Category: Food Safety

Upcoming Event (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

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A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

This event is free and open to the public. Lunch will be served.

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

Caffeine and the Law

Emily Largent 1 Comment

By Emily Largent

Generally speaking, law school goes more smoothly when the law student is caffeinated.  Consider that Justice Elena Kagan was known at Harvard Law School as the “coffee dean” for instituting free coffee for students (and, as an aside, expects to be known as the “frozen yogurt justice” for bringing frozen yogurt to the SCOTUS cafeteria).

Last year, the deaths of Logan Stiner and James Wade Sweatt drew attention to another place where caffeine intersects with the law: the regulation (or lack thereof) of powdered caffeine by the FDA.  Both men died after ingesting powdered caffeine.  One teaspoon of powdered pure caffeine is roughly equivalent to 25 cups of coffee.  Manufacturers encourage consumers to take between 1/16 and 1/64 teaspoon (see, e.g., here), though measuring such minute amounts with common kitchen tools may be impossible.  On it’s blog, FDA observes that the people most drawn to powdered pure caffeine are “children, teenagers, and young adults.”  It is not clear how common it is for individuals to overdose on caffeine powder, as the cause of death may be listed as “heart attack” in many cases.

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Protect Those Who Protect Our Food

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Check out a new op-ed by our friends, Jacob E. Gersen and Benjamin I. Sachs at Harvard Law School!

CAMBRIDGE, Mass. — EVERY year, 5.5 million people are sickened by norovirus, a highly contagious gastrointestinal bug. According to the Centers for Disease Control and Prevention, norovirus is the leading cause of food-borne illness in the United States and is spread primarily by “infected food workers.” Last year cooks, waiters and other workers were involved in about 70 percent of the outbreaks.

This is just one example of the critical role that food workers play in our nation’s economic and public health systems. And yet, while we often tailor employment rules for work that has a special impact on the public, the law has yet to recognize food workers as a distinct class — an approach that harms consumers, the economy and the workers themselves.

Sick restaurant workers provide a particularly vivid example of the kind of legal reform that’s needed. Until recently, very few restaurant workers had the legal right to paid sick time, which meant that many of them went to work very ill (last week voters in Massachusetts and three cities passed paid-sick-leave laws). Federal law can fix this problem by requiring employers to provide their workers with paid time off. […]

To read the full op-ed, please click here.

Questioning Quorn

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By Diana R. H. Winters
[Cross-posted on HealthLawProfBlog.]

There was an article a couple of weeks ago in the New York Times about “engineered foods,” and how “a handful of high-tech start-ups are out to revolutionize the food system by engineering ‘meat’ and ‘eggs’ from pulverized plant compounds or cultured snippets of animal tissue.”   The author discussed some of the business models, interviewed some of the entrepreneurs, and contemplated some of the implications of “Food 2.0.” The concerns she noted involved the nutritional impact of these foods, and the possibility of resource-intensive production.

But what sort of screening will these food products go through before they enter the food supply? How will FDA vet these new foodstuffs for toxicity or allergenic properties? It won’t. Manufacturers can self-affirm that food products are safe, based on their own studies, and market them on that basis with no prior FDA approval. This is the GRAS (generally recognized as safe) route to marketability. A manufacturer could also choose to submit to the formal food additive approval process, which is extremely time-consuming, but considering the breadth of the GRAS exception, they probably won’t. Many more GRAS notifications are filed per year than food additive petitions.  Read More

Public Health Trumps Corporate Speech

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By David Orentlicher
[Ed Note: Cross-posted at HealthLawProfBlog.]

Reversing its previous deference to corporate speech interests, the U.S. Court of Appeals for the D.C. Circuit came down in favor of consumer protection in a July 29 decision. In American Meat Institute v. U.S. Dept. of Agriculture, the court upheld a federal government regulation requiring meat companies to disclose the countries of origin for their products. If your beef comes from Argentina or Canada, you will know that from its label.

More importantly, the court gave the Food and Drug Administration greater freedom to reduce tobacco use in the United States. In explaining its reasoning, the court repudiated the logic of an earlier decision by the court that rejected the FDA’s graphic warnings for cigarette packs. According to the meat labeling opinion, the cigarette warning decision did not allow sufficient leeway for the government to mandate warnings or other informational disclosures to consumers.

Perhaps the U.S. Supreme Court will restore the D.C. Circuit’s previous balance, but for now, the tide has turned in favor of the public’s health.

