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.
by Diana Winters
I was lucky over the last few days to attend and present at the MSU College of Law Global Food Law Program’s fantastic Global Food Law Current Issues Conference. At the conference there was a mix of academics, practitioners, scientists, and industry representatives, and a truly global focus. Wednesday’s discussions of dietary supplement labeling, developments in organic foods, issues regarding animal food labeling were fascinating, and the keynote on food litigation by Bill Marler, was, for a food law aficionado, a dream come true. Thursday’s talk on professional consumers in China and their effect on food safety provided an opportunity to reflect on the absence of a citizen suit provision in the FDCA, and the discussion of new technologies in product supply chains was a chance to engage with blockchain, 3D printing, and other fun stuff. These are only a few highlights of the conference, which also included discussions of intellectual property, food security, and innovation in the food space, as well as opportunities to explore the food and environment of greater Lansing, Michigan. Note: if you find yourself in East Lansing, don’t miss the Zaha Hadid designed Broad Museum of Art—a short walk from campus (picture above).
The value of a conference that provides a space for academics, practitioners, and scientists to meet and mingle is immense, and I’m so glad I went.
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…
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?