The answer is legally complicated since the Food and Drug Administration (“FDA”) has defined the term “healthy” to apply to foods, not dietary supplements. On the other hand, in some circumstances, certain types of oils — like olive oil — are now eligible to use the “healthy” label. Thus, if your supplement is an oil or other food-like consumable, your supplement might be able to make the “healthy” claim. This is an evolving area of law.

That being said, while it might be possible to use the “healthy” label, it is probably better to make defensible “health benefits” claims instead. Use of labels like “healthy” and FDA approval of health claims for dietary supplements is a confusing legal labyrinth, and you will need experienced FDA Approval Lawyers to help. Call us here at Revision Legal for more information. Here is more information on the use of the “healthy” label and recent changes made by the FDA.

The FDA recently changed/updated the criteria for lawful use of the “healthy” label on foods (and, potentially, other food-like products). Under the old definition (from 1994), the “healthy” label required that the food product be limited in fats, saturated fats, cholesterol, and salt/sodium, and also had to provide 10% of the recommended daily amounts of vitamin A or C, calcium, iron, protein, or fiber. In practice, this was a relatively easy standard to meet. As an example, many heavily sugared cereals were able to meet this standard since such foods were/are low in fats and provided a good daily dose of fiber.

As stated in an FDA fact sheet here, the new definition of “healthy” requires that a food product:

1. Contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy, and protein foods) recommended by the Dietary Guidelines for Americans, and

2. Meet specific limits for added sugars, saturated fat, and sodium

Among other significant changes is the addition of limits on added sugars and the abolition of quotas for things like vitamins, various minerals, protein, etc.

Examples listed that will automatically qualify for the new “healthy” labeling claim include anything that is “nutrient-dense” and that has nothing added other than water. These include unadulterated versions of:

• Vegetables and fruits — even “high fat” fruits like avocados
• Water
• Whole grains
• Fat-free and low-fat dairy
• Lean game meat
• Seafood — including higher-fat fish like salmon
• Eggs
• Beans, peas, and lentils
• Nuts and seeds
• Olive and some other types of oil

As noted, if you produce and market supplements, your supplement might be eligible to use the “healthy” label. Given the new definition, a supplement that is, for example, ground or dried vegetables (and nothing else) might qualify. In the alternative, it may be better, if possible, to make a “health claim” or “disease claim,” which are claims that explicitly link a supplement to the amelioration or prevention of a disease or health-related condition.

Contact the FDA Approval Attorneys at Revision Legal

For more information, contact the experienced FDA Approval Lawyers at Revision Legal. You can contact us through the form on this page or call (855) 473-8474.