|Scott Gottlieb, FDA Commissioner|
“A key part of our mission is helping enable innovation and technological advances in the food sector, ensuring the safety of the products,” Gottlieb said. “As part of this mission, the FDA is constantly evaluating new areas of food innovation and establishing guidelines on how new technology can safely advance. One such area is the development of products that are intended to resemble conventional meat, poultry and seafood. These “cultured” products are generally made from cells collected from animals that are multiplied using non-traditional food technologies. These technologies could offer certain new opportunities over conventionally developed food products.”
Cultured cell technology as a method of food production raises questions from a technical and regulatory standpoint, Gottlieb said. The agency intends for the public meeting to be forum to discuss opportunities and challenges cultured cell technology presents. FDA is seeking input and information regarding:
- What considerations specific to animal cell culture technology would be appropriate to include in evaluation of food produced by this method of manufacture?
- What kinds of variations in manufacturing methods would be relevant to safety for foods produced by animal cell culture technology?
- What kinds of substances would be used in the manufacture of foods produced using animal cell culture technology and what considerations would be appropriate in evaluating the safety of these uses?
- Are the potential hazards associated with production of foods using animal cell culture technology different from those associated with traditional food production/processing? Is there a need for unique control measures to address potential hazards associated with production of foods using animal cell culture technology?
In 2000, researchers found that allowing the protein created by stem cells to grow for three weeks produces a muscle fiber that is microscopically identical to whole-muscle steak. Fast-forward to 2013 when Mark Post, MD, Ph.D., chairman of physiology and vice dean of biomedical technology at Maastricht Univ., Netherlands, organized the first public tasting of a lab-grown hamburger that cost more than $300,000 to create.
Since then, several companies have emerged with ambitions to scale cultured meat technology. Memphis Meats, a company founded by three scientists, along with Modern Meadow Inc. and Dr. Post’s Mosa Meat aim to become the first to bring cultured beef to consumers. Memphis Meats received significant backing from Tyson Foods Inc. which announced a minority stake in the cultured meat company in January 2018, and DFJ, Atomico, Cargill, Bill Gates and Richard Branson.
Gottlieb acknowledged that cultured cell technology is a “…dynamic space that’s gaining interest among companies” because of the appeal to consumers, animal welfare concerns and commercial incentives. But the technology driving these products is complex and evolving.
“We expect that most or all starter cells for food applications will come from living animals for the foreseeable future for commercial and marketing reasons,” he noted. “While currently, animal cells can be produced from the starter cells in bioreactors (a scaled-up application of traditional cell culture techniques) businesses are also working to commercialize processes by which cells can be cultured using biocompatible scaffolding or other techniques to permit the formation of complex tissues, similar to strategies being explored for therapeutic organ or tissue replacement.
“In either case, a significant technical challenge with respect to the use of animal cell culture technology to develop foods intended to resemble conventional meat, poultry and seafood products involves the development of the growth medium used to multiply the cells and ensure that they differentiate into the correct cell types.”
He added that the food products made using suspension-cultured (unstructured) and scaffold-cultured (structured) techniques would then be further processed using traditional food manufacturing processes. These processes fall under FDA regulations such as the Food Safety Modernization Act.
“The July 12 meeting will provide an important opportunity for the FDA to share our experiences in evaluating and ensuring the safety of novel technologies in the food sector,” Gottlieb said. “We will share our initial thinking for how we intend to appropriately apply our existing regulatory tools and policies to this novel area of technology. The forum will also provide an opportunity to discuss with stakeholders the potential benefits and challenges of developing and regulating these products.”
FDA is encouraging attendees to register online to attend the meeting in person or by live webcast. Registration is free, and early registration is strongly recommended as seating is limited. For questions regarding registration, contact Cindy Nachman-Senders, CNS Consulting Group, 7826 Whiterim Terrace, Potomac, Maryland, 20854, call (301) 648-4466, or email firstname.lastname@example.org.