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Structure-function Claims – FDA Approved? Pt 9

Structure-function Claims – FDA Approved? Pt 9

It is not uncommon for people to take notice on product labels, Company website, Commercials promoting a new product of treatment or heard some marketers saying the word’s “FDA approved”. What does that even mean and is it really FDA approved? How can you know for sure what the US food and drug administration approves? This article will discuss structure-function claims on dietary supplements and other foods.

FDA does not approve structure-function claims on dietary supplements and other foods

A structure-function can be defined as the way in which the structure of something relates to how it works. Structure-function claims describe the role of a food or food component (nutrients) and its effect on body structure or function. One example is “calcium builds strong bones”.

Dietary supplement companies that make structure-function claims on labels must submit a notification to the FDA. Such notification must be submitted within 30 days after first marketing the dietary supplement with the structure-function claim. The notification must include the text of the claim and other information; e.g. the name and address of the notifier. Structure function claims on dietary supplements carry a disclaimer. Additionally, this disclaimer states that the claim has not been reviewed by the FDA. In addition, the disclaimer states that the product is not intended to diagnose, treat, cure or prevent any disease.

However, the FDA does not require conventional food manufacturers to notify the agency about their structure function claims. In addition, the agency require conventional food manufacturers to carry a disclaimer on its labels.

FDA Logo Use

It is important to note that the misuse of the FDA’s logo may violate federal law. In fact, the FDA’s logo is for official government use only. Therefore, the logo should not be used to misrepresent the agency. Neither should it suggest FDA endorsement on private organizations, products or services.


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