FDA official clarifies agency's position on NDI filing exemption

Recent FDA guidance for the dietary supplement industry created some confusion over an exemption from an NDI (new dietary ingredient) filing requirement.

But an FDA official addressed the confusion last week during a United Natural Products Alliance (UNPA) workshop in Salt Lake City to discuss the 2016 draft NDI guidance.

The statements by Cara Welch, Ph.D., could help to dispel concerns that the agency is seeking to unlawfully restrict a well-known exemption from an NDI notification requirement for ingredients that have been present in the food supply and not chemically altered.

The supplement industry noticed the exemption was phrased slightly differently in the 2016 guidance than in a 2011 document.

In the Q&A section of the 2011 draft NDI guidance, FDA posed a question on whether an NDI notification is required for a “dietary ingredient that has been listed or affirmed by FDA as generally recognized as safe (GRAS) for direct addition to food, self-affirmed as GRAS for direct addition to food, or approved as a food additive in the U.S."

The agency’s answer was that an NDI notification is not required if “the direct food additive or GRAS substance has been used in the food supply" and wasn’t chemically altered.

The 2011 guidance gave companies some assurance that they could avoid the NDI notification requirement if either a GRAS notification on the ingredient had been submitted to FDA, or they made a self-affirmed GRAS determination without notice to the agency, and otherwise complied with FDA regulations and the 1994 Dietary Supplement Health and Education Act (DSHEA). In 2015, The Pew Charitable Trusts estimated 1,000 chemicals have been put into foods without notifying FDA based on self-affirmed GRAS determinations.

However, when posing a similar question as above in the 2016 draft NDI guidance, FDA left out the “self-affirmed as GRAS" language; this caused some in the dietary supplement industry to question the implications of the omission.

An industry source this week appeared to question whether the agency no longer recognizes self-affirmed GRAS substances as it relates to the exemption from the NDI notification requirement. Another industry source also raised the issue last week during UNPA’s NDI Guidance Workshop.

Welch, senior advisor to FDA’s Office of Dietary Supplement Programs, addressed the issue at the workshop.

“The important thing to consider is that if the ingredient is legitimately GRAS, no matter how it got to a GRAS status, if it is legitimately GRAS, in the food supply and not chemically altered, a notification isn't required," she said. "Why that particular wording was removed I don't think is important to the concepts. …It doesn't matter either way, whether it was an FDA notice or not an FDA notice. If it's legitimately a GRAS ingredient and it fits the other requirements, a notification would not be required."

Welch further noted an NDI that is exempt from the filing requirement is still subject to an “adulteration" standard in the law. However, DSHEA places the burden on FDA in establishing that an ingredient is adulterated or unlawful.

The relevant adulteration standard, the 2016 guidance explains, “provides that a dietary supplement containing the NDI is adulterated unless there is adequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury."

Commenting on the standard, and the burden to show an NDI is adulterated, Welch said, "It's just inadequate information. It's not that it definitely does present a risk. It's that we don't know enough about it to know that it doesn't present a risk."

She also noted substances are deemed GRAS for a specific use, and if a company goes beyond that use, Welch recommended a company examine how that affects the safety profile of the ingredient.

Editor's Notes: Interested in learning more about what’s happening at FDA around dietary supplements? Join FDA’s Cara Welch, Ph.D., senior advisor to the Office of Dietary Supplement Programs in the SupplySide West Featured Speaker session on Thursday, Oct. 6, at SupplySide West 2016.

The audio/synchronized PPT presentations from UNPA’s NDI Guidance Workshop will be available later this week at unpa.com/store.