Food and Drug Law

An Injunction in the Des Moines Water Works Lawsuit Won’t Hurt Farmers, Here’s Why Not

September 15, 2015
Agriculture, Environmental Law, Food and Drug Law

James Meinert, MJLST Lead Managing Editor

Last spring, the public water utility for the Des Moines, Iowa metro area filed suit in federal court alleging that agricultural drainage districts are emitting nitrates to the Raccoon River in violation of the Clean Water Act (CWA). The utility’s remedy under the citizen suit provision of the CWA would be an injunction; and in the alternative, the utility’s associated common law claims could yield injunctive relief and damages (The utility’s private nuisance claim in particular seems likely to survive pre-trial dispositive motions, if not win outright at trial, as Iowa Code § 657.2(4) makes it a nuisance to “render[] unwholesome . . . the water of any river . . . to the injury or prejudice of others.”). Most commentators have focused on the novel CWA claim, that nitrate pollution flowing from tile drain outlets is point source pollution and thus subject to NPDES permitting just like a factory outfall. If successful, the CWA claim would categorize nitrate pollution from tile drains as a third type of flow off agricultural fields that is separate from otherwise exempt “agricultural stormwater” and “return flows from irrigated agriculture” (33 U.S.C. § 1362(14)).

The utility has been criticized by the Governor of Iowa, State senators, and farming associations, for not collaborating with the upstream farming communities, and for not waiting to see if they State’s two year old nutrient reduction strategy will lead to lower pollution over time. Is this a real dichotomy—suing versus working collaboratively?

The CWA has never had a strong regulatory regime for nonpoint source pollution. Section 303 says that “States shall” complete a number of planning activities: first, decide what uses each water should have (wildlife habitat, recreation, drinking water, etc.); then set water quality standards protective of those uses; then maintain lists of waters impaired under these standards; and finally calculate total maximum daily loads (TMDLs) the impaired waters could receive and still be clean enough for their use (33 U.S.C. § 1313(d)). There is no actual implementation or regulatory requirement for nonpoint sources. After the TMDL, there are federal grants to identify best management practices, and more grants for parties who volunteer to implement the identified activities. These are in addition to grant money farmers could receive from USDA to implement similar practices through EQIP or CRP contracts, but all of the implementation measures are voluntary.

Iowa has largely completed the planning steps, the Raccoon River has TMDLs for nitrates, and specifically tailored best management practices for the watershed, but traditionally Iowa has not spent its federal grants directly at pollution on farm fields, but rather on broader projects like a K-12 state-wide education program to foster a “culture of conservation,” or creating wetlands areas upstream of lakes to mitigating silting and nutrient-based algae blooms.

There is an entire sector of Iowa’s economy surrounding the study and development of agricultural practices, however, there has been little governmental urgency in directing resources towards implementation of agricultural conservation practices for water quality improvement. In 2010, Iowa voters approved a constitutional amendment to create a 3/8ths of one percent state sales tax to fund water quality initiatives and to protect natural areas. However, the State legislature has yet to collect any revenue through the tax. Iowa even has its own grant funding program to pay farmers to implement water quality practices under the nutrient reduction strategy. But Governor Branstad has vetoed attempts by the legislature to fund those programs, last year vetoing the $22.4 million the Iowa house and Iowa senate agreed to appropriate for water quality initiatives.

In the world of Clean Water Act regulation of nonpoint source pollution, a lawsuit is the only way to get everyone to the table to get something done. In the 1980s and 1990s, most states completely ignored the impaired waters lists and TMDL requirements until citizens filed lawsuits in 35 states arguing progress was so slow that States and EPA had violated duties under the act. In general, courts held a duty was breeched only if the States and EPA truly did nothing, a low standard to meet, but nonetheless, EPA settled most of the suits and entered court-administered consent decrees to promulgate tens of thousands of TMDLs across the country. In the DMWW suit, the utility asks the court to “frame an injunction that permits sufficient flexibility for the Drainage Districts to comply with the injunction without undertaking an unreasonable burden.” Under such a request, the parties would be negotiating a binding timeline for farmers to take advantage of otherwise voluntary measures. If Governor Branstand doesn’t veto the State legislature’s appropriation for water quality grants this coming year farmers could implement best practices on the taxpayer’s dime, something Iowa voters asked for years ago. The utility could try for specific requirements like that all landowners physically abutting the Raccoon River make every effort to enroll in state and federal grant programs to conserve land and improve water quality. But whether the requirements are buffer strips funded by USDA Conservation Reserve Program contracts, or best practices from Iowa’s nutrient reduction strategy, that’s for the utility and farmers to negotiate in settlement conference.

USDA Heightened Country of Origin Labelling Laws: Good Start, Can Be Tightened

April 25, 2015
Agriculture, Food and Drug Law, Regulatory

Vinita Banthia, MJLST Staff Member

The Country of Origin Labeling (COOL) laws have long been debated and amended in the Unites States. COOL regulation dictates the degree to which a product’s label must indicate which countries were involved in the production of the product. Currently, a product’s countries of origin must be labelled for the all of its ingredients, with the exception of where the product has been processed. These standards apply to food such as meat that had been born and raised in the United States but contains elements that have been produced in other countries like China. Hence, all raw foods and its ingredients must be labelled, including “raw muscle cuts, ground commingled meat, or live imported animals are not excluded.”

