Tag: food

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

BullmonLast November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.

The complaint alleges that the FDA failed in its statutory duty to take a “hard look” at how GE salmon will impact the environment. The plaintiffs warn that the FDA did not appreciate the risk that the farmed salmon would inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .”

The plaintiffs also take aim at the FDA’s authority to regulate GE animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), arguing that, back in 1938, Congress did not expect the FDA to regulate genetically engineered animals for human consumption: “GE animals present enormously different risks and impacts than drugs, requiring different expertise, analyses, and regulation than were contemplated when Congress enacted the FFDCA.”

Whether additional lawsuits will follow this one remains to be seen. In our November post, we predicted that consumers could sue to challenge the labeling of the GE fish. Although the FDA initially determined that AquaBounty would not need to label its salmon as GE, a provision in December’s 2016 Omnibus Appropriations Bill required the FDA to ban GE salmon imports until it published labeling guidelines for the fish. In February, the FDA issued that ban and announced its plans to establish labeling guidelines.

Even if AquaBounty puts FDA-approved labeling on its product, consumers still may sue under failure to warn and related legal theories. The food industry has had some success defending state law food labeling claims based on federal preemption. But the federal Nutrition Labeling and Education Act exempts claims based on the adequacy of safety warnings unless the FDA has actually considered a risk and determined that no warning is necessary. So, the key question in any consumer personal injury suit involving GE salmon likely will be whether the FDA considered the risk of the alleged harm in implementing its new labeling guidelines.

Article By Amy M. Rubenstein & Katia Asche of Schiff Hardin LLP

© 2016 Schiff Hardin LLP

Gluten-Free Go-Round re: Food Labeling

CookiesGingerbreadMenFDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods.

  • FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting the results of current test methods for detecting gluten in such foods.

  • On February 12, FDA announced its intent to extend the comment period for this proposed rule.  Although the comment period technically closes on February 16, FDA will be reopening it to extend the timeframe for an additional 60 days (to be counted from the date that a notice reopening the comment period appears in the Federal Register).

  • The proposed rule would affect the labeling of foods and ingredients such as yogurt, hydrolyzed soy protein, distilled vinegar, and FDA-regulated beers (i.e., beers that are not made from malted barley and hops).  The rule also could affect beers regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), as TTB has indicated that it may revise its own gluten claim policy once FDA has issued a final rule or other guidance.  Interested stakeholders are invited to submit comments via Regulations.gov (Docket Number FDA-2014-N-1021).

Article By Food & Drug at Keller and Heckman LLP

© 2016 Keller and Heckman LLP

California Court Curbs Chipotle GMO Case

Chipotle dodges non-GM class action lawsuit…for now.

Sign is seen at a Chipotle Mexican Grill restaurant in San Francisco, California
A sign is seen at a Chipotle Mexican Grill restaurant in San Francisco, California July 21, 2015. REUTERS/Robert Galbraith

  • In 2015, Chipotle Mexican Grill launched a nationwide advertising campaign premised on the chain’s pledge to serve food made only with non-genetically modified (GM) ingredients.  However, the company continued to serve meat and dairy products from animals that consume GM crops, as well as beverages with GM ingredients (e.g., sodas with corn syrup from GM corn).  A class action lawsuit was filed against Chipotle in the “Food Court” (Northern District of California), based on allegations that the chain’s non-GM advertising campaign violates California consumer protection, false advertising, and unfair competition laws.

  • On February 5, the lawsuit was dismissed.  The judge found that the plaintiff had failed to specify that she purchased food in the “GM” categories (i.e., meat, dairy, or soft drinks) and thus failed to connect economic injury to the allegedly deceptive claims.  In the dismissal order, the judge also questioned the plaintiff’s allegations that a reasonable consumer would interpret Chipotle’s non-GM ingredient claims to extend to meat and dairy products derived from animals that never consumed any GM ingredients.

  • Although the plaintiff in this case may file an amended complaint in the future, the dismissal suggests that the court may be looking for additional support for the notion that reasonable consumers hold the same strict interpretation of non-GM claims.  Even Vermont’s GM labeling requirements provide exemptions for animal products derived from animals that consumed GM crops, which suggests that it might be an uphill battle to establish that such products should themselves be considered “GM.”

Article By Food & Drug at Keller and Heckman LLP
© 2016 Keller and Heckman LLP

Vermont GMO Battle Continues in Second Circuit

The Second Circuit Court of Appeals is currently in the midst of an interlocutory appeal by the Grocery Manufacturer’s Association (“GMA”) and others of the District Court of Vermont’s denial of a request for a preliminary injunction against Vermont’s “Right to Know” Act.

