Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

Misbranded food includes false or misleading labels, not properly named, identified, etc. But FDA does nothing on misleading food labels. Dual issue of misbranded and permissible but questionable food claims.

First amendment does not cover false, deceptive, or proven to be misleading speech. It DOES, however, protect potentially misleading speech and for that can only require disclosure. Weak requirements/enforcement product names, fortification and new terms. Nutrient content claims are allowed to be made even if there is disqualifying levels of bad stuff.

Energy drinks can list themselves as beverages and not another category can avoid lots of regulation. Pop tarts are very unhealthy, fortified, but allows to make claims about its protection. Arizona iced tea has litigated whether it is “all natural” as labeled. The court found that citric acid and high fructose are in it, just rhetoric. The most famous case is Kellogs Cocoa Krispies, helps support your child’s immunity. FDA does not have authority over structure/function claims, that is FTC’s authority.

FDA’s only authority is to issue a warning letter that is not that scary. “If we get a warning letter we will change the package.” No civil monetary penalties in this area. No substantiation documents when FDA challenges a claim (FTC can). After warning letter can theoretically work with DOJ to prosecute but almost never happens. Also lack of resources, very little budget for these areas.

No private right of action here, but consumers have tried to sue using consumer protection/tort and industry litigates through Lanham Act. Clear labels are in both cases. Lanham act cases are hard to win, but have to do polling data of consumers. These are ineffective methods for getting change of labels, need more regulation!

At a minimum…Pomerantz argues that there should be preapproval for structure function claims, disqualifying levels of transfat and added sugar, enable FDA to require substantiate terms, and other proposals.

But she thinks this is just a band-aid solution. Industry is 5 steps ahead of us with new terms like “gluten free”.

So she would say let’s have a pre-authorization rule for ALL claims (like EU), must be scientifically based and not misleading, require substantiation documents during approval, and disqualifying nutrient list expanded and apply to all claims, and house it all in a claims database that it transparent for consumers and industry. She would fund this through user fee system. She would give ability to FDA to get civil fines for non-compliance.

Diana Winters, Indiana University, From Industrial to Artisanal: A New Regulatory Program for a Changing Food Landscape

FDA regulations 80 to 90% of food supply. 24% of FDA budget go to food program. Implementing 2011 Food Safety Modernization Act (FSMA), most important overhaul since 1938.

U.S. food supply among the safest in the world. But still 48 million a year of Americans get sick from food, 128,000 people hospitalized, and 300 people die.

FSMA does not do enough. First, the major initiatives will be ineffective. Second, focuses only on food-borne illness and not issues like obesity and count for 10% of national medical budget. Third, incoherent model of food safety – rigid federal standards that are haphazardly applied by authorities, and patchwork of state and local apply to other specific ones.

We need a unified food regulator. We need to rethink federal-state relation here too. Our food supply regulated by FDA, USDA, and others. State and local governments have independent control over retail food establishments and overlap in some areas like food production facilities. USDA has primary responsibility over meat and agriculture. It has more resources than FDA for food even though it does much less on food safety. USDA requires an inspector to be present whenever a plant is operating, which is why it is expensive to run.

FSMA begins to move FDA to USDA model. Statute provides for preventative controls, science-based standards for produce harvesting, increased compliance oversight (more inspections for facilities) and more so “high risk” facilities. It also aspires to better integrate federal and state regulation, but largely aspirational.

FSMA will be ineffective. Almost 75% of growers will be exempt from preventative control and science-based standard under FDA’s most recent role, which is very, very complex! Exemptions are problematic because smaller is not safer. The Spinach illness outbreak in 2008 was from a small farm.

The preventative control model itself may be flawed. The foods that caused 2010 outbreaks were already part of this model. Producers may view this as ceilings not floors. Information costs may prevent small producers from entering the market.

Winters recommends more authority and discretion to state and local governments with increased oversight by feds. “Centralized decentralization” that has central intelligence and local discretion. States have to submit food safety plans to FDA. This would improve information acquisition, matching policies to outcomes, reliance on evidence-based policies, assist in crisis prevention, and assist in rationalization across localities. Although debate is long-standing, need for unified food agency under one umbrella even if politically difficult.

Joanna Sax, California Western School of Law, The Tobacco Diaries: Lessons Learned and Applied to Regulation of Dietary Supplements

Dietary supplements include weight loss, vitamins, St. John’s Wort, etc. Some are benign, e.g., Vitamin C. St. John’s Wort may interfere with anti retro virals. Jack3D is a workout supplement associated with multiple deaths but still on shelves.

