FDA publishes interim final rule regarding infant formula
SILVER SPRING, Md. — The Food and Drug Administration on Thursday published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.
“Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” Michael Taylor, the FDA’s deputy commissioner for Foods and Veterinary Medicine, said. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”
While breastfeeding is strongly recommended and many mothers hope to breastfeed, only 75% of infants in the United States start out being breastfed. By age three months, two-thirds or 2.7 million U.S. infants rely on infant formula for some portion of their nutrition. The interim final rule applies only to infant formulas represented for use by healthy infants without unusual medical or dietary problems.
The interim final rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. The interim final rule also establishes current good manufacturing practices specifically designed for infant formula, including required testing for microbial contamination. This microbial testing includes testing representative samples of finished products to prevent the distribution of infant formula products contaminated with the pathogens Cronobacter and Salmonella. The interim final rule also establishes quality factor requirements to support healthy growth.
Companies currently manufacturing infant formula in the United States already voluntarily conduct many of the current good manufacturing practices and quality control procedures included in the interim final rule. Following publication of the rule, the FDA will be accepting and reviewing comments on issues or information not previously considered.
Tyson announces new breakfast line
SPRINGDALE, Ark. — Tyson Foods is adding a new line of breakfast items to its product offerings. Tyson Day Starts, a line of frozen breakfast sandwiches, aims to offer consumers protein-rich meals made with high-quality ingredients, the company said. Day Starts varieties will include biscuit sandwiches, breakfast flatbreads and wrapped omelets.
“We value the feedback and input of our consumers and turned to breakfast eaters to understand what they are looking for at breakfast time. These insights revealed they want a breakfast they can heat quickly and take on-the-go,” Carolyn Rehbock, VP for insights and innovation at Tyson Foods, said. “Tyson Day Starts products provide consumers with a satisfying breakfast to fuel their day in a fast and easy-to-prepare way that fits their schedules.”
Tyson Day Starts breakfast sandwiches are offered in seven varieties:
- Southern Style Chicken Biscuit;
- Sausage, Egg and Cheese Biscuit;
- Natural Colby and Monterey Jack Cheese Crispy Wrapped Omelet;
- Ham, Onion and Green Pepper Crispy Wrapped Omelet;
- Egg, Bacon and Colby Jack Cheese Flatbread;
- Egg, Sausage and Colby Jack Cheese Flatbread; and
- Ham, Egg, Cheese, Onion and Green Pepper Flatbread
Tyson Day Starts can be found in the freezer aisle at leading food retailers.
Anheuser-Busch to purchase Blue Point
ST. LOUIS and LONG ISLAND, N.Y. — Anheuser-Busch announced that it agreed to purchase Blue Point Brewing Co., a craft brewery. The purchase will bring additional resources to Blue Point’s operations, allowing it to better meet consumer demand for its brands. Terms of the agreement were not disclosed.
Blue Point was founded by Mark Burford and Peter Cotter 15 years ago in Patchogue, N.Y., where the brewery will continue to operate.
"As we welcome Blue Point into the Anheuser-Busch family of brands, we look forward to working with Mark and Peter to accelerate the growth of the Blue Point portfolio and expand to new markets, while preserving the heritage and innovation of the brands," Luiz Edmond, CEO of Anheuser-Busch, said. "With Anheuser-Busch’s strong beer credentials, we share a commitment to offering high-quality beers that excite consumers. Blue Point brands have a strong following and even more potential."
The purchase is expected to close in early second quarter of 2014.