FDA’s Role in Supporting Innovation in Food Technology

Remarks by Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition

Future Food-Tech Summit
March 22, 2018
San Francisco, CA

More on Dr. Mayne

(Remarks as prepared for delivery)

I am very excited to be here. Government and innovation are two words that you might not expect to see in the same sentence. But I’m here to let you know that they do indeed belong in the same sentence. In fact, we are already writing that sentence together. Through meetings like this, and other conversations, we are developing a better understanding of the challenges we face and the goals we share.

One of the things I’ve learned in my three years as director of FDA’s Center for Food Safety and Applied Nutrition is that the people I work with, from researchers in the labs to the agency’s leadership, are committed to supporting innovation. I share that commitment. We know that you want to make innovative products; you’re on the cutting edge of food technology. And consumers are demanding innovative products for both health and convenience.

We can help you bring these new products to the market. We look at new products like these through the lens of food safety. It’s our mission to protect public health and we are on board with supporting innovative products, but they must be safe products. You’re consumers. I’m a consumer. We all want our food supply to be safe.

And this is a key point. There are many lessons learned from the past 20 years of bioengineered foods. I believe what we have learned is that technology and transparency go together. Consumers today are increasingly demanding transparency around how their foods are made. They want credible information that they can understand without having an advanced degree.

And, if we want consumers to have confidence in the safety of those foods, then having food technology innovators engage with food safety experts and regulatory authorities is essential to build that consumer confidence. Consumers care deeply about both safety and labeling surrounding their foods, and these are both roles that FDA has been charged with carrying out for the products we regulate.

I’d like to divide my talk today into four key questions that address the larger question of how we reach our common goals to provide consumers with innovative products that are safe and lawful.

How can food-tech innovators get the support and information they need from FDA to bring a product to market that that is safe and lawful?

If you’re an innovator and you have a product you believe in, we’re interested. We want to help, especially if you have no regulatory experience. It’s in everyone’s best interest to work together.

I think the key is to come to us early in the process, even if the marketing plan isn’t fully fleshed out. Even if it may be years before you intend to market your product. We can provide feedback that will give you a better understanding of what regulations you’ll be required to meet as you move forward to bring your product to market.

For example, FDA has set up a voluntary consultation process to engage with the developers of foods derived from genetically engineered plants. This process helps developers determine the necessary steps to ensure the resulting food products are safe and lawful. To date, we have completed over 170 different biotech consultations on foods derived from genetically engineered plant varieties. While many of these consultations come from large companies with considerable experience, this kind of collaboration can be particularly helpful for smaller developers who have limited resources and little experience with the regulatory process.

A good example of this kind of partnership is how we helped a researcher with the U.S. Department of Agriculture’s (USDA) Agricultural Research Service develop a plum variety that is resistant to plum pox virus. The developer was new to the regulatory system and was working with limited resources, but we were able to help him identify how he might most efficiently use his resources.

As another example, with early consultations we have been able to guide developers to approaches that would reduce food safety risk such as evaluating the potential allergenicity of new proteins early in development and avoiding the use of proteins that raise allergenicity concerns. And there are cross-reactive allergen concerns to be aware of. For example, people who are allergic to peanuts may also react to lupin, a legume belonging to the same plant family. These reactions can be severe and life-threatening.

But no matter where you are in your development process, we want to help you innovate. There has probably never been a more exciting time to be working at the cutting edge of food technology. With new, innovative products may come questions we have not faced before -- all the more reason to come and talk to us. It’s free – your tax dollars at work. We can provide informed advice about how to navigate the regulatory process, specific to your product, at no charge to you.

You can reach us through our website – fda.gov – or by calling 1-888-SAFEFOOD.

Before I go on to the next question, I’d like to note that the guidance documents we produce are often good sources of information about requirements that might apply to you and help establish some guard rails for safe innovation. For example, we published a guidance a few years ago that describes how to consider the impact of a significant change in a manufacturing process on the safety and regulatory status of a food substance. This includes the use of emerging technologies, such as nanotechnology.

