ByHeart Celebrates the FDA Registration of its Reading, Pa., Facility – Quality Assurance & Food Safety

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The company said the new facility gives it full oversight of its production, supply chain and research and development, enabling it to rewrite the formula recipe from scratch and have control over every step of the process.
READING, Pa. — ByHeart, a baby nutrition company, officially announced the Food and Drug Administration registration of its Reading, Pa., manufacturing facility, becoming the fourth vertically integrated United States infant formula brand to have full oversight of its production, supply chain and research and development —enabling it to rewrite the formula recipe from scratch and have control over every step of the process, from farm to formula — something no new infant formula entrant has accomplished in over 15 years, the company claimed.
“I’m thrilled to invest in innovation in the infant nutrition industry with $1.75 million in state support,” said Governor Tom Wolf. “In addition to supporting good health from birth, this investment in ByHeart will create good jobs, economic impact and support for agriculture in the commonwealth and indeed the entire country currently suffering from shortages in this supply — it’s an all-around win.”
In 2019, ByHeart acquired and updated its own manufacturing facility in Reading, Pa., rather than using a third-party contract manufacturer as every other new entrant has done, the company claimed. It has invested $21.6 million to date, including enhancements in preventative food safety measures to convert the plant from toddler food production to infant formula capability, and engaged Pennsylvania-based companies for the engineering and construction. The team was able to tailor the facility specifically to the ByHeart formula as well as accommodate full in-house research and development capabilities. It created a proprietary small batch blending process that it claims requires half the steps of the industry norm and is designed to maintain the nutritional integrity and quality of the ingredients throughout every step and uphold the highest standards of food safety. Reduced processing means ByHeart is able to maintain the natural goodness and functional benefits of their ingredients, the company said.
“We spent two years auditing infant formula plants around the world,” explained ByHeart CEO and Co-Founder, Ron Belldegrun. “We chose the commonwealth as our home base because of local expertise, rich agricultural heritage and a commitment to furthering value-add dairy, which — together with our expertise in infant nutrition innovation — has the potential to transform Reading into a national and global hub for the export of the most fundamental and vital food in the world.”

The donation is intended to commemorate the 2021-22 college football season.
SMITHFIELD, Va. — Smithfield Foods, the Utah Pork Producers Association (UPPA) and the Fredette Family Foundation delivered a nearly 30,000-pound truckload of protein to the Utah Food Bank following a joint-pledge to donate for every point scored by Brigham Young University and Utah State University during the 2021-2022 football season.
The donation marks the third consecutive year of the college football-themed partnership between Smithfield, UPPA and the Fredette Family Foundation to fight hunger and support Utah Food Bank’s work to fight hunger statewide.

“One in seven children in Utah face food insecurity,” said Ginette Bott, president and CEO of Utah Food Bank. “We are incredibly grateful that this program generates nutritious protein donations to help us feed families facing hunger while driving awareness of the significant need that exists in our communities.”
“On behalf of UPPA, we are proud to work with Smithfield, the Utah Food Bank and pork farmers across the state to provide this important donation to Utah families in need,” said Jim Webb, president-elect, Utah Pork Producers Association. “Too often, Utahns suffer because they do not have access to a nutritious meal. Our farmers are committed to raising healthy pork products and working with community leaders so that Utahns do not have to go without a healthy protein option.”
“Food, football and community go hand-in-hand,” said Jonathan Toms, community development manager for Smithfield Foods. “We can’t think of a better way to close the Cougar and Aggie football season than by coming together to fight hunger in our Utah communities.”
Helping Communities is one of seven featured pillars in Smithfield’s sustainability program spanning initiatives to promote animal care, diversity, equity and inclusion, environmental stewardship, food safety and quality, health and wellness, helping communities and worker health and safety. The company has donated hundreds of millions of protein servings to food banks, disaster relief efforts and community outreach programs through Helping Hungry Homes®, its signature hunger relief initiative, since 2008.
