FDA approves “qualified health claim” for early introduction of peanuts

I was interested to see the FDA’s announcement that it “acknowledges” and will “exercise enforcement discretion” (translation: will not oppose) a qualified health claim linking the early introduction of peanuts into the diets of young children with severe eczema or egg allergies as a means to reduce their risk of peanut allergy.

Here’s the claim, which the FDA says manufacturers can use right away:

For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study. If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.

The FDA’s decision is based on:

• That one study, which I’ve written about in two previous posts (see here and here).
• Epidemiological evidence on the increasing prevalence of peanut allergies among U.S. children
• Recommendations of pediatric authorities, particularly the 2017 Addendum Guidelines for the Prevention of Peanut Allergy in the United States.

But why a qualified health claim?  Whenever you see one, you know that business interests are at stake.

In this case, the claim is in response to a petition filed by Assured Bites, Inc., maker of Hello Peanut products.  Check the astonishing prices of these products and you can see why this company wanted a health claim, and why it is already advertising it.

Really, you can do this at home.  We are talking here about starting high-risk kids out—under medical supervision—with a small taste of plain, ordinary peanut butter.

The FDA allows qualified health claims because industry wants them for marketing and pressures Congress to force the FDA to allow them.

What’s wrong with qualified health claims?  The qualifications get lost in the marketing.  Parents may think Hello Peanut works better than much less expensive alternatives.

 The FDA documents

• FDA Response to Petition for a Qualified Health Claim for Ground Peanuts and Reduced Risk of Developing Peanut Allergy
• FDA Commissioner Statement
• Questions and Answers: Qualified Health Claims in Food Labeling
• Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
• Qualified Health Claims: Letters of Enforcement Discretion
• 2017 Addendum Guidelines for the Prevention of Peanut Allergy in the United States (NIAID, NIH)

Also see

• Critical commentary in JAMA