FDA Commissioner Scott Gottlieb resigns

by Diana R. H. Winters

Much of the coverage of the resignation of FDA Commissioner Scott Gottlieb highlights his work to regulate the e-cigarette and tobacco industries and his mixed record on the opioid addiction epidemic.  See here, here, and here, for example.  Despite criticism for delaying certain e-cigarette regulations, Commissioner Gottlieb stood out in the Trump administration for his willingness to regulate and to challenge the tobacco, e-cigarette, and drug industries.  Similarly, and surprisingly, the FDA under Gottlieb continued to move ahead with certain Obama era nutrition policy initiatives and began to spearhead some of its own.  The agency moved ahead with changes to the nutrition facts label, with requirements that certain restaurants post calories on menus, and with an FDA initiative to reduce sodium levels in the food supply.  Moreover, in a speech to the National Food Policy Conference delivered in March 2018, Gottlieb outlined a new FDA nutrition strategy, designed to reduce the toll that poor nutrition takes on Americans’ health.  Gottlieb explained that the FDA would “use our tools and authorities to create better ways of communicating nutrition information to consumers so they can be empowered to make good choices. And we’ll advance new ways to make science-based claims that provide more incentives for food manufacturers to produce products with more healthful attributes.”

What’s next for the FDA?  As the FDA’s tobacco and e-cigarette initiatives are now up in the air, so are those regarding nutrition policy.

Food Law News

Today was just chock full of food law & policy news.

1. The Supreme Court turned down challenges to two of California’s animal welfare laws: A) Proposition 2, California’s Prevention of Farm Animal Cruelty Act, which mandates that the state’s farm animals need be able to “turn around freely, lie down, stand up, and fully extend their limbs,” and B) CA’s foie gras ban.

The New Food Economy has a good summary of these laws and the challenges here: https://newfoodeconomy.org/supreme-court-animal-welfare-law-cage-free-egg-foie-gras-ban/

2. A federal judge in Iowa found the state’s “ag gag” law unconstitutional, saying that it violates the First Amendment.  https://www.desmoinesregister.com/story/money/agriculture/2019/01/09/ag-gag-law-iowa-struck-down-federal-judge-ia-agriculture-first-amendment-free-speech-puppy-mills/2527077002/

3. The government shutdown’s effect on food safety inspections has been widely noted: https://thehill.com/homenews/administration/424562-fda-says-most-food-inspections-have-been-halted-amid-shutdown.  FDA Commissioner Scott Gottlieb weighed in on Twitter, however, to explain that the FDA has NOT stopped inspections, but has postponed a small amount of routine inspections.  He wrote, “Food Safety During Shutdown: We’re taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities. 31% of our inventory of domestic inspections are considered high risk…”

See thread: https://twitter.com/SGottliebFDA/status/1083055700593516545

He also explained, “We wouldn’t have conducted inspections during the 2 weeks around Christmas and New Years, so this is really the first week where there might have been *some* inspections postponed while we put in place mechanisms to continue high risk food surveillance inspections during shutdown”

For more discussion on the background of food safety inspections, and for fantastic food policy tweeting in general see Politico’s Helena Bottemiller Evich’s tweets: https://twitter.com/hbottemiller

 

 

The foodralist paradigm

by Diana R. H. Winters

Laurie Beyranevand at the Vermont Law School and I wrote a paper about striking a balance between federal and state decision-making in the area of food policy, called Retooling American Foodralismand the University of Pennsylvania’s Regulatory Review wrote a thoughtful analysis of the paper here.  In the article, author Nicholas Bellos writes:

“[F]or an industry as sprawling and complex—and vital—as the nation’s agricultural sector, should states be the principal actors ensuring consumer safety?

In a recent paper, two scholars argue that they should. University of Vermont Law School’s Laurie Beyranevand and University of Indiana Robert H. McKinney School of Law’s* Diana Winters say that more states should take initiative like California to enact food safety regulations of their own, rather than depend on federal regulators to lead the way. The balance between federal and state decision-making—what they call “foodralism”—needs to tilt more toward state governments, they argue. States need to fill the gaps in the current patchwork of U.S. food regulations and serve as laboratories for developing new rules and standards.”

