FDA

An Eyedropper’s Worth of Juice

April 29, 2014
FDA, Food and Agriculture

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.

E-Cigarette Trend Will Likely Subside After Federal and State Regulation Weighs In

March 16, 2014
FDA

George David Kidd, MJLST Managing Editor

Who could have predicted that development of better portable-battery technology would unleash such a radical transformation of tobacco consumption? By vaporizing nicotine-infused water vapor via the e-cigarette, the new trend, called “vaping,” has certainly turned a few heads. Not only has the use of electronic cigarettes doubled among middle and high school students from 2011-2012, but Bloomberg Industries predicts that the sale of electronic cigarettes might surpass the sale of other tobacco products by 2023. As of 2014, e-cigarette sales are still growing rapidly. Bold predictions in e-cigarette sales growth, however, fail to take into account the role that tobacco regulation will play in discouraging the trend. Federal and state regulations have yet to definitively weigh in on the issue.

Despite its announced plans to regulate e-cigarettes as tobacco products in 2011, the FDA has not yet taken action. Future FDA regulation will almost certainly be modeled upon current tobacco regulation to the extent that e-cigarettes are comparable to combustible tobacco products. For example, nicotine is still addictive. It can still be dangerous for those with heart problems and might cause other cardiovascular ailments over time. Those who stop the consumption of nicotine may face withdrawal symptoms that could include irritability, depression, restlessness, and anxiety. However, e-cigarette vapor avoids consumption of carcinogenic chemicals in smoke that are released by the combustion process.

To the extent current federal tobacco regulations are concerned with the direct consumer consequences of smoking, such as the disclosure of ingredients, labeling requirements, and ingredient quality, FDA regulation of e-cigarettes will closely mirror that of traditional tobacco products. Consequently, quality-control procedures and required labeling will only serve to increase the cost of e-cigarettes to consumers, and discourage sales.

State laws, such as those discussed in Smokers: Nuisances in Belmont City, California–In Their Homes, But Not on Public Sidewalks, by Georges Tippens, are primarily concerned with the effects of secondhand smoke. As of 2014, most states have banned smoking in enclosed public places due to concerns over the dangers of secondhand smoke. However, there is no definitive study as to whether e-cigarette vapor has any secondhand effect. Some states are, nevertheless, proactively seeking to extend current regulations, which ban smoking in enclosed public areas, to e-cigarettes. Other states, however, seem to be waiting until more information becomes known about whether e-cigarette smoke is harmful.

Even if e-cigarette vapor is found to be harmful, the question of whether e-cigarette vapor is “as dangerous” as the smoke produced by traditional combustible tobacco products will take decades of research to answer. In this day and age, if scientific evidence provides that secondhand smoke does have a secondhand effect on others, it is improbable that the question of how similar e-cigarettes are to traditional combustible products will have any impact on the extent of state regulation. In this case, e-cigarette regulation will feasibly mirror current state regulations that ban the use of combustible tobacco products in enclosed public places, and will provide a disincentive to e-cigarette sales.

Uh-Oh Oreo? The Food and Drug Administration Takes Aim at Trans Fats

December 4, 2013
Administrative Law, FDA, Food and Agriculture

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.

Required GMO Food Labels Without Scientific Validation Could Undermine Food Label Credibility

November 18, 2013
FDA, Food and Agriculture

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?

Ready Or Not, Here It Comes: The FDA’s Attempt to Regulate the e-Cigarette Industry

October 21, 2013
FDA

by Dylan Quinn, UMN Law Student, MJLST Staff

While the United States partial government shutdown created widespread uncertainty for federal employees and the monetary system, some are worried that the shutdown may cause the FDA to miss its self-imposed October 31, 2013 deadline for releasing the highly anticipated e-cigarette regulations. The FDA has already failed to meet its initial, self-imposed deadline of April 2013. While there are clearly no penalties for missing a self-imposed deadline, there are increasing external pressures that may force the FDA into action before the agency has a full grasp of the issues surrounding e-cigarettes.

