FDA’s Relationship with Marijuana: It’s Complicated

By Elizabeth Guo

Marijuana and marijuana-derived products are top of mind for state legislatures these days. On March 10, the Virginia state legislature passed a bill legalizing cannabidiol oil, a marijuana-derived product, for patients who suffer from epilepsy. Other legislatures are actively debating measures to legalize cannabis-related products in their states, and many of these legislative proposals would allow cannabis-use for patients suffering from specific medical conditions. Last week, the Alabama state legislature debated a bill that would allow people to take cannabidiol to treat certain conditions, and Utah recently defeated a bill that would have allowed people with certain debilitating conditions to use a marijuana-related extract.

As more states pass bills allowing patients to use marijuana-derived products, will state laws clash with federal policies implemented by the Food and Drug Administration (FDA)?

Marijuana is complicated. Marijuana refers to the dried leaves and flowers of the cannabis plant. All marijuana plants contain a mixture of molecules, including cannabinoids. Different cannabinoids can have different effects, and scientists have identified more than 200 different cannabinoids from marijuana plants. Some of the most well known cannaboids in marijuana include tetrahydrocannibonol (THC), cannabidiol (CBD), and archidonoyl ethanolamide (anandamide). Read More

The FDA de-regulates the first genetically-engineered animal

By Joanna Sax

On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon.  This salmon is genetically engineered to grow faster.  This is the first time the FDA has de-regulated a genetically engineered animal.

Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food.  Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.

The genie came out of the bottle a long time ago and it’s not going back in.  This happens time and again with scientific advances.   Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially.  Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.

Read More

Introducing New Blogger Peng Zhao

Zhao_peopleThe Petrie-Flom Center is pleased to welcome Visiting Scholar Peng Zhao to the Bill of Health as our newest contributor, who will blog primarily about China’s drug and food law and regulatory policy.

Peng Zhao earned his BA (2003), MA (2009), and PhD (2009) in law from the China University of Political Science and Law (CUPL, Beijing). He serves as associate professor of law and vice director of the Center for Government Reform and Development at CUPL. Peng’s research and teaching interests include food law, administrative law, and risk regulation theory. He has authored more than a dozen articles on food law and risk regulation theory, and is now presiding over two research projects sponsored by the Chinese central government on these two fields. Peng is a director and member of the Chinese Association of Administrative Law, and deputy secretary general of a committee affiliated with this organization which focuses on legal issues on governmental regulation. Peng has also participated actively in professional service activities. He had served as member of an expert commission for the National Health and Family Planning Commission on amendments to Chinese Food Safety Law, and currently is serving as advisor to the Ministry of Science and Technology on amendments to Chinese regulation of laboratory animal management. In addition, Peng was recently recognized by CUPL students as one of the Top Ten Popular Teachers at CUPL from 2013 to 2015.  Read More

Does FDA Need a Dietary Supplement User Fee Act?

By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along , a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

Read More

The FDA’s Determination On Artificial Trans Fat: A Long Time Coming

By Diana R. H. Winters

[cross-posted at Health Affairs Blog]
On June 16, 2015, the Food and Drug Administration (FDA) released its final determination withdrawing the generally recognized as safe (GRAS) designation for partially hydrogenated oils (PHOs), which are the main source of artificial trans fat in processed foods. The agency gave the food industry three years, until June 18, 2018, to phase out the use of PHOs. The FDA’s order was expected based on the agency’s tentative determination that PHOs were no longer GRAS, published in November 2013.

This action is a milestone in — although perhaps not the culmination of — the FDA’s decades-long attempt to grapple with increasing scientific recognition that trans fat poses a serious health risk to consumers. The action is also unusual, in that it is quite rare for the FDA to withdraw GRAS status from a food product, a move that most likely will mean the ingredient is no longer used in foods.

What is not unusual, unfortunately, is the lengthy timeframe of this regulatory trajectory in the context of FDA action. To be sure, this action will lead to a dramatic reduction in the use of PHOs in processed foods, which in turn, will lead Americans to eat less trans fat – a good thing. What this regulatory action does not do, however, is speak to problems with the GRAS process as a whole.

Read More

The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

By Timo Minssen

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Read More

Bioethicist Art Caplan: Deep-Fat Fryers in Schools is Business, Not Freedom

A new piece by contributor Art Caplan on NBC News:

How bad is the obesity epidemic among kids in America?

Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.

And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”

The freedom to develop cardiovascular disease?

School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]

Read the full article here.

Call for Abstracts: Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics & Tobacco Products

The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC’s O’Neill Institute for National and Global Health Law.

The deadline for submitting abstracts is June 1, 2015. Download more information about the symposium here.

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

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.

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

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.