Administrative Law

The FDA’s Role in Innovative Change

April 11, 2015
Administrative Law, Food and Drug Law

Paul Overbee, Articles Editor

In Volume Six, Issue Two of the Minnesota Journal of Law, Science and Technology, Susan B. Foote and Robert Berlin penned a piece titled “Can Regulation be as Innovative as Science and Technology? The FDA’s Regulation of Combination Products.” Published in 2005, this piece set out to explore whether an agency as slow as the FDA could keep pace with ongoing technological innovations and respond in an appropriate and timely manner. Ultimately the authors concluded that the FDA is an agency that progresses in an iterative and incremental manner, and that both politics and administrative law were likely to prevent the FDA from being a force for innovation. The authors tried to justify the potential block to innovation by arguing that innovators and manufacturers benefit from the predictability and certainty and that a slow regulatory is the essential cost of these benefits. As such, the authors offered that regulation would come after innovations occurred rather than predicting upcoming innovation and issuing preliminary regulation.

Since the time of the author’s predictions, they have been proven correct in many ways. For instance, nanotechnology is an emerging technology with many predicting how it will be implemented in the future, and it has already has appeared in products such as sunscreens and spray paints. Despite its current presence in society, the FDA has failed to issue a formal definition of what nanotechnology is and what it is not. As such the predictability and certainty that is desired by innovators is lacking. One of the most recent developments that continue to show that the FDA is ill-equipped to deal with fast paced innovation is their recent draft guidance on combination products. A full 10 years after Foote and Berlin criticized the FDA’s ability to act swiftly, the FDA has finally issued a draft guidance to clarify and explain the current good manufacturing practices for combination products. This guidance has been made available by the FDA

The FDA defines a combination product as any combination of a drug, device, or biological products, taken individually as constituent parts of the combination product. Additionally, a combination may be two or more separate products that have been packaged together in a single package such as pre-filled syringes. The new FDA guidance gives multiple options for combination products to meet current good manufacturing practices. First, the producer may demonstrate compliance under the current drug manufacturing practices or by meeting qualify system regulations; this option is available where the combination is both a drug and device. The other option is that the manufacturer may demonstrate compliance will all good manufacturing practices that are applicable to each constituent part that makes up the whole combination product.

Both Berlin and Foote justified the slow moving nature of the FDA by stating that it may provide the type of predictability and certainty that is desired by innovators. Since that date, actions by the FDA have put that predictability and certainty in question. Instead of having a clear practice in place, the FDA may leave manufacturers guessing for years before the agency comments on their appropriateness. Berlin and Foote both agreed that perhaps the FDA wasn’t properly tooled to deal with ongoing innovation, but ongoing developments continue to drive that point home.

A Story to Warm Your Iron-Rich Hemoglobin

April 4, 2015
Administrative Law, Food and Drug Law, Health Law

Becky Huting, MJLST Articles Editor

While recently home in Chicago on spring break, I offered to make my dad a spinach-packed smoothie. My dad (a good sport) agreed, but asked me to make it light on the spinach as he understood men at his age (60) should be taking it easy on the iron intake. I had heard this principle before, and knew that men’s and women’s vitamin supplements were different in part due to the additional iron needs of women. My dad was right about one thing: he needs a lot less iron than me. His recommended dietary allowance for iron is 8 mg/day whereas mine is a lofty 18 mg/day. In actuality, men rarely suffer from iron deficiency so supplements are usually unnecessary, and in fact too much iron can indeed be harmful. There are possible links with excessive iron consumption to diabetes as well as neurodegenerative disease.

But where his concerns are unfounded are in the nutritional numbers. One cup of uncooked spinach contains only .8 mg of iron. That is only one-tenth of his daily iron needs. Three ounces of ground beef containing 15% fat contains 2.2 mg of iron. What about his daily serving of canned, drained clams, you ask? Fine, you have me there: if my father actually consumed such item, he’d have gone over at 23.8 mg of iron. It is very hard though for a human to overdose on iron from food, because an adult body has systems in place to regulate the amount of iron it absorbs. In short, my dad need not be concerned about spinach in his smoothie, except for reasons of palatability.

