The new dietary ingredient notification draft guidance is a “radical departure” from current industry practice and FDA should extend the comment period on the draft to one year, an attorney says.

FDA previously failed to provide guidance or feedback on compliance with the NDI notification requirement of the Dietary Supplement Health and Education Act, and “industry practice based on DSHEA is now well established,” attorney A. Wes Siegner writes in a July 26 comment to the agency.

A. Wes Siegner

Considering the differences between the guidance and industry practice and “to allow a full analysis of the draft guidance and balanced response,” FDA should allow a comment period of at least a year, writes Siegner, an attorney with the firm Hyman, Phelps & McNamara.

The agency granted a 90-day comment period when it published the guidance July 5.

There is “no urgent public health need” for a shorter comment period, and FDA “already has numerous tools” to identify unsafe supplements and remove them from the market, Siegner adds.

The draft guidance differs from industry practice in at least three areas, according to his comment.

The guidance suggests a notification “is required almost every time the formulation of a dietary supplement containing an NDI is changed, as well as each time any part of the manufacturing process is changed,” he writes.

As written, the guidance would require notifications for “thousands of dietary ingredients,” a departure from FDA’s practice for addressing the safety of conventional foods through food additive requirements.

Additionally, FDA’s requirement that firms submit a notification even after another manufacturer already has for the same ingredient “is based on FDA’s novel interpretation of DSHEA to mean that dietary supplements are not part of the food supply,” Siegner writes.

The Food, Drug and Cosmetic Act and DSHEA “state the exact opposite” and industry has interpreted supplements as being part of the food supply since the passage of DSHEA in 1994, he adds.

The new interpretation in the draft guidance from FDA’s Center for Food Safety and Applied Nutrition would result in the need to file “potentially thousands” of additional notifications, he writes.

Finally, the guidance requires that firms not only have “documented proof” an ingredient was marketed prior to the Oct. 15, 1994, cutoff date under the act, but also evidence that the current manufacturing method is identical to the pre-DSHEA method.

“As a result, most pre-DSHEA ingredients that for 15 to 20 years have been considered grandfathered would now require” notifications, Siegner adds (Also see "NDI Safety Data Guidance Sets Evidence Bar Too High, Attorney Says" - Pink Sheet, 18 July, 2011.).

By Carolyn B. Phenicie

NDI Guidance Is “Radical Departure” From DSHEA; More Comment Time Needed – Attorney

More from Archive

More from Pink Sheet