cGMPs expected today?

The Food and Drug Administration (FDA) has stated that it will be making an announcement about dietary supplements at 11:30 am EDT today, without specifying what the topic is.

According to a release by the American Herbal Products Association (AHPA), the association has received an invitation from FDA to attend a “stakeholder teleconference… to discuss a new food safety initiative.”​

“Although the final rule on current good manufacturing practice (cGMP) for dietary supplements is not explicitly identified as the subject of the discussion, an accompanying phone number bears a message that identifies it as FDA’s Division of Dietary Supplements ‘cGMP final rule line’,”​ state AHPA.

Good Manufacturing Practices (GMPs) form part of the 1994 Dietary Supplement Health and Education Act, and are the final piece of the puzzle before this law governing the supplements industry is fully implemented.

Adoption of GMPs is seen by the supplement industry as a means to quelling criticism from outside the industry that products from the United States lack sufficient regulatory oversight.

The 13-year wait has been a source of frustration to the industry, who has badgered FDA all along to get the guidelines materialized.

“The FDA staff that will be present on the call include Dr. Robert Brackett, Director of the Center for Food Safety and Applied Nutrition, and Dr. Vasilios Frankos, Director of the Division of Dietary Supplements. AHPA therefore assumes that the topic of this teleconference is publication of the long-awaited final rule on dietary supplement cGMP,”​ said the association.

Material related to this teleconference is set to be posted on the FDA website (www.fda.gov) at the same time as the teleconference, with suggestions that this will be formatted in a “prepublication” layout, reported to run to over 1,000 pages.

A more concise format is expected to be made available when the rule is published in the Federal Register.