So given the different nutritional needs of men, women, and also children, what entity is telling consumers whether a vitamin is for them by way of labels? The Food and Drug Administration (FDA) relinquished that duty back in October of 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. This law created a new regulatory framework for the safety and labeling of dietary supplement that places the responsibility on the product manufacturers rather than the FDA. The DSHEA was a response to lobbying by health food companies to vote down several bills that would have had the effect of increasing the FDA’s powers over supplement labeling. Celebrities even got involved. In one commercial, Mel Gibson portrayed a citizen being raided and arrested by FDA agents for possessing a bottle of Vitamin C.

This mentality that too much government oversight is a bad thing is a popular ideal. After all, it’s only a vitamin. Perhaps a label signifying use by pregnant and nursing moms is enough, but consider the 60-year-old guy grabbing this supplement in haste. He is now getting 27 mg iron per day from the vitamin alone, perfect for a pregnant woman, but over 3X his nutritional needs. Are a few words on a label enough to signify safety to a consumer? Certainly there is an argument that too much information will lead to a cluttered, confused label. So where do you come down, bring the FDA back in or leave it to the companies? And do you feel like a green smoothie? I promise you the banana masks the spinach flavor.

State Agency Deference Under PURPA

January 29, 2015
Administrative Law, Environmental Law

Doug Kincaid, MJLST Staff Member

Recently, in Exelon Wind L.L.C. v. Nelson, 766 F.3d 380 (5th Cir. 2014), the Fifth Circuit Court of Appeals (Fifth Circuit) held that state agencies are entitled to deference under the Public Utilities Regulatory Policies Act of 1978 (PURPA) – a cooperative federalism regulatory scheme. The case revolved concerned the Texas Public Utilities Commission (PUC), which claimed that under state law a wind farm generating intermittent power (“non-firm”) power could not enter into a legally enforceable obligation (LEO) under Texas law, and that such an obligation was not required under PURPA. Unable to enter into a fixed price agreement, the generator was subject to highly variable market prices, increasing the financial risk of the project dramatically.

The Federal Energy Regulatory Committee (FERC) responded by declaring that federal law required all qualifying facilities under PURPA have the option to enter into a LEO. The Fifth Circuit, faced with competing state and federal interpretations, upheld the state interpretation despite the fact that FERC authored the relevant statutes. Because wind and solar energy, by nature, cause scheduling difficulties and extra costs to state agencies overseeing regional energy grids, an incentive may exist for other state agencies to follow the PUC’s lead. The Fifth Circuit’s holding in Exelon frustrates renewable energy development by refusing renewable generators the option to enter into LEOs and expands the deference state agencies are entitled to in a cooperative federalism regulatory scheme.

To the extent federal and state agencies disagree on the interpretation of a cooperative federalism statute, district courts are fragmented and little scholarship exists regarding how to resolve these conflicts. In determining whether to defer to a state agency’s interpretation of federal law, five out of six federal circuits which have considered the issue elected to give state agencies no deference. The underlying basis for federal deference in these cases was a sentiment favoring federal supremacy. The Fourth Circuit, an outlier, granted deference to state agencies citing state agency expertise in tailoring federal regulations to local conditions. Here, the Fifth Circuit in Exelon v. Nelson created a novel line of reasoning on this issue.

In relevant part, PURPA states that “Each qualifying facility shall have the option either: (1) To provide energy. . . based on the purchasing utility’s avoided costs calculated at the time of delivery; or (2) To provide energy or capacity pursuant to a legally enforceable obligation.” The plain meaning of this language, under traditional principles of statutory interpretation, creates a mandatory choice vested in the qualifying facility. The Fifth Circuit, however, read the statute as a bare-bones framework on which state agencies can project any regulation not expressly denied by the statutory language. Because PURPA contains no specific language addressing the obligation of firm or non-firm generators to form LEOs, the PUC regulation presents no facial conflict with PURPA.

