Recently in Food and Agriculture Category
Nihal Parkar, MJLST Notes and Comments Editor
Coca Cola's Minute Maid Pomegrenate Blueberry Juice Blend contains about an eye-droppper's worth of pomegranate and blueberry juices, with apple and grape juices constituting 99.4% of the blend. POM Wonderful, a competitor that mainly markets pomegranate juice, filed a false advertising suit against Coca Cola under the Lanham Act. The Ninth Circuit held that federal food regulations preclude private actions challenging food product labels.
Specifically, the federal Food, Drug, and Cosmetic Act grants the FDA authority over food labeling. However, it is not quite clear if the FDA has exclusive authority over potentially deceptive food labeling. Coca Cola has argued that exclusive authority was granted to the FDA so that food manufacturers could rely on a uniform set of standards for food naming and labeling. POM has countered by saying that the FDCA and FDA regulations only provide a minimum floor for food regulations, while other laws intended to protect consumers and competition are still applicable to food manufacturers.
The Supreme Court granted cert and recently heard oral arguments. Coca Cola has continued to argue that its labeling meets all federal regulations. However, various Justices expressed skepticism, and asked why meeting federal labeling regulations, while necessary, would be sufficient to grant Coca Cola immunity even if the labeling did mislead consumers. The following exchange from the oral arguments is indicative of the tenor of the hearings:
Kathleen M. Sullivan (for Coca Cola): Because we don't think that consumers are quite as unintelligent as POM must think they are. They know when something is a favored blend of five juices, non-min -- the non-predominant juices are just a flavor.
Justice Anthony Kennedy: Don't make me feel bad, because I thought that this was pomegranate juice.
It remains to be seen though, if the Supreme Court ultimately agrees with POM. A decision is expected later this year.
Ke M. Huang, MJLST Staff
Once upon a time, a farmer and his new wife, who had no means to support the farmer's first wife's children, decided to abandon the children in the woods. These children--Hansel and Gretel--found in the woods a charming little house made of sweets. A wicked witch lived in that house.
Earlier this month, President Obama signed into law the Farm Bill of 2014. According to a New York Times article, the President called the Farm Bill a "jobs bill," and "innovation bill," a "research bill," and a "conservation bill." Yet, amid the provisions of the Farm Bill that addressed topics such as crop insurance, conservation, and trade, there were also provisions that touched on the issue of healthy nutrition of families.
Senator Stabenow (D-MI), chairwoman of the Senate Agriculture Committee and the author of the Farm Bill, emphasized that part of the Bill's purpose was to improve nutrition choices in families. Changes such as doubling SNAP benefits (formerly called food stamps) for buying healthier foods and financing new grocery stores in underserved areas reflect that purpose.
A question remains whether the Farm Bill of 2014 will be effective in achieving that purpose. Especially for nutrition among the children, the article by Termini et al. in the Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology offers some answers. In other words, the article addresses the predicament of modern day Hansel and Gretel who are lured by sugared snacks, french fries, and company.
In Food Advertising and Childhood Obesity (2011), Termini et al. (1) provide some alarming data about nutrition-related health complications among American children, (2) discuss the relationship between the health complications and food advertising, and (3) propose several solutions to address these health complications. While Termini et al. mention advocates of consumer choice, the authors primarily propose measures for the food industry, the government, and parents. For example, akin to the SNAP benefits for buying healthier foods, Termini et al. propose tax incentives for buying healthy food.
In final analysis, even if the often-regarded villain in the story of Hansel and Gretel is the witch, at least the government was partly responsible for the predicament of the children. Had the government funded a SNAP benefit program for the children's family, or even subsidized the family farm through a crop insurance program, the parents would not have to leave the children alone in the woods. Just some food for thought.
by Paul Overbee, UMN Law Student, MJLST Staff
In the near future, food currently part of your everyday diet may undergo some fundamental changes. From cakes and cookies to french-fries and bread, a recent action by the Food and Drug Administration puts these types of products in the spotlight. On November 8th, 2013 the FDA filed a notice requesting comments and scientific data on partially hydrogenated oils. The notice states that partially hydrogenated oils, most commonly found in trans fats, are no longer considered to be generally recognized as safe by the Food and Drug Administration.
