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FDA’s modernized approach to nutrition

Helping Clear up Mixed Messaging on what is “Healthy”: A look at FDA’s New Proposed Rule on Food Packages .

In an attempt to help consumers make better dietary decisions, to modernize FDA’s approach to nutrition, to tackle health disparities, and to reduce the burden of diet-related chronic diseases like Type 2 Diabetes and cardiovascular disease, the FDA recently revealed a proposal to change the criteria for which packaged foods are considered “healthy”.

The definition, established in 1994, currently allows for food manufacturers to add the word “healthy” to their products so long as the products have limited amounts of total fat, saturated fat, cholesterol, and sodium, and provide at least 10 percent of the daily value of one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein or dietary fiber. Some products such as seafood, game meat and raw fruits and vegetables have somewhat different criteria.

FDA updated its guidelines in 2016 to allow for some foods to contain more total fat and to include some that provide at least 10 percent of the daily value of vitamin D or potassium.

Oddly enough, under the current definition, there is no current limit on added sugars, which FDA believes is inconsistent with today’s nutrition science. Theoretically, you could create any food that meets the nutrient criteria and label it as healthy!

The proposed rule represents a major advance, by introducing a new limit on added sugars to generally, no more than 2.5 grams per serving, with some variability depending on the food. It also restricts the amount of sodium to no more than 230 mg per serving and limits the amount of saturated fat, with similar variability based on the food. FDA’s goal with its proposed rule is to encourage healthy eating by prioritizing a blend of vegetables, fruits, grains, dairy, proteins and certain oils, including vegetable oils.

A ”healthy” food needs to contain at least one of these food groups recommended by the Dietary Guidelines, and comply with the proposed limits for certain nutrients such as saturated fats, sodium and added sugars.

Raw whole fruits and vegetables are an automatic shoo-in! Avocados, nuts and seeds, fatty fish like salmon and certain oils, which currently don’t qualify for the term “healthy” could earn the new badge of honor. In comparison, sugary yogurts and cereals would likely no longer be able to be labeled as “healthy” under the new definition. To address consumer interest in having quick signals to readily identify healthy foods, FDA also advised that it’s looking into developing a symbol that manufacturers can use to demonstrate products meet the “healthy” claim criteria.

By emphasizing a “healthy” food as part of fitting into a healthy overall dietary pattern while improving health, as opposed to focus on a food’s individual nutrients, (e.g. salmon can now be considered “healthy” because it is rich in beneficial omega-3 fatty acids and protein, and low in saturated fat and cholesterol), the proposed rule has met with general praise of heading in the right direction. Electronic or written comments on the proposed rule must be submitted by December 28, 2022.  

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I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
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