Speaking with NutraIngredients at the recent Probiota in Dublin, Wasserman, managing partner at Amin Wasserman Gurnani, explained that, for the GRAS (Generally Recognized as Safe) issue, there is reportedly a proposed rule that has been drafted that would require all ingredients claiming to be self-affirmed GRAS to submit to the U.S. Food and Drug Administration.
Health and Human Services Secretary Robert F. Kennedy, Jr. discussed the GRAS pathways during his confirmation hearings and directed the FDA commissioner in March to take steps to explore potential rulemaking to revise its Substances GRAS Final Rule and related guidance to eliminate self-affirmed GRAS.
Originally, proposals were expected to be released by the FDA last October, but a government shutdown delayed this and, six months on, the industry is still awaiting details.
“We do expect there to be a proposed rule that will describe FDA’s plan in detail for what it’s going to require, et cetera, that if it’s done correctly will open up a notice and comment period where industry will have an opportunity to provide comments to FDA on what they think is good, bad or indifferent, about the proposed rule,” Wasserman said. “After this, FDA should publish another document in the Federal Register responding to those comments, making any changes, and then issuing a final rule with an effective date.”
Wasserman noted that estimates peg the number of affected ingredients in the region of 10,000, which begs questions about how FDA would review all of these.
“Will it involve artificial intelligence? Will they get more money to hire more staff? All that remains to be seen,” he said. “And there is certainly the concern about stifling innovation in the food ingredient space, which no one wants.”
Modernizing dietary supplement regulations
There is also talk from FDA about modernizing the dietary supplement regulations, and trade associations have also proposed a number of reforms that the agency can achieve without congressional action.
“Another potential accomplishment that they [FDA] are hoping to do in 2026 is at least look into ways to modernize the regulation of dietary supplements in the United States,” said Wasserman. They’re somewhat, of course, limited in what they can do, because they’re bound by the law, so there’s only so much modernization that they can do. But one thing that I know everyone is concerned about is the is the prohibition against launching dietary supplements if they’ve been studied as drugs.
“They already issued a great enforcement discretion document about placement of the DSHEA disclaimer on every panel, they just issued something about artificial colors. So we’ll see exactly what they do, but the language they used was promising.”
Just this week, the Agency announced a public meeting exploring the scope of dietary supplement ingredients, which will cover three key areas:
- The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” as used in DSHEA;
- New methodologies to produce existing dietary ingredients; and
- Specific ingredient types, including proteins, enzymes and microbials.
More details about this meeting and options to register to attend can be found HERE.
“I said [previously] that 2026 could be the biggest year since GMPs were introduced,” Wasserman said. “The dietary supplements industry could be in for a lot of regulatory change this year.”
