AG Today, October 16, 2017

Where the FDA Is Going Under Trump

Commissioner Scott Gottlieb says it isn’t about more or fewer regulations. It’s about efficiency

By Jacob Bunge,Wall Street Journal

Food and Drug Administration Commissioner Scott Gottlieb serves a president who regularly speaks of rolling back business regulation. Dr. Gottlieb has postponed Obama-era food-labeling rules, pleasing some food manufacturers.

But at the same time, he says, the FDA is working to implement another law passed under the former administration: the Food Safety Modernization Act, which will require companies to develop plans to prevent foodborne illness.

Dr. Gottlieb talked about his job with Wall Street Journal reporter Jacob Bunge. Edited excerpts follow.

  • BUNGE: You are part of an administration looking for ways to roll back regulation. Does this mean that food becomes less safe?
  • GOTTLIEB: I certainly don’t look at it that way. It is true we are undertaking an effort to look across a lot of regulations where we can make regulations more efficient. Where things might be outdated we’re going to need to pull certain regulations or update them. But there is a lot of opportunity to look across our regulatory portfolio to try to find efficiencies in what we do. There are some things we do that maybe don’t make a lot of sense, relative to the modern world. We have a regulation that establishes a standard of identity for cherry pie. I’m not sure FDA in a modern, risk-based environment needs to be regulating the contents of cherry pie.

But remember, we introduce innovation and efficiency by issuing regulations. So part of what FDA does is issue regulations to try to create a more modern framework for new technologies, new ways of doing business. It isn’t a question of regulations or no regulations. I think it is a question for us of smart regulations.

  • BUNGE: With the example of the cherry pie, the Obama administration tried in certain ways to drive more transparency in food with regulations around labeling. What happens to that under your watch?
  • GOTTLIEB: We’re committed to the food labeling regulations, if that is what you’re talking about. Menu labeling and nutrition facts.

 

This isn’t just an issue of transparency. This is an issue of public health. There is evidence that there is public-health value in providing this information to consumers in a restaurant, or providing information in a better way on the nutrition-facts label.

 

This was a comprehensive rethinking of the nutrition-facts label. We have implemented some delays in the implementation of those regulations. But those delays were required to make certain adjustments to make sure that they’re sustainable for the long run.

 

You talk about them as transparency initiatives. I look at them as public-health initiatives. I see evidence of public-health benefit in providing this information to consumers. We’re going to go forward and provide it to them.

  • BUNGE: What is your operating definition of “healthy,” and why is it important for FDA to regulate this?
  • GOTTLIEB: There’s a broader question. “Healthy” is obviously a term that is becoming used in certain labeling. It is a subject of litigation in California.

 

There’s a broader principle of what role FDA plays more generally in the regulation of labeling. When certain claims that might be important to providing information to consumers get made in the absence of a scientific framework and get litigated in state courts and torts, outside our review, I think that isn’t what was intended. I think we have a role to play.

I want to see the agency step in to adjudicate some of the important claims that product developers want to make on labeling that could be important in informing consumers. So we intend to do that. We’re taking a more wholesale look right now inside the agency at the full range of claims that product developers want to make on labeling or are making on labeling where FDA hasn’t played a role, and making a decision from a public-health standpoint where it is important for us to step in.

“Healthy” might be one of those claims. We might make a decision that that claim is more of a commercial claim and doesn’t really convey something important from a public-health standpoint to a consumer. I don’t know where we’re going to come out on that. But we’re going to prioritize from a public-health standpoint which claims we think we should be providing more adjudication of.

If a manufacturer can’t make a claim around some attribute of the health of a food product, then they’re going to innovate in areas where they can make claims. And invariably it is around portion size and taste and convenience. And those are all important attributes. They provide value to consumers.

But I’d like to see more manufacturers trying to innovate around things that actually deliver health attributes to people, because I’m the FDA commissioner, and I think in order to allow innovation around things that produce public-health benefits, we need to allow people to make claims around those public-health attributes.

  • BUNGE: What happens to the Food Safety Modernization Act now?
  • GOTTLIEB: Implementation is moving forward. We’ve recently made again certain accommodations to push out certain deadlines related to FSMA to make sure we get it right. These are very important laws. FSMA is an exceedingly important change in the whole posture of the FDA toward food safety, to an environment of preventive controls, as you know.

We need to make sure we get it right. And there are certain aspects of that implementation that certain sectors weren’t really ready to accommodate. The produce industry had certain concerns around us going onto the farms and whether or not they were ready for the inspections. And so we talked about pushing out another year the actual inspectional regime and doing more readiness inspections for the next year.

There were concerns around how we were going to assess agricultural water on the farms. So we’ve extended a deadline on the imposition of a requirement on how we’re going to do that. We’re going to go back and take a look at that and make sure we have the right tools for doing that, the right standards for doing that so they can actually be implemented by producers.

So there are aspects of FSMA that we’re continuing to look at very closely to make sure that we get it right. I’ve been at the agency before. And I worked with three different commissioners. And I will tell you, when you get it wrong the first time, it is very hard to unwind that.

  • BUNGE: How do you think about providing an atmosphere of predictability for the companies that have to plan and invest for years in the future in this industry?
  • GOTTLIEB: Well, you come to forums like this and you talk about what you intend to do. I think we’ve been pretty transparent. I’ve been pretty communicative with the press. I was very clear from the outset that with respect to FSMA, nutrition-facts labels, menu labeling, and there are others, that we’re fully committed to implementing these; and when we talked about what aspects of it we were going to try to push out a little bit to give industry more time to come into compliance, to give us more time to come up with ways to implement these things so we’re being efficient and not overly burdensome.

The administration’s fully committed to the ethos of food safety. And FSMA was an important, broadly bipartisan, wholesale change in how we approach food safety. But I think from the standpoint of the policy and the politics of this, because you keep going back to the politics of this, what we want to do is make sure we do this efficiently. That’s the key from my standpoint, that we’re not imposing undue costs on industry, that we’re doing this in an efficient way and providing very clear rules that people could actually implement.

Appeared in the October 16, 2017, print edition.