Impossible Burger Shows How Impossible FDA’s Job Is When It Comes to Food
​​​[Posted on: Thursday, May 24, 2018]

One of FDA’s key roles in regulating food is to determine if the ingredients used are GRAS (Generally Recognized As Safe). It also requires food manufacturers to seek approval for using new dietary ingredients (NDI). Although FDA also regulates other aspects of food, such as quality, food manufacturers do not need preapproval from FDA before selling their products, and for good reason. It would be too cumbersome and onerous if every time a chef or a food company comes up with a new kind of food, they had to get approval from FDA. Under the law, food manufacturers can self-determine if the ingredients used in their products are GRAS and if the ingredients are an NDI. And that’s why it is practically impossible for FDA to truly enforce GRAS and NDI requirements as highlighted by the case of Impossible Burgers sold by Impossible Foods, Inc. of California. Impossible burgers contain an ingredient purified from Soy, called Heme, that when added to veggie burger makes the burger look, smell and taste like beef burger. It is claimed that it would give the consumer the same feeling as a beef burger but as a healthy vegetarian option. A few years back, Impossible Foods filed a GRAS petition with the FDA for heme. When FDA raised criticisms for the information provided in support of the GRAS petition, Impossible withdrew the petition and started selling the burgers anyway. To support its claims Impossible convened a review committee of its own who determined that heme is GRAS and not an NDI. This is completely legal. Impossible Foods still wanted to pursue the official GRAS notification from FDA so filed a petition for it again, possibly for business reasons. It would be a great sales pitch for Impossible Foods if FDA officially grants a GRAS status to heme. Meanwhile Impossible Food has been busy marketing its Impossible burgers. In the last few years, Impossible Foods has sold millions of Impossible burgers according to its website and has expanded into several markets. This case points to some very important strategic considerations for food manufacturers in similar situations. With the increasingly diverse US population and the spread of various kinds of food habits, it is hard to determine if an ingredient is truly NDI in the US. Also, for any new ingredient, a manufacturer can calculate the “normal” exposure levels of the ingredient and self-claim the GRAS levels. Based on these two self-assessments, food manufacturers can market new ingredients. According to independent surveys, there are anywhere from 1000-10,000 ingredients in the US food supply that FDA is unaware of based on public records. An average consumer is unaware of FDAs role and is willing to consume new foods, as seen by the impressive sales of Impossible burgers. So, why would a food manufacturer ever bother to spend resources to get an official GRAS notification? For all intents and purposes, one can market practically all kinds of foods, so unless FDA objects or there are business reasons, don’t worry about GRAS and NDI notifications. Practically FDA cannot even find or object about these ingredients unless they are in the news and most food ingredients are not.