The creative judicial interpretation employed to circumvent the mandatory choice interpretation reveals that the Fifth Circuit treated state sovereignty as a controlling concern in the examination of conflicting state and federal agency interpretations. A previous holding in F.E.R.C. v. Mississippi, 456 U.S. 742 (1982), held that PURPA subtly circumvents the anti-commandeering doctrine by allowing states to “comply with the statutory requirements by issuing regulations, by resolving disputes on a case-by-case basis, or by taking any other action reasonably designed to give effect to FERC’s rules.” Perceiving a potential Tenth Amendment conflict caused by forcing state governments to implement FERC’s PURPA regulations, the court hesitated to “wade unnecessarily into such murky waters” and instead elected to defer to the PUC. Exelon v. Nelson may remain an outlier, but considering the importance of state and federal agency cooperation in the energy sector, granting deference to state agency interpretations on constitutional grounds could have a significant effect on energy law. Nonetheless, in terms of implementation of PURPA, the court’s ruling is a setback for renewable energy and may require legislative action to clarify the intent of the law.

PURPA serves to promote renewable generation by creating a mandatory purchase provision for small generation facilities, an increasingly important function considering the massive carbon footprint of the power sector. The holding in Exelon v. Nelson reduces FERC’s power to promote renewable power. A simple legislative fix would preserve state implementation authority under PURPA while eliminating the state’s ability to frustrate renewable energy development through state regulations dictated by purchasing utilities.

Congress sets forth in PURPA’s text three express purposes: “to encourage (1) conservation of energy supplied by electric utilities; (2) the optimization of the efficiency of use of facilities and resources by electric utilities; and (3) equitable rates to electric consumers.” Congress should enact a fourth purpose for PURPA: “to encourage” renewable resources and long-term reduction of carbon emissions. Pursuant to this change, the purpose of PURPA would in fact change very little as renewable energy is already a key component of the statute. State regulations singling out renewable generators would be necessarily rejected in federal or state court pursuant to the express will of Congress. The amendment would honor the structure of cooperative federalism inherent to PURPA by balancing the state role of implementation with the federal role of enforcement, while strengthening the benefits derived by renewable generators from the mandatory purchase requirement.

In sum, Exelon v. Nelson presents a new and potentially significant holding on cooperative federalism – a staple legislative tool in today’s agency intensive power sector. It remains to be seen whether this case will bear significantly on future agency deference or remain an outlier, but the holding certainly calls into question the ability of renewable energy generators to enter into LEOs under PURPA. To counteract this negative effect, Congress should make “encouraging renewable resources and long-term reduction of carbon emissions” an express goal of PURPA, cementing the purpose that the statute already serves.

Cable TV Providers and the FCC’s Policy-Induced Competition Amidst Changing Consumer Preferences

October 3, 2014
Administrative Law, Business Law, Ethics, Internet

Daniel Schueppert, MJLST Executive Editor

More and more Americans are getting rid of their cable TV and opting to consume their media of choice through other sources. Roughly 19% of American households with a TV do not subscribe to cable. This change in consumer preferences means that instead of dealing with the infamous “Cable Company Runaround” many households are using their internet connection or tapping into local over-the-air broadcasts to get their TV fix. One of the obvious consequences of this change is that cable TV providers are losing subscribers and may become stuck carrying the costs of existing infrastructure and hardware. Meanwhile, the CEO of Comcast’s cable division announced that “it may take a few years” to fix the company’s customer experience.

In 2011 Ralitza A. Grigorova-Minchev and Tomas W. Hazlett published an article entitled Policy-Induced Competition: The Case of Cable TV Set-Top Boxes in Volume 12 Issue 1 of the Minnesota Journal of Law, Science & Technology. In their article the authors noted that despite the FCC’s policy efforts to bring consumer cable boxes to retail stores like Best Buy, the vast majority of cable subscribing households in America received their cable box from their cable TV operators. In the national cable TV market the two elephants in the room are Comcast and Time Warner Cable. One of these two operators are often the only cable option in certain areas and together they provide over a third of the broadband internet and pay-TV services in the nation. Interestingly, Comcast and Time Warner Cable are currently pursuing a controversial $45 billion merger and in the process both companies are shrewdly negotiating concessions by TV networks and taking shots at Netflix in FCC filings.

