Making Health Claims on Food Labels: The FDA Rules You Need to Know
Many of the food products on any given grocery store shelf have some sort of claim on the packaging. Consumers use these claims to inform what they buy, and as manufacturers, we use them to help promote and sell our products.
A lot of new food manufacturers ask me about making health claims on food labels, so today I wanted to shed some light on what can sometimes be a complex process. In order to successfully navigate the world of claims for your food product—from health claims to nutrient content claims and everything in between—here are the FDA rules you need to know.
What are Health Claims on Food Labels and How Can I Use Them?
I find that many people get health claims confused with other types of claims, but it’s important to understand the differences. Health claims, according to the FDA, are statements about the relationship between a food product or ingredient and a reduced risk of disease or a health condition.
Basically, the FDA distinguishes two kinds of health claims: “authorized” and “qualified.”
Authorized Health Claims: Claims that have significant scientific agreement (SSA). This means there is a consensus in the publically available scientific information on the matter.
- Example: “Adequate dietary calcium and vitamin D may reduce the risk of osteoporosis in later life.”
If you are considering using an authorized health claim on your food product, I suggest you look at the complete list of the FDA’s approved health claims to see which ones your product may be eligible for. Remember, authorized health claims must still be submitted to and reviewed by the FDA before you can use them on your product.
Qualified Health Claims: Claims that don’t have the requirements for SSA but are still backed by a significant amount of scientific evidence. So as not to mislead consumers, qualified health claims must include a disclaimer or qualifier that makes the amount of scientific evidence clear.
- Example: “Some scientific evidence supports, but does not prove, that eating X servings of whole grains daily may reduce the risk of Type 2 diabetes.”
If you want to use a qualified health claim, it’s smart to familiarize yourself with the list of qualified health claims in order to make sure you are using them properly. Keep in mind that once you submit your qualified health claim, the FDA will issue a letter of enforcement discretion and post the letter on their website. From there, the FDA will speak with the manufacturer about how exactly the claim is to be used, but essentially, the letter shows that the FDA won’t deny the use of such a claim.
Using Other Claims for Your Food Product
As you have likely gathered, using health claims on your product is a bit of a process. It can take several months to get the go-ahead to use either authorized or qualified health claims, so you may want to consider other claim options in the meantime. You can use these instead of health claims or if you have your heart set on your health claim, you can use one of these on your product while you wait for approval.
Here are the two other types of claims the FDA allows on food products:
Structure/Function Claims: Structure/function claims make a statement about how a nutrient impacts the structure and/or function of the body (not with regards to preventing disease). These claims must be truthful, but they are not reviewed by the FDA.
- Example: “Fiber promotes regularity” or “Calcium helps create strong bones.”
Dietary Guidance: Dietary guidance either refers to a broad class of foods (rather than a specific substance in a food) or does not express a connection to a specific disease or condition. One element (the specific food or the disease/condition) may be present, but the two can’t be included together.
- Example: “Carrots are good for you” or “Diets high in fruits and vegetables may reduce the risk of some types of cancer.”
Nutrient Content Claims: Nutrient content claims make a statement about the levels of a certain ingredient in a product. They have no reference to human health.
- Example: “Low-fat” or “1 serving includes your daily recommended intake of Vitamin A.”
What’s particularly great about using any of the above claims for your product is that as long as they are truthful, not misleading to consumers, and can be substantiated, you are completely free to use them—no FDA approval required.
Nutrition Analysis for Your Food Products
The first step to using any of these claims is to nutritionally analyze your recipes to see what claims they qualify for. For instance, your product must have high levels of calcium in order to use a structure/function claim about calcium. Likewise, your product must have certain levels of fat to use a low-fat nutrient content claim.
I recommend using an online nutrition analysis software to analyze your recipes if you are interested in using one of the above claims because they provide highly accurate analysis. With software like LabelCalc to create your nutrition facts panel, all your nutrient levels will be instantly generated (even the involuntary ones), making it easy to see what claims you can use. Plus, if you work with one of our expert food labeling consultants, they can advise you about which claims may be best suited to your product and they will ensure you are using the claims in compliance with the FDA’s guidelines.
I hope this overview of claims you can make on your food product has given you a better idea of what type of claim you want to use and how to find what claims your product may qualify for. Remember, while the process of using any claim can be a bit daunting, help is always here if you need it.
LabelCalc provides food manufacturers with affordable, user-friendly, accurate nutrition analysis software, making it easier for you to use claims on your food product. To learn more, contact us today.