- Speech by
Scott Gottlieb, M.D.
(Remarks as prepared for delivery)
Good morning. I’d like to thank all the participants joining us here in the room and tuning in online. I’d also like to thank Secretary Perdue and others at USDA for partnering with FDA on this meeting.
We’re here over the next two days to discuss cell culture technology. In the food industry, adoption of this technology has advanced rapidly over the past few years. And numerous companies are currently working to harness this technology to develop new products.
In recent years, FDA has been contacted by firms interested in developing foods using cultured animal cells from various species. And we’ve had several stakeholder engagements on this topic.
It’s clear from these meetings that cell-cultured products will take many forms. Products derived from livestock and poultry will be the focus of this meeting. But cell-cultured seafood is also on the horizon. And at FDA, we foresee that this technology could be used for a variety of multicomponent foods and the development of innovative food products that can only be imagined at the present moment.
And it won’t be long before these products reach a wide market.
Reports indicate that the cost of using cell culture technology to develop food products derived from livestock is 1/50th what it was just a few years ago. While I don’t have a crystal ball, I wouldn’t be surprised to see cell-cultured burgers on restaurant menus in the coming years.
This two day meeting presents an opportunity for the FDA and USDA to hear from stakeholders about the potential hazards, oversight considerations, and labeling of cell cultured food products.
We fully anticipate that FDA and USDA will both have roles in the regulatory oversight of cell-cultured products. And the feedback we hear from you today will help us to advance our interagency discussions.
We take very seriously our mission of protecting the public health.
While there are many considerations regarding proper oversight of the use of cell-culture technology to produce food, consumer safety will always be at the forefront of our work. One of my priorities as commissioner is enabling innovation and consumer choice while supporting public health and safety.
For FDA, these products stand at an interesting intersection of medical technology and food technology.
As many of you know, the field of animal-derived cell-culture technology began in the medical products space. Today, animal cell-culture technology along with human cell-culture technology is used to create products such as recombinant proteins, cell therapies, and gene therapies for human or veterinary use.
In the near future, we expect that this technology will also be expanded to produce products such as regenerative medicine products derived from stem cells. It will also be used for tissue-engineering products such as tissue grafts and solid organs created from living cells in ex-vivo culture.
FDA has already approved many novel medical products that use different cell-culture technologies. As these novel products manufactured using various cell-culture technologies emerged, our scientists recognized the unique risks introduced by these technologies. We required proper controls needed to prevent the introduction of hazards into these products, while helping these tools advance.
As a result, we’ve issued a number of guidance documents for the production of these products. I believe that our technical and scientific work has assured the safety of these products and provided life-changing novel therapies to patients. And, our consistent regulatory approach provides certainty to companies currently making these medical products or considering entering the market in the future.
That’s our medical products experience.
But now, we’re grappling with the challenge of determining how to ensure that food products derived from these same technologies are safely produced. Cell-culture derived tissues that are inserted into the human body and become part of the living tissue are a very different application than cell-cultured products that are ingested. We want to define the aspects of our medical products experience that are pertinent to food products. And identify those pieces that are different. We also need to examine whether existing food safety oversight tools are sufficient for these products, or whether is more needed. These are questions we’re actively discussing. I hope we will have robust discussion on these issues today.
We also have a long history of ensuring the safety of the country’s food supply. This encompasses our oversight of food additives, added substances, and dietary supplements. You’ll hear more about the FDA’s broad regulatory authorities for foods later today. So here I’d like to say a few words about the work we are doing to implement the FDA Food Safety Modernization Act (FSMA).
FSMA is transformative because of the tools it gives FDA to help prevent foodborne outbreaks before they occur. The law requires facilities that manufacture, process, pack, or hold human food to create and maintain a food safety plan. Among other components, this plan must include a hazard analysis of known or reasonably foreseeable hazards, controls to prevent allergen or sanitation issues, and plans in the event of a recall. FSMA also provides the FDA with new enforcement authorities. And it gave us important new tools to hold imported foods to the same standards as domestic foods.
The risk-based, prevention-oriented food safety framework that the FDA is working hard to strengthen lends itself well to evaluating and ensuring the continued safety of new food technologies such as cell-culturing. The USDA, of course, has its own safety framework for the foods under its jurisdiction. And there’s no question that our two agencies – working together -- have the right regulatory tools in our toolboxes to ensure the safety of new food products. This includes cell-cultured food. But deciding whether and how to use available tools is the “art” of regulation. And I know our success will both depend on – and help secure -- consumer and stakeholder support, confidence, and buy-in.
Yesterday, FDA’s Science Board walked through some of the basics of animal cell culture. Our board provided its input to a series of questions aimed at understanding potential hazards in the source materials, culture media, and structural materials. It also provided valuable insight into questions of the nutritional properties of the future-state finished products.
This public meeting today helps us build on those discussions. First, it gives FDA and USDA a chance to walk you through our current safety and labeling frameworks. But more importantly, FDA and USDA will learn from you about the potential hazards you anticipate as well as hear your suggestions on possible strategies to address them. We also look forward to hearing from you on the labeling of these products – both in terms of naming and what claims may be appropriate for some of these new products.
Cell-cultured food sits at the nexus of many constituencies. It includes tech startups, consumer advocates, producers of traditional food products. Everyone in this room might have a different view on the regulatory considerations for these products depending on their profession or personal conviction.
That’s one of the reasons cell-cultured foods are so exciting, but also so challenging. We don’t pretend to have all the answers yet. You’ll help us identify the best path forward.
The FDA and our partners at USDA know the value of stakeholder input.
Whether you provide your opinion, expertise, or just raise related issues we may not have thought of -- we welcome your continued engagement today and in the future.
Throughout this process, FDA is committed to working with USDA and with you to determine an efficient and effective regulatory oversight framework for these novel products. We want to advance these promising technologies. But to be clear, regulatory efficiencies won’t come at the expense of consumer safety. And that’s why the USDA and the FDA are holding this meeting together today.
Partnership and coordination between our two agencies will be critical as we work together to leverage our respective expertise in considering these novel technologies.
I look forward to hearing your thoughts and concerns today and in the coming months.