FDA discusses its approach to the safety assessment of food ingredients

In a webinar held Dec. 14, Kristi Muldoon Jacobs, acting director of FDA’s Office of Food Additive Safety, shed light on consumer and agency concerns. While consumers are focusing on ingredients already on the market, her office is looking at existing additives, and at the same time, evaluating an ingredient base that is rapidly evolving. Technology is creating brand new ingredients. Previously unused substances are coming into the market.

Consumer distrust concerning ingredients that are GRAS comes, she believes, from the lack of a requirement that GRAS authorization comes from the agency. The GRAS notification program is voluntary.

“Because it is not a requirement, this does raise a challenge of perception and of possible actuality that there might be substances that are coming into food without FDA knowing about them,” she said.

Under the voluntary program, industry can submit data and their determination that the data would meet the GRAS standard. “FDA will evaluate that data and we will publish our final letter on our website, along with the notification that industry has submitted,” Jacobs explained. “We encourage industry to work with us and they generally do, but under the law, they do not have to. It is their right to make a determination on their own and go to market.”

Her office is responding to the challenges the program presents. “We are developing tools to survey the food landscape,” she said. “We’re looking at and developing computational systems.”

The Warp Intelligent Learning Engine (WILEE) is pulling data integration and analytics and building an application that can crawl the internet. The system will compare what ingredients are out there and what information the office has, such as data on exposure level and authorized uses. The data will allow the system to predict a potential problem. The system will identify signals, conduct trend analysis and help guide the office’s post-market work.

“Another thing that’s driving our work is food innovation and industry innovation,” Jacobs said. She noted that many of these new products are manufactured in an interest in making the food supply healthier, offering more choices, and making food more sustainable and more accessible.

While she recognizes this is a good thing, the result is a significant amount of innovation that must be evaluated. “We see innovation in food ingredients, new things that are being developed through novel applications: genetic engineering, fermentation, bio processing,” Jacobs explained. “These are coming to the food industry, and we need to make sure that ingredients that are produced using these technologies meet the reasonable, safe certainty of no harm safety standards. We’re seeing nano-scale substances more in the area of packaging. We haven’t seen this include ingredients yet, but there’s an interest in taking advantage of this technology.

“We’re seeing active packaging and new innovation in this space to make food safer by protecting it better and we need to make sure that any chemicals that would migrate from the use of these active packaging are just as safe as the substances that are currently on the market,” she maintained.

She also mentioned huge innovation in manufacturing food colors and in identifying newer natural colors: “We need to make sure that the data on these are safe as well.”

As the agency recognizes the world is advancing, she said, “Regulatory programs should advance. We are working to modernize our approaches. We know these new technologies are evolving to meet consumer preferences and we’re seeing an increase in these submissions. We’re observing these trends and we want to make sure that we’re monitoring contaminants as well as new additives to prevent or reduce exposures. I think a role for us is in communications. We’re living in an information age where there’s a lot coming at us all the time and we want to be able to provide factual information to help people make informed decision about their food choices.”

Safety can never be assumed, Jacobs pointed out. “It would be nice to think that safety would be an inherent property of a substance,” she explained. “We’d like to say some things are safe and some things are unsafe. But in fact, any toxicologist will tell you that is not true. You will always be able to find a level or a condition under which something can be unsafe. And for most substances, there’s a level or a condition under which substances can be used safely. The job in all that is to be able to do that determination, to look under which intended conditions we can say this substance can be used safely and to make the appropriate regulatory action concurrent with that with that determination.”