Speech by Scott Gottlieb, M.D.

Leadership Role Commissioner of Food and Drugs - Food and Drug Administration



Remarks by Scott Gottlieb, M.D.

Commissioner of Food and Drugs

NASDA Winter Policy Annual Conference

Arlington, VA

(Remarks as prepared for delivery)

Thank you for inviting me to join you today and for your continued partnership with FDA. I appreciate the strength of the partnership between FDA and NASDA, especially as we implement the Food Safety Modernization Act.

Since I spoke at last-year’s Winter Policy Conference, we’ve taken many steps together to address key issues of food safety and public health. I’d like to expand on a few today.

One of the most significant areas of our joint work is on produce safety. When I spoke in 2017, I announced that routine inspections associated with the Produce Safety Rule, other than for sprouts operations, would begin in the spring of 2019. We agreed to work together to prepare for a successful initiation of these new inspections.

I’m pleased to say that, working together, we’ve delivered on our plans to provide training to both farmers and regulators, to dedicate regionally based FDA staff to work with farmers and state partners, and to collaborate with NASDA on many other workstreams, including the On-Farm Readiness Review program. We’ve also released additional guidance and resources to help prepare for these inspections.

This year we also completed work with NASDA on two new documents that are key to supporting the regulatory process for these new inspections. The first is a produce farm inspection form, now known as FDA 4056. This form is designed specifically for Produce Safety Rule inspections.

We believe it’ll give farmers more clarity about what’s being examined in an inspection. We’ll use this form as an alternative to our traditional 483 form. We’re working with NASDA and states to promote consistency across the produce program through the new form and other produce-specific material developed through our partnership.

The second finalized document is the produce safety Dispute Mitigation and Resolution Procedures. While we anticipate that such instances will be rare, we understand it’s important to have processes in place to prevent differences of interpretation and quickly resolve any disagreements.

The finalized Dispute Mitigation and Resolution Procedures are now incorporated into Field Management Directive 152. And we’re ensuring that our investigators and compliance staff are aware of these new procedures.

Even as we start these routine inspections, we know we need to ensure that standards for agricultural water are strong enough to protect public health but flexible and practical enough to be feasible for farms of all sizes and kinds. We’re working with farmers, the produce industry and other stakeholders and considering lessons learned from the most recent outbreaks as we work to make sure the agricultural water standards will help protect all produce.

Another step forward is our work to address the issue of parity in our oversight of domestic and imported foods.

I know that this is an important issue for NASDA and the nation’s farmers. And we want consumers to be confident that food imported from abroad is held to the same standards as food produced domestically.

To these ends, we’ve released FDA’s “Strategy for the Safety of Imported Food,” outlining a comprehensive approach to ensure the safety of food imported into the U.S.

The strategy highlights how our different tools and authorities work together in a comprehensive system.

The food safety standards under FSMA, such as preventive controls and produce safety, apply to both domestic and foreign growers, manufacturers, processors, packers and holders. FSMA also provides new authorities to specifically address the safety of imported food. Foreign supplier verification programs and accredited third-party audits of foreign facilities and farms strengthen FDA’s oversight.

The strategy describes how FDA is combining new tools and partnerships with our established authorities, such as inspections and border surveillance, to create a multi-layer safety net approach to imported food safety, while we maintain a level playing field for domestic and foreign producers. We aim to strength our approach by advances in technology and data analytics, as well as new ways to measures how effectively we’re executing this strategy.

FDA has also been working closely with NASDA and the Association of American Feed Control Officials on our shared responsibility for animal food safety.

NASDA’s Model FSMA Preventive Controls for Animal Food Implementation Framework will help states update their existing animal food programs to incorporate the principles of prevention embodied by FSMA. Many states have animal food safety programs with a long history of protecting the animal food supply. So, the framework was able to leverage and build on previous work done to promote uniformity and consistency across animal food regulators. And we’re committed to the success of this ongoing work.

There are other topics beyond FSMA that I know many NASDA members care about, including the regulatory framework for ensuring the safety of cell-cultured foods.

After convening a joint public meeting on this topic and holding thoughtful discussions with USDA, we’ve concluded that both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry with a transition of regulatory oversight from FDA to USDA during the cell harvest stage.

We believe this regulatory framework will protect public health by leveraging the FDA’s experience regulating cell-culture technology and living biosystems, as well as the USDA’s expertise regulating livestock and poultry products for human consumption. And we look forward to continued work with our USDA counterparts to refine the details of this framework.

I also know there’s interest among NASDA members in the regulatory framework for products derived from cannabis.

When the Agriculture Improvement Act of 2018 was signed into law, hemp was removed from the definition of marijuana under the Controlled Substances Act. But the law specifically preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds.

We’re concerned when products not approved by the FDA make unproven claims of therapeutic benefit. Marketing unproven treatments raises public health concerns, because it could keep patients from accessing approved therapies to treat serious diseases. We’ll continue to warn consumers and take enforcement action to protect public health.

Moreover, it remains unlawful to introduce food containing added cannabidiol, also known as CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements. This is because both CBD and THC are active ingredients in FDA-approved drugs and both substances have been the subject of substantial clinical investigations. As such, for CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing.

We’re planning to seek broad public input on this pathway, including information on the science and safety behind CBD. But we know that this process could take time. So, we’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches; to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.

While we consider these issues, it’s important to note that CBD isn’t risk free. There are potential risks associated with its use. Moreover, companies can seek approval from the FDA to market human or animal drugs derived from cannabis. We’ve approved the drug Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy. We also recently completed an evaluation of three Generally Recognized as Safe notices related to hulled hemp seeds, hemp seed protein and hemp seed oil. These products can be legally marketed in human foods.

Another area of shared interest is the use of terms like “milk” and “cheese” on plant-based products.

The FDA issued a request for information to help us examine the use of dairy food names like “milk,” “cheese,” or “yogurt” in the labeling of plant-based foods and beverages. The comment period ended in late January, and we are currently reviewing the more than 10,000 comments we’ve received.

We’re committed to promoting choice and innovation in the marketplace and recognize that some consumers may prefer to use plant-based products instead of dairy products for a variety of reasons. But we have concerns that the labeling of some plant-based products – which we know can vary widely in their nutritional content -- is leading consumers to believe that those products have the same key nutritional attributes as dairy products. Our goal is to help make sure that consumers are empowered with the information that they need to make informed dietary choices.



Finally, I’d like to introduce our next speaker – Frank Yiannas, who joined FDA in November as Deputy Commissioner for Food Policy and Response.

Frank is a food safety champion. Throughout his private sector career at Walt Disney Company and Walmart he has helped advance the safety of consumers and put the consumer at the center of his work. He’s a globally recognized pioneer in advancing food traceability and helping to shape food safety culture within organizations.

Given his deep experience on food safety issues, Frank shares my commitment to the FDA’s important work with NASDA. I’ve asked Frank to provide leadership for FDA’s interactions with NASDA on food safety issues. He’ll work with you to quickly develop and implement solutions whenever new challenges arise in our joint efforts to create a prevention-oriented food safety system for consumers.

I know that Frank and his team, working across FDA’s foods program, will be valuable partners in continuing our work to ensure the safety of the American food supply.

Thank you.