Some partially hydrogenated oils are created during a stage of food processing in order to make vegetable oil more solid. The effects of this process contribute to a more pleasing texture, greater shelf life, and stronger flavor stability. Additionally, some trans fat is naturally occurring in some animal-based foods, including some milks and meats. The FDA's proposal is meant to only to restrict the use of artificial partially hydrogenated oils. According to the findings of the FDA, exposure to partially hydrogenated oils raises bad cholesterol levels. This raised cholesterol level has been attributed to a higher risk of coronary heart disease.
Some companies have positioned their products so that they should not have to react to these new changes. The FDA incentivized companies in 2006 by putting rules in place to promote trans fat awareness. The new regulations allowed companies to label their products as trans fat free if they lowered the level of hydrogenated oils to near zero. Kraft Foods decided to change the recipe of its then 94-year-old product, the Oreo. It took 2 ½ years for Kraft Foods to reformulate the Oreo, and once that period was over, the trans fat free Oreo was introduced to the market. The Washington Post invited two pastry chefs to taste test the new trans fat free Oreo against the original product. Their conclusion was that the two products were virtually the same. This fact should act as a form of reassurance for consumers that are worried that their favorite snacks will be pulled off the shelves.
Returning to the FDA's guidance, there are a few items worth highlighting. At this stage, the FDA is still in the process of formulating its opinion on how to regulate these partially hydrogenated oils. Actual implementation may take years. Once the rule comes into effect, products seeking to continue to use partially hydrogenated oils will still be able to seek approval on a case by case basis from the FDA. The FDA is seeking advice on the following issues: the correctness of its determination that partially hydrogenated oils are no longer considered safe, ways to approach a limited use of partially hydrogenated oils, and any other sanctions that have existed for the use of partially hydrogenated oils.
People interested in participating with the FDA in determining the next steps taken against partially hydrogenated oils can submit comments to http://www.regulations.gov.
by George David Kidd, UMN Law Student, MJLST Managing Editor
GMO food-label laws that are on the voting docket in twenty-four states will determine whether food products that contain genetically modified ingredients should be either labeled or banned from store shelves. Recent newspaper articles raise additional concerns that states' voting outcomes may spur similar federal standards. State and perhaps future federal regulation, however, might be jumping the gun by attaching stigma to GMO products without any scientific basis. FDA labeling regulation, discussed in J.C. Horvath's How Can Better Food Labels Contribute to True Choice?, provides that FDA labeling requirements are generally based upon some scientific support. Yet, no study has concluded that genetically modified ingredients are unsafe for human consumption. Required labeling based upon the belief that we have the right to know what we eat, without any scientific basis or otherwise, could serve to further undermine the credibility of food labeling practices as a whole.
The argument for labeling GMO food products is simple: we have a "right to know what we eat." The upshot is that we should know, or be able to find out, exactly what we are putting into our bodies, and be able to make our own consumer decisions based upon the known consequences of its manufacture and consumption. But, the fact that we do not know whether our food is synthetic or its exact origins might not matter if the product is both better for us and the environment. Indeed, the FDA admits that "some ingredients found in nature can be manufactured artificially and produced more economically, with greater purity and more consistent quality, than their natural counterparts." If some manufactured products are better than their natural counterparts, why are we now banning/regulating GMO products before we know whether they are good or bad? If we knew they were bad in the first place, GMO products would likely already be banned.
Analysis is an important part in establishing the underlying credibility of labeling claims on food products. Without some regulation of label credibility there would be an even greater proliferation of bogus health claims on food packaging. Generally, the U.S. Food and Drug Administration has held that health claims on food labels are allowed as long as they are supported by evidence, and that food labeling is required when it discloses information that is of "material consequence" to a consumer in their choice to purchase a product. For example, the FDA has found that micro- and macro-nutritional content, ingredients, net weight, commonly known allergens, and whether "imitation" or diluted product is used, must be included on food labeling. The FDA has not, however, required labeling for dairy products produced from cows treated with synthetic growth hormone (rBST) because extensive studies have determined that rBST has no effect on humans. Just imagine the FDA approving food labeling claims without evaluating whether or not that claim was supported by evidence.
