FDA Issues New Rules for Baby Formula and Cronobacter
A new ruling announced by the Food and Drug Administration (FDA), has led to new regulations, which will go into effect Sept. 8, to require that manufacturers of infant formula adhere to stricter standards than was previously the case.
These new regulations will require companies to follow good manufacturing practices, including a test designed to detect harmful pathogens, such as Cronobacter. In addition, manufacturers will now have to demonstrate that the formulas they release onto the market support a child’s normal physical growth. And finally, during the final product stage, formulas will have to be tested for nutrient content before being released onto the market, as well as at the end of the formula’s shelf life.
The FDA has always been a key element for suring that infant formulas were safe, by setting up requirements that companies notify the agency before marketing a new formula. The agency also required companies to show that all formulas met federal nutrition requirements, they conducted annual inspections of all manufacturing plants that produce infant formula, and they attempted to determine whether or not a safety recall would be needed in some cases. These new regulations simply strengthen that oversight.
The FDA notes that, even though it is setting new standards, many infant formula manufacturers already comply with the new regulations. Therefore, the agency doesn’t expect to see any major changes with regard to the manufacturing of infant formulas. They note that manufacturers know they could lose a lot of money if they don’t keep their plants and products free from contaminants.
These new rules come at the same time a new study released by the Centers for Disease Control and Prevention shows that instances of Cronobacter, which is commonly linked to contaminated infant formula, are on the rise. For infants less than a year old is possible for an infection to enter the bloodstream, resulting in blood infections. In some cases, they develop urinary tract infections, and in some severe cases, Cronobacter infection results in the infant contracting meningitis, or seeing a swelling of the spine and brain. In all, approximately 1.8 out of every 100,000 infants contract Cronobacter.
While the same study found that more than twice as many people over 65 became infected by Cronobacter bacteria (3.9 out of 100,000), the infant numbers are actually more troublesome. While symptoms are relatively mild for adults, even those over 65, Cronobacter bacteria kills nearly 40% of those infants who contract meningitis through this type of infection.
The CDC recommend that parents who want to reduce or minimize their child’s exposure to Cronobacter should breastfeed whenever possible When formula is needed, use liquid formula, which has been pasteurized. If there is no other option available, the CDC recommends that powdered formulas be prepared with water that has been heated to at least 158°F, to eliminate any potentially harmful bacteria.
If your baby has been sickened or died, and you believe the illness was caused by contaminated baby formula, please contact the Texas Baby Product Liability Lawyer at Hill Law Firm as soon as possible. It is important to act quickly to protect your rights.