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FDA Hones in on Definition of “Healthy”: Food Law

FDA to revisit definition of “healthy” on food labels.

  • FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per serving.  (Fish and meat are required to contain 5 grams or less of total fat per serving and 2 grams or less of saturated fat per serving).  FDA received a Citizen Petition requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.

  • According to media reports, FDA is planning to “re-evaluate the regulations concerning nutrition [sic]content claims, generally, including the term, ‘healthy,’ in light of evolving research.”  As part of this effort, FDA reportedly plans to solicit stakeholder comments “in the near future” regarding what “healthy” should mean on food labels.

  • If FDA takes the same approach that it appears to be taking in the “natural” claim arena, then the next step will be a request for comments to help inform and initiate the formal rulemaking process.  However FDA ultimately decides to proceed, we anticipate that it will take several years at a minimum before any official change to the nutrient content claim criteria can become effective.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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