The claims turn the products into unapproved drugs.
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Warning letters were issued to two companies in the space, Before Brands, which markets a line of products under the SpoonfulOne brand name, and Prollergy Corp., which markets the Ready Set Food line. In both warning letters FDA alleges that the claims the companies are making to help prevent children from developing crippling allergies to peanuts, milk, eggs and other foods are illegal and in effect turn the products into unapproved drugs.
The two companies, and others in the space, started to bring products to market after FDA published a qualified health claim and enforcement discretion document in 2017 that related to the prevention of peanut allergies in children. This is a particularly troubling allergy, as it can lead to anaphylactic reactions that can be life threatening. In addition, peanuts are ubiquitous in the US food supply, making the condition a challenge to successfully manage.
The qualified health claim was based on results of the so-called LEAP study published in early 2015 in the New England Journal of Medicine that showed that small amounts of peanuts fed to children starting at age 4 months could be highly effective in preventing the development of a subsequent food allergy. Prior to the issuance of the health claim, the accepted wisdom for preventing this allergy was to make sure children had no exposure to peanuts as infants.
SpoonfulOne launched in 2017 after the qualified health claim appeared to open the door for making allergy prevention claims for products aimed at children under the age of two. The company markets what it calls a ‘foundational food blend,’ with small amounts of proteins from 16 different foods. The company claims its products can help prevent the development of allergies to peanuts, other tree nuts, milk, eggs, seafood and others. The Ready Set Food products include milk, egg and peanuts.
In the warning letters FDA alleges that the companies have gone beyond the scope of the qualified health claim, which the agency said pertains to peanuts only and only for a set of high risk children. This notation appears in both warning letters:
“The qualified health claim for which FDA stated its intent to exercise enforcement discretion is limited to the use of ground peanuts in infants to reduce the risk of developing peanut allergy and is further limited to infants with severe eczema and/or egg allergy. The claims on the label and labeling of your product are not specifically for reducing the risk of developing peanut allergy but are for reducing the risk of developing food allergies in general. Furthermore, the claims are directed at infants in the general population rather than infants with severe eczema and/or egg allergy.”
FDA also noted in the letters that it’s not allowed to make health claims of any sort on products aimed at children unless such claims are expressly allowed via regulation.
Greg Shewchuk, CEO of SpoonfulOne, issued this statement in response: “We are currently reviewing the FDA’s letter and working internally to evaluate next steps. We appreciate their interest and are taking their notice seriously. SpoonfulOne was created as a simple solution to help families get diverse foods into their babies' diets. As the leading innovator in this category, we include the 16 foods most commonly associated with food allergies. While these foods can easily be found at your local grocery store, we offer our products in convenient and precisely portioned formats.”
FDA did not respond with a statement on the situation before publication time. Similarly, Prollergy Corp. did not issue a statement in response to a request from NutraIngredients-USA.
Experts in the space say it’s reasonable to assume that what works for peanuts could work for other food allergies. Some observers say the qualified health claim needs to be widened to include new information that is being developed in the space. But Marc Ullman, an attorney at counsel with the firm Rivkin Radler, said a major sticking point could be which company would undertake to petition FDA for a broadening of the qualified health claim, given that such a broadening would also benefit the company’s competitors.
“With qualified health claims, for the company that puts in the petition, it’s not like a drug approval. It applies to the whole space. When Quaker Oats petitioned for the qualified health claim on whole oats and cardiovascular health, it made sense, because Quaker dominated the market. There was a real benefit for them and because they controlled so much of the market there was no real downside,” he said.
“If the science really does exist to broaden the claim it might be beneficial for these companies to form a trade association and have the association put in to expand the qualified health claim and enforcement discretion,” Ullman added.
Ullman said companies operating in the childhood food allergy space would need to be extra vigilant on claims language to avoid future warning letters.
“You are making claims for infants, which FDA is very sensitive about, and you are making claims for allergens, which FDA is also very sensitive about. I would advise clients that you need to be extra cautious because you are operating in two areas where FDA is extra vigilant,” he said.
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