As it signaled it would be doing earlier
this year, FDA has initiated a public process to redefine
the implied nutrient content claim "healthy" when it
is used on food labels and labeling. In addition, while
the process is underway, the Agency intends to exercise enforcement
discretion for (meaning it will not take action against) foods
labeled with the term "healthy" as long as they meet
the conditions in the regulatory definition at 21 CFR
101.65(d) and other criteria laid out in a newly issued guidance document.
FDA explained in announcing this initiative late
last month that:
"Redefining 'healthy' is part of an overall plan to
provide consumers with information and tools to enable them to
easily and quickly make food choices consistent with public health
recommendations and to encourage the development of healthier foods
by the industry. ... Public health recommendations
for various nutrients have evolved, as reflected by the 2015-2020
Dietary Guidelines for Americans and the updated Nutrition Facts
label. For example, healthy dietary patterns now focus on
food groups, the type of fat rather than the total amount of fat
consumed and now address added sugars in the diet. Also, the
nutrients of public health concern that consumers aren't
getting enough of have changed."
Questions the Agency is asking stakeholders to weigh in on
What current dietary recommendations should be reflected in the
definition of "healthy?"
What are the public health benefits, if any, of defining the
term "healthy" or other similar terms in food
What is consumers' understanding of the meaning of the
term "healthy" as it relates to food? FDA states
that it is especially interested in any data or other information
that evaluates whether or not consumers associate, confuse, or
compare the term "healthy" with other descriptive terms
What factors and criteria should be used for the new definition
If "healthy" is not the best term to characterize
foods that should be encouraged, what other words or terms might be
appropriate (e.g., nutritious)
The Agency's recent Final Rules that revamp the Nutrition
Facts label, as well as federal serving size guidelines, to reflect
new scientific information play an important role in the effort to
redefine "healthy." The framework for this and
other nutrient content and health claims are linked to various
elements of food product serving sizes, Nutrition Facts, and the
Daily Values of individual nutrients. Compliance with the
new Nutrition Facts label will phase in between July 2018 and July
2019, but manufacturers may want to comply earlier as they launch
new products or redesign food labels. FDA was also urged to
reexamine the rules for "healthy" through a Citizen
Petition filed by KIND LLC after last year's dispute with the
company regarding label claims for some of its KIND Bar
The comment period for this FDA consultation is scheduled to end
on January 26, 2017 (see formal notice and link to the e-docket here). The comparable public comment
period for the label claim "natural" was extended by
the Agency, but interested stakeholders should not assume that this
"healthy" comment period will also be extended.
Accordingly, individuals planning to comment should be
targeting the January 26th deadline for all submissions.
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products.
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