The term “healthy” as commonly used is quite
subjective—meaning different things to different types of consumers.
Culturally, there are sometimes fast-changing trends about what is
healthy—foods rejected by consumers a few years ago are now regaining
popularity and vice versa.
Nevertheless, the FDA defines
“healthy” and regulates how the term may be used on product labels.
Until now, that regulatory definition was based on science from the 1990s, when
low-fat foods were all the rage, and products made from avocados, nuts, and
fatty fish could not be labeled as “healthy.”
However, following an active summer of policymaking, the FDA announced on Monday, September 26, that it is
redefining “healthy.” This move is likely the result of a December 2015 petition to the FDA by KIND Bar, in response to an
FDA warning letter challenging its use of the term on its nut bars. The FDA
also noted that the move reflects updated nutrition science and dietary
recommendations contained in the 2015-2020
Dietary Guidelines for Americans and its recently revised Nutrition Facts panel and serving size regulations.
Under existing regulations, in order for a food
to be labeled as “healthy,” it must contain limited amounts
of total fat, saturated fat, cholesterol, and sodium, and higher amounts of
other nutrients, including vitamin A, vitamin C, calcium, iron, protein, and
fiber. 21 C.F.R. § 101.65(d). Foods higher in fat (even if “beneficial” fat)
are not “healthy,” while foods that are low in fat but high in sugar are
“healthy.”
The FDA recognized that much of these
regulations derive from relics of a prior era of health science. FDA is taking
steps to bring its regulations into alignment with more modern nutrition
perspectives. As the first step in its process to define the term, it is seeking information and comment on issues such as:
·
What types of food, if any, should be allowed to bear
the term “healthy”?
·
Is “healthy” the best term to characterize foods that
should be encouraged to build healthy dietary practices or patterns? What other words or terms might be more appropriate (e.g.,
“nutritious”)?
·
What is consumers’ understanding of the meaning of the
term “healthy” as it relates to food? What are consumers’
expectations of foods that carry a “healthy” claim?
·
How will the food industry and consumers regard a
change in the definition of “healthy”?
·
What would be the costs to the industry of
the change?
In the meantime, the FDA’s recently published guidance reflects the agency’s intent “to exercise
enforcement discretion with respect to [use of] 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 per reference amount
customarily consumed of potassium or vitamin D.”
Two cautions before relying on this enforcement
discretion:
First, remember that guidance documents are not binding on
the agency. The FDA can change its mind about this enforcement discretion at
any point.
Second, and more noteworthy, the FDA’s exercise of
enforcement discretion may not deter plaintiff’s attorneys from bringing suit
alleging that labels are misleading. This is not just speculation. Recently,
General Mills, Kellogg, and Post Foods were each sued in California on similar grounds—the
complaint filed in the General Mills case asserts that “statements that these
products are ‘healthy,’ ‘nutritious,’ or ‘wholesome’ are false, or at least
highly misleading, because, due to their high sugar content, consumption of
these products is decidedly unhealthy.”
The FDA’s request and guidance may give food
companies some idea of where the new regulations are likely headed. In the
request for comment, the FDA noted KIND Bar’s suggestion that the FDA “emphasize
whole foods and dietary patterns rather than specific nutrients” in amending
the regulations. In addition, we also expect the FDA to limit sugar (or at
least “added sugar”) content in foods that make a “healthy” claim.
Food companies that would like to make “healthy”
claims on their labels should consider submitting comments to the FDA. The
opportunity to shape a regulation with this much impact in the food industry
does not come around very often and making sure the FDA hears from as many
perspectives as possible will help them draft a better-informed rule that the
food industry will have to operate under for a long time.
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