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FDA Awards 19 Grants and Two Contracts Related to Rare Diseases, including ALS

U.S. Food and Drug Administration announced it has awarded 19 new grants and two new contracts totaling more than $38 million in funding over the next four years to support clinical trials, natural history studies and regulatory science tools related to rare diseases.



Today, the U.S. Food and Drug Administration announced it has awarded 19 new grants and two new contracts totaling more than $38 million in funding over the next four years to support clinical trials, natural history studies and regulatory science tools related to rare diseases. These grants and contracts, which were funded by the FDA’s Orphan Products Grants Program, aim to advance the development of medical products to treat rare diseases. Several awards support the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS) which recently established the FDA Rare Neurodegenerative Disease Grant Program to promote medical product development for rare neurodegenerative diseases such as ALS. 

“One of the greatest obstacles facing individuals who suffer from rare diseases is the limited treatment options currently available,” said FDA Commissioner Robert M. Califf, M.D. “Since the beginning of the Orphan Products Grants Program in 1983, it has facilitated the approval of more than 80 rare disease products. Through this and other efforts focused on rare diseases, the FDA continues to advance the development and evaluation of safe and effective medical products that help address patients’ unmet needs.”

The FDA received 33 clinical trial grant applications and awarded more than $25 million spread over the next four years to 11 clinical trials that support product development for rare disease treatments. Seven of the awards fund studies of rare cancers, mostly targeting cancers of the brain and peripheral nerves. Visit Orphan Products Grants (clinical trials) for more information.

Natural history studies look closely at how specific diseases progress over time. The FDA received 43 natural history grant applications and funded eight new grants totaling more than $11 million spread over the next four years for natural history studies that support innovative research to inform medical product development. Several studies seek to characterize certain subgroups within a disease, identify novel clinical outcome measures and biomarkers, which have the potential to improve the current standard of care and inform future drug development, including gene therapies. Visit Orphan Products Grants (natural history studies) for more information. 

The Rare Neurodegenerative Disease Grant Program was established specifically for ALS and neurodegenerative conditions upon enactment of the ACT for ALS in December 2021. The ACT requires that the FDA award grants and contracts to public and private entities to cover costs of research on, and development of interventions intended to prevent, diagnose, mitigate, treat, or cure ALS and other rare neurodegenerative diseases in adults and children. Three of the natural history studies awarded by the FDA are related to rare neurodegenerative diseases including for ALS, Myotonic Dystrophy Type 1, and Ataxia-Telangiectasia. The study for ALS, partially funded by the National Institutes of Health (NIH) has the potential to advance existing knowledge of the natural history of ALS, inform drug development and possibly support future regulatory decisions. 

Additionally, the FDA funded two contracts related to rare neurodegenerative diseases. One contract, co-funded by NIH and the FDA, will study whether a physical assessment of ALS patients, typically done in a health care professional’s office, can be done remotely at home to minimize the burden on patients. This can ultimately lead to lower clinical trial costs and enable decentralized trials, where appropriate, improving access to trials for patients in rural areas and lower-resource healthcare settings. 

The second contract is a landscape analysis of patient preference information (PPI) studies focused on brain-computer interface (BCI) devices. The FDA is specifically interested in BCI devices that communicate with the brain and provide patients, who are no longer able to speak or move, with the ability to interact with their families and health care professionals. The contract will review the literature to determine what is already known about BCI devices and PPI studies in ALS. In total, through collaborative efforts, the FDA and its partners were able to support nearly $6 million in research and science to advance the mission of the ACT for ALS Act. Visit Rare Neurodegenerative Disease Grant Program for more information about the contracts. 

“These grants provide important funding to researchers who are working to develop better treatments for rare disease patients,” said Sandra Retzky, D.O., J.D., MPH, director of the FDA’s Office of Orphan Products Development (OOPD). “The contracts aim to advance treatment options for patients, help inform regulatory decision making, and promote diversity, equity and inclusion in clinical research. OOPD will continue to make investments in progressive studies to advance medical product development.” 

Earlier this year, the FDA announced the agency’s Action Plan for Rare Neurodegenerative Diseases, including ALS – a five-year plan to further the development of safe and effective medical products and facilitate patient access to novel treatments. The plan was developed in accordance with the ACT for ALS Act. The FDA recently announced a call for comments on current funding needs in the rare neurodegenerative disease space that could be supported by grants from the Office of Orphan Products Development.  

The FDA remains committed to supporting rare disease research by providing existing grantees with critical funding and encouraging innovative trial designs, collaborations among stakeholders, early and ongoing patient engagement, use of innovative methods, and use of established infrastructure. 

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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.



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


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


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!



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, 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.




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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)

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)



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