New FDA Labeling Regulations are Here – Are you Prepared?

Preparing for the New Nutrition Facts Panel Rules: 10 Tips for the Food Industry
Posted by Dan Berg, Food Scientist, Senior Client Program Development Manager

Most food manufacturers have less than 18 months to meet the FDA’s new rules regarding the revision of Nutrition and Supplement Facts Labels. At Covance, our food scientists have noticed that many manufacturers appreciate additional guidance on these amendments.

Based on commonly asked questions we’ve received in several key areas, we created this article to help educate manufacturers on how to meet the new regulations in the Nutrition Facts and Supplement Facts labels.

1. Review your RACCs (Reference Amounts Customarily Consumed)

Several categories of beverages, dairy and bakery products are among those getting an update to their Reference Amounts Customarily Consumed (RACC). So, what does that mean to your label? The new rules define when a product is considered a single serving or would require dual column labeling depending on the product’s size and the applicable RACC. Because of these changes, some products marketed as Zero Calories, Low Sodium, Fat Free, etc., may not be able to make those claims with a larger serving size. Alternatively, the change in RACC may allow for a higher declaration of some beneficial nutrients.

 2. Adjust your Vitamin A

With the new Daily Values (DV), carrots are losing some of its luster. If you were making a claim of Vitamin A content from natural fruit or vegetable sources, your claim will likely decrease significantly. Vitamin A is now measured in Retinol Activity Equivalents (RAE), with 1 mcg of retinol equal to 1 mcg RAE, while beta-carotene has an equivalence of 12 mcg beta-carotene to 1 mcg RAE. This is a big departure from the IU conversion factors. In the past, 1 cup of whole milk and 1 cup of tomato soup both had about 400 IU and that calculated to 8% daily value for Vitamin A. But with RAE, 1 cup whole milk’s 112 mcg RAE increases to 12% and round to 10% DV. While a cup of tomato soup’s 20 mcg RAE is just 2% DV. Keep in mind that supplemental beta-carotene has half the potency of retinol, so if this is used for vitamin claims, that conversion factor needs to be used.

3. Rebalance your multi-vitamin

Due to the change in DVs, your multi vitamin that is labeled with 100% of the DV for a dozen or so vitamins and minerals may contain between 50-1000% DV using the new rules if you don’t reformulate. Same goes for fortified cereals and functional beverages. Thirty nutrients have a new daily value content, two of which: added sugar and choline, are completely new. With changes in the units of measure, conversion factors and actual daily value contents, there are lots of factors to consider in reformulation or making claim adjustments.

4. Dealing with Vitamin D

Vitamin D is the new mandatory vitamin, and there is solid evidence that a higher level in our diet will lead to health benefits. Although Vitamin D needs to be declared, if your product isn’t fortified or contain one of a few natural sources: meats, fish, dairy or some yeast and fungi exposed to sunlight or irradiation, your product won’t contain Vitamin D and you can save the expense of testing and simply state “not a significant source of Vitamin D” on your label. Look for potential new fortification routes as public health and industry balance strategies to increase D in our diets.

5. Evaluate your source of Vitamin E

Do you know if your source of Vitamin E is natural or synthetic? Don’t let the names fool you. Alpha-Tocopherol, Tocopheryl acetate and Tocopheryl succinate can all be natural or synthetic. Tocopherol can be esterified to improve its stability, but it’s the source of that tocopherol that makes the difference if its natural or synthetic for the purpose of label potency.

Natural products will state d-alpha or RRR- form, while its synthetic counterparts are referred to as dl-alpha or all-rac (all racemic). Mixed tocopherols and tocotrienols have value for their antioxidant properties and potentially other health benefits, but only the alpha form should be included in vitamin content calculations. With the new conversion factors, there may be reason to review the economics of using natural or synthetic sources as the potency advantage of natural went from 1.49 to 2X that of synthetic.

6. Analyze your Folic Acid and Folates

FDA implemented a number of changes to align with the current understanding of nutritional science from Institute of Medicine/National Academy of Medicine. Among this is the use of Dietary Folate Equivalents (DFE) to account for the differences in bioavailability of synthetic folic acid compared to natural folates in foods.

Changes like this complicate existing data on our diets, such as the USDA National Nutrient Database and NHANES survey, where historical data did not account for any difference. Fortunately for the food industry, the declared contents will either remain unchanged (from natural folates) or increase in allowable declaration (from synthetic folic acid) from the same level of fortification. Pay close attention to the methods of analysis chosen and how results are reported, so that a proper calculation to DFE units can be made.

7. Review your fiber claim with the new FDA definition

In the long drama of what is and is not fiber, a new hurdle exists in FDA’s definition, which includes this stipulation: “…isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”

No longer does an analysis define what is considered fiber, but rather the sources need to be considered and complemented by analytical data. Seven isolated or synthetic fibers were originally named as meeting this criteria then later FDA issued their review of 26 other fibers, linked here:

Several citizen petitions were submitted for inclusion of these fibers, and in June 2018, FDA stated they intend to add the following: Mixed plant cell wall fibers, Arabinoxylan, Alginate, Inulin and inulin-type fructans, High amylose starch (RS 2), Galactooligosaccharide, Polydextrose and Resistant maltodextrin / dextrin. So that covers many, but not all of the functional fibers marketed today. It’s worth checking your formulas to see if everything can be included.

8. Added sugar from dairy sources

Although whey powder may contain levels of around 75% sugar, FDA clarified that milk-based ingredients are not considered added sugar. Only the purified lactose is considered as added sugar. Rules around fruit-based ingredients have drawn the most attention, and processes like fermentation which may alter the sugar content from formulation to the consumed product are also a detail to consider. A good understanding of the regulations or seeking expert advice can avoid miscalculations of this new nutrient declaration.

9. Defining Daily Values for a Healthy Claim

The changes in Daily Values (DV) and serving sizes may disqualify a product’s ability to make a “healthy” claim, since there are specific maximum limits to nutrients such as fat, sodium and cholesterol, while also requiring some number of nutrients to be above 10% DV such as protein, fiber or calcium. But considering current views on nutrition, FDA issued guidance on using the term “healthy” (
) and is exercising enforcement discretion relative to products not low in fat, but containing predominately mono- and polyunsaturated fats, and to allow the new mandatory nutrients: Potassium and Vitamin D, to be options for nutrients present at 10% DV. FDA also asked for comments on how to define healthy, so look for more to come as this definition is revamped.

10. Aligning Several Regulatory Changes

As if compliance to the new Nutrition Fact Panel and RACCs was not enough, the transition overlaps with several other regulatory changes. Companies that distribute products in vending machines or through restaurant or food service venues have their own rule changes.

USDA FSIS proposed an update for their label rules on meat containing products to parallel the FDA rules, and made for an allowance to voluntarily follow FDA rules until a final rule is issued. However, this rule making is now on an inactive list, and there is no mention of enforcement discretion so we will continue to have the old rules for USDA regulated products for the foreseeable future.  USDA is also tasked with creating labeling rules for the declaration of bioengineered (genetically engineered) foods. This rule was supposed to be finalized by July 29, 2018, but with the proposed rule just published in May, that deadline is unlikely. Food manufacturers are hoping this can be finalized to allow for a single label update to accommodate both rules.

 Adding 1 Bonus Tip for Canada

Health Canada is also making updates to their Food and Drug Regulations. Similar to the US, adjustments were made to the Reference Amount for serving sizes, but not fully aligned with US RACCs. Daily Values of most nutrients, vitamins and minerals are equivalent to the changes that FDA is making, following the same nutritional science recommendations. But Canada is taking a different path on sugars with a % DV for sugars based on a total of 100g rather than the 50 g added for US regulations. There are some other differences, but Canada is giving more to time to comply with enforcement not set to begin until Dec 14, 2021.

With many changes on the horizon, Covance Food Solutions experts are available to provide advice on how to properly calculate your nutrient declarations and align with the new regulations. Please contact us to discuss your needs.


Changes to the Nutrition Facts Label

Link to guidance doc