It isn’t a secret that eating healthy promotes good health and that certain foods have been linked to preventing or even helping the cure of certain chronic diseases.
As food science and technology evolves, more and more “functional foods” are emerging on the market that are linked to health benefits and the FDA is continuously reviewing scientific evidence and adding approved health claims that can be used in the food industry.
At Roybal Food Consulting, we frequently meet clients who have started their business due to a family member being diagnosed with a disease and having to look to an alternative diet to help their well-being.
So, is there a way that you can state health benefits on your product that have not yet been approved by the FDA?
Qualified Health Claims are statements made about the relationship between a food, dietary supplement, or ingredient and a disease or health condition. Unlike authorized health claims, which have been reviewed and approved by FDA, qualified health claims are supported by scientific evidence, but have not yet been fully substantiated.
The process to get a Qualified Health claim is as follows:
Food Manufacturers submit a petition to the FDA along with supporting scientific evidence.
Once the FDA reviews the evidence, they then decide whether to allow the claim to be made, and if so, what language should be used.
Qualified Health Claim is approved by the FDA and all food manufacturers are allowed to add it on packaging of qualifying products.
A great example of a recent qualified health claim that was approved by the FDA was due to a petition made on behalf of Ocean Spray Cranberries, Inc. The FDA determined that there wasn’t enough evidence to support the proposed health claim. However, even though this didn’t result in an “approved health claim”, the following “qualified health claims” are now approved for cranberry juice beverages:
“Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
“Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
“Consuming one serving (8 oz) each day of [this identified cranberry juice beverage] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
You might be interested in knowing about: Authorized Health Claims: What You Need To Know
References:
Nutrition U.S. Food And Drug Administration. FDA Announces Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections | FDA
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