Category: Food & Hospitality

Food Packaging: FSANZ Reports on Nanotechnology in Food Packaging Find No Health Risks

food packagingA review of scientific literature on exposure to nanoscale silicon dioxide, titanium dioxide, and silver in food, including from sources of food packaging, did not find any significant health risks, according to the results of a study which was recently commissioned by Food Standards Australia New Zealand (FSANZ).  The results of the study were published in two reports: Nanotechnologies in Food Packaging: an Exploratory Appraisal of Safety and Regulation and Potential Health Risks Associated with Nanotechnologies in Existing Food Additives.

The report on nanotechnologies in food packaging noted that current applications of nanomaterials in food packaging include:

  • Enhancement of barrier properties through the incorporation of nano-fillers (e.g., nano-clay)

  • “Active” food packaging, with controlled release of active substances such as antimicrobials to improve the shelf-life of food (e.g., nanosilver)

  • Improvement of physical characteristics to make the packaging more tensile, durable, or thermally stable (e.g., nano-titanium dioxide, titanium nitride)

The food packaging report states that no evidence was found in the literature review to indicate that nano-clay is likely to cause adverse effects on health when used in food packaging.  Further, the majority of migration studies on nanosilver have shown levels of migration of ionic silver into foods and food simulants below thresholds set by well-established scientific and regulatory bodies, such as the European Food Safety Authority’s (EFSA) specific migration limit (SML) of 0.05 mg Ag/kg food. Overall, the data reviewed for most of the studied nanomaterials in food packaging indicate that migration of intact nanoparticles from food packaging into food simulants is negligible, implying consumer exposure to these materials is likely to be low. The authors conclude that this suggests “there is low potential for safety issues related to the ‘nano-ness’ of the materials incorporated into food packaging.”

The report points out that the majority of the existing patents for nanomaterials originate in the United States.  No patents for nanomaterials in food packaging were identified in Australia and New Zealand, implying that domestically-sourced nanomaterials may not presently be used in food packaging applications in Australia or New Zealand; however, the report suggests that food and packaging materials incorporating imported nanomaterials may be used in Australia and New Zealand.

While neither report identified any health concerns from any of the nanotechnologies described, FSANZ did note that nanotechnology is a rapidly evolving field, and that the conclusions set forth in the reports may need to be revisited as the sophistication and application of nanotechnologies to food and food packaging continues to advance.

ARTICLE BY Packaging Law at Keller and Heckman

© 2016 Keller and Heckman LLP

Biomass Research And Development Initiative Provides Seven Projects With Up To $10 Million In Funding

On May 9, 2016, the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), and the National Institute of Food and Agriculture (NIFA) announced the recipients of up to $10 million in funding through the Biomass Research and Development Initiative (BRDI). BRDI is a joint program through DOE and USDA that helps develop sustainable sources of biomass and increase the availability of biobased fuels and products. DOE selected two of the grant winners to receive between $1 million and $2 million: the Ohio State University (OSU) project is “Biomass Gasification for Chemicals Production Using Chemical Looping Techniques,” and the Massachusetts Institute of Technology (MIT) project is “Improving Tolerance of Yeast to Lignocellulose-derived Feedstocks and Products.”

USDA then selected five grant winners to receive a total of $7.3 million in funding:

  • University of California-Riverside, to convert poplar to ethanol and polyurethane via pretreatment and lignin polymer synthesis;

  • University of Montana, to quantify ecological and economic opportunities of various forest types and to quantify benefits of replacing fossil fuel with forest-based bioenergy;

  • North Carolina Biotechnology Center, to optimize production of educational resources on biomass sorghum production in the Mid-Atlantic region;

  • Dartmouth College, to overcome the lignocellulosic recalcitrance barrier; and

  • State University of New York College of Environmental Science and Forestry, to provide life cycle understanding for the production of willow and forest biomass to mitigate investment risk.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

FDA Issues Menu Labeling Final Guidance

Tomato labelThe enforcement date will likely begin in May 2017.

The US Food and Drug Administration (FDA) issued its final guidance on April 29 on Menu Labeling (Final Guidance).[1],[2] Importantly, the FDA intends to begin enforcing the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Rule (Menu Labeling Final Rule)[3] one year from the date that the Final Guidance’s Notice of Availability (NOA) is published in the Federal Register. The NOA for the Final Guidance is expected to be published in early May 2016. Thus, enforcement of the Menu Labeling Final Rule will likely begin in May 2017.

The 58-page Final Guidance is largely a reprint of the previous draft guidance of the same name. The Final Guidance contains many nonsubstantive changes from the draft guidance and provides additional examples (as well as several new, revised, and/or reformatted questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record-keeping requirements).
The more notable changes in the Final Guidance include the following:

  • The inclusion of examples for temporary menu items (e.g., jack o’lantern cookies or holiday gift tins of popcorn).

  • Exemptions for private off-site catering events from menu labeling, even where the catered items are standard menu items.

  • Mobile vendors who walk through entertainment venues (such as baseball parks) and sell food and beverages are not considered covered establishments, and thus are not required to comply with the Menu Labeling Final Rule.

  • Additional information provided to explain a menu board, where a “menu board” can include multiple forms of written material. The crucial factor of what constitutes a menu board is whether the written material is or is a part of the primary writing from which a customer makes an order selection.

  • Standalone coupons that can be used to place an order (i.e., the coupon contains the name of the standard menu item, the price, and the phone number/website) must provide calorie declaration. However, if a coupon does not include a web address or phone number for placing orders, then it is not considered a menu, and a calorie declaration is not required.

