Health Claims and FDA Labels

Health claims on food regulated by the FDA can be confusing for new food entrepreneurs. There are two types of claims; “Authorized” and “qualified.” They are required to be reviewed by the FDA, cannot be about cures, treatments of disease or diagnosis of diseases. They must contain the elements of a substance and a disease or health condition. There is not a limit on claims about disease risk reduction. ALL claims MUST undergo review by the US FDA through a petition process.

Here is a list of authorized health claims and links to the associated rules to use them:CLICK HERE

Authorized health claims are statements made on a product’s labels and/or the manufacturers websites about purported claims that eating a certain food will have a beneficial health related out come to a specific disease or general healthiness of the individual customer consuming the product. These types of claims need to be well vetted and thought through before you or your company put them on your food product.

This is not something that should be done just for marketing purposes or based on non-scientific evidence. In fact, the FDA requires significant scientific agreement, which includes evidence from studies and other publicly available evidence, with qualified experts in agreeance with the claim.

A qualified health claim is when a claim has some evidence that it is true but not strong enough to be an authorized health claim. With qualified health claims, disclaimers need to be added. An example the FDA uses is “scientific evidence suggests, but does not prove.” This statement or one like it in your qualified health claim is needed. These claims exists today, because of litigation around First Amendment rights.

Here are two links to guidance documents on making qualified health claims:

https://www.fda.gov/food/guidance-documents-regulatory-information-topic/guidance-industry-evidence-based-review-system-scientific-evaluation-health-claims

https://www.fda.gov/food/guidance-documents-regulatory-information-topic/guidance-industry-fdas-implementation-qualified-health-claims-questions-and-answers-final-guidance

What is unique for these labels for the FDA regulated food is that pre-market approval is required for either type of health claim. The FDA has a specific process for getting the labels reviewed and approved and this must be done prior to marketing the product. As you are probably aware, this is unique because typically the FDA does not make pre-market approvals of labels except in the case of these claims.

WHAT ABOUT OTHER CLAIMS:

 Your company is proud of your product, perhaps you want to claim organic, Non-GMO, Vegan, Kosher, Fair Trade, etc. These claims cannot be misleading or confusing to the customer and most of them all have regulations or governing bodies controlling what can and cannot go on the label of your product. It is crucial to understand this before making your labels.

I normally see marketing or sales teams responsible for the majority of making labels but be sure those teams are aware or are working with food safety teams that typically know and understand the guidelines for claims.