This action is intended to reduce the potential for negative health effects from dietary exposure to lead, and supports the agency's Closer to Zero action plan that sets forth the FDA's science-based approach to reducing exposure to toxic elements in foods.
SILVER SPRING, Md. — The Food and Drug Administration this week issued draft action levels for lead in single-strength (ready to drink) apple juice and other single-strength juices and juice blends. This action is intended to reduce the potential for negative health effects from dietary exposure to lead, and supports the agency’s Closer to Zero action plan that sets forth the FDA’s science-based approach to reducing exposure to toxic elements in foods.
“Exposure of our most vulnerable populations, especially children, to elevated levels of toxic elements from foods is unacceptable,” said FDA Commissioner Robert M. Califf. “This action to limit lead in juice represents an important step forward in advancing FDA’s Closer to Zero action plan, which we are confident will have a lasting public health impact on current and future generations.”
The draft guidance outlines action levels, which are recommended limits of lead in juice that can be achieved by industry and progressively lowered as appropriate.
In particular, “Action Levels for Lead in Juice: Draft Guidance for Industry” provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice.
As part of its commitment in the Closer to Zero action plan to consider the biological effects from exposure to harmful elements in food, the draft action levels for lead in juice were guided by FDA’s interim reference level (IRL) for lead, a measure of the contribution of lead in food to blood lead levels. FDA estimates that establishing a 10 ppb action level could result in as much as a 46% reduction in exposure to lead from apple juice in children. For all other fruit and vegetable juices, establishment of an action level of 20 ppb is estimated to result in a reduction of 19% in exposure to lead from all other juices in children. The FDA issued a lower draft action level for apple juice because it is the most commonly consumed juice that young children drink.
“As we outlined in the Closer to Zero action plan, the agency is increasing targeted compliance activities as part of our efforts to monitor levels of these elements in foods through the FDA’s Total Diet Study, Toxic Elements in Food and Foodware program and sampling assignments,” said Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition. “In addition, our work in this important area of food safety will progress with advancements in science. For example, action levels may be progressively lowered over time, as appropriate, to make continual improvements in reducing the levels of lead, arsenic, cadmium and mercury in foods eaten by babies and young children.”
FDA is accepting comments on the draft guidance. A manufacturer may choose to implement the recommendations in a draft guidance before the guidance becomes final. FDA will work with manufacturers of these products to encourage the adoption of best practices to lower levels of lead in juice. FDA routinely monitors levels of toxic elements in food and considers on a case-by-case basis whether a food that contains a contaminant is adulterated under the Federal Food, Drug and Cosmetic Act and subject to enforcement action.
Because lead is in the environment as a naturally occurring element and from consumer and industrial products and processes, it is not possible to remove it entirely from the food supply, FDA said. However, the action levels recommended in the draft guidance document will help limit consumer exposure. FDA recommends that for good nutrition, parents follow the Dietary Guidelines for Americans, which recommends limits on juice intake for children. Decreasing juice consumption would also reduce potential exposure to lead from juice. The Dietary Guidelines recommends that children should get at least half of their fruit needs each day from whole fruit rather than juice and that children under 12 months of age should not consume juice.
Issuing the draft guidance for lead in juice is part of FDA’s broader efforts to reduce exposure to lead, arsenic, mercury and cadmium from foods and to advance the goals laid out in the Closer to Zero action plan, initiated in April 2021. As it enters the second year of the Closer to Zero action plan, FDA is working to identify reference levels for arsenic, cadmium and mercury, and to issue draft guidance to industry on action levels for lead in foods commonly eaten by babies and young children. The agency said it is also continuing to work towards issuing final guidance on an action level for inorganic arsenic in apple juice.
The letter urges the Food and Drug Administration to strengthen leadership and accountability in its food safety and nutrition program.
Editor’s Note: Read our Q&A with Steven Mandernach, AFDO’s executive director, on the organization’s white paper on recall modernization.
This week, 30 organizations that represent food industry leaders, consumers and state and local regulators released a letter urging the Food and Drug Administration to strengthen leadership and accountability in its food safety and nutrition program. The organizations include the Association of Food and Drug Officials, International Fresh Produce Association, Consumer Reports and more.
