Food and Drug

A Farm Bill for Hansel and Gretel

February 18, 2014
Agriculture, Food and Drug, Healthcare, Public Health

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.

Crime and Treatment: A Creative Drug Policy

February 3, 2014
Criminal Law, Food and Drug

by Shirshira Kother, MJLST Staff

In our society, it seems as though drug addiction is a commonality for prison inmates. It tends to play some role in every crime scene and horrific headline that we hear about. Drugs have been a driving force for many criminals because it significantly alters their decision-making and ultimately affects their actions. While there is no mistake that those who act under the influence of drugs will be subject to justice system, there perhaps a better way to discourage this behavior by redefining addiction.

An article titled Why Neuroscience Matters for Rational Drug Policy in volume 11 of the Minnesota Journal of Law, Science and Technology, explores the possibility of addiction as a neurological problem that may be solved by specific treatment to rewire an individual’s brain. David M. Eagleman, Mark A. Correro & Jyotpal Singh analyze how consistent use of chemical substances destruct areas of the brain that control voluntary actions.

David M. Eagleman, Mark A. Correro & Jyotpal Singh analyze how consistent use of chemical substances destruct areas of the brain that control voluntary actions. The article continues to explain how policy regarding drug use and addiction should be more geared toward treating those affected by the condition versus punishing them for becoming addicted. They suggest that chronic users may not actually continue their use on their own accord but are driven their brains. Chemical abuse can restructure the functions within the brain and lead many criminals to act out of deprivation of the drug. This concept has come across several arguments, most of which revolve around the policy effect of allowing criminals to “blame their brains” for their actions. The authors however suggest that the mere explanation of chemical abuse and how its effects have led to a crime does not, relieve the individual of their responsibility. It allows the system to better rehabilitate the individual.

The process suggested would mirror the procedure used to treat an aliment in order to restore one’s health. The use of drugs is associated with positive stimulus and once the brain has been repeated exposed to a chemical, it becomes dependent on that stimulus to function and destroys behavior inhibition, which often leads to impulsivity. Depriving it of the substance can cause severe side affects to the individual and drive them to act without thought or reason. The article introduces two new radical methods in rehabilitating these individuals. Most medications used to treat addicts either reduce the positive response the drug elicits or counter acts the reaction by producing a negative one. By using real time neuroimaging, doctors can better understand cues associated with craving and try to override the responses to those cues. A second suggested method is a vaccine to block the receptors related to the positive response addicts experience when using drugs. This vaccine would not allow the addict to get high thus reducing their use.

While still fairly new, these two innovations can change rehabilitation of those incarcerated from chemical use and abuse related crimes. Perhaps, the biggest concern is whether these options will have long-term positive effects and keep the individuals off of drugs. If successful, this method would not only remove potentially dangerous individuals from society but also groom them to rejoin the world: chemical free.

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

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

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

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
Administrative Law, Food and Drug

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.

The Art of War on Drugs

September 26, 2013
Food and Drug

by Ke M. Huang, UMN Law Student, MJLST Staff

Ke M. Huang.jpg A recent New York Times article addressed the research of a psychology professor at Columbia University that aimed to discredit misperceptions about drug addicts. The article cited Professor Carl Hart saying: “Eighty to 90 percent of people who use crack and methamphetamine don’t get addicted,” Hart continued, “And the small number of who do become addicted are nothing like the popular caricatures. His research showed that, for example, recruited addicts who were given a choice between a dose of crack and $5.00 sometimes chose the money. Findings such as this led Professor Hart to conclude that addicts can make rational economic decisions.

In the Volume 11, Issue 1 of the Minnesota Journal of Law, Science & Technology, Eagleman et al. also shed light on drug addiction by offering two additions to drug policy. After presenting an overview of the shortcomings of the U.S. drug policy, and a summary of the modern neuroscientific understanding of chemical dependency, Eagleman et al. suggested that the government should try implementing (1) cocaine vaccines, and (2) neuroimaging feedback to treat drug addiction. The first measure creates on the recipient of the vaccine an immune response to cocaine molecules that can weaken, if not eliminate, the high of the cocaine. The second measure, like biofeedback, allows an individual to view a graphical representation of the activity in a certain area of her brain, and let her practice to control it. Thus Eagleman et al. support a more rehabilitative, rather than retributive, policy to addressing issues of chemical dependency.

