FDA

Food Label Regulations Fall Short

by Bobbi Leal, UMN Law Student, MJLST Articles Editor

Thumbnail-Bobbi-Leal-ii.jpgA recent study, published in Agricultural Economics, found that the average body mass index for consumers that read nutrition labels is lower than those that do not read the labels. This finding implies that understanding and utilizing food and nutrition labels provides consumers with the information needed to make informed decisions about what they eat. However, a recent article by J.C. Horvath published in the Minnesota Journal of Law, Science & Technology, “How Can Better Food Labels Contribute to True Choice?” makes evident that food labeling has a long way to go before it truly gives consumers the information necessary to make informed decisions.

Food label regulations, outlined by the Food and Drug Administration, have a number of flaws. The FDA has declined to define strict standards for use of the food label “all-natural,” claiming that the term is too nebulous to be strictly defined and standardized across the entire food industry. Undoubtedly, consumers assume that a food labeled as “all-natural” has not been chemically processed or structurally altered from its natural state. Unfortunately, this is not the case. The FDA has a vague policy which defines the term “natural,” to mean “nothing artificial or synthetic…is included in, or has been added to, the product that would not normally be expected to be there.” According to the Wall Street Journal, some ingredients that have been labeled as “all-natural” include high fructose corn syrup, genetically modified plants, and sodium benzoate.

Similarly, the approved use of certain terms, such as “artificial flavor,” “natural flavor,” and “artificial coloring” often hide significant details about the nature of the food. These three phrases can stand in for over 3900 food additives that come from a wide range of sources, giving the consumer no real notice of the substance or origin of the “flavor” or “coloring.” For example, beef tallow, gelatin, and lard can all be covered by these three phrases. Even the requirements for listing allergens is incomplete, as the FDA only requires that eight of the known allergic-reaction-inducing ingredients be explicitly listed: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

This recent study concerning the use of nutrition labels makes clear that when consumers read and understand food labels, they can make better choices for their health. In order for this to occur, however, it is imperative that the food labels which consumers rely upon are transparent and accurate. Food label regulations have not yet accomplished this objective.


FDA Approvals are a Matter of Life and Death

Sapien-Transcatheter-Heart-Valve.jpg
mjlst-logo-button.pngMJLST faculty editor-in-chief Ralph Hall and Andrew Von Eschenbach, former commissioner of the U.S. Food and Drug Administration (2005-2009), wrote an opinion piece in the June 18 Wall Street Journal on ways to move medical devices more quickly into the hands of health care practitioners. They cite the example of the American-made SAPIEN Transcatheter Heart Valve (pictured right) that was available to patients in Europe four years before those in the United States. Read “FDA Approvals Are a Matter of Life and Death” (WSJ). (NOTE: the WSJ article can be viewed in full by using Google to search “FDA Approvals Are a Matter of Life and Death” and then clicking the first link to WSJ in the results.).

In a related article in MJLST issue 13.1, Professor Hall and Eva Stensvad outlined problems with the 510(k) medical device clearance process and argued that while the Institute of Medicine (IOM) is generally an invaluable policy resource, invaluable policy resource, its Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process is not fairly balanced and unable to fairly and accurately perform its duties. Read: Left to Their Own Devices: IOM’s Medical Device Committee’s Failure to Comply.