The current fad of cutting cable TV implicates a pushback against the traditional policy of vertically integrating media, infrastructure, customer service, and hardware like cable boxes into one service. In contrast to the expensive cable box hardware required and often provided by traditional cable, internet media streaming onto a TV can usually be achieved by any number of relatively low cost and multi-function consumer electronic devices like Google’s Chromecast. This arguably gives customers more control over their media experience by providing the ability to choose which hardware-specific services they bring into their home. If customers no longer want to be part of this vertical model, big companies like Comcast may find it difficult to adjust to changing consumer preferences given the considerable regulatory pressure discussed in Grigorova-Minchev and Hazlett’s article.

An Eyedropper’s Worth of Juice

April 29, 2014
Administrative Law, Agriculture, Food and Drug Law

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
Administrative Law, Food and Drug Law

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, Agriculture, Food and Drug Law

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
Administrative Law, Agriculture, Food and Drug Law

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?

All Signs Point Toward New Speed Limits on the Information Superhighway

November 11, 2013
Administrative Law, Internet

by Matt Mason, UMN Law Student, MJLST Staff

The net neutrality debate, potentially the greatest hot-button issue surrounding the Internet, may be coming to a (temporary) close. After years of failed attempts to pass net neutrality legislation, the D.C. Circuit will soon rule as to whether the FCC possesses the regulatory authority to impose a non-discrimination principle against large corporate ISP providers such as Verizon. Verizon, the plaintiff in the case, alleges that the FCC exceeded its regulatory authority by promulgating a non-discrimination net neutrality principle. In 2010, the FCC adopted a number of net neutrality provisions, including the non-discrimination principle, in order to prevent ISPs like Verizon from establishing “the equivalents of tollbooths, fast lanes, and dirt roads” on the Internet. Marvin Ammori, an Internet policy expert, believes that based on the court’s questions and statements at oral argument, the judges plan to rule in favor of Verizon. Such a ruling would effectively end net neutrality, and perhaps the Internet, as we know it.

The D.C. Circuit Court is not expected to rule until late this year or early next year. If the D.C. Circuit rules that the FCC does not have the regulatory power to enforce this non-discrimination principle, companies such as AT&T and Verizon will have to freedom to deliver sites and services in a faster and more reliable fashion than others for any reason at all. As Ammori puts it, web companies (especially start-ups) will now survive based on the deals they are able to make with companies like Verizon, as opposed to based on the “merits of their technology and design.”

This would be terrible news for almost everyone who uses and enjoys the Internet. The Internet would no longer be neutral, which could significantly hamper online expression and creativity. Additional costs would be imposed on companies seeking to reach users, which would likely result in increased costs for users. Companies that lack the ability to pay the higher fees would end up with lower levels of service and reliability. The Internet would be held hostage and controlled by only a handful of large companies.

How the FCC will respond to the likely court ruling rejecting its non-discrimination principle is uncertain. Additionally, wireless carries such as Sprint, have begun to consider the possibility of granting certain apps or service providers preferential treatment or access to customers. Wireless phone carriers resist the application of net neutrality rules to their networks, and appear poised to continue to do so despite the fact that network speeds are beginning to equal those on traditional broadband services.

In light of the FCC potentially not having the regulatory authority to institute net neutrality principles, and because of the number of failed attempts by Congress to pass net neutrality legislation, the question of what can be done to protect net neutrality has no easy answers. This uncertainty makes the D.C. Circuit’s decision even more critical. Perhaps the consumer, media, and web company outcry will be loud enough to create policy change following to likely elimination of the non-discrimination rule. Maybe Congress will respond by making the passage of net neutrality legislation a priority. Regardless of what happens, it appears as though we will soon see the installation of speed limits on the information superhighway.

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

October 21, 2013
Administrative Law, Food and Drug Law

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.

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