SECAUCUS, NJ. – Devon Gholam, vice president of Step Change Innovations, doubts self-affirmed Generally Recognized As Safe (GRAS) status will go away since it would take an act of Congress to do so.

”But I think we can all agree that a lot of things have been done lately going around normal checks and balances,” she said in an April 8 panel at SupplySide Connect in Secaucus.

The US Department of Health and Human Services has ordered the Food and Drug Administration to find a “pathway” to eliminate the self-affirmed GRAS status. Under that scenario, the FDA would take a more active role in determining the status of ingredients, even though job cuts are happening at the FDA. Eliminating self-affirmed GRAS could add to the backlog at the FDA and slow industry innovation, Gholam said.

She encouraged companies to police themselves, such as by performing safety studies and clinical studies.

“Just kind of self-policing while government figures out its role in things,” Gholam said.

Larisa Pavlick, left, of Informa Markets and Devon Gholam of Step Change Innovations.

| Source: Sosland Publishing Co.

The FDA has “low morale,” said Larisa Pavlick, regulatory program manager for Informa Markets. She spent eight years as an FDA investigator.

“It was always a difficult place to work,” Pavlick said. “I’m going to be really honest.”

She spent about 50% of her time traveling, and that percentage rose to 70% during safety outbreaks.

“It’s a hard job, and you really have to live out of a suitcase,” she said.

Whenever arriving at companies for inspections, “I did not have one person say, ‘Hey, I’m glad you’re here today,’” she said.

Pavlick added, “Be kind when you’re working with the FDA. They are doing their very best.”