The Act, passed by the Vermont legislature on May 8, 2014, and effective July 1, 2016, has the stated goal of establishing a system to allow for informed decisions by consumers with respect to the potential health effects of “genetically engineered foods,” commonly referred to as “GMOs.”  The Act applies to products entirely or partially produced with genetic engineering, with a focus on raw agricultural commodities and covered processed foods.  Labels on covered food products must either state that they are “produced with genetic engineering” or “may be produced with genetic engineering.”  Limited exceptions are made for foods derived entirely from animals, restaurant foods, alcoholic beverages and foods that have been independently verified to have “minimal” GMO content.  Penalties under the Act include $1,000.00 per day, per product, fines for food manufacturers.

The GMA filed its initial Complaint with the District Court in June 2014, and sought a preliminary injunction in September 2014.  U.S. District Judge Christina Reiss refused to enjoin the law in a ruling issued on April 27, 2015, which was promptly appealed to the Second Circuit.  Oral argument in the appeal took place on October 8, 2015.

The crux of the issue before the Second Circuit is the proper standard for evaluating GMA’s position that the Act violates the First Amendment by imposing a burden on speech by, inter alia, food manufacturers, based upon the content of that speech.  In reaching her decision to deny the preliminary injunction, Judge Reiss applied the less-stringent First Amendment analysis set forth in Zauderer v. Office of Disciplinary Counsel,  471 U.S. 626 (1985).  Given what the appellants term the “controversial” information/disclosures mandated by the Act, they argue the U.S. Supreme Court’s decision in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980) and its stricter level of scrutiny applies.  Appellants further rely on Second Circuit precedent, arguing that the case of Int’l Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2d Cir. 1996), bars the state legislature from enacting a law that “trammel[s] manufacturer’s free speech rights to appease “consumer curiosity” and was ignored by the District Court.  The State of Vermont continues to argue that the District Court’s reliance on Zauderer and its less-stringent “rational basis” test was proper, in that the Act merely serves to provide consumers with “factual information.”

The Second Circuit panel reviewing the case addressed the issue of ripeness during oral argument, and remains, given the impact of the Act as the first of its kind to have a set effective date, at the forefront of debate over the regulation of GMO food and food products.  The Second Circuit’s decision bears watching, as the costs to industry resulting from enactment of the Act and the potential domino effect of similar acts being passed by other state legislatures could be significant and will require extensive advanced planning to ensure compliance.

The Second Circuit case is Grocery Manufacturers Association, et al. v. Sorrell, Case No. 15-1504.  The District Court case is Case No. 5:14-cv-117 and the Court’s order denying the preliminary injunction is Document #95.  A link to a .pdf copy of the Order is provided immediately here.

Article By Scott K.G. Kozak of Armstrong Teasdale

© Copyright 2015 Armstrong Teasdale LLP. All rights reserved

Mixing Things Up: Let’s Talk Recipes, Part Two of a Four-Part Series (Patent)

Discussions about protecting intellectual property often focus on cutting-edge technologies, corporate branding campaigns, and widely distributed artistic works like movies and music.  But let’s mix things up a bit.  Follow us through this four-part series as we answer a question that is sure to hit home for anyone with taste buds—can you protect a food recipe?  In Part 1, here, we examined whether food recipes are eligible for copyright protection.

CupcakeWe concluded that, although a recipe itself is not eligible, you can claim copyrights in certain commentary, illustrations, or other expressive elements used to present the recipe.  Here, in Part 2, we investigate whether patent protection offers a viable solution for chefs, bakers, restaurateurs, and others hoping to safeguard their culinary creations.  Later, in Parts 3 and 4, we will break down whether recipes are eligible for trade secret protection (Part 3) or trademark/trade dress protection (Part 4).

PART 2: Can you Patent a Recipe?

To qualify for patent protection, an invention must be useful, new, and nonobvious. See 35 U.S.C. §§ 101-103. It must also fall into one of the Patent Act’s defined categories of “patent-eligible subject matter” (some things are outright barred from receiving patent protection, such as a mathematical algorithm). See 35 U.S.C. § 101. To warrant patent protection, a recipe must satisfy all four requirements.

On the “patent-eligible subject matter” front, a recipe would need to qualify as either a “process,” a “machine,” a “manufacture,” or a “composition of matter.”  See 35 U.S.C. § 101.  Of those categories, we can safely eliminate “machine” as a potential candidate and focus on the remaining possibilities.