  • An additional description for the inclusion of sauce(s) nutrition information served in multiserving standard menu items.

  • Confirmation that the calorie declaration requirements for electronic menus and menus on the Internet are the same as the requirements for printed menus.

  • Clarification that standard menu items in different sizes are not considered variable menu items unless they come in different flavors, varieties, or combinations and are listed as a single menu item.

  • Additional examples of declarations of calories in combination meal products when a meal comes in multiple sizes with multiple choices of sides.

  • Clarification that, if a covered establishment has multiple digital menu boards with rotating displays, then the disclosure statements should appear on each rotating display of each digital menu board to help ensure that the statements are clear and conspicuous to the consumer and posted prominently.

  • Calorie declarations directly on the package of grab-and-go items should declare the calories for the entire package as they are usually prepared and offered for sale (rather than based on reference amounts customarily consumed (RACCs)).

  • Any substantiation records for nutrient values should be maintained either at the covered establishment or the corporate headquarters for the duration of the time that the standard menu items are offered for sale at the covered establishment. FDA also recognizes that it is not necessary to maintain information on nutrient values for foods that are no longer standard menu items and are no longer offered for sale at a covered establishment, because this information is no longer beneficial for consumers if they cannot purchase those items.

  • Further explanation of when FDA-required statements from responsible individuals employed at covered establishments for nutrient determinations are required, along with sample statement language.

  • Additional guidelines for alcohol—

    • For caloric declaration of multiple beers that have the same calorie amounts, a single calorie declaration can be used, provided that the declaration specifies that the calorie amount listed represents the calorie amounts for each individual beer variety.

    • Clarification that, to the extent that beers on tap are not self-serve, they are exempt from the requirements for calorie declarations of standard menu items.

    • Further explanation regarding the acceptability of covered establishments’ reliance on calorie information and nutrition information on alcohol beverage labels consistent with Alcohol and Tobacco Tax and Trade determinations.

    • Discussion about the inclusion of calorie information for “suggested” alcohol pairings.

    • The applicability of the Menu Labeling Final Rule to covered establishments that sell only one type of standard menu item (e.g., beer).

As previously stated, the Menu Labeling Final Rule and Final Guidance provide that the categories of covered establishments include not only restaurants and similar retail food establishments, but also movie theaters, amusement parks, bowling alleys, sports arenas, other entertainment venues, food service vendors, food takeout and delivery establishments, quick service restaurants, table service restaurants, convenience stores, coffee shops, bakeries, delis, grocery stores, supercenters, and fitness clubs.
However, the Common Sense Nutrition Disclosure Act of 2015, which passed in the US House of Representatives and is pending in the US Senate, would

  • direct the secretary of the US Department of Health and Human Services to issue new rules that allow a food establishment to post nutritional information exclusively on its website if the majority of its orders are placed online,

  • clarify that advertisements are not necessarily considered menus, and

  • aim to protect establishments from being sued for human error.[4]

We will continue to monitor congressional and FDA menu labeling activities.

Article By Robert G. Hibbert, Kathleen M. Sanzo, Christine Forgues Schlenker & Hilary L. Lewis of Morgan, Lewis & Bockius LLP
Copyright © 2016 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

[1] FDA CFSAN Constituent Update, FDA Issues Final Guidance on Menu Labeling (Apr. 29, 2016), available here.

[2] A Labeling Guide for Restaurants and Retail Establishments Selling Away From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 C.F.R. 101.11): Guidance for Industry (Apr. 2016), available here.

[3] Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Calorie Labeling of Articles of Food in Vending Machines; Final Rule. 79 Fed. Reg. 71156 (Dec. 1, 2014), available here.

[4] See Text of the Common Sense Nutrition Disclosure Act of 2015, H.R. 2017 (Referred to Senate Committee Feb. 22, 2016), available here.

Hotels and Hospitality in Cuba: OFAC and Obama Paving the Way

cuba_800_11429With more flights, relaxing regulations, a historic presidential trip to Cuba, and news of hospitality services expanding into Cuba, the pathway into Cuba for hotels and hospitality companies seems smooth.  But businesses should look out for the potential hurdles and compliance risks.  Don’t fret – we can help you welcome your guests.

Reserve Your Room: Regulatory Background. Since President Obama announced the intent to improve our country’s relationship with Cuba and its people a year and a half ago, several revisions to the sanctions regime have focused on easing restrictions related to travel between the two nations.  In February 2016, Cuba and the United States agreed to reestablish commercial air travel between the two countries.  According to media reports, this agreement means the potential for 110 daily round-trip flights in and out of Cuba, including 20 daily flights to Havana.

Soon after the agreement was announced, major U.S. airlines submitted applications to fly commercial flights to Cuba.  Though tourist travel is still prohibited, twelve fairly broad categories of travel are authorized, including family visits, travel for government work, journalism, professional research, humanitarian work and educational activities, and “people-to-people” educational travel.

In mid-March of this year, the U.S. Department of Treasury’s Office of Foreign Assets Control (OFAC) again revised the Cuban Asset Control Regulations (CACR), permitting more travel-related transactions.  According to OFAC, the steps “expand opportunities for economic engagement between the Cuban people and the American business community.”  The agency announced the changes in preparation for President Obama’s historic trip to Cuba.

  • People-to-people educational travel. Previously, the general authorization for educational travel required that trips took place under the sponsorship of an organization and required that a representative from the organization accompany the travelers. The regulations no longer require booking through an authorized organization when going to Cuba under the people-to-