FDA Will Ease Enforcement of Baby Formula Regulations To Address Shortage
(Ivy Ceballo/ZUMA Press/Newscom)
Easing labeling and WIC rules is expected to get more baby formula to consumers. The Food and Drug Administration (FDA) has emerged as one major impediment to ending America's current shortage of baby formula. Now, the agency is taking small steps to get out of the way.
The infant formula shortage arose in response to a recall of formulas produced at an Abbott Laboratories facility in Michigan and the temporary shutdown of that plant.
In a healthy and competitive environment, the shutdown of one facility shouldn't have sent such shock waves through the formula market of the entire country. But the American baby formula market is both highly concentrated and a beneficiary of immense government protectionism in the form of trade restrictions and other regulations. Easing some of these rules and fees could allow more foreign formula to flood U.S. shelves, alleviating the current shortage and ending the state-created hold that a few big companies have over the U.S. market.
Baby formulas made in the European Union could be a good substitute since many of them already meet most safety and nutritional standardsset by the FDA. But because a lot of these formula brands don't meet all FDA labeling requirements, they've been placed on the agency's "red alert" list, meaning they cannot be imported, sold, or purchased here and shipments will be detained if discovered.
Formula brands can be placed on this list for "transgressions" that are incredibly minor, such as not listing nutrients in a specific order or failing to include step-by-step pictures of how to prepare the formula in close proximity to the written directions for use. This means failure to meet these very specific yet arbitrary labeling rules can keep perfectly safe and nutritious formula from getting to U.S. customers.
On Monday, the FDA announced that it would temporarily ease enforcement of some labeling rules in order to allow for the importation of foreign formulas that meet U.S. safety and nutrition regulations but may run afoul of label requirements. To this end, the FDA issued new guidance for baby formula manufacturers, foreign and domestic, effective now through November 14, 2022.
"Today's action paves the way for companies who don't normally distribute their infant formula products in the U.S. to do so efficiently and safely," said FDA Commissioner Robert M. Califf in a statement. "We anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks."
Current regulations "require an infant formula manufacturer to submit notice (i.e., a new infant formula submission) to FDA at least 90 days before the infant formula is introduced or delivered for introduction into interstate commerce," notes the agency in the new guidance. To be permitted, infant formula must contain specified levels of protein, fat, essential fatty acids, 15 vitamins, and 12 minerals, as well as meet FDA labeling requirements.
Under the new guidance, the FDA will decide on a case-by-case basis whether "to allow the introduction into interstate commerce (including importation) of infant formula that is safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements." Formula manufacturers can submit safety and nutrition information to the FDA to be granted a reprieve from enforcement of these regulations.
"The extent to which we exercise enforcement discretion may vary," states the new FDA guidance on baby formula:
For example, an infant formula whose label does not list the nutrients in the order required … would need an exercise of enforcement discretion regarding that particular labeling requirement, and FDA may determine that enforcement discretion is appropriate. In contrast, an infant formula whose level for a specific nutrient is below the minimum that we require or does not contain a specific nutrient we require might not be an appropriate candidate for enforcement discretion, especially if the low level or absence of the nutrient could present a safety issue for infants.
The Biden administration is also urging states to loosen up other regulations that are making it harder for American families to find and buy baby formula right now.
"About half of infant formula nationwide is purchased by participants using WIC benefits," noted the White House in a fact sheet last week, referring to the federally run nutrition program for low-income women, infants, and children. Because of this, WIC program requirements for eligible formula (set by both the federal government and states) greatly influence the type of formula that U.S. manufacturers produce.
The U.S. Department of Agriculture "is urging states to allow WIC recipients to use their WIC benefits on a wider variety of products so that if certain sizes or types of formula are out of stock, they can use their benefits on those that are in stock," stated the White House. "And, USDA is urging states to relax their requirements that stores keep a certain amount of formula in stock. This will offer relief to retailers and allow companies to manage inventories to meet demand."
During the height of the COVID-19 pandemic, officials eased rules regarding everything from telemedicine to take-out sales of alcoholic beverages, showing that many of these rules weren't necessary in the first place. Perhaps one silver lining of the current formula crisis is that it will do the same thing for excessive regulation of baby formula.