Tobacco as a model. They avoided being classified as drugs as supplements do and many supplement users are using same technique. Tobacco created its own research arm to support its interest and criticize other peer-reviewed scientific research on the other side. Published in journals reviewed by other tobacco allies, a form of peer-review. Good at controlling Congress and disseminating info in the lay press and promoting their industry. Also very good at direct to consumer marketing such as the joys of smoking.

Other industries have done some similar things, see study by Jenny White and Lisa Bero – lead paint, vinyl chloride, silicosis-containing items industries all used similar playbooks to avoid regulation.

Are dietary supplements trying to avoid regulation? Some tactics used by them that are similar to these other industries. They employ consultants. They have relationships with members of Congress, especially in Utah where they are a big industry. They do direct to consumer marketing. They use pharmaceutical-like ingredients, so chemically modified a pharmaceutical to avoid detection by FDA (alter structure of pharma chemical), but is that really a pharmaceutical? Hard to know about other tactics being used. Maybe we won’t know until a master settlement, as with tobacco.

How could you regulate? Look to FDA? But maybe it should have a different scheme for dietary supplements. Tension is that what people like about supplements is that low cost, freedom to purchase, people think it is natural therefore safe. But FDA is all about paternalism, preventing ingestion of unsafe things. Have to think about magnitude of risk in determining right form of regulation. Vitamin C is very different from an altered pharmaceutical that is now a supplement. You need a scheme where amount of regulation is proportional to risk.

Could look at non-FDA measures? Tax them as we do tobacco? But the taxes are very regressive and main users tend to be lower income people. Could have state and local regulations like minimum age requirements, marketing prohibitions, limits on advertising, but may be ineffective. Warning labels? Education? These are all slow, ineffective, and don’t really address the real concerns. All arrows point back to FDA, with drug-like regulation.

Q & A

EMILY BROAD LEIB: Everyone wants FDA to do more on this panel. Does that suggest that we really need to reconceptualize FDA’s role versus other actors to step in.

GEORGE: Our paper is definite call for being more holistic if not more expansive. Maybe combine FDA and USDA.

FRANCIS: A radical possibility is that food has outgrown FDA. Also preemption is tough issue. Food labeling preempted by states.

WINTER: FDA might do less on my proposal. More state and local discretion. But does involve some functions that are new to FDA.

SAX: Largest consumers tend to be lower income people, because expense of fresh produce is so high is that they need to use dietary supplements to supplement it. Also more likely to try weight loss drugs if poorer than higher income categories.

GLENN COHEN: Say more about why lower SES users are main consumers of supplements? Also fro Francis and George, why certain consumer preferences relating to ethics and religion but not others. Also what about conflicts between sub-parts of the right to food, such as supply and preferences? Is this more deontological or more consequentialist account?

FRANCIS: There are international human rights documents that speak to human rights to food, embedding an argument in that which could be used. We really think important to open up the question – DDC treated anything beyond safety as mere consumer preference is problematic. Maybe should be outside the FDA. FDA for example has no jurisdiction of labor and how food is produced, but that seems to be outside of FDA’s purview and require a kind of reimagining.

DAVID KORN: Supplements are exempt from FDA because of Senator Orin Hatch. Almost all our foods are genetically engineered and have been for a long time. What is new or specific that you want to identify by label. You could label every food we eat that it is genetically modified, engineered, or husbandry.

GEORGE: We struggled with this in writing the paper. We want to take consumer preferences seriously. For some people they still care. We may develop is why we feel different from husbandry vs. cross-species genetic modification.

FRANCIS: The focus was not on husbandry/seed selection. We are only talking about rDNA in this talk.

DAN WIKLER: To Francis and George you are not engaging the question you asked earlier. What kind of preference is it not to ingest a GM food. Not in any holy books. If not harmful, safe, why would it be ethical. The fact that it gets you upset can’t be enough. Maybe it is based on ignorance or fear. Why honor that preference for that reason? What does a label mean in this context? It means that government using the research apparatus has figured out what it thinks is important for you to know.

FRANCIS: In longer paper our argument is much more limited. That there is a lack of transparency of determination process for individual foods. That is the important pieces relating to current GRAS process. No way for consumers to know if there has been adequate scrutiny of a particular GM food. Isn’t determination that all GMs food are safe. We have current regulatory environment.

I. Glenn Cohen

I. Glenn Cohen

I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School and current Faculty Director of the Petrie-Flom Center. A member of the inaugural cohort of Petrie-Flom Academic Fellows, Glenn was appointed to the Harvard Law School faculty in 2008. Glenn is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Glenn has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues. He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).

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