Premature adoption of new state or federal labeling policy would contradict and undermine the current scientific FDA standards underlying labeling regulation. The decision of whether to require labeling or ban GMOs, absent any scientific rigor as to whether GMO products are safe, only serves to perpetuate the problem of "meaningless" food labels. Further, the possible increases in food cost and labeling requirements might ultimately be passed on to the consumer without enough information to justify the increase. But now that GMOs are allegedly commonplace ingredients, shouldn't legislation wait until the verdict is in on whether GMO products are good or bad for human health before taking further action?
by Daniel Schueppert, UMN Law Student, MJLST Staff
The USDA has recently lifted restrictions on the practice of shipping US Chicken to China for processing, for an eventual return to the US. Under the present regulations, chicken originating from US farms can be shipped to China for processing, then shipped back to the US for sale. This chicken need not include Country of Origin Labeling (COOL) to indicate that it has been processed in China. This change comes in the wake of a years of food safety scares relating to China's food supply. Although the Food Safety Inspection Service (FSIS) has completed audits of the China's "poultry processing inspection system" and certified some of the Chinese processing plants and procedures, American consumers have retained some reservations about the safety of chicken processed in China. As it stands, this system leaves consumers in the position of not knowing which country their chicken products have been processed because the Chinese operations are considered a comparable food component to what results from US processing.
This recent action by the USDA clearly raises questions concerning the United States' food safety, and perhaps security. A sophisticated consumer may nevertheless be able avoid chicken products known to be processed in China, but absent COOL disclosures this may be a difficult task and arguably involve some guess work. This is not necessarily the case with generic pharmaceuticals, an area in which there are substantial parallels to the chicken debate. Some of the concerns raised relating to the quality and safety of chicken processed in China also bring to light the COOL requirements for other consumables like pharmaceuticals. Import screening and labeling for pharmaceuticals, and particularly off patent generics, is a convoluted area of regulatory law where Federal agencies to not always agree. Currently many of the various components of just one pharmaceutical drug are manufactured all over the world and come from a variety of sources. Manufacturing in India, China, and Eastern Europe account for a large part of the market.
The FDA's main measure on determining the quality of components in generic drugs is a fuzzy spectrum concerning the "bioavailability" of certain chemicals but this measure does not necessarily take account of inert components or varying quality or quantities of active ingredients. Much like chicken, a consumer or regulatory agency would be hard pressed to find a problem with these products until a quality control issue develops and American consumers are put at risk. COOL labeling regarding Chicken and Drugs are developing issues without a clear regulatory action in sight. Stay tuned to the Minnesota Journal of Law, Science & Technology for further updates.
by George David Kidd, UMN Law Student, MJLST Staff
Globally, obesity and its underlying ailments have overtaken tobacco as the top preventable cause of death. But, while eating right and exercising might go a long way towards solving the problem, the solution might not be that simple. What drives consumer buying behavior, through more modern forms of how we interact with the world, might substantiate food science and advertising as powerful mechanisms to attack the obesity epidemic.
by Maya Suresh, UMN Law Student, MJLST Staff
Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm's financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.
by George Kidd, UMN Law Student, MJLST Staff
The recent multi-billion dollar loss as a result of the 5th worst drought ever recorded in U.S. history adds fuel to an already raging debate over genetically modified organisms ("GMOs"). Amanda Welters, in "Striking a Balance: Revising USDA Regulations to Promote Competition Without Stifling Innovation," delivers a fantastic overview of key issues in the GMO debate while also introducing novel legislative ideas garnered from the pharmaceutical industry. Ms. Welters' article provides important insights into the continuing struggle to provide society with an optimal outcome.
by Bryan Morben, UMN Law Student, MJLST Staff
What happened to the days when kids would get together to play a game of football in the neighborhood? Or what about playing with Barbie dolls, cabbage patch kids, or a slumber party? Children today are just not entertaining themselves like this anymore. I have three younger brothers, and all I ever see them doing is sitting on the computer, playing videogames, or watching TV.
by Johanna Smith, UMN Law Student, MJLSTStaff
Looking at the packaging on a food item can be very overwhelming. Not only does the product contain required nutritional information and an ingredients list, many products also contain health claims or statements on the front of the package to grab the customer's attention. Common terms to see include organic, low-fat, high fiber, and low-carb. In "How Can Better Food Labels Contribute to True Choice?," recently published in the Minnesota Journal of Law, Science & Technology, J.C. Horvath discusses the evolution of the regulation of claims made on food packaging. In addition to regulatory pressure, the other major source of pressure that determines what shows up on food packaging is consumer preference.