The joint letter, which also recommends adding a dedicated FDA food program, follows recent reports on serious issues within the FDA, including problematic organizational structure, governance, and performance.
“For these reasons, we are troubled by the recent Politico reporting of serious problems in the FDA food program’s organizational structure, governance, and performance,” the letter stated. “Many throughout the consumer community and food industry have observed such problems and are concerned about their impact on the well-being of both consumers and industry. All of us depend on the FDA to perform its regulatory role effectively, efficiently, and transparently. And every American wants to have confidence in FDA’s ability to do that. We fear public confidence is in jeopardy.”
Read the full text here.
The company's 2021 Corporate Responsibility report details progress across focus areas of food, people and footprint. Highlights include solidifying diversity, equity and inclusion goals, climate and sustainable packaging progress and new ESG compensation metrics for company executives.
Editor’s Note: Read our Life Lessons with Liliana Esposito, Wendy’s chief corporate affairs and sustainability officer.
DUBLIN, Ohio — Today, The Wendy’s Company released its 2021 Corporate Responsibility report, outlining progress under the company’s Good Done Right platform focus areas of food, people and footprint. The report announces Wendy’s newly formalized diversity, equity and inclusion goals and shares progress on the company’s climate roadmap and sustainable packaging goals. In the report, the company also details its board of directors’ decision to tie executive compensation to environmental, social and governance (ESG) performance, with a portion of company executives’ 2022 incentive compensation linked to Wendy’s achievements against its goals.
“Advancing our Good Done Right goals is a team effort, and I’m incredibly proud of the progress we made in 2021,” said Chief Corporate Affairs and Sustainability Officer Liliana Esposito. “We continue to work to meet the high expectations our stakeholders have for Wendy’s through cross-functional collaboration across our System, which includes employees, franchisees, suppliers and industry partners.”
The report demonstrates progress against the company’s corporate responsibility goals announced in 2021 and includes the following highlights:
Food: Defining responsible sourcing goal focus areas and investing further in food safety and quality innovation. Wendy’s evaluated the environmental and social impacts associated with each of the company’s top 10 priority food categories, validating each of the categories’ inclusion on the priority list, and defined key metrics to measure progress as part of the company’s goal to responsibly source its top 10 priority food categories in the U.S. and Canada by 2030. Wendy’s also continued to invest in food safety and quality innovation, launching its enhanced global Food Safety Assessment program in partnership with EcoSure, a division of Ecolab, and testing new technologies, such as augmented reality smart glasses, to further enhance its quality assurance program.
People: Formalizing DE&I goals and continuing work to find forever homes for children in foster care. Wendy’s established an office of Diversity, Equity and Inclusion, led by the company’s vice president, chief diversity, equity and inclusion officer, and solidified five areas the company will focus on in the coming years. Through this work, Wendy’s aims to increase the representation of underrepresented populations among the company’s leadership and management, as well as the diversity of franchisees. The Wendy’s System also raised more than $22.5 million for its signature cause, the Dave Thomas Foundation for Adoption, which helps fund adoption professionals who are dedicated to finding loving, permanent homes for children waiting in foster care.
Footprint: Increasing cup recyclability, consumer recycling education and climate transparency. As part of the company’s goal to sustainably source 100% of its customer-facing packaging in the U.S. and Canada by 2026, Wendy’s collaborated with packaging and plastics industry leaders to move from plastic-lined paper cups with limited recyclability to single-substrate, clear plastic drink cups that more customers will be able to recycle. Additionally, the company joined the How2Recycle label program in the U.S. and Canada to educate consumers by adopting the organization’s on-package label, which provides information on the proper ways to dispose of and recycle packaging. For the first time, Wendy’s also reported 2020 climate data to CDP, a leading disclosure practice for environmental reporting, receiving a B score on the submission, an important step as the company prepares to set a science-based target to track and reduce emissions in its operations and supply chain and to disclose Scope 1, 2 and 3 emissions in 2023 in alignment with that target.

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