FDA recently announced that it will take a second look at its “healthy” regulations, and it is soliciting public comments on a dozen or so topics.
Walk down any aisle at the grocery store and you will find foods advertised as “healthy” or “nutritious.” But what does that really mean? Food and Drug Administration (FDA) regulations currently allow a food manufacturer to use a “healthy” label in connection with a nutrient if it meets certain conditions. One of those conditions is that the food is “low fat” (defined as containing three grams or less of fat per reference amount customarily consumed). But is low fat always considered healthy by today’s standards? Many foods we are encouraged to eat more of, like nuts and avocados, are not low fat. And we know that there are “good fats” (Omega 3, for example) and “bad fats” (saturated fats). Things have changed, and science has evolved. Now we recognize that all fat is not created equal, and the amount of fat is less important than the type of fat consumed.
Recognizing that its regulatory definitions are outdated, FDA recently announced that it will take a second look at its “healthy” regulations, and it is soliciting public comments on a dozen or so topics, ranging from “what types of food, if any, may bear the term ‘healthy’” to the public health benefits of defining “healthy” in the first place. FDA also states that it is planning other forums to receive additional public input.
In addition, FDA issued a guidance document on the use of “healthy” in food labeling. Recognizing that the rulemaking process can be (and usually is) lengthy, FDA advised that it would exercise enforcement discretion in evaluating “healthy” claims until the new regulations are in place. It outlined two instances where food companies could claim their food is healthy without meeting the current definition:
A food does not need to meet the “low fat” requirement to be labeled as healthy, provided the food manufacturer declares the amounts of monounsaturated and polyunsaturated fats (i.e., the good fats) on the label and these amounts constitute the majority of the fat content.
A food does not need to contain at least 10 percent of the Daily Value (DV) of vitamins A or C, calcium, iron, protein or fiber, as required under the current regulation, so long as it contains at least 10 percent of the DV of potassium or vitamin D, which are considered nutrients of public health concern.
FDA’s decision to revisit its healthy regulations should hardly come as a surprise. In May 2016, FDA overhauled the Nutrition Facts label, making changes to serving-size regulations, the DV of individual nutrients and the types of nutrients that must be declared. Notably, the Nutrition Facts label will no longer have a reference to “calories from fat,” which acknowledges that, while certain fats increase the risk of heart disease, other fats can reduce that risk. These changes were part of FDA’s overall strategy to bring its regulations in line with the latest nutritional science and reflect the dietary recommendations set forth in its 2015-2020 Dietary Guidelines for Americans. FDA’s latest retooling of the “healthy” regulations meets these goals.
Moreover, FDA has received pressure from the industry and academics alike. For example, in December 2015, snack bar manufacturer KIND LLC filed a Citizen Petition, urging FDA to reconsider its definition of “healthy” and pointing out that current regulations prohibit food companies from labeling such foods as nuts, whole grains and fruits as healthy, even though they are currently recommended as key components to a healthy diet. Notably, earlier in 2015, KIND received a Warning Letter from FDA over its use of the term “healthy” on its snack bars; FDA pointed out that the bars contained too much fat to fit within the regulatory definition of healthy. But FDA reversed its position and allowed KIND to use the term. It was a good result on the regulatory front, but the Warning Letter spurred significant litigation for KIND over its snack bar labeling, including its use of the term “healthy.”
FDA and the industry hope that the new regulations will be more informative for consumers and food companies — and reflect what the science tells us about the foods we eat and whether they are, indeed, healthy. Of course, the devil is in the details. Based on the long list of issues up for public comment, there are many nuances to iron out. But safe to say, FDA’s actions represent a step in the right direction and likely will be the first of many changes to food regulations that are sorely due for a makeover.
The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.