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.
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.
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.
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.
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.
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.