FDA asks if supplement labeling notifications are a burden

Since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplement manufacturers or distributors making structure/function claims on their products have had to notify FDA of these claims within 30 days of going to market.

The agency is now calling for comment on this information collection process, specifically with regard to the reporting burden on industry, and the usefulness of the information.

Information that must currently be submitted includes:

· the name and address of the manufacturer, packer, or distributor of the dietary supplement product;

· the text of the statement that is being made;

· the name of the dietary ingredient or supplement that is the subject of the statement;

· the name of the dietary supplement (including the brand name);

· a signature of a responsible individual who can certify the accuracy of the information presented, and who must 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.

In a notice published yesterday in the Federal Register (Docket No. FDA2009N0221), FDA called for comment on:

· whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

· the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

· ways to enhance the quality, utility, and clarity of the information to be collected;

· ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

FDA said it believes the burden on industry of this information collection is “minimal” as the information required is immediately available to companies.

Based on submissions received over the past two years, the agency estimates that 2,200 firms will be subject to these reporting requirements per year, and that each company will require 0.75 hours to gather the necessary information. This makes a total industry burden of 1,650 hours.

Supplement makers and distributors have 60 days to send in their comments.