By Diana R. H. Winters
[Cross-posted on HealthLawProfBlog.]
There was an article a couple of weeks ago in the New York Times about “engineered foods,” and how “a handful of high-tech start-ups are out to revolutionize the food system by engineering ‘meat’ and ‘eggs’ from pulverized plant compounds or cultured snippets of animal tissue.” The author discussed some of the business models, interviewed some of the entrepreneurs, and contemplated some of the implications of “Food 2.0.” The concerns she noted involved the nutritional impact of these foods, and the possibility of resource-intensive production.
But what sort of screening will these food products go through before they enter the food supply? How will FDA vet these new foodstuffs for toxicity or allergenic properties? It won’t. Manufacturers can self-affirm that food products are safe, based on their own studies, and market them on that basis with no prior FDA approval. This is the GRAS (generally recognized as safe) route to marketability. A manufacturer could also choose to submit to the formal food additive approval process, which is extremely time-consuming, but considering the breadth of the GRAS exception, they probably won’t. Many more GRAS notifications are filed per year than food additive petitions.
FDA does not have the time or the resources to screen every new substance added to food, and indeed, it is not clear that it should be doing so. There is a difference between entirely new substances that have never been in the food supply, common substances that have been altered, and common substances that are being used in a new manner. Nevertheless, the public relies on FDA to ensure the safety of the food supply, and the GRAS process leaves gaps in this oversight.
The trajectory of one such engineered substance is illuminating. “Quorn” is a food product made from something called mycoprotein, a meat-free protein source. Quorn states that mycoprotein is made through a fermentation process, “like yeast in bread,” while the Center for Science in the Public Interest calls it a “vat-grown fungus.”
Quorn’s manufacturer waited fifteen years for FDA to review its petition requesting approval for food additive status for mycoprotein. The company then filed a GRAS notification with the agency on the basis of its own studies, which FDA quickly approved. Not included in its submission to the agency, however, was a study from the 1970s showing that five percent of 200 participants became ill after eating mycoprotein. Soon after FDA approved Quorn’s self-designated GRAS status in 2001, CSPI wrote a letter recommending that GRAS status for mycoprotein be revoked, and that further study be undertaken.
In 2011, a state court in Connecticut threw out a lawsuit brought by a woman against Quorn Foods, Inc. 2011 WL 2418628 (Sup. Ct. CT 2011). Kathy Cardinale had eaten Quorn’s “Chik’n Patties” three times. Each time she became extremely ill. Cardinale alleged that Quorn engaged in deceptive marketing by failing to declare that its products were allergenic, and sought damages and an injunction under Connecticut state law.
The court held Cardinale’s claims preempted by the Food, Drug, and Cosmetic Act, finding that she was actually trying to have mycoprotein declared a food allergen, or have its GRAS status revoked. While noting the “glacial” pace of FDA in reviewing Quorn’s food additives petitions, the court nevertheless commented,
“Surely [FDA] with its staff of food scientists, nutrition experts and vast regulatory authority over our nation’s food supply is in a far better position and possessed of more adequate resources to properly assess the pros and cons of additional or specific labeling for the food product at issue here. If it is not, an argument could be made that the FDA should be disbanded and the money to run its operations should be delegated to each of the fifty states to better enforce their own consumer protection laws. If there is one area that cries out for uniformity and the application of neutral scientific principles, it is the labeling of potential food allergens for the fifty states.”
Quorn is also used as a prominent example in a recent Washington Post article on the lax FDA oversight of food additives.
But whether or not Quorn’s mycoprotein is a significant health hazard, the product entered the food supply—and remains there still—with no meaningful FDA oversight. As the Washington Post article points out, the number of food additives in the food supply has grown greatly over the past few decades. Moreover, we will see more engineered foods entering the food supply over the coming years. As exemplified by the Cardinale court, there is a misguided public perception that FDA is ensuring the safety of these products.
What to do? Vastly increased resources for FDA to thoroughly and expeditiously review new additives would be ideal, but these are not forthcoming. Disclosure may be an imperfect first step. Consumers could be alerted when a product contains a substance that has been self-affirmed as GRAS. But education as to the meaning of this would be difficult, as would the parsing of GRAS categories. Moreover, the stigma attached to such labeling may inhibit innovation. The debate here would echo that on the labeling of GM foods. The Grocery Manufacturers Association has recently announced an initiative to create a database of all food additives and the scientific information companies have relied on to make their determinations that these products are GRAS. This database, however, will not be available to the public, but only to FDA. Still, it’s a start.