Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports. The AER legislation is set to come into practice by the end of 2007, meaning companies will have to have their reporting systems in place.

FDA guidances are not legally binding and instead represent the authority's thinking on any current topic.

"This draft guidance document is intended to assist the dietary supplement industry in complying with the adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors…" advises FDA on the draft guidance.

To complete the drafting of the AER document in question, the agency is giving industry the opportunity to issue comments and suggestions.

FDA will publish the draft guidance on Monday, thereby fulfilling a portion of the requirements for its role under the AER bill.

Once the 60-day comment period for the document closes and the final guidance is issued, industry is still free to follow the AER bill requirements through its own interpretation, as long as it does so legally.

"You can use an alternative approach if such approach satisfies the requirements of the applicable statute and regulations," advises FDA on the draft guidance.

As it stands, the guidance is comprised of questions and answers concerning the mandatory reporting to FDA of serious adverse events for dietary supplements. This includes the minimum amount of data required to be submitted by a supplement manufacturer, packer, or distributor.

Examples of the questions in the draft guidance are:

-What is FDA's definition of a dietary supplement?

-Who must submit the serious adverse event report for a dietary supplement to FDA?

-Are retailers required to submit serious adverse event reports for dietary supplements to FDA?

-Does a sample of the dietary supplement that is the subject of the serious adverse event report have to be submitted to FDA?

-When am I required to submit the new medical information to FDA?