What is the thought process behind the regulation of composition, quality, safety and labeling of foods?

FDA regulates about 80 percent of the food supply, except for meat and processed egg products that are overseen by USDA. FDA approaches the various regulatory issues with different tools, each of which is designed to ensure that consumers are getting what they expect to get and that the product is safe.

• Food manufacturers have long been required to meet Current Good Manufacturing Practices, called CGMPs, to help ensure food safety. These requirements were the foundation of a whole new set of food safety measures under the FDA Food Safety Modernization Act, called FSMA. The FSMA regulations shift FDA’s focus from reacting to foodborne illnesses to preventing them. They create science and risk-based standards for the oversight of produce and manufactured foods, both domestic and imported.
• The safety of food and color additives, and food contact substances, must be evaluated by FDA in a premarket review process.
• FDA establishes Standards of Identity for certain food products, such as white chocolate, that specify what ingredients must be present for a food to be marketed under that name.
• A food substance is generally recognized as safe, or GRAS, if data and qualified expert opinions support that there is general recognition that it is safe under the conditions of its intended use.
• The Federal Food, Drug, and Cosmetic Act has broad prohibitions against the entry of adulterated and misbranded foods into interstate commerce.

Food safety has to be part of your mission too. You can’t scale up otherwise. If you don’t know which of these regulations apply to you, ask us. I know it can be confusing.

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How can regulatory bodies and food-tech innovators better collaborate to achieve greater success in scaling truly innovative solutions?

FDA supports a robust, effective and responsive premarket review program for food contact substances, food additives and color additives. FDA also reviews a company’s conclusion that a substance is GRAS through a voluntary notification program. The program consistently responds to almost 200 industry submissions annually in addition to pre-submission consultations.

Let me give you some examples.

• One of the more interesting substances that we have reviewed in the past year was for mung bean protein isolate. The mung bean protein isolate is being used in a new vegan egg product.
• Another novel substance that we reviewed was for algal fat, which is intended to be used to make a butter-like product. The product, scheduled for launch this year, is a palm-oil free, non-hydrogenated solution for use by the bakery, spreads and confectionery markets.
• And we reviewed allulose, a sugar that is not well metabolized and thus is lower in calories, as a substitute for sugar or fructose, first through the GRAS notification process, and now we are in the midst of reviewing it for the purposes of labeling in light of the new added sugars declaration on the Nutrition Facts label.

Depending on the regulatory status of the product, pre-market authorization may be required by law. Even where pre-market authorization may not be required, if you don’t consult with FDA, you can put your investments at risk because things can go wrong. It’s really important to understand that people can become seriously ill if you haven’t followed all the required steps. If you have, for example, undeclared allergens in your product, how many months of production will be wasted while you correct that problem?

Products that target niche audiences are just as vulnerable to outbreaks or other food safety risks as those that serve the general population if they do not have sufficient food safety measures in place. For example, 32 people became ill last year in an E. coli outbreak traced to soy nut butter and insanitary conditions in a food facility. Several people were hospitalized, and nine developed hemolytic uremic syndrome, a potentially life-threatening type of kidney failure.

While food safety is of utmost importance, it is also important to work with us to ensure that you meet our labeling requirements for where you are in your marketing. For example, if you have a food product that you are selling directly to restaurants, then package labels aren’t a concern. But if you decide to market this product directly to consumers, then you’ve got to be aware of additional requirements to ensure that what you say on the label is true, not misleading, and meets requirements so consumers will know what they’re getting.

How is the convergence of biotech and digital technologies shaping the future of food?

We are helping to lay the groundwork for a future in which these technologies are an important part of the food industry.

Beginning with biotechnology, Federal agencies are doing a lot of work together in the broad area of biotechnology. Congress appropriated $3 million to fund the Agricultural Biotechnology Education and Outreach Initiative, which calls upon the FDA to work with the U.S. Department of Agriculture to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology.

