DSHEA Tutorial: FDA Claim Notification


When making a structure / function claim online, in print, or inserted into your product packaging, you have thirty days to notify the FDA of this claim. It appears that if there is no claim made, that this notification does not need to take place. That can simplify things somewhat, perhaps I should have mentioned that earlier. :)

There are few clear instructions on what this notification needs to include. The FDA says:

Sec. 190.6(b)(4) states that the manufacturer or distributor is not required to do a complete literature search. It is required only to provide “the basis on which it has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe” (section 413(a)(2) of the act). That is all that the regulation requires.

However, the FDA’s Final Rule on Notification Procedures for Statements on Dietary Supplements, we find the following requirements:

(1) The name and address of the manufacturer, packer, or distributor of

the dietary supplement product;

(2) the text of the statement that is being made;

(3) the name of the dietary ingredient or supplement that is the subject of the statement;

(4) the name of the dietary supplement (including the brand name); and

(5) a signature signed by a responsible individual or the person who can certify the accuracy of the information presented and contained in the notice. The individual shall certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

Send the above information to:

Office of Special Nutritionals (HFS-450),

Center for Food Safety and Applied Nutrition,

Food and Drug Administration,

200 C St. SW.,

Washington, DC 20204


Next: adequate substantiation defined.

Last modified: August 3, 2009  Tags: ,  В·  Posted in: Claims