FDA permits certain claims on conventional foods and dietary supplements. Typically, there are three categories of permitted claims:
• Nutrient Content Claims
• Health Claims
• Structure/Function Claims
According to U.S. FDA, “Health Claims” are those that describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. Health claims are specifically authorized by U.S. FDA.
“Nutrient Content Claims” are defined as explicit and implied claims that characterize the level of a nutrient in a food or dietary supplement, such as “high in fat,” and “low in sodium.”
Lastly, U.S. FDA recognizes “Structure/Function” claims as those that describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function in humans, characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, describe general well-being from consumption of a nutrient or dietary ingredient, or describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy). In order to make a structure/function claim for a dietary supplement, the manufacturer must possess substantiation and inform U.S. FDA within 30 days of marketing that the claim is being made. Appropriate application of structure/function claims can depend heavily on the classification as “conventional food” and “dietary supplement.”
An important distinction stated in U.S. FDA guidelines is that conventional foods may make claims based solely on “nutritive value,” while dietary supplements may make claims based on nutritive and non-nutritive value. A conventional food that makes a claim based on a non-nutritive ingredient risks being deemed misbranded by the U.S. FDA.
Tea manufacturers should especially be careful about what claims they put on the product’s labels. Often, tea companies will state the therapeutic value of their tea on their product’s labels. These health claims are carefully regulated by the U.S. FDA.
In an age where everyone is riding the green tea wagon, companies must understand how to navigate this regulatory landscape. Companies must have the proper supporting data and properly register their facilities to be compliant with U.S. FDA requirements.
Furthermore, U.S. FDA has specific regulations about what may or may not be included on your label or your website about your product. U.S. FDA monitors claims made on your labels and on your company’s website. The claim presented on your website should be consistent with the qualified health claims you make on your label or you risk exposing your product and firm to enforcement action by U.S. FDA, which includes but is not limited to administrative and/or judicial actions.
For questions related to labeling of your particular product or any U.S. FDA regulation, please contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.