Botulism Outbreak Expands to All ByHeart Products: NPR

A new study finds a link between ultra-processed foods and an increased risk of multiple cancers

A growing body of research has linked ultra-processed foods – like sugary drinks,packaged snacks,and processed meats – too a variety of health problems.Now, a new study published in eLife adds to that evidence, finding a meaningful association between higher consumption of these foods and an increased risk of developing several types of cancer.

Researchers from the International Agency for Research on Cancer (IARC) and Imperial Collage London analyzed data from nearly 50,000 UK adults over a period of 10 years. They categorized participants based on their intake of ultra-processed foods, using data collected from 24-hour dietary assessments.

The study found that individuals who consumed the highest 25% of ultra-processed foods had a 36% increased risk of developing any cancer compared to those in the lowest 25%. Specifically,the research identified links between ultra-processed food consumption and increased risks of cancers of the digestive system – including bowel,liver,and pancreatic cancer – and also cancers of the ovaries and brain.

“This study adds to the growing evidence that ultra-processed foods are likely to be a key driver of cancer,” says Dr.Eszter Vamos, lead author of the study and a researcher at Imperial College London. “Further research is needed to confirm these findings and understand the specific mechanisms by which ultra-processed foods might contribute to cancer advancement.”

While the study doesn’t prove causation, the strong association raises concerns about the impact of these foods on public health. Ultra-processed foods are frequently enough high in sugar, fat, and salt, and low in essential nutrients. They also contain additives and other ingredients that may have harmful effects on the body.

Experts recommend focusing on a diet rich in whole, unprocessed foods like fruits, vegetables, whole grains, and lean proteins.reducing the intake of ultra-processed foods can be a significant step towards improving overall health and possibly lowering cancer risk.

Infant Botulism Outbreak Linked to ByHeart Formula Widens to Include All Products Since March 2022

Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.

The U.S.food and Drug Governance said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.

Infant Botulism Outbreak Linked to ByHeart Formula Expands to 51 Cases

The outbreak of infant botulism potentially linked to ByHeart formula has expanded to include at least 51 infants across 19 states, according to the U.S. Centers for Disease Control and Prevention (CDC). The case definition now encompasses “any infant wiht botulism who was exposed to ByHeart formula at any time as the product’s release,” with the most recent illness reported on December 1st. No deaths have been reported to date.

Previously, the outbreak included 39 suspected or confirmed cases reported since August. An additional 12 cases were identified following an expanded definition, including some dating back to December 2023 and extending through July 2025.

ByHeart,a New York-based organic infant formula manufacturer founded in 2016,initiated a recall of all its U.S. products on November 11th. The company, holding approximately 1% of the U.S. infant formula market,had been distributing around 200,000 cans monthly.

The news of potential long-term contamination has been particularly upsetting for parents like Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized with infant botulism in December 2023 after consuming the formula. Galindo chose ByHeart based on a lactation consultant’s recommendation, believing it to be a “very natural, very gentle, very good” option.She expressed concern about potential accountability if manufacturing issues existed from the company’s inception.

Amy Mazziotti, whose son Hank was treated for botulism in March after starting ByHeart formula, shared that inclusion in the outbreak investigation “feels like a win for all of us.”

ByHeart Formula Linked to Expanding Infant Botulism Outbreak

Lab tests have detected contamination in ByHeart infant formula, prompting an expanded investigation into a growing outbreak of infant botulism. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are currently working to understand the full scope of related cases, with ByHeart officials stating they are fully cooperating with federal officials.

The recent cases reported by the CDC and FDA will aid ByHeart’s investigation as they continue to pinpoint the source of the contamination.FDA inspectors visited ByHeart plants in Allerton, Iowa, and Portland, Oregon, last month, but results from those inspections have not yet been released.

Previously, ByHeart reported that independent lab tests revealed the presence of bacteria capable of causing infant botulism in 36 samples from three different production lots. The company acknowledged the possibility that all ByHeart formula,across all lots,may have been contaminated.

According to Dr. Jennifer Cope, a CDC scientist leading the investigation, the contamination appears to have been widespread. “It looks like the contamination appeared to persist across all production runs, different lots, different raw material lots,” she stated, adding that they haven’t been able to isolate the issue to specific batches or time periods.

Inspection documents reveal a history of contamination issues for ByHeart. In 2022, the company recalled five batches of formula after a sample tested positive for cronobacter sakazakii. In 2023, the FDA issued a warning letter outlining areas needing corrective action. A ByHeart plant in Reading, Pennsylvania, was also temporarily shut down in 2023 after inspectors identified issues with mold, water leaks, and insects.

Infant botulism is a rare, but serious, illness affecting fewer than 200 babies annually in the U.S., caused by ingesting a specific type of bacteria.

ByHeart Formula Linked to Infant Botulism Cases, Lawsuits filed

recent reports indicate that several infants have been treated for botulism after consuming ByHeart baby formula, leading to lawsuits against the company. The lawsuits allege the formula was defective and that ByHeart was negligent in its sale and distribution. this situation raises concerns about infant formula safety and the potential risks associated with even carefully manufactured products.

What is Botulism?

Botulism is a rare but serious illness caused by a toxin produced by the bacterium Clostridium botulinum. In infants, it typically occurs when spores of the bacteria are ingested and then grow in the intestines, producing the toxin. https://www.cdc.gov/botulism/infant-botulism.html Symptoms can include constipation, weak cry, trouble feeding, and generalized muscle weakness. Infant botulism requires hospitalization and treatment with botulism antitoxin.

The ByHeart Botulism Cases

The Centers for Disease Control and prevention (CDC) began investigating reports of infant botulism linked to ByHeart formula in February 2024. as of February 29, 2024, the CDC reported four confirmed cases in multiple states: Ohio, Tennessee, North Carolina, and Illinois. https://www.cdc.gov/botulism/updates/byheart-formula.html The CDC investigation is ongoing to determine the source of the contamination.

Lawsuits Allege Formula Defects and negligence

Families affected by the botulism cases have filed lawsuits in federal courts against ByHeart, Inc. These lawsuits claim the formula was defective and that ByHeart failed to adequately test for or prevent contamination. According to reporting by NPR, the lawsuits seek financial compensation for medical expenses, emotional distress, and other damages incurred by the families. https://www.npr.org/2024/02/29/1159419999/byheart-baby-formula-botulism-lawsuits

ByHeart’s Response and Voluntary Recall

ByHeart voluntarily recalled its formula on February 28, 2024, urging parents to discontinue use and contact their healthcare providers. https://www.byheart.com/recall The company stated it is cooperating fully with the CDC and the Food and Drug Administration (FDA) investigation. ByHeart maintains that its manufacturing facility meets stringent safety standards, but is taking the precautionary step of recalling the product out of an abundance of caution.

FDA Investigation and Ongoing safety Concerns

The FDA is also investigating the botulism cases and working with ByHeart and the CDC to identify the source of the contamination. The FDA has stated it will take appropriate action to protect the public health. https://www.fda.gov/food/recalls-outbreaks-emergencies/fda-investigates-infant-botulism-cases-associated-byheart-infant-formula

This incident underscores the importance of rigorous safety testing and quality control in the infant formula industry. While infant formula is a life-saving product for many babies, it is crucial that manufacturers prioritize safety and transparency to protect vulnerable infants.

Looking ahead

The CDC, FDA, and ByHeart continue to investigate the source of the botulism contamination. Parents should stay informed about the recall and follow the guidance of their healthcare providers. This situation will likely lead to increased scrutiny of infant formula manufacturing processes and potentially stricter regulations to prevent future incidents.