Retooling American Foodralism is forthcoming in the American Journal of Law and Medicine.

 

*Although I used to be at I.U. McKinney, I am now the Assistant Director of Scholarship at the Resnick Center for Food Law & Policy at UCLA Law.

 

Conference: FDA – Past, Present, and Future

Last Friday I attended a terrific conference sponsored by American University Washington College of Law’s Health Law and Policy Program and the Food and Drug Law Institute (FDLI) on the FDA – Past, Present, and Future.  From a discussion with four former FDA Commissioners—Califf, Hamburg, Kessler, and von Eschenbach—to a conversation with four former FDA chief counsels—Cooper, Hutt, Masoudi, Troy—the conference provided a fantastic perspective on the agency, both current and historical.  There was a keynote address by Henry T. Greely, the Director of the Center for Law and the Biosciences at Stanford Law School, and a plethora of fantastic breakout sessions on drugs, devices, tobacco and cosmetics, food and animal products, and biological products.  You can find the agenda and conference papers here.  This was a conference for the ages, and I was lucky to be there.

Reefer Madness

by Diana Winters

I just read two very interesting articles, both arguing that states and the federal government have to do more to regulate marijuana products as more and more states move to legalization. In Marijuana Edibles and “Gummy Bears,” published this month in the Buffalo Law Review, Paul J. Larkin, Jr. looks closely at marijuana edibles, discussing their retail distribution, potential harms, and regulatory options available to local, state, and federal governments. The solution Larkin advocates is compelling—that the FDA declare foods with THC as adulterated, and either seize such products or require edibles to comply with standards that reduce the risk that children would ingest the product.

In “High” Standards: The Wave of Marijuana Legalization Sweeping America Conveniently Ignores the Hidden Risks, forthcoming in the Ohio State Law Journal, Steve P. Calandrillo and Katelyn J. Fulton also focus on marijuana edibles and argue that these products pose special risks to the population. The authors make certain specific recommendations, including the increased study of edibles, a refinement of edible labels, a ban on edibles that resemble children’s candy, and more.

Beyond the specific issues of marijuana regulation, these articles are fascinating in regards to the federalism issues they present, especially in this time of some confusion about the federal government’s stance towards the state legalization of medical and recreational marijuana. I better go eat some “brownies” and try to figure it all out…

FDA Commissioner Scott Gottlieb Proposes Sweeping Label Updates – COMMENTS OPEN

by Diana Winters

On March 29, FDA Commissioner Scott Gottlieb spoke at the Consumer Federation of America’s National Food Policy Conference about how the agency “can make further improvements in public health by both empowering consumers with information and facilitating industry innovation toward healthier foods that consumers want.” He focused not just on reducing chronic disease, but also on how better information can help to narrow nutrition and health disparities.

As to specific steps, Commissioner Gottlieb discussed: (1) modernizing health claims, (2) re-defining “healthy”, (3) changing the process by which the agency reviews qualified health claims, (4) clarifying the term “natural”, and (5) modernizing the names for ingredients, and standards of identity. He also talked about implementing the new nutrition facts label and menu labeling rules, and working on reducing sodium in foods.

You can watch the speech here.

For an administration committed to deregulation, Commissioner Gottlieb’s stance is surprising, and exciting. The Center for Science in the Public Interest provided FDA with some great preliminary suggestions for moving forward. I’m opening comments for this post – what do you think about Commissioner Gottlieb’s speech? What should or shouldn’t FDA do?

N.Y. Times on animal antibiotics in animal feed

There was a really interesting article on the use of antibiotics in animal feed in the N.Y. Times last week. Two very interesting takeaways: (1) the article highlights the flaws in FDA’s initiative to prohibit the use of antibiotic for growth promotion—as many critics noted, allowing companies to use these drugs for disease “prevention” is essentially a loophole, and (2) the market is eclipsing regulation in the context of antibiotics, as consumers increasingly demand antibiotic-free meat.

Further reading:

  • Emilie Aguirre wrote about California’s stricter rules and democratic experimentalism here.
  • Lisa Heinzerling wrote about the FDA’s poor record on animal antibiotics here.
  • I link to some resources on the background of this issue in a 2014 blog post, here.

Powered by WordPress.com.

Up ↑