The FDA is currently working on this initiative in consultation with USDA and the Environmental Protection Agency. The tentative timeline for the launch of the educational and outreach materials is by the end of 2018 or early 2019. We’re examining the latest science and research studies, conducting message testing through focus groups, and plan to solicit feedback from risk communication experts, to help inform the development of all the final materials for this initiative. As part of this initiative, we want consumers to better understand that foods derived from genetically engineered sources are not just being developed for the benefit of farmers. Rather, products on the market today include apples that don’t brown, reducing food waste; potatoes that form less acrylamide when cooked, with acrylamide being associated with higher cancer risk; and soybeans that produce greater amounts of oleic acid, the primary monounsaturated fat found in olive oil.

The agency also worked closely with other federal agencies to provide input to the Interagency Task Force on Agriculture and Rural Prosperity on ongoing biotech activities and to help identify concrete future actions. The task force was established in April 2017 by President Trump and its report was released in January 2018.

FDA has a flexible, risk-based approach to oversight of food and animal products of biotechnology. We will take the necessary steps to update or clarify science-based policies to advance agricultural innovation, promoting risk-based regulatory approaches and increasing regulatory predictability.

For example, we’ve recently issued two documents for public comment in January 2017. In light of advances in biotechnology, most notably the ability to “edit” the genome of plants and animals via “CRISPR” and other techniques, FDA took steps to provide the public and industry with its current thinking on how its oversight would best apply to products of these technologies, and to receive feedback on that thinking.

FDA published a Request for Comments in January 2017, in which it also posed a series of questions on how certain types of genome editing might mitigate certain kinds of risks, and how to take those potential mitigations into account as part of FDA’s voluntary consultation process for foods from new plant varieties. We are currently working diligently to review public input and current science as we consider our next steps. For those of you who are new to the regulatory process, FDA seeks public comment on the approaches we put forward through guidance documents and through rulemaking. Stakeholder input is critical to much of our work. And just to give you a sense of the process, we can receive anywhere from a handful of comments up to more than 300,000 comments, for example, which is what we received on the Nutrition Facts label update that I will turn to in a moment.

Moving on to digital technologies, we know that increasingly we are living in a digital world, which has the potential to change how consumers access information about the foods they eat, and even access the foods themselves. The retail food sector is changing as we speak. And from a food safety point of view, some of those changes are really exciting. For example, blockchain technology has the potential to create a community of users recording, amending and updating information that can be used to track food throughout the supply chain. This has many business advantages, including the ability to trace contaminated food precisely back to its source in record time. That kind of innovation by industry has great potential for food safety/recalls and is most welcome.

The Nutrition Initiative

As I briefly mentioned and as I am sure you are aware, FDA has been updating the Nutrition Facts label for the first major overhaul in 20 years, and FDA is also preparing in earnest to implement menu labeling when we reach the compliance date of May 7, 2018. As consumers increasingly see the new nutrition labels, calorie declarations on menus, and have the ability to request additional nutrition information upon request with foods that are subject to menu labeling, we expect that to drive reformulation. We know that consumers are demanding healthier foods, and industry, including many of your companies, is seeking new ways to deliver products that meet consumer needs.

The more that we know about nutrition, the more we can see that there is space for innovation. I am sure some of you are responding to this by creating innovative products to help reduce added sugars, reduce sodium, or add key nutrients or sources of those nutrients to foods. FDA is interested in hearing how we can facilitate nutrition innovation, including the types of products we are hearing about here. One of the most interesting things about being at FDA is hearing about new discoveries and approaches, and finding a path forward to help those products safely come to market.

There is also the critical challenge we have ahead of feeding the growing global population, and the potential for innovation here knows no bounds. As this audience is well aware, we are in the early days of new approaches for delivering protein, with many options in varying stages of development ranging from plant-based proteins such as pea protein, to the development of cultured meats created in a laboratory.

Whether your focus on food technology includes foods derived from genetically engineered sources, new approaches for plant-based foods, new ingredients, or other areas of innovation, your work may have implications for both food safety and for labeling. I encourage you to work with FDA, to bring your brainpower and imagination to the challenge of feeding the world, helping people have healthier diets, and providing innovative new options for consumers.