A “process” is “a mode of treatment of certain materials to produce a given result.  It is an act, or series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing.”Gottschalk v. Benson, 409 U.S. 63, 70 (1972). Most recipes are essentially a set of step-by-step instructions for combining specified ingredients to produce a dish or food product. Thus, as a “series of acts” that transforms ingredients into a different end product, a recipe could constitute a patent-eligible “process.”

A “manufacture,” more commonly called “an article of manufacture,” is “an article produced from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by handlabor or by machinery.” Diamond v. Chakrabarty, 447 U.S. 303, 308 (1980). A recipe itself does not qualify as an article of manufacture, but many consumer food products created according to a recipe likely qualify (think Hot Pockets® sandwiches, for example).

A “composition of matter” is “all compositions of two or more substances and all articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids, for example.” Chakrabarty, 447 U.S. at 308.  Most recipes—a basic cake batter recipe, for instance—call for the mechanical or chemical mixture of “fluids” and “powders or solids” (e.g., water and flour).  Accordingly, although a recipe is not a “composition of matter,” the end product could be.

Thus, a recipe can be a patent-eligible process, while a resulting dish or food product can be a patent-eligible article of manufacture or composition of matter. But whether or not a recipe is patent-eligible subject matter is only one of four hurdles along the road to patent protection. The recipe must also be useful, new, and nonobvious.  The bar for what counts as “useful” under the Patent Act is low and, as a result, virtually every recipe will satisfy the usefulness requirement.

When it comes to demonstrating that a recipe is “new” and “nonobvious,” however, the road gets much tougher.  Every recipe seeking patent protection must distinguish itself from the millions of recipes that preceded it (eating is, after all, one of our most basic needs). Not only are multitudes of recipes already known, but in many cases the properties and effects of the underlying ingredients are also well-known. Adding a roux to a soup, for example, will predictably thicken the soup. Adding chocolate chips to a cake recipe will predictably increase the likelihood that the resulting cake will taste like, well, chocolate. When examining patent applications, the U.S. Patent and Trademark Office often views the results obtained from combining well-understood ingredients as having been predictable or obvious to people of ordinary skill in the culinary arts.

But take heart, innovative foodies, because the Patent Office does occasionally grant patents for recipes, dishes, and food products.  Many of them involve an unconventional step, ingredient, or end product.  Check out, for instance, U.S. patent number 5,894,027 titled Milk and protein powder-coated cereal products; U.S. patent number 8,147,893 titled Refrigerator stable pressurized baking batter; U.S. patent number 5,510,137 titled Sweet ice stuffs and jellied foods; or U.S. patent number 8,236,366 titled Flavorful Waterless Coffee. As the Patent Office recently put it, “[i]f you look at most of these patents, you’ll find that the recipe was more likely to have been created in a laboratory than on a kitchen counter.”  Larry Tarazano. Can Recipes Be Patented?  United States Patent and Trademark Office. InventorsEye 4:3 (June 2013). With the popularity of modernist techniques like “molecular gastronomy” on the rise (molecular gastronomy focuses on transforming physical and chemical properties to produce new tastes and textures), we could see a slight uptick in recipe patents in the coming years.

In short, returning to our original question—can you patent a food recipe?—the answer is “yes, if you can overcome the difficult nonobviousness hurdle.” Stay tuned for the next part of our series as we investigate the benefits of safeguarding a recipe under the banner of trade secret protection.

ARTICLE BY Kyle N. Siegal of Lewis Roca Rothgerber LLP

©2015 All Rights Reserved. Lewis Roca Rothgerber LLP

Settlement Between U.S. Department of Labor and Oregon Blueberry Growers Vacated

Varnum LLP

In 2012, the Department of Labor accused Oregon blueberry growers of employing “ghost workers” resulting in minimum wage violations. The DOL then issued what is known as a “hot goods order” to block shipment of their product to market until the violations were remedied.  This, of course, created an untenable situation for the blueberry producers as their products were highly perishable. With no real alternative, the blueberry growers signed consent agreements with the DOL, in which they agreed to substantial fines and waived their rights to contest the allegations.

The blueberry growers later challenged the consent judgment and in January a federal magistrate judge agreed with the growers finding that “the tactic of putting millions of dollars of perishable goods in lock up was unlawfully coercive.” That decision was upheld just last week by the United States district judge. Invaliding consent judgments, particularly those with the federal government, is extremely difficult and rarely happens. But in this case, the combination of over-the-top, coercive of tactics by the DOL, as well as the court’s view that there was little or no evidence of underlying labor violations to begin with, paved the way for the growers in this case.

