FDA CDC News

FDA Seeks $7.2 Billion to Protect and Advance Public Health by Enhancing Food Safety and Advancing Medical Product Availability

Published

2 years ago

March 10, 2023

Today, the U.S. Food and Drug Administration announced it is requesting $7.2 billion as part of the president’s fiscal year (FY) 2024 budget. This funding will allow the agency to continue to leverage new and emerging technologies, recruit and support a highly skilled workforce and adapt oversight to new production and business models. This is work that will have an immediate impact on food, tobacco and medical product safety in this country while also preparing the agency to address rapid innovation across the food and medical products fields. The request includes an increase of $372 million in budget authority — or 10% above the FY 2023 Enacted Level — and a $150 million increase in user fees.

“This year’s funding request builds on our accomplishments and lessons learned over the past year and adds new funding to continue modernizing the FDA and its capabilities for the future. We continue to deliver on a wide range of priorities and have strategically focused our request to ensure our program areas have the funding they need to operate with the highest success for the good of public health,” said FDA Commissioner Robert M. Califf, M.D. “Our investments to strengthen medical product safety and availability, along with funding for vital oversight of tobacco products continue to be a central focus. The budget also provides a historic investment to strengthen the FDA’s food safety and nutrition capacity—especially for infants and young children, demonstrating the Administration’s ongoing commitment to these responsibilities. As always, our foremost focus is on the well-being of patients and consumers, and we look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”

The FY 2024 request, which covers the period from Oct. 1, 2023, through Sept. 30, 2024, includes new efforts for high priority program areas. Highlights of the agency’s request include:

Enhancing Food Safety, Nutrition and Cosmetics

$128.2 million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. While the agency is in the process of defining its future vision for the Human Foods Program, there is significant need for additional resources to strengthen its foundational food safety and nutrition capacity. The budget seeks to strengthen consumer protection and implement lasting solutions for more efficient operations through continued investments in the New Era of Smarter Food Safety. Building on lessons learned from the infant formula supply chain response, the budget includes funding to modernize infant formula oversight and strengthen efforts to respond to shortages of critical foods, empower consumers to make healthier food choices and reduce exposure to toxic chemicals in the food supply. The budget will also help position the FDA to keep pace with innovative and novel technologies being used to develop animal food ingredients while addressing foundational gaps in the oversight of the animal food industry as these ingredients are combined, packaged, and sold as animal food.
$5 million toward modernizing oversight of cosmetics. The budget includes new funding for the development of regulations, compliance policies, product registration and listing platforms, adverse event reporting and other activities to start to implement new authorities recently signed into law related to the safety and proper labeling of cosmetic products.

Advancing Access to Safe and Effective Medical Products

$23 million in additional funds to advance the goal of ending the opioid crisis. Funding will support broader development of opioid overdose reversal treatments and treatments for substance use disorders and enhance regulatory oversight, expand compliance, enforcement and laboratory support. Additionally, the budget request assists in advancing the development, evaluation and market authorizations of related digital health medical devices.
$11.6 million increase toward improving the medical device supply chain and shortage programs. The agency will continue to build its capabilities to ensure patients have access to medical devices at all times. The budget will allow the FDA to expand efforts to work proactively with medical device companies, health care providers, device distributors, and patients to enhance resiliency in the supply chain of critical medical devices and prevent shortages of critical devices that most often impact vulnerable populations.
$2.5 million to implement ACT for ALS to foster development of treatments for ALS and other rare neurodegenerative diseases. To help the FDA implement the ACT for ALS Act, additional funding will strengthen the FDA’s ability to issue new grants and contracts, hire dedicated expert staff and allow the FDA to facilitate access to investigational therapies and medical devices for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., ALS, also known as Lou Gehrig’s disease, a progressive and fatal disease).

Reigniting Cancer Moonshot

$50 million to advance the president’s Cancer Moonshot goals. This funding will advance the President’s Cancer Moonshot, including by expanding resources and collaborations for innovative and new diagnostic and therapeutic products to treat rare cancers, and other efforts to address cancer morbidity and mortality. This budget will enhance efforts to improve evidence generation for underrepresented subgroups in oncology clinical trials, and to support pragmatic and decentralized trials and our sources of evidence through patient-generated data, learnings, and real-world evidence. Additionally, these resources will also assist the FDA’s expansion of its efforts to facilitate the approvals of innovative and new cancer treatments by international regulatory authorities at the time of the FDA’s approval and will foster collaboration of cancer treatments in other countries with standards comparable to the U.S. standard of care.

