Editorial Comment Guest Editorial


Gottlieb Will Leave Lots Of Unfinished Business At FDA

Dick Groves
Cheese Reporter

March 15, 2019


What happens when an activist head of a federal regulatory agency resigns without seeing a lot of his goals through to fruition? In the case of Scott Gottlieb, the soon-to-be former commissioner of the US Food and Drug Administration, the dairy industry will find out in the coming months and years.

As we reported last week (for details, please see the story on page 16 of last week’s issue), Gottlieb will be leaving his post next month, after serving as FDA commissioner for just under two years. But he’s been kind of a whirlwind of activity during that time.

Chief among Gottlieb’s food industry initiatives has been the multi-year Nutrition Innovation Strategy, which he announced a year ago this month. That initiative includes several key elements, including modernizing standards of identity, reducing sodium, modernizing claims, modernizing ingredient labels, and implementing the new Nutrition Facts label and menu labeling.

Only that final item is close to completion, and that’s not really because of Gottlieb’s efforts. FDA published the final Nutrition Facts rule in May of 2016, although the final compliance dates for that rule were extended by about one and a half years under Gottlieb’s leadership. The agency had published the final menu labeling rule in late 2014, and the compliance dates for that final rule were also extended, although the regulatory steps to extend those dates were undertaken before Gottlieb became FDA commissioner.

Labeling issues aside, the Nutrition Innovation Strategy includes several ambitious undertakings that have barely made it off the ground and now will likely be delayed, perhaps indefinitely.

Chief among these is in the area of standards of identity. From a dairy industry perspective, there are at least three different, but somewhat related, initiatives underway involving dairy product standards.

First, as part of its Nutrition Innovation Strategy, FDA held a public meeting last July and also accepted public comments on several questions related to that strategy, including the issue of modernizing the standards of identity to provide more flexibility for the development of healthier products.

The agency received over 1,000 comments in response to its request, including a number of comments that addressed various aspects of dairy product standards of identity (for more details, please see Dairy, Cheese Groups Ask FDA To Revise Standards of Identity For Cheese, Yogurt, on the front page of our Oct. 12, 2018 issue).

Second, before that comment period closed, FDA opened another docket, seeking comments on the labeling of plant-based products with names that include dairy terms, such as “cheese,” “milk,” “butter” and “yogurt.” The agency received over 13,000 comments in response to that specific request (for more details, please see Enforce Rules Against Mislabeled Plant-Based Products, FDA Urged, on the front page of our Feb. 1, 2019 issue).

Third, and perhaps most important (at least in the long run), FDA late last year included, among its regulatory priorities for fiscal year 2019, the reopening of the comment period on a proposed rule, issued jointly with USDA’s Food Safety and Inspection Service back in 2005, that proposed to establish general principles that would be the first step in modernizing and updating the framework for standards of identity.

FDA’s intention was to reopen the comment period on this standards proposal sometime during the first half of 2019. After the agency has reviewed comments it receives, as well as comments submitted when the 2005 proposal was published, FDA expects to be in a position to either publish a new proposed rule or to issue a final rule based on the full record.

Reducing sodium is another key element of FDA’s Nutrition Innovation Strategy. Back when Robert Califf was serving as FDA commissioner (during the final year of the Obama administration), FDA published draft guidance that provided voluntary sodium reduction targets for a variety of food products.

In the wake of last week’s report from the National Academies of Sciences, Engineering, and Medicine updating Dietary Reference Intakes for sodium and potassium (for more details, please see Sodium Intake
Should Be Cut If It’s Above 2,300 Milligrams A Day: Report, on page 18 of last week’s issue), it would appear that FDA might be poised to move ahead on finalizing those sodium targets.

So what happens with all of these initiatives, now that Gottlieb is leaving the agency in less than a month? Obviously, that depends on who the next FDA commissioner is. Or maybe on who the next commissioners are.

Looking over the recent history of FDA commissioners, they seem to fall into three categories. Some, such as Margaret Hamburg, tend to serve for relatively long periods of time (she was FDA commissioner from May of 2009 through April of 2015). Others tend to serve for relatively short periods of time (the aforementioned Califf served for less than a year).
And then there are gaps, where there are acting commissioners (such as the roughly 10-month gap between Hamburg and Califf).

So imagine a scenario in which Gottlieb is succeeded first by an acting commissioner, then a new commissioner is appointed by President Trump, then Trump loses in the 2020 election and his FDA appointee is replaced in early 2021. Under that scenario, FDA’s Nutrition Innovation Strategy might not move much over the next couple of years.


Dick Groves

Dick Groves has been publisher/editor of Cheese Reporter since 1989. He has over 35 years experience covering the dairy industry. His weekly editorial is read and referenced throughout the world.
For more information, call 608-316-3791 dgroves@cheesereporter.com

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