FDA seeks to ease confusion on supplements

Health officials are seeking to clear up confusion about safety rules for dietary supplements by issuing draft guidelines for when manufacturers need to notify regulators about new ingredients.

The Food and Drug Administration asked for public comment on the document, which was issued over the weekend.

It is intended to help companies comply with a 1994 law regulating new dietary ingredients in tablets, powders, liquids and other supplements.

The law requires manufacturers to file a safety notification with the FDA before marketing dietary ingredients that were not on the market when the law passed.

But in about 16 years, the FDA received only about 700 notifications of new dietary ingredients. The agency believes there are more than 55,000 dietary supplement products.

Companies often struggled to determine which products required a notice and to provide the documentation to show products were safe, said Ivan Wasserman of law firm Manatt, Phelps & Phillips.

Cara Welch, vice president of science and regulatory affairs at the Natural Products Association, said some companies had to submit notifications multiple times.

A food safety reform law passed in January included a requirement that gave the FDA six months to issue draft guidelines for when to file a new dietary ingredient notification, or NDI, and what evidence is required to show product safety.

The draft document answers questions such as whether an ingredient used in food, but not marketed as a dietary ingredient, needs an NDI notification. The answer is “yes” and the guidelines provide a template for filing notices.

“Once everyone understands what it means and how to comply with it, you’ll see compliance increasing,” Wasserman said. “If (the FDA) doesn’t see an increased number of NDI submissions… I wouldn’t be surprised to see some type of uptick in enforcement.”

Welch said the Natural Products Association plans to ask the FDA to ease up on some guidelines, such as the documentation to show an ingredient was on the market before 1994.

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By Emily Stephenson

WASHINGTON