Pile of colorful pills in blister packs

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariAviva Wang, Liam Bendicksen, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. A full posting of abstracts/summaries of these articles may be found on our website.

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Up close details of a dark soda in ice.

Why soda taxes, an awesome public health policy, are rare

By Daniel Aaron

This post is, in part, a response to a panel discussion on soda taxes and obesity, given by Professors Emily Broad Leib, Steven Gortmaker, and Carmel Shachar on February 14, 2020.

Diet is devastating the public’s health

Diet is the top cause of death and disability in the United States and abroad. Diet-related disease has been rising for forty years, and we cannot seem to control it. Currently 39.8% of Americans are obese. By 2030, this will climb to half of all Americans. Obesity causes numerous health risks, including heart attacks and strokes, and increases the risk of many different types of cancer.

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Photograph of commercial fishing vessels

How Thailand’s Fishing Industry and Your Tuna Melt Are Linked to Human Trafficking

By Stephen Wood

I used to be averse to mayonnaise and I still am for its use as a condiment or in dishes like coleslaw or potato salad. My grandmother made our potato salad with oil and vinegar and lots of garlic and our coleslaw was vinegar-based too. I would tell friends that I was allergic to mayonnaise so that they wouldn’t slather it on my bologna sandwich or make me eat chicken salad. I’m not sure why this is the case; mayonnaise is made from stuff I like — eggs, salt, and vinegar — and when homemade can be really delicious. It’s just weird. But something changed that. I wanted to eat tuna. Not the blue or yellow-fin tuna that you grill as a steak or to enjoy as sushi, but canned tuna. This transition happened when I moved out of my family’s home and into an apartment. I was working and living on my own and soon realized I needed to eat on the cheap. I wasn’t used to eating on the cheap. I like lobster, escargot, flank steaks, and good wine. But I was broke and on a budget so I decided that I was going to brave it and eat canned tuna. With mayonnaise. I perfected a recipe. It has tuna, mayo, celery, onion, cumin seeds, and salt. It’s topped with shredded cheese and toasted and it is delicious. I’ve overcome my aversion to mayonnaise for this one thing, and also occasionally deviled eggs. But there is a problem.

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Three eggs in a carton with sad faces drawn on.

Can Ethical Labelling Make Food Systems Healthy, Sustainable, and Just?

By Christine Parker

Consumers are often encouraged to “vote with their fork” and “say no” to unhealthy, unsustainable and unfair food. Food packaging is typically littered with claims about the nutrition, ethics and social goods associated with the product inside. Claims like “organic”, “GMO free”, “fair trade”, and “anti-biotic free” are common. But can consumer preference base labelling make a difference to the health, sustainability and ethics challenges facing the food system?

Governments, civil society groups and industry all act as if label claims make a big impact on consumers and food businesses. Governments mandate that certain safety and nutritional information should be displayed on food labels. Public health advocates campaign for mandatory disclosure of more information (like added sugars) hoping  it will nudge both consumers and businesses towards healthier options. Businesses use label claims to promote themselves as ethical and environmentally responsible. A plethora of other groups have put forward their own independent certifications and trademarks from dolphin friendly tuna to sustainably farmed coffee. Read More

A pile of rotting food on a table.

Revisiting an Old Proposal on Aesthetic Adulteration of Food

This Winter Session I am enrolled in Harvard Law School’s “Food and Drug Law” course. One of the topics covered in the first week of class is “filth”—a category including natural food adulterants like mold, insect parts, and rot.

As the FDA has noted, there is no feasible way to prevent some filth from getting into practically all of our food supply. Of course, the FDA has tools to address this problem where it causes actual harm. The FDA’s poisonous and deleterious substances controls empower the agency to preempt and remediate safety risks in food. And, through its “aesthetic adulteration” standards, the FDA is also empowered to address filth in food even where it causes no direct harm to human health.

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two glasses of milk

The Cry Over Fake Milk

A debate has been brewing between the cattle milk industry and the plant-based milk industry (producing drinks made from ingredients such as almonds, soy, and rice), regarding what products can actually be labeled “milk.”

This has motivated the Federal Drug Administration to review how milk is defined under federal regulations, in order to protect public health and ensure that consumers are purchasing what they expect based on a product’s label.

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Cottage Food and Food Freedom Laws – New LawAtlas data

The newest map on LawAtlas.org analyzes state laws governing the production, sale, and regulation of cottage food operations.

Typically, commercial food production is required to take place in certified commercial kitchens that are heavily regulated. Cottage foods laws regulate the production and sale of certain foods (foods less likely to cause foodborne illness, such as jams and baked goods) made in home kitchens, rather than a licensed commercial kitchen, and a person’s ability sell them in venues like farm stands or retail stores. Similar state laws, called “food freedom laws,” expand upon cottage food laws to include potentially hazardous products like meat and poultry.

These laws are quickly becoming an increasing area of debate at the state level.  Part of this debate centers on the economic rights of “small-batch” home bakers and cooks versus public health and safety concerns. These private bakers, canners, and cooks want the liberty to sell their products to consumers free from the onerous licensing requirements required of their larger commercial counterparts, restaurants and food processing plants, are subject to.  At the same time, there is concern that this individual economic interest is riding roughshod over existing regulations designed to protect consumers from foodborne illnesses that can be caused by improperly prepared foods.

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Jelly Beans, Booze, and B-Vitamins

By Seán Finan

The FDA’s policy guidelines on nutritional fortification include the so-called “jelly-bean rule:” the FDA considers it inappropriate to fortify candy or soda with nutrients because to do so would allow “misleading health claims” to be made about a putatively unhealthy product. Candy companies that tried to add vitamins their products to market them as “healthier” have already been targeted by the FDA. But take a quick glance at the shelves of any convenience store: the “healthy”, vitamin enriched snacks and drinks are so full of sugars, flavors and sweeteners that it would take a doctorate in metaphysics, rather than medicine, to distinguish them from the candy and soda. So, maybe the FDA’s stance on adding a spoonful of sugar to help the medicine go down has relaxed. With that in mind, here’s a little thought experiment. I’d like to bring a proposal back from the eighties: that inexpensive alcoholic beverages be fortified with allithiamine, a fat-soluble analogue of Vitamin B1.[1] Why? The fortification could dramatically reduce the incidence of Wernicke’s encephalopathy and Korsakoff’s Syndrome among the homeless and alcoholic population.

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George Annas on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5
This week we talked with George J. Annas, Chairman of the Bioethics & Human Rights Department, and William Fairfield Warren Distinguished Professor, at Boston University. George’s work is legendary among health policy experts; a 1998 tribute from Jay Katz gives some sense of its breadth and depth. Having reviewed numerous works, Katz states:”I have barely conveyed the richness of George Annas’ observations on the ambiguities in motivations and actions that persist in current research practices. The many recommendations he makes, should be of valuable assistance to those interested in reforming current rules governing research on humans. Plagued by Dreams…reveal[s] another facet of George Annas’ personality: His commitment to public advocacy. He values scholarship but he also wants it to have an impact on shaping institutions and health care policies…In the many settings in which I have encountered George Annas over the years, I have admired his boldness, intellect, compassion and moral vigor.” Our conversation had the theme  “paternalism & its critics,” based on articles George had recently authored (or co-authored with last week’s guest, Wendy Mariner) on informed consent, genomics, and sugary drinks.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw