The leadership of the US Department of Health & Human Services is pushing the U.S. Food and Drug Administration to explore the elimination of self-affirmed GRAS (General Recognized as Safe) for food ingredients. The government shutdown meant the agency’s own deadline of October to announce proposals came and went, but the proposals will arrive once the government reopens.
“Everybody’s concerned, obviously, and it doesn’t only affect probiotics, it affects the entire supplement space,” Paraskevakos, IPA’s executive director, told NutraIngredients at the recent SupplySide Global in Las Vegas. “So, we’ve been very active, proactive. Our regulatory affairs committee is pretty huge, because regulatory affairs for probiotics at the global level is an issue right now. Our task force that looks at North America specifically, we’ve had a few calls lately and basically have put together a task force to proactively collect and put forth comments.
“Back at an open meeting at the FDA in 2017 or 2016 where we submitted comments around what the NDI process was supposed to be, we talked about grandfathering list, we talked about criteria for safety, we talked about possibly using master files,” he added. “So, these are things that we submitted already and are in the public docket and are a good basis to revise and to bring forward and to prepare comments when and if that [elimination of self-affirmed GRAS] will come to fruition.”
China
The global business climate remains uncertain, and this has impacted forecasting for potential market growth, he added. Despite this, the market for probiotic supplements in China is expected to grow at double digits.
Paraskevakos said that the global market is estimated to be around US$ 9.4 billion, with the APAC region worth about US$ 3.7 billion. Of that, China represents between 55% and 57%.
IPA recently opened offices in China right outside Shanghai with the aim of opening the market more to IPA members.
“I’m headed there to actually officially launch it [during] a pretty big event in November, and we’re expecting government officials to be there as well. It’s up and running.”
Paraskevakos also discussed the regulatory challenges simmering across different jurisdictions around the world. Watch the video for the full interview.
