FDA CDC News
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.
Related Information
- Office of Orphan Products Development
- Developing Products for Rare Diseases and Conditions
- Rare Diseases Program
- Accelerating Access to Critical Therapies for ALS Act – ACT for ALS
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Food and Beverage
Cinnamon, spice and ‘everything nice’ – why lead-tainted cinnamon products have turned up on shelves, and what questions consumers should ask
A Consumer Reports investigation revealed alarming lead levels in ground cinnamon, prompting concerns over safety, especially for children and pregnant women.
Katarzyna Kordas, University at Buffalo
Spices bring up feelings of comfort, cultural belonging and holidays. They can make our homes smell amazing and our food taste delicious. They can satisfy our cravings, expand our culinary horizons and help us eat things that we might normally dislike. Spices have health-enhancing properties and, in medicine, have been used to heal people since the ancient times.
Recently, however, spices have been getting a bad rep.
In September 2024, Consumer Reports, a nonprofit organization created to inform consumers about products sold in the U.S., investigated more than three dozen ground cinnamon products and found that 1 in 3 contained lead levels above 1 part per million, enough to trigger a recall in New York, one U.S. state that has published guidelines for heavy metals in spices.
The Food and Drug Administration issued three alerts throughout 2024, warning consumers about lead in certain brands of cinnamon products. Such notices rightfully put consumers on alert and have people wondering if the spice products they buy are safe – or not. https://www.youtube.com/embed/QxAwznMht8M?wmode=transparent&start=0 A Consumer Reports investigation of more than three dozen ground cinnamon products found that 1 in 3 contain lead levels above 1 part per million.
As an environmental epidemiologist with training in nutritional sciences, I have investigated the relationship between nutritional status, diets and heavy metal exposures in children.
There are several things consumers should be thinking about when it comes to lead – and other heavy metals – in cinnamon.
Why is lead found in cinnamon?
Most people are familiar with cinnamon in two forms – sticks and ground spice. Both come from the dried inner bark of the cinnamon tree, which is harvested after a few years of cultivation. For the U.S. market, cinnamon is largely imported from Indonesia, Vietnam, Sri Lanka, India and China.
One way that lead could accumulate in cinnamon tree bark is when trees are cultivated in contaminated soil. Lead can also be introduced in cinnamon products during processing, such as grinding.
When ground cinnamon is prepared, some producers may add lead compounds intentionally to enhance the weight or color of the product and, thus, fetch a higher sale price. This is known as “food adulteration,” and products with known or suspected adulteration are refused entry into the U.S.
However, in the fall of 2023, approximately 600 cases of elevated blood lead levels in the U.S., defined as levels equal to or above 3.5 micrograms per deciliter – mostly among children – were linked to the consumption of certain brands of cinnamon apple sauce. The levels of lead in cinnamon used to manufacture those products ranged from 2,270 to 5,110 parts per million, indicating food adulteration. The manufacturing plant was investigated by the FDA.
More broadly, spices purchased from vendors in the U.S. have lower lead levels than those sold abroad.
There is some evidence that cinnamon sticks have lower lead levels than ground spice. Lead levels in ground cinnamon sold in the U.S. and analyzed by Consumer Reports ranged from 0.02 to 3.52 parts per million. These levels were at least 1,500 times lower than in the adulterated cinnamon.
There are no federal guidelines for lead or other heavy metals in spices. New York state has proposed even stricter guidelines than its current level of 1 part per million, which would allow the New York Department of Agriculture and Markets to remove products from commerce if lead levels exceed 0.21 parts per million.
What does it mean that ‘the dose makes the poison’?
The current FDA guideline on daily intake of lead from diets overall is to limit lead intake to 2.2 micrograms per day for children. For women of reproductive age, this value is 8.8 micrograms.
The lead dose we are exposed to from foods depends on the level of lead in the food and how much of that food we eat. Higher doses mean more potential harm. The frequency with which we consume foods – meaning daily versus occasionally – also matters.
