FDA looks to limit health claims on formula– comments needed by Nov 8, 2016

clip-art-of-a-baby-bottle-filled-with-milk-2pwc9y-clipartThe Food and Drug Administration (FDA) is finally taking some major steps to tighten scrutiny of the labeling (and accompanying advertising) messages that the infant formula industry has been using to market their products in the US. 


Formula companies are in fierce competition and making more and more “structure/function” labeling claims, often linked to an underlying marketing message that infant formula is “closer to breast milk than ever.” An example of a structure/function claim is a statement that the formula “supports digestion.”   These claims often  confuse and mislead parents, and contribute to the kind of marketing that undermines both exclusive breastfeeding and the duration of breastfeeding.

On September 9, FDA, for the first time ever, proposed draft guidance for industry, entitled “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling,” which describes the type and quality of evidence that FDA thinks industry should use to substantiate structure/function claims, recommends that the evidence meet “competent and reliable evidence” standards, and strongly suggests that companies use clinical research trials to back up their assertions.

As of October 24, the Infant Formula Nutrition Council of America (INCA), the lobbying arm of the infant formula industry, wants FDA to extend the comment period on the Structure/Function Claims Proposed Guidance by 90 days — until February 8!  If FDA extends the process into the period of transition to a new Administration, the proposed guidance could be badly delayed, lost in the mists of time, or completely derailed. 

We need your help before Nov 8, 2016 (Election Day)

The FDA needs to hear from as many people as possible. Please consider submitting a comment letter by the November 8 deadline, using the template provided. We have revised the earlier template to ask the FDA maintain the November 8 deadline.

Also, please spread the word to your networks, so that we can counter expected industry push-back by generating as many letters as we can in the next few weeks.

This draft guidance is a huge step in the right direction, and it’s very likely that industry will push back with many objections. FDA needs to hear from breastfeeding experts that they are doing the right thing, and need to do even more, to protect mothers and babies from misleading labels and marketing.

Numbers DO count: FDA officials are required to read and track each comment letter that they get, and report the results publicly. So let’s get those letters pouring in to FDA!


About the template letter: A group of legal and technical breastfeeding advocates, convened by Berkeley Media Studies Group in late September, decided to work together to draft comments and get the word out to advocates. A detailed legal and technical comments letter (see attached) was submitted to FDA by ChangeLab Solutions on the group’s behalf, and the Template letter (see attached) is a simpler and shorter version of the ChangeLab letter, but fully supports it.

How to Comment and Generate Letters

  1. Download and adapt one of Template Letters to complete your comments. Use the prompts (in red) to add your evidence, stories and additions. Choose “we” if your letter is coming from an organization or coalition, “I” if from you as an individual. Put the letter on your organizational or personal letterhead.
  1. Submit your letter electronically by going right to docket number FDA-2016-D-2241. (The link is https://www.regulations.gov/docket?D=FDA-2016-D-2241.) The Proposed Guidance is the first of the two FDA documents listed there. Click on “COMMENT NOW!” Fill in the top box by simply saying you are pleased to comment on the Proposed Guidance Docket Number FDA-2016-D-2241, then upload your letter following the instructions below that. You can also go to the Federal Regs website at https://www.regulations.gov and find the FDA Proposed Guidance by searching for it using FDA-2016-D-2241.

Template letter for individuals: revised-template-for-breastfeeding-advocates

Template letter for organizations: revised-template-for-public-health-advocates

Change Labs letter: changelabcommentsstructurefunctionfinal20161014

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