After receiving thousands of comments on what the term “natural” should mean with regards to foods (see previous post here), the FDA is now reexamining the term “healthy” in food labeling.  In addition, they also released an immediately effective guidance to describe their thoughts on their proposed enforcement discretion relative to the use of the term.

Consumers see the term “healthy” on so many products and, certainly, manufacturers love to use that term in today’s marketplace to denote something that consumers would want to eat to promote a healthy lifestyle.  But what does it mean exactly?  Even though the FDA has a definition of the term in its regulations (21 CFR 101.65(d)), if you ask 100 consumers what it means, you will probably get that many answers, and my bet would be that, in many cases, the answers would not likely jibe with the FDA regulations or the contents of the product.

FDA states that:

“More specifically, this guidance is intended to advise food manufacturers of our intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim “healthy” on their labels which:

(1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or

(2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

This guidance is immediately effective because the agency has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).”

It is likely that the FDA will also receive thousands of comments on the term “healthy,” even though they have defined it already, but you know the American public!  So, as far as enforcement discretion goes, it looks like there will be some leeway in the use of the term until FDA provides further clarification at some point in the future.  Perhaps some of those anticipated comments will help shape the Agency’s final position.  The full guidance can be found here.