For spices like cinnamon, the amount and frequency of consumption depends on cultural traditions and personal preference. For many, cinnamon is a seasonal spice; others use it year-round in savory dishes or sauces.
Cinnamon is beloved in baked goods. Take a cinnamon roll recipe calling for 1.5 tablespoons (slightly less than 12 grams) of the spice. If a recipe yields 12 rolls, each will have around 1 gram of cinnamon. In the Consumer Reports investigation, some cinnamon products were classified as “okay to use” or “best to use.”
The highest value of lead in cinnamon products in the “okay to use” category was 0.87 parts per million, and in the “best to use” category, it was 0.15 parts per million. A child would have to consume 2.5 or more rolls made with the “okay to use” cinnamon to exceed the FDA guideline on limiting lead intake from foods to 2.2 micrograms per day, assuming that no other food contained lead. To exceed this guideline with “best to use” cinnamon, a child would have to eat 15 or more rolls.
Can cinnamon contribute to elevated blood lead levels?
Because of lead’s effects on development in early life, the greatest concern is for exposure in young children and pregnant women. Lead is absorbed in the small intestine, where it can latch onto cellular receptors that evolved to carry iron and other metals.
The impact of a contaminated spice on a person’s blood lead level depends on the dose of exposure and the proportion of lead available for intestinal absorption. For several spices, the proportion of available lead was 49%, which means that about half of the lead that is ingested will be absorbed.
Lead absorption is higher after a fast of three hours or more, and skipping breakfast may contribute to higher blood lead levels in children.
People who have nutritional deficiencies, such as iron deficiency, also tend to absorb more lead and have higher blood lead levels. This is because our bodies compensate for the deficiency by producing more receptors to capture iron from foods. Lead takes advantage of the additional receptors to enter the body. Young children and pregnant women are at higher risk for developing iron deficiency, so there is good reason for vigilance about lead in the foods they consume.
Studies show that among children with lead poisoning in the U.S., contaminated spices were one of several sources of lead exposure. Studies that estimate blood lead levels from statistical models suggest that consuming 5 micrograms of lead or more from spices daily could substantially contribute to elevated blood lead levels.
For occasional or seasonal consumption, or lower levels of contamination, more research is needed to understand how lead in spices would affect lead levels in the blood.
For people who have other sources of lead in their homes, jobs or hobbies, additional lead from foods or spices may matter more because it adds to the cumulative dose from multiple exposure sources.
How to test for elevated blood lead levels
The Centers for Disease Control and Prevention recommends that children at risk for lead exposure get a blood lead test at 1 and 2 years of age. Older children can also get tested. Finger-prick screening tests are often available in pediatric offices, but results may need to be confirmed in venous blood if the screening result was elevated.
Adults in the U.S. are not routinely tested for lead exposure, but concerned couples who plan on having children should talk to their health care providers.
What to consider when using or buying cinnamon or other spices
If the product is on an FDA Alert or the Consumer Reports “don’t use” list, discard it.
Other questions to consider are:
- Does your household use spices frequently and in large amounts?
- Do young children or pregnant women in your household consume spices?
- Do you typically consume spices on breakfast foods or beverages?
If the answer to any of these questions is yes, then buy good-quality products, from large, reputable sellers. Think about using cinnamon sticks if possible.
And continue to enjoy spices!
Katarzyna Kordas, Associate Professor of Epidemiology and Environmental Health, University at Buffalo
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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In early November, the U.S. Food and Drug Administration (FDA) announced a Class II recall concerning Hannaford Seafood Salads, affecting over 1,600 units across five states: Maine, New Hampshire, Vermont, Massachusetts, and New York. The recall, initiated on October 31, was due to a mislabeling incident that poses a significant risk to consumers with soy allergies.
Understanding the Class II Risk Level
The FDA has classified this recall as a Class II risk, indicating that exposure to the affected products may cause “temporary or medically reversible adverse health consequences.” However, the risk of experiencing serious health consequences remains “remote.” Despite this classification, consumers with an allergy or severe sensitivity to soy must take this recall seriously, as they could face life-threatening allergic reactions if they consume the mislabeled salads.