It is estimated that e-cigarette sales in the U.S. will reach $1.7 Billion this year. E-cigarette use by students in middle and high school more than doubled from 2011 to 2012, according to the Centers for Disease Control and Prevention. They have become so popular that the use of the e-cigarette product has been coined, “vaping“.

While the FDA regulates e-cigarettes that are marketed for therapeutic purposes, it has made clear that it intends to treat e-cigarettes as a “tobacco product”, and establish regulatory control over the entire industry. However, by seemingly having this plan for years, the question arises of why the agency is on the brink of missing another deadline. The practical, and probable, answer is that the agency has no idea how to approach (or regulate) e-cigarettes.

Earlier this month the European Parliament took a “permissive approach” to e-cigarettes by shooting down proposals that called for strict regulation. European law makers seem to be influenced by the potential of e-cigarettes to be a healthy alternative to smoking, and are likely hesitant to place constraints on an industry that offers immense potential benefit to public health.

While the U.S. may benefit from taking the same approach, many think that the e-cigarettes are making nicotine addiction worse among youth, and there seems to be added pressure on the FDA to tightly regulate the industry. Just last month, Attorneys General from 41 states urged the FDA to issue the promised regulations, and there have been months of talks over a possible ban of online e-cigarette sales. However, the Obama Administration has just recently announced a significant funding program to operate 14 research centers focused on regulatory policy over tobacco products, and the FDA has expressly stated that more research is needed in regards to e-cigarettes.

There is no doubt that the public health impacts of e-cigarettes are not fully understood, and while this may not be a good enough reason to hold off strict regulation, the FDA may simply not know enough to effectively regulate the industry. Although continually missing deadlines, and gaining a better understanding, may lead to better regulation in the long run, the external pressures facing the FDA will not allow it to put off the regulations for much longer.

Is Food the New Tobacco: Science, Advertising, and the War against Obesity?

April 18, 2013
FDA, Food and Agriculture, Public Health

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.

In Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions, published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, life and health sciences author Roseann Termini and others add advertising to the already-large list of “other” factors affecting childhood obesity rates. Indeed, children are not as informed as adults about health and may be more likely influenced by certain channels of advertising, such as television. To address this concern, one of her proposed solutions is to ban, regulate, or even shift tax structure in order to control advertising that specifically targets children. While this might be an effective mechanism to reduce demand, it may only be a partial solution. For one, because children are not, generally, the direct purchaser of food, but rather depend upon parents, to what extent does advertising actually affect the buying decisions of parents?

An article recently mentioned in The New York Times, The Extraordinary Science of Addictive Junk Food, might help answer this question. Mr. Moss similarly explores the “obesity epidemic,” but from a corporate standpoint, positing that consumers are primarily driven to buy what “tastes good.” While Mr. Moss’s article also agrees that advertising is part of the problem, he paints a more complete picture of what might be the underlying cause of parental acquiescence in a child’s poor dietary choices. The perfect combination of salt, fat, and sugar might be, in part, to blame as addicting foods that influence buying behavior. In this way, food is likened to tobacco, except, unfortunately, while people can choose whether to begin smoking, all people must eat.
While the analogy between food and tobacco may be imperfect, the point is there. If the majority of the food available to the everyday consumer is manufactured as addicting, to what degree is there a choice to eat healthy? If, in order to survive in the marketplace, a corporation has to manufacture “addicting” foods to compete, how can we make these addicting foods into disease-preventing rather than disease-aiding choices? Food science and advertising may contain the answer.

United States v. Caronia After-The-Fact: What Was All That Fuss About, Again?

April 9, 2013
FDA, Pharmaceuticals

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

United States v. Caronia After-The-Fact: What Was All That Fuss About, Again?

April 9, 2013
FDA, Pharmaceuticals

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

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