FDA issues new guidance on AER labeling

By Lorraine Heller

- Last updated on GMT

Related tags: Adverse event, Dietary supplement

FDA has issued another draft guidance document on the labeling of dietary supplements to facilitate adverse event reporting, despite earlier calls from industry that the guidance should be withdrawn.

The new document clarifies what information needs to be included in an address listing, and provides a deadline for the enforcement of the new labeling guidelines.

The new labeling requirements are part of the Dietary Supplement and Nonprescription Drug Consumer Protection Act - also known as the serious adverse event reporting bill.

This was signed into law in December 2006, as an amendment of the Federal Food, Drug and Cosmetic Act (FFD&C Act), and came into effect one year later. In the architectural stages it had strong support for many in the industry, which saw it as extra post-market precautionary measure to secure more credibility for supplement makers.

The draft guidance, which can be accessed here​, follows a previous version issued in December last year. FDA is again calling for comments.

Full address

Section 403(y) of the FFD&C Act requires the label of a dietary supplement being marketed in the United States to include "a domestic address or domestic phone number through which the responsible person ... may receive a report of a serious adverse event with such dietary supplement."

If the label does not include this information, the product is considered to be misbranded.

Following some confusion and debate on what information must be included in an address or phone number listing, FDA’s latest guidance document clarifies that full details must be disclosed.

These include the street address or P.O. box, city, state, and zip code of the responsible person (i.e., the manufacturer, packer, distributor, or retailer identified on the dietary supplement label). A phone number listing must include the area code.

According to FDA, leaving this information incomplete may prevent some adverse event reports from reaching their destination, or it may even deter consumers from filing them.

Additional language

FDA also recommends that product labels bear a “clear, prominent statement” ​informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.

The agency said it would not object to this statement being combined with additional language informing consumers that the contact details can also be used for other purposes, as long as the information provided is not false or misleading.

It provides an example of such a ‘dual-purpose’ label statement: "To report a serious adverse event or obtain product information, contact..."

Deadlines

FDA said industry has until January 1, 2010, to label products in accordance with the new requirements.

Although the requirements have in theory been in effect since December 2007, FDA said it intends to exercise enforcement discretion until the start of next year as it had not provided guidance to industry in time for this initial deadline to be met.

Opposition

Supplement trade associations earlier this year voiced opposition to FDA’s initial draft guidance.

In comments submitted to the agency, groups including AHPA and CRN said FDA should withdraw the guidance.

Amongst other concerns, comments included the fact that the guidance was essentially imposing new mandatory requirements on industry without going through a notice and comment rulemaking.

Related topics: Regulation, GMPs, QA & QC

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