Cultured meat, like any true innovation, will require a new regulatory approach to help ensure consumer safety. While progress is being made, plenty of questions remain. We can play an important role in answering these questions, given our extensive experience in regulated environments.
06 AUG 2020
Cultured meat resides at the intersection of food and biotechnology, combining expertise and technologies from both industries with a goal of creating a robust, safe and cost-effective approach to production. As with any innovation in these industries, clarifying and navigating the regulatory landscape will be critical for advancing the field and ensuring consumer safety. But which government agencies should provide oversight to ensure safety? Who will oversee labelling? Is cultured meat no different from a hamburger we consume today, or a whole new type of food?A little of both? Clearly, there are many questions to be answered when it comes to ensuring consumer safety. The good news is that progress is being made.
Let’s take a look at the regulatory landscape in the U.S., where food production is overseen by two agencies – the Food & Drug Administration (FDA) and the US Department of Agriculture (USDA). When it arrived on the scene, cultured meat didn’t fall precisely within the responsibility of either the FDA or USDA. Not surprising for a food product that has been described as coming from the pages of a science fiction novel.
To produce cultured meat, stem cells are first extracted from livestock; stem cells have the potential to form any kind of cell in the body, including skeletal muscle. Once engineered (or “differentiated”) to become muscle, these cells are grown in laboratory conditions along with other components such as edible polymer scaffolds and then processed into the meat product.
The FDA and USDA addressed the need for coordinated oversight in 2019, announcing an agreement to jointly manage cultured meat. The FDA will oversee all the steps to produce cultured meat before it is actually meat. The USDA then takes over and oversees processing of the cultured tissue into meat and labelling of the final product.
In Europe, cultured meat falls within the scope of the EU Novel Foods Regulation and will require a pre-market authorization, as well as approval by the European Food Safety Authority (EFSA).
“Despite the alignment authorities in the US and defined regulatory pathway in the EU, not all questions related to consumer safety have been resolved,” notes Luke Grocholl, Ph.D., one of our experts in regulatory affairs. “Many of the ingredients used for growing cultured meat have never been reviewed or approved for food consumption, for example, and this needs to be addressed.”
Consider cell culture media, the nutrient-rich liquid in which the cells forming the cultured meat is grown. Media presents a few risks; it could introduce unwanted contaminants and traces of the media could remain in the end product. Use of “food grade” media, which is not currently available, could address this concern as it would, by definition, be safe for human consumption. Similar scrutiny will apply to every ingredient used for manufacturing cultured meat.
While we aim to become a technology enabler for the nascent cultured meat industry, we have the opportunity to also apply our extensive, global regulatory expertise to advance this innovation and help ensure consumer safety.
“Commercial success of the cultured meat industry will depend on inspiring a high degree of consumer confidence,” added Dr. Grocholl. “It’s clear that we can make a significant contribution to this effort – on both the technology and regulatory sides.”