As someone who was raised in the country with one of the least criminalized drug policies in Europe–Portugal, I stumbled upon literature that also suggested that a country’s war on drugs does not have to be a hot war. Since 2001, Portugal implemented a drug decriminalization reform. A drug user is not arrested, but referred to a squad often times made up of a lawyer, a social worker, and a medical professional. The squad finds whether the user is addicted. If yes, he may be then referred to a treatment or be penalized, such as being banned from a certain neighborhood or losing a driver’s license. If not, he is unlikely to be sanctioned. About 5% users are brought before the squad the second time in the same year. A 2010 study in the British Journal of Criminology concluded that Portugal’s drug policy reform was quite successful. Teen drug use decreased, law enforcement authorities seized more drugs, and, though adult drug use rates climbed, the rates were lower than the neighboring nations that did not adopt drug policies like those in Portugal.

About 2500 years ago, Sun Tzu wrote “the skillful leader subdues the enemy’s troops without any fighting.” Similarly, the literature discussed indicates that the war on drugs could be a peaceful fight after all.

Country of Origin Labeling for Food and Pharmaceutical Products

September 26, 2013
Agriculture, Food and Drug, Pharmaceuticals, Public Health

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.

FDA Warning Letters: Knocking on the Doors of Courthouses

April 23, 2013
Administrative Law, Food and Drug

by Katelyn DeRuyter, UMN Law Student, MJLST Staff

The FDA is responsible for safeguarding public health by “assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” The FDA inspects products and manufacturing facilities in order to ensure these important goals. If the inspection finds that a company has fallen short of the applicable standards, the FDA often will issue a Warning Letter. An FDA warning letter is written correspondencee “that notifies regulated industry about violations that FDA has documented during its inspections or investigations.” The FDA views warning letters as giving the recipient an opportunity to take voluntary and prompt corrective action before the FDA initiates official enforcement action. Despite the fact that the FDA Warning Letter is considered a mechanism for inducing “voluntary” compliance, in recent student note published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, entitled “FDA Goes Loko,” Rebecca Boxhorn argues that warning letters do not induce truly voluntary compliance because recipients that do not wish to voluntarily comply have limited options. Under the current state of the law, FDA Warning Letters are not subject to judicial review. This lack of judicial review is problematic because warning letters subject recipients to real consequences. Boxhorn proposes that FDA Warning Letters should be subject to judicial review.

This positions runs contrary to current case-law but is supported by many industry participants. The crux of the Boxhorn’s argument is that given the consequence of receiving a warning letter, “judicial review of warning letters must be allowed to protect regulated parties from agency coercion and potential misapplications of the law.”

A recent Supreme Court decision in Sacketts v. EPA has sparked speculation over whether courts will begin to re-evaluate their previous view of FDA Warning Letters as not fit for judicial review. The Court in Sackett analyzed whether an EPA Compliance Order constituted final agency action that was subject to APA judicial review. The Sacketts brought suit in U.S. District of Idaho claiming the EPA’s compliance order was arbitrary and capricious and deprived them of life, liberty, or property, without due process of law, in violation of the Fifth Amendment. The district court dismissed the claims based on the lack of subject matter jurisdiction and the Ninth Circuit affirmed. The Court granted certiorari, reversed the Ninth Circuit’s decision, and held that the contested compliance order constituted “final agency action for which there [was] no adequate remedy other than APA review, and that the Clean Water Act does not preclude that review.”

The Court analyzed whether the compliance order in question constitutes final agency action and concluded that it “has all of the hallmarks of APA finality that our opinions establish.” The opinion walked through three factors that support the finding that the compliance order is final agency action: (1) the fact that “[t]hrough the order, the EPA ‘determined’ ‘rights or obligations;'” (2) the fact that “‘legal consequences . . . flow[ed]’ from issuance of the order;” and (3) that the agency action “mark[ed] the ‘consummation’ ‘of the agency’s decision making process.'” Whether applying Sackett would lead a court to conclude that an FDA warning letter is final agency action depends on the extent to which the warning letter in question is similar, or dissimilar, in language and ramifications, to the compliance order addressed in Sackett–at least in regards to the “hallmarks of finality.” A key component of the Sackett Court’s analytical approach is the fact that the Court looked beyond the EPA’s stated intent of compliance orders, and evaluated the actual effect of the compliance order on the Sacketts. If courts adopt this approach and look at the consequences of receiving a warning letter, recipients might finally gain access to judicial review.

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

April 18, 2013
Administrative Law, Agriculture, Food and Drug, 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
Administrative Law, Food and Drug, 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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