The Regulation of Dietary Supplements

jsax 4 Comments

By Joanna K. Sax
[Ed. Note: Cross-posted on HealthLawProfBlog.]

How have the massive amounts of dietary supplements on the market evaded significant regulatory oversight for so long? Dietary supplements are regulated as food, which means that for practical purposes the FDA only has the ability to pull them off the shelves upon a showing that they are harmful.

Many consumers use dietary supplements for the same purposes that someone may use a non-prescription drug. Some consumers actually feel safer using a dietary supplement because it is labeled as “natural,” rather than using an FDA approved over-the-counter drug. This doesn’t and shouldn’t make sense. Many natural things are harmful – would you eat any wild mushroom? Tobacco in in cigarettes is natural. Just because something is natural doesn’t mean that it is safe. Conversely, just because something isn’t “natural” in a drug doesn’t mean it is unsafe.

One of the main problems with regulating dietary supplements is that they are not all the same. We probably don’t need heavy regulation for Vitamin C, except maybe in formulation/content. We know, for example, that it is water soluble, so it is hard to take too much. So, maybe Vitamin C doesn’t pose the same safety concerns as other supplements. However, a recent article in Nature, vol. 510, pages 462-4, described different scientific viewpoints about the efficacy of vitamin supplements in healthy populations. So, unless you have a Vitamin C deficiency, then there is probably little reason to take it.

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“Gluten-Free” Labeling – Feeding a Fad

Emily Largent 1 Comment

By Emily Largent

As of August 5, 2014, all foods labeled “gluten-free” must meet the requirements of the gluten-free labeling final rule.  The rule implements a portion of the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, which directed the Secretary of Health and Human Services to issue a regulation to define the term “gluten-free.”  The U.S. Food and Drug Administration (FDA) set a gluten limit of less than 20 parts per million for foods that carry the “gluten-free” label, which is the lowest level that can be reliably detected using scientifically validated analytical methods.

According to the FDA, the “final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet.” Celiac disease is an immune reaction to eating gluten–a protein occurring in wheat, rye, and barley–that causes damage to the lining of the small intestine. This damage limits patients’ ability to absorb nutrients and can lead to a host of serious health problems. While there’s no cure for celiac disease, following a strict gluten-free diet can alleviate its symptoms. The new labeling requirements will surely give patients with celiac disease a powerful tool for managing their health, and has been lauded by patient advocacy organizations such as the American Celiac Disease Alliance.

Yet, folks with celiac disease won’t be the only ones keeping an eye on the new labels. While only three million Americans have celiac disease, avoiding gluten has become a food fad. Eleven-percent of households report that they buy gluten-free products, and almost a third of Americans report that they are trying to avoid gluten. Food producers feeding the growing appetite for gluten-free have put the gluten-free label on foods that never included gluten, like vegetables and yogurt. As a result, U.S. sales of foods labeled gluten-free (which may or may not have had gluten to begin with) have doubled to $23 billion in the past year from $11.5 billion four years ago.

Unfortunately, current research doesn’t support the numerous health claims that have been made about gluten-free diets. Moreover, buying gluten-free isn’t necessarily a healthier option—many gluten-free foods contain fewer vitamins, less fiber, and more sugar.  It will be interesting to watch what happens to the sale of “gluten-free” foods as the gluten-free labeling final rule takes effect.

What are GM Foods?

jsax 3 Comments

By Joanna Sax
[Ed Note: Cross posted at HealthLawProfBlog.]

I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.

The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.

But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.

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Antibiotics in animal feed and thin statutory interpretation: NRDC v. EPA

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By Guest Contributor Diana R. H. Winters

Legal commentators have spent a lot of time this week sparring over statutory interpretation and the contrasting readings of the ACA by the Halbig and King courts.  The potential consequences of these cases demonstrate just how high the stakes of this enterprise can be.

With less fanfare, the Second Circuit decided a case yesterday that may too have large consequences for the health and welfare of the public.  In NRDC v. EPA, the court reversed a district court’s decision to require FDA to hold hearings on the withdrawal of approval for the use of two antibiotics—penicillin and tetracyclines—in animal feed.  This issue has enormous public health consequences, but the consequences of this case extend beyond antibiotic use, to agency practice in general.  The opinion sanctions egregious agency delay and a tremendous lacuna in decision making.

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