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