Strengthening Public Health and Mission Support Capacity

$10 million in further investments in enterprise data and IT modernization. The budget will expand data exchange capabilities and underlying technology platforms to better meet the challenges of the FDA’s programs and mission-critical responsibilities. Specific focuses include emerging threats, supporting needs for real-time evaluation, and more continuously accessing, analyzing and aggregating multiple sources of information, such as for recalls, adverse events, outbreaks and pandemics.
$16 million for regulatory and mission support functions within the Office of the Commissioner. These resources will enable the FDA to provide the appropriate crosscutting strategic direction, policy coordination, and business services to ensure that the FDA’s programs operate effectively, efficiently, and are well coordinated. The budget includes funding for the new enterprise transformation effort to improve business process, data and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work.
$9.4 million for FDA buildings, facilities and infrastructure improvements. The budget includes additional funding to help ensure that the FDA’s offices and laboratories across the country are secure, modern, reliable and cost-effective spaces that empowers the FDA’s workforce to protect and promote the safety and health of American families.

To complement the funding requests, the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health. Notable proposals include efforts to:

Require animal drug sponsors to make post-approval safety-related labeling changes based on new data; develop programs for safe use of certain products; and require post-approval studies based on new safety information that becomes available after approval.
Provide the FDA the ability to exclude certain products or classes of products that the FDA and the Environmental Protection Agency (EPA) agree are more appropriately regulated by the EPA as pesticides; and facilitate an orderly transfer of regulatory responsibility from the EPA to the FDA of specified products that are currently registered as pesticides that the two agencies agree are more appropriately regulated by the FDA as animal drugs. The proposed changes would remove regulatory uncertainty and provide clarity to sponsors about which agency intends to regulate a given product or type of products.
Expand the drug shortage notification requirements to include situations when a drug manufacturer is unlikely to be able to meet an increased demand. Currently, the FDA generally does not receive notice or adequate information from drug manufacturers regarding increases in demand that would position the agency to assist in preventing or mitigating drug shortages.
Broaden the FDA’s authority to request records or other information in advance of or in lieu of inspections to include all FDA-regulated product areas, explicitly to include food, tobacco products and cosmetic establishments. Currently remote regulatory inspections are limited to drug, device and biomedical research, with only drug assessments requiring mandatory participation. This proposal will promote regulatory compliance and help facilitate certain oversight activities prior to arriving for or instead of an inspection.
Remove limitations that require manufacturers to notify the FDA about interruptions or discontinuances in the manufacture of certain medical devices only during or in advance of a Public Health Emergency (PHE). Medical device shortages occur in many situations that fall outside of or are unrelated to PHEs, including natural or human-made disasters, recalls, geopolitical conflicts, production shutdowns and cybersecurity incidents. These events can lead to device shortages that significantly impact patient care and jeopardize healthcare worker safety. Therefore, the FDA is seeking the requirement for manufacture notifications at all times, as well as the authority to require and review risk management plans to help ensure that manufacturers are prepared for situations where their ability to manufacture product may be disrupted or may be insufficient to meet demand.
Expand the FDA’s mandatory recall authority to cover all human and animal drugs. The agency currently has authority to order the recall of controlled substances, biological products, medical devices, tobacco products, cosmetics and foods. The agency lacks mandatory recall authority for other human and animal drugs.
Enhance tools to help reduce exposure to toxic elements in the food supply, including food consumed by infants and young children. The FDA is seeking new authority to establish binding contamination limits in food and efficiently update such limits as new scientific information becomes available.
Require industry to test final food products marketed for consumption by infants and children for toxic elements and allow FDA access to those records. This new authority would help the FDA better understand levels of toxic elements in these products, allow the FDA to monitor industry progress in reducing levels of these toxic elements over time and identify where the FDA should devote more time and resources.
Assess user fees on and collect fees from manufacturers and importers of all tobacco products. The budget also requests an additional $100 million in funding to support regulatory activities including for oversight of e-cigarettes, which currently have high rates of youth use. The additional funding will support hiring more staff and help the FDA strengthen its tobacco product work—including application reviews, compliance and enforcement, policy development and research programs.

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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.

Published

1 month ago

December 22, 2024

The Conversation

It’s important to buy cinnamon from reputable dealers. Anjelika Gretskaia/Moment via Getty Images

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.

Horizontal photo of cinnamon trees, with trunks in foreground. — Cinnamon trees in Zanzibar, Tanzania. Zanzibar is known the world over as the ‘spice islands.’ Dong Jianghui/Xinhua via Getty Images

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.

Stick cinnamon and cinnamon powder on rustic wooden table. — Research suggests that ground cinnamon contains higher lead levels than cinnamon sticks. Helen Camacaro/Moment via Getty Images

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.

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FDA CDC News

Seafood Recall: Important Information on Hannaford Seafood Salads

Published

2 months ago

November 30, 2024

Rod Washington

seafood based dish served on white plate — Photo by Valeria Boltneva on Pexels.com

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!

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pets

Urgent Dog Treat Recall: Carolina Prime Pet Issues Warning Due to Salmonella Risk

Published

2 months ago

November 27, 2024

Lynette Young

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.

@stmblog
🚨🍖 Important: Carolina Prime Pet is recalling dog treats due to Salmonella risk! Check your pantry and stay safe! 🐾 #DogSafety #Recall ♬ original sound – STMDailyNews

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.