Article By:

Aaron M. Phelps
Of:
Varnum LLP

Supreme Court Will Rule on Whether Agency-Approved Beverage Label Can Be Challenged as ‘False Advertising’ in Federal Court

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On January 10, 2014, the U.S. Supreme Court agreed to hear an appeal by Pom Wonderful LLC against The Coca-Cola Company.  The Court will examine whether Pom can bring a federal Lanham Act false advertising claim against a Minute Maid juice product label that had been approved by the U.S. Food and Drug Administration (FDA).  (Pom Wonderful LLC v. The Coca-Cola Co., U.S. Supreme Court case no. 12-761).

At issue in the lawsuit is a Minute Maid label for “Pomegranate Blueberry Flavored Blend of 5 Juices.”  The label presents the words “Pomegranate Blueberry” in larger type than the remainder of the phrase.  Pom claimed that the label was misleading because the product contains 0.3 percent pomegranate juice and 0.2 percent blueberry juice.

A California federal trial court and the 9th Circuit federal appeals court in California both ruled that Pom could not bring a Lanham Act false advertising claim against the label, since it had been specifically examined and approved by the FDA.  Pom has argued that the decisions were contrary to established law in other U.S. courts, and that federal regulations establish a floor –but not a ceiling — on what an advertiser is required to do to avoid a claim that the advertising is false and misleading.  Coca-Cola has argued that product labeling that is specifically authorized by the Food, Drug and Cosmetic Act (FDCA) and approved by the FDA cannot be charged as false or misleading under another federal statute such as the Lanham Act.

Although the question before the Supreme Court is whether a private party can bring a Lanham Act claim challenging a product label regulated under the FDCA, the Supreme Court’s decision could potentially have significant implications for the alcohol beverage industry.  For example:

  • If the Supreme Court rules that a competitor cannot bring a Lanham Act claim against a label that has been approved by the FDA, a natural question is whether the same rule will apply with regard to alcohol beverage labels that have been reviewed and approved by the Alcohol and Tobacco Tax and Trade Bureau (TTB) (by its terms, the Federal Alcohol Administration Act does not preempt the Lanham Act); and
  • If a Lanham Act claim would be barred against labels approved by TTB, a question may arise about whether a Lanham Act claim would be barred on elements of the label that TTB does not specifically review as a matter of policy – such as contrast, size and placement of label elements.

The Supreme Court is expected to hear argument this spring and decide the case by June 2014.  Depending on the decision, alcohol beverage industry members could find they have additional insulation against a federal false advertising claim, but they may likewise be limited in bringing a federal false advertising lawsuit against a competitor’s label that has been approved by TTB.

Article by:

Robert W. Zelnick

Of:

McDermott Will & Emery

FDA (Food and Drug Administration) Declines Courts’ Requests to Define “Natural” with respect to GMO (Genetically-Modified Organisms) Foods

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The FDA recently issued a letter to three federal district court judges declining the courts’ requests to adopt a definition of “natural” or to state whether the terms “natural” or “all natural” can be used to refer to foods containing genetically-modified organisms (GMOs) to help resolve pending consumer class actions over the term. The FDA cited three reasons for its decision not to define the term(s): (1) it would prefer to use a public, administrative process than to define the term in the context of private litigation; (2) the definition implicates other agencies, most notably, the USDA; and, (3) the FDA has limited resources and other matters currently take priority.

As noted in our August 2013 Alert on the issue, Judge Yvonne Gonzalez Rogers of theNorthern District of California started the trend in Cox v. Gruma Corp., a case in which the plaintiff alleges that Gruma’s use of “all natural” on its tortilla shells violates various consumer protection laws because they contain genetically-modified corn. In Van Atta v. General Mills, pending in Colorado and involving GMOs in granola products, a magistrate judge agreed with Judge Rogers and recommended a stay of proceedings in the case pending the FDA’s response to Judge Rogers’s request. Most recently, in Barnes v. Campbell Soup Co., also pending in the Northern District of California and involving GMOs in various soups, a different judge also stayed the case pending the FDA’s response.

These cases are potentially quite important because there are many pending consumer class actions, particularly in California, over whether the use of some variant of the term “all natural” is proper in light of one or more ingredients in the food at issue. Indeed, some quip that food labeling litigation has replaced tobacco and asbestos as the favorite category of suit for the plaintiffs’ bar. Thus, the FDA’s response to the request by these courts, and the courts’ further actions based on the response, could resolve or guide the resolution of many of these cases.

In a related development, the Grocery Manufacturers’ Association has recently filed a citizen’s petition asking FDA to state that GMO foods may be labeled “natural.” The FDA alluded to the possible filing of this petition in its letter, but did not state whether it is willing to take up the issue using that procedure, which does allow for public comment.

A copy of the FDA’s letter can be found here.

Article by:

Of:

Barnes & Thornburg LLP