However, if meat has been born and raised in the United States, and then shipped to China for processing, then shipped back to the United States for consumption, it does not need to be labelled as being processed in China. Except for locations of processing, meat must be labelled for the countries where the animal lived during its life, and where it was subsequently “raised, slaughtered, butchered, and prepared for sale.” These laws have become increasingly strict since changes in the U.S. Department of Agriculture (USDA) consumer information policies in 2009 and 2013.

The recent Note, Country of Origin Labeling Revisited: Processed Chicken from China and the USDA Processed Foods Exception published in the Minnesota Journal of Law, Science, and Technology, by Daniel Schueppert highlights the stringent COOL requirements for raw and live foods. The Note discusses the recent change in the USDA funding and regulation policies that allowed the United States to export chicken to China for processing, and then import it back in to the US for commercialization without labelling the meat’s journey. The agricultural industry and grocery stores have been largely opposed to the laws as requiring excessive labelling for non-processed meats. Canada and Mexico have challenged the U.S. COOL laws at the WTO, stating that the COOL requirements for non-processed meat are overly burdensome on Canadian and Mexican beef exporters, thereby creating an unfair advantage for U.S. domestic beef. In October 2014, the WTO ruled in favor of Canada and Mexico. Canada has threatened retaliatory actions if the U.S. does not relax its COOL laws.

In contrast, Schueppert argues that some, limited COOL standards should also be applied to meat processed in China. This position supports greater restrictions not only for non-processed and raw foods, but also for processed meats. In addition, Schueppert argues that the current definition of processed foods is too broad and over-inclusive, leading to potential safety concerns in non-processed products. This argument holds more ground that the views of industries and countries unwilling to invest greater resources in ensuring the safety and disclosure of products. The USDA should continue to take measures to ensure that meat products are increasingly safe and well-labelled for consumers.

The FDA’s Role in Innovative Change

April 11, 2015
Food and Drug Law, Regulatory

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
Food and Drug Law, Pharmaceuticals, Regulatory

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.

Driving Under the Influence: Recent Legal Developments in Cellulosic Ethanol Industry

January 16, 2015
Agriculture, Environmental Law, Food and Drug Law, Litigation

Ke M. Huang, MJLST Lead Articles Editor

As a second-year law student, I met an energy law attorney who told me that sometimes his job felt like mediating between two parents. Two parents butting heads.

The more recent legal developments in the cellulosic ethanol industry since the publication of my student note in the Volume 15, Issue 2 of the Minnesota Journal of Law, Science & Technology echo the words of the attorney I met. In the note–published in Spring 2014 and entitled A Spoonful of Sugarcane Ethanol–I argue that the U.S. should enact tax benefits to spur cellulosic ethanol based on existing Brazilian tax benefits for sugarcane ethanol. Ethanol, or ethyl alcohol, is a fuel fermented from renewable resources. In the case of cellulosic ethanol, the resource is vegetative and yard waste; in the case of sugarcane ethanol, the resource is sugarcane juice.

Unlike the note, which focuses on tax benefits, the recent developments in the cellulosic ethanol industry center on blending mandates, both in the U.S. and Brazil. Under these mandates, motor fuel–which contains mostly gasoline–must be blended with a certain amount of ethanol. The U.S. motor fuel mandate is the Renewable Fuel Standard (RFS). RFS, which generally requires the petroleum industry to blend in motor fuel specific amounts for cellulosic ethanol, was already subject to litigation in American Petroleum Institute v. EPA, 706 F.3d 474 (D.C. Cir. 2013). However, the concerned industries of that case, primarily the petroleum industry and the cellulosic ethanol industry, continue to disagree. Broadly speaking, as further elaborated in this Bloomberg BNA blog entry, the petroleum industry takes the position that the RFS is unworkable. To much the vexation of the cellulosic ethanol industry. What makes the recent development more interesting is that, since early 2014, the cellulosic ethanol production seemed to have increased. Extending the metaphor of fighting parents, it is as if the ethanol parent continues to grasp the motor fuel teen, a teen that has grown bulkier in size, when the petroleum parent is ready to send the teen off to college.

In Brazil, a similar “family tale” ensues. In late 2014, Brazilian President Dilma Rousseff signed the legislation to increase Brazil’s blending percentage of ethanol from 25% to 27.5%. Still, the semi-public petroleum producer Petrobras expressed concern that, before the change in the mandate can be put in effect, more study is needed. These articles further explain these events (1)(2). As such, in this “family,” the parents are at a deadlock.

On a more serious tone, as I reread my student note, I would like to make two corrections. I apologize for the misspelling of Ms. Ruilin Li’s name on page 1117, and for the missing infra notations on page 11141 (notes 218 to 221).

An Eyedropper’s Worth of Juice

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

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
Food and Drug Law, Regulatory

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.

A Farm Bill for Hansel and Gretel

February 18, 2014
Agriculture, Food and Drug Law, 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 Law

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 Law, Regulatory

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.

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