What Happened?
The problem arose when the printer responsible for the salad labels provided Elevation Foods, the manufacturer of the salads, with labels that did not accurately reflect the current product formulation. Instead of the correct labels, the printer mistakenly issued labels meant for an upcoming formulation change. As a result, the affected salads may contain undeclared hydrolyzed soy protein, a known allergen that must be clearly stated on product labels to protect consumer safety.
Product Details
The implicated Hannaford Seafood Salads were distributed between October 25 and 29, and they feature use-by dates of November 13 and 14. Consumers can find these dates printed on the lid of the containers. Following the recall announcement, all affected products were promptly removed from store shelves.
Health Risks Associated with Soy Allergies
For individuals with soy allergies, the immune system mistakenly identifies soy proteins as harmful invaders, leading to a range of symptoms that can vary in severity. Common reactions include stomach issues, coughing, itching, wheezing, vomiting, hives, and difficulty breathing. In severe cases, these reactions can escalate to life-threatening conditions, such as anaphylaxis.
To mitigate risks, those with soy allergies are advised to carry an epinephrine injection (Epi-Pen) to counteract severe allergic reactions swiftly.
What Should Consumers Do?
Customers who purchased Hannaford Seafood Salads before the recall are urged not to consume the products. Instead, they can return them to the store where they made the purchase for a full refund. Elevation Foods has not reported any known cases of illness related to these salads, but consumer safety remains a top priority.
Conclusion
This seafood salad recall serves as a crucial reminder about the importance of accurate labeling, especially when it comes to potential allergens. Consumers should remain vigilant and informed about the products they purchase, particularly if they have food allergies. Stay safe and always check your labels!
Related Links:
https://www.newsweek.com/seafood-salad-recall-update-fda-risk-level-hannaford-1992294
At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.
Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.
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Dog Treat Recall
In a recent announcement that has concerned dog owners across the Southeastern, Midwestern, and Mid-Atlantic regions of the United States, the FDA has reported a recall of “Hollywood Feed Carolina Made Chicken Chips” dog treats manufactured by Carolina Prime Pet, Inc. of Lenoir, North Carolina. This recall, affecting approximately 400 bags of these popular dog treats, is attributed to the potential risk of Salmonella contamination.
Why Is This Recall Important?
While there have been no reported illnesses linked to the consumption of these chicken chips, the safety of pets—and by extension, their human companions—is paramount. Salmonella, a bacteria that can cause severe gastrointestinal distress in animals and humans alike, can be particularly dangerous for pets, leading to symptoms such as vomiting, diarrhea, and lethargy. For individuals, Salmonella can also result in serious health complications, especially in young children, elderly adults, or those with weakened immune systems.
Details of the Recall
The recall specifically pertains to 16-ounce bags of “Hollywood Feed Carolina Made Chicken Chips” that carry the lot number 20051324L2 and an expiration date of 11/13/25. Consumers can easily identify the affected product by checking the back of the packaging, which features a distinctive purple-and-black design. The recall extends to retail locations across 19 states, including:
- Alabama
- Arkansas
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Michigan
- Mississippi
- Missouri
- North Carolina
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- Tennessee
- Texas
For those who purchased the treats online, they were also available on the company’s website at www.hollywoodfeed.com.
What Should Consumers Do?
Carolina Prime Pet, Inc. has advised consumers to check their homes for the affected product. If your dog treats match the recalled lot number and expiration date, it is crucial not to feed them to your pet. Instead, return the products to the place of purchase for a full refund. For those who have questions or need more information, the company encourages contacting their customer service.
Final Thoughts
As pet owners, it is our responsibility to stay informed about the products we give our furry friends. The safety of our pets is essential, and recalls like these serve as a reminder to always check product packaging and stay updated on food safety announcements. If you have any concerns about your pet’s health or have noticed any unusual symptoms after consuming potentially contaminated food, it is advisable to consult with a veterinarian immediately.
Stay alert, stay informed, and together we can ensure the safety and well-being of our beloved pets.
Related links:
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