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American Focus > Blog > Health and Wellness > ByHeart response to infant formula botulism outbreak draws criticism
Health and Wellness

ByHeart response to infant formula botulism outbreak draws criticism

Last updated: November 14, 2025 3:35 am
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ByHeart response to infant formula botulism outbreak draws criticism
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ByHeart, a popular infant formula maker, has recently come under fire for an infant botulism outbreak linked to its products, leading to a nationwide recall. This outbreak is particularly unusual because the risk of infant botulism from formula is typically very low, as the condition is usually caused by bacterial spores found in dust and soil or contaminated honey. So far, 15 infants have been hospitalized after consuming ByHeart formula, although thankfully no deaths have been reported.

What has raised eyebrows in this situation is ByHeart’s response to the outbreak. The company initially downplayed the risk to consumers and even implied disagreement with regulators’ findings. ByHeart’s co-founder Mia Funt went as far as to state in a video on Instagram that there is no reason to believe that infant formula can cause infant botulism. However, as the situation escalated, ByHeart eventually expanded the recall to include all of its products.

Food safety experts have criticized ByHeart for its handling of the situation, with some saying that they have never seen a company fight so aggressively to deny evidence against them. ByHeart’s initial communications were seen as minimizing the risk to consumers, but their later statements struck a more serious tone and expressed a commitment to working with regulators.

Customers have expressed anger at ByHeart for its handling of the outbreak, with some accusing the company of downplaying, burying information, and misleading parents. Lawsuits have been filed against ByHeart by families of infants hospitalized with infant botulism after consuming the formula.

ByHeart, founded in 2016 by Mia Funt and Ron Belldegrun, aims to provide health-conscious consumers with a formula made with clean ingredients, organic whole milk, and a patented protein blend that resembles breast milk. The company’s marketing appeals to “crunchy” moms and emphasizes the benefits of using whole milk over skim milk in formula.

Despite the criticism, ByHeart remains a significant player in the infant formula market, with a 1% share of U.S. formula sales. The company has received backlash for its initial communication regarding the recall, with experts noting that some statements may have misled consumers about the severity of the situation. Moving forward, ByHeart has expressed a commitment to working with regulators and ensuring the safety of its products. Centers for Disease Control and Prevention have reported an increase in cases of infant botulism in the U.S., with a total of 122 cases in 2025, up from 108 in 2024 and 94 in 2023. This rise in cases is concerning and requires further investigation to determine the root cause and prevent future occurrences.

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Additionally, the response from ByHeart to the outbreak has raised questions about transparency and accountability in the infant formula industry. The company’s initial reluctance to acknowledge a link between its product and the illnesses, as well as its focus on testing unopened cans of formula, has been criticized for downplaying the severity of the situation. The FDA’s warning letter and previous recall of ByHeart’s formula in 2022 further highlight the company’s history of regulatory issues and raise concerns about its manufacturing practices.

The broader context of increased scrutiny on infant formula safety by the FDA following the Abbott Nutrition formula recall in 2022 underscores the importance of maintaining high standards in the industry. The loss of experienced inspectors at the FDA in 2025 has also raised questions about the agency’s ability to effectively oversee food safety practices.

In conclusion, the ByHeart infant formula outbreak serves as a cautionary tale for the infant formula industry and highlights the need for greater transparency, accountability, and regulatory oversight. The rise in infant botulism cases in the U.S. underscores the importance of vigilance in monitoring and addressing potential health risks associated with infant formula products. Moving forward, it is crucial for companies like ByHeart to prioritize consumer safety and take swift action in response to public health concerns. Infant botulism is a rare but serious condition that typically records about 100 cases per year. However, in 2021, the Centers for Disease Control and Prevention saw 181 cases, indicating a concerning increase in the number of cases. This surge in cases has prompted investigations by the FDA and CDC, along with California’s department of public health.

One of the main concerns highlighted by experts is the lack of adherence to guidelines regarding the feeding of honey to infants. Honey should not be given to babies under 12 months of age due to the risk of botulism. Despite this, some “natural” brands and influencers recommend honey as a remedy for children, potentially exposing infants to the dangers of botulism. Dr. Abrams emphasized the importance of following safety guidelines to prevent infants from being hospitalized and placed on ventilators for weeks.

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Operation Stork Speed, a program aimed at addressing infant formula safety, has been urged to prioritize microbial contamination as an issue. While efforts have focused on trace contaminants like heavy metals, experts believe that more attention should be paid to microbial risks in infant formula.

The recent government shutdown did not impact the staff working on outbreaks, but concerns were raised about the understaffing at the FDA and the elimination of the CDC office in Washington, D.C. These staffing issues have hindered the enforcement process and communication of critical information to policymakers. Experts emphasized the need for a robust enforcement process and transparent communication to address public health concerns effectively.

In conclusion, the increase in infant botulism cases in 2021 highlights the importance of following safety guidelines for feeding infants. It is crucial for parents to be aware of the risks associated with giving honey to babies and to adhere to recommendations from healthcare professionals. Efforts to address microbial contamination in infant formula should be prioritized to ensure the safety of infants. By enforcing stringent regulations and improving communication, authorities can effectively manage and prevent outbreaks of infant botulism. The COVID-19 pandemic has brought about significant changes to the way we live our lives, including how we work, socialize, and travel. One of the industries that has been greatly impacted by the pandemic is the travel industry. With restrictions on international travel, mandatory quarantine measures, and concerns about health and safety, many people have put their travel plans on hold.

As the world begins to slowly reopen and vaccination rates increase, there is a sense of optimism in the travel industry. However, it is clear that travel will not be the same as it was before the pandemic. Here are some of the ways in which travel will be different in the post-COVID-19 era:

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Health and safety protocols: One of the biggest changes in the travel industry post-COVID-19 is the implementation of strict health and safety protocols. Airlines, hotels, and other travel providers have implemented enhanced cleaning procedures, social distancing measures, and mandatory mask-wearing policies to ensure the safety of their passengers and guests. Travelers can expect to see hand sanitizer stations, temperature checks, and contactless check-in procedures becoming the norm.

Flexibility in booking: With the uncertainty surrounding travel during a pandemic, many airlines and hotels have introduced more flexible booking policies. Cancelation fees have been waived, and travelers can often change their travel dates or destinations without penalty. This flexibility gives travelers peace of mind knowing that they can easily adjust their plans if needed.

Rise of domestic travel: With international travel still facing restrictions and uncertainties, many travelers are turning to domestic travel as a safer alternative. Road trips, camping, and visits to national parks have all seen an increase in popularity as people seek to explore closer to home. This trend is expected to continue in the post-COVID-19 era as people prioritize safety and convenience when planning their trips.

Focus on sustainability: The pandemic has highlighted the impact of travel on the environment, with reduced air travel leading to lower carbon emissions. As the world begins to reopen, there is a growing awareness of the need for sustainable travel practices. Travelers are seeking out eco-friendly accommodations, supporting local communities, and choosing modes of transportation that have a lower environmental footprint. This shift towards sustainable travel is expected to continue in the post-COVID-19 era as people become more conscious of their impact on the planet.

Overall, the travel industry is facing a period of transition as it adapts to the new realities brought about by the COVID-19 pandemic. While there are challenges ahead, there is also a sense of optimism as people look forward to exploring the world once again. By prioritizing health and safety, embracing flexibility, and supporting sustainable practices, the travel industry can navigate these changes and emerge stronger in the post-COVID-19 era.

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