FDA Regulation of Infant Formula, or, why are people recommending toddler formula for my infant

For a long time I’ve been referring to infant formulas as “FDA approved” or “not FDA approved.” Turns out that’s not a thing.

It also makes it all the more confusing why certain manufacturers have not gone through the process to market their formula as infant formula.

Does FDA approve infant formulas before they are marketed?

No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula. If an infant formula manufacturer does not provide the elements and assurances required in the notification for a new or reformulated infant formula, the formula is defined as adulterated under Section 412(a)(1) of the FFDCA and FDA has the authority to take compliance action if the new infant formula is marketed. Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA’s Regulation of Infant Formula March 1, 2006.  

Questions & Answers for Consumers Concerning Infant Formula

What does that mean?

It’s half “buyer beware” and half “don’t make me come after you.” A company could market an infant formula without going through this process, but then the FDA would come after them. In the meantime, consumers wouldn’t necessarily know that they were using a formula that hadn’t gone through this process.

In order to be marketed as infant formula, the manufacturer needs to

  • register
  • notify the FDA they intend to market an infant formula
  • demonstrate they are meeting the requirements for infant formula
  • demonstrate that these requirements are met throughout the shelf life
  • demonstrate good manufacturing processes

Registration. Section 412(c)(1) of the FFDCA requires a person who plans to introduce or deliver for introduction any new infant formula into interstate commerce, to register with FDA the name of the person (manufacturer) and their place of business, and all establishments at which the person intends to manufacture the new infant formula. Submission of the required registration and the required notification at the same time will facilitate the agency’s review.

Who are you, where do you work, and where do you intend to make the formula? Reasonable.

Notification. Section 412(d)(1) of the FFDCA requires persons responsible for the manufacture of infant formula to submit information relative to the manufacture of the new infant formula at least 90 days before marketing their infant formula. This 90 day notification for a new infant formula must include 1) the quantitative formulation of the infant formula, 2) a description of any reformulation of the formula or change in processing of the infant formula, 3) assurances that the infant formula will not be marketed unless it meets the quality factors and the nutrient requirements of the FFDCA, and 4) assurances that the processing of the infant formula complies with good manufacturing practices, including quality control procedures.

Let’s break this down.

1) the quantitative formulation of the infant formula — what are the ingredients, and in what amounts?

2) a description of any reformulation of the formula or change in processing of the infant formula — what are the changes, if this formula has been previously marketed?

3) assurances that the infant formula will not be marketed unless it meets the quality factors and the nutrient requirements of the FFDCA — a promise that you won’t market formula that doesn’t meet the requirements, both in terms of nutrients and in terms of good manufacturing

4) assurances that the processing of the infant formula complies with good manufacturing practices, including quality control procedures. — quality control. Seems reasonable.

Verification. Section 412(d)(2) requires persons responsible for the manufacture of any new infant formula to submit a written verification that summarizes test results that such formula complies with specific requirements of the FFDCA. This written verification is to be submitted after first production and before the introduction into interstate commerce of the new infant formula.

Then you need to submit the results of testing that shows that the formula that you produce actually contains the nutrients you have said it contains.

Again, more succinctly:

What must an infant formula manufacturer provide to FDA in the notification for a new infant formula?

Before a new infant formula can be marketed in the United States, the infant formula manufacturer must provide FDA with a notification about the proposed infant formula as required under section 412 of the FFDCA. This premarket infant formula notification must contain detailed information about the formulation, an explanation of what has changed (if it is a reformulation), and nutritional and manufacturing assurances. The infant formula manufacturer must provide assurance that the formula will provide adequate nutrition for infants to thrive, that the formula will be manufactured under current good manufacturing practices including quality control procedures, and that every batch of the formula will meet all of the nutrient requirements under the FFDCA and its implementing regulations in 21 CFR. [emphasis mine]

Tell us what’s in it, show us it meets the requirements, prove it, and make sure that every batch meets the requirements.

If you think back to certain formula manufacturers who claim — aggressively — that their formula is appropriate for infants, even though it’s marketed as a toddler formula, and they provide nutritional labels that show the product meets the requirements of an infant formula, then what’s left? Demonstrating this is the case, and manufacturing practices.

This company claims they don’t go through the process because they want to support breastfeeding, but what part of “we have demonstrated our product is actually meeting nutrient requirements” and “we have demonstrated good manufacturing practices” undermines breastfeeding? Formula is formula. If people are breastfeeding and not using formula, it’s moot. If they’re using formula, it’s because they need or want to use formula. It’s not out of confusion. It’s not because they don’t know infant formula exists. If the product is an infant formula, then register to market is as infant formula.

Similarly, if it’s not a toddler formula — keeping in mind there are no requirements or definitions for toddler formula — then marketing it as a toddler formula seems misleading.

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