Page de couverture de E280: Industry user fees could fix a food safety loophole for FDA

E280: Industry user fees could fix a food safety loophole for FDA

E280: Industry user fees could fix a food safety loophole for FDA

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 The Food and Drug Administration or FDA regulates roughly 78% of the US food supply. This includes packaged products, food additives, infant formula, ultra-processed foods, and lots more. However, an analysis by the Environmental Working Group found that 99% of new food ingredients enter our food supply through a legal loophole that skirts FDA oversight and seems, to me at least, to be incredibly risky. Today we're speaking with two authors of a recent legal and policy analysis published in the Journal Health Affairs. They explain what this loophole is and its risks and suggest a new user fee program to both strengthen the FDA's ability to regulate food ingredients and address growing concerns about food safety. Our guests are Jennifer Pomeranz Associate Professor of Public Health Policy and Management at New York University School of Global Public Health and Emily Broad, director of Harvard Law School Center for Health Law and Policy Innovation. Interview Summary So Jennifer, let's start with you, help our listeners understand the current situation with food ingredient oversight. And what is this legal loophole that allows food companies to add new ingredients without safety reviews. Sure. So, Congress passed the Food Additives Amendment in 1958, and the idea was to divide food additives and generally recognized as safe ingredients into two different categories. That's where the GRAS term comes from generally recognized as safe? ‘Generally Recognized As Safe’ is GRAS. But it circularly defines food additives as something that's not GRAS. So, there's not actually a definition of these two different types of substances. But the idea was that the food industry would be required to submit a pre-market, that means before it puts the ingredient into the marketplace, a pre-market petition to the FDA to review the safety. And then the FDA promulgates a regulation for safe use of a food additive. GRAS ingredients on the other hand, initially thought of as salt, pepper, vinegar, are things like that would just be allowed to enter the food supply without that pre-market petition. The problem is the food industry is the entity that decides which category to place each ingredient. There's no FDA guidance on which category they're supposed to ascribe to these ingredients. What has happened is that the food industry has now entered into the food supply an enormous amount of ingredients under what we call the GRAS loophole, which is allowing it to just bring it to the market without any FDA oversight or even knowledge of the ingredient. So, in essence, what we're having now is that the food industry polices itself on whether to submit this pre-market petition for a food additive or just include it in its products without any FDA knowledge. When you said ‘enormous number of such things,’ are we talking dozens, hundreds, thousands? Nobody knows, but the environmental working group did find that 99% of new ingredients are added through this loophole. And that's the concerning part. Well, you can look at some ultra-processed foods and they can have 30 or 40 ingredients on them. That's just one food. You can imagine that at across the food supply, how many things there are. And there are these chemicals that nobody can pronounce. You don't know what's going on, what they are, what they're all about. So, what you're saying is that the food industry decides to put these things in foods. There's some processing reason for putting them in. It's important that the public be protected against harmful ingredients. But the food industry decides what's okay to put in and what's not. Are they required to do any testing? Are there criteria for that kind of testing? Is there any sense that letting the industry police itself amounts to anything that protects the public good? Well, the criteria are supposed to be the same for GRAS or food additives. They're supposed to be meeting certain scientific criteria. But the problem with this is that for GRAS ingredients, they don't have to use published data and they can hold that scientific data to themselves. And you mentioned food labels, the ingredient list, right? That doesn't necessarily capture these ingredients. They use generic terms, corn oil, color additive, food additive whatever. And so, the actual ingredient itself is not necessarily listed on the ingredient list. There is no way to identify them and it's unknown whether they're actually doing the studies. They can engage in these, what are called GRAS panels, which are supposed to be experts that evaluate the science. But the problem is other studies have found that 100% of the people on these GRAS panels have financial conflicts of interest. Okay, so let me see if I have this right. I'm a food company. I develop a new additive to provide color or flavor or fragrance, or it's an emulsifier or something like that. I develop a chemical concoction that hasn't really been tested for human safety. I declare it safe. And the ...
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