FDA Issues Industry Guidance on “Healthy” Labeling
The U.S. Food and Drug Administration (FDA) has opened a docket
and released industry guidance on the use of the term “healthy” in the
labeling of human food products. Responding to Kind LLC’s citizen
petition asking the agency to align its nutrient content claim regulations
with federal dietary guidance, FDA invites “public comment on the term
‘healthy’, generally, and as a nutrient content claim in the context of food
labeling.”
Current regulations reportedly establish “the parameters for use of the
implied nutrient content claim ‘healthy’ or related terms… on the label
or in labeling of a food to suggest that a food, because of its nutrient
content, may be useful in creating a diet that is consistent with dietary
recommendations, if the food meets certain nutrient conditions, and
the claim is made with an explicit or implicit claim or statement about a
nutrient.” Among other things, the conditions take into account serving-size
regulations and set criteria for nutrients to limit—including fat,
cholesterol and sodium—as well as those to encourage.
The citizen petition asks FDA to “amend the regulation defining the
nutrient content claim ‘healthy’ with respect to total fat intake and
amend the regulation to emphasize whole foods and dietary patterns
rather than specific nutrients.” In particular, the petition seeks to permit
“healthy” claims on foods that meet fat, saturated fat, and cholesterol
criteria exclusive of total fat or saturated fat content derived from whole
fruits, vegetables, nuts, seeds, legumes, whole grains, and seafood—or
foods in these categories that “have been processed in such a way that did
not materially degrade their nutrition value.”
Meanwhile, FDA has asked stakeholders to weigh in on a number
of questions, including: (i) “Is the term ‘healthy’ most appropriately
categorized as a claim based only on nutrient content?”; (ii) “If criteria
other than nutrient content (e.g., amount of whole grain) are to be
included in the definition of the term ‘healthy,’ how might we determine
whether foods labeled ‘healthy’ comply with such other criteria for
bearing the claim?”; (iii) “What types of food, if any, should be allowed to
bear the term ‘healthy?’”; (iv) “Is ‘healthy’ the best term to characterize foods that should be encouraged to build healthy dietary practices
or patterns?; (v) “What nutrient criteria should be considered for
the definition of the term ‘healthy?’.” The agency also seeks input on
consumer and industry perceptions regarding a changed definition of
“healthy.”
In addition, FDA clarifies in its industry guidance that it intends “to
exercise enforcement discretion with respect to the implied nutrient
content claim ‘healthy’ on foods that have a fat profile of predominantly
mono and polyunsaturated fats, but do not meet the regulatory definition
of ‘low fat’, or that contain at least 10 percent of the Daily Value (DV) per
reference amount customarily consumed (RACC) of potassium or vitamin
D.” See Federal Register, September 28, 2016.
Issue 618
