C Yellow No. 5, also called tartrazine or E102. This synthetic food dye is commonly used in soda, colored candy, and pastries. For individuals with asthma or an aspirin intolerance, allergic and intolerance reactions may occur.


Customer safety and well-being are of utmost importance, and the voluntary recall by Charles Boggini Company, along with FDA classifications of the health hazards posed by undeclared ingredients, demonstrates their commitment to consumer protection. By being aware of the potential risks associated with undisclosed ingredients, individuals can make informed choices and support a culture of transparency in the food and beverage industry.

Check out the article in Newsweek.

https://www.newsweek.com/fda-food-recall-soda-food-dye-sulfites-1907882

https://stmdailynews.com/category/food-and-beverage

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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.”

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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)

https://stmdailynews.com/category/food-and-beverage/

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