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FDA Releases New Guidance for Using "Healthy" Claims on Food Labels
Practical Law Legal Update w-003-6663 (Approx. 4 pages)
FDA Releases New Guidance for Using "Healthy" Claims on Food Labels
by Practical Law Commercial Transactions
| Law stated as of 29 Sep 2016 • USA (National/Federal) |
The Food and Drug Administration (FDA) has released new guidance for manufacturers that use the implied nutrient content claim "healthy" on their food product labels. The agency has also invited public comment on the term "healthy" generally and as a nutrient content claim on food labels.
On September 28, 2016, the Food and Drug Administration (FDA) released new guidance for using the implied nutrient content claim "healthy" on food labels (see FDA: Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products). This new guidance is effective immediately.
A manufacturer can use the term "healthy" (or a related term) as an implied nutrient content claim on a food label only if the food product complies with the FDA's requirements for:
- Limiting certain nutrients in a person's diet, such as total fat, saturated fat, cholesterol, and sodium.
- Encouraging certain nutrients in a person's diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber.
The nutrient criteria for using a "healthy" claim varies for different food categories.
Because the science supporting public health recommendations for nutrient consumption has evolved, as reflected in the updated Nutrition Facts Label, the FDA has decided to exercise discretion with respect to how it enforces some of the criteria for using a "healthy" claim. In particular, this new guidance advises food manufacturers of the FDA's intent to exercise discretion in enforcing "healthy" claims on foods that either:
- Have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of "low fat."
- Contain at least 10 percent of the Daily Value per reference amount customarily consumed of potassium or vitamin D.
For more information on the updated Nutrition Facts Label, see Legal Update, FDA Finalizes New Nutrition Facts Label for Packaged Foods.
This guidance represents the FDA's current thinking on this topic, but is not binding on the FDA or any person. For more information on federal food labeling requirements, see Practice Note, FDA Food Labeling: Overview.
The FDA has also established a docket to receive information and comments on using the term "healthy" in food product labels (Use of the Term "Healthy" in the Labeling of Human Food Products, 81 Fed. Reg. 66562-01 (Sept. 28, 2016)). The agency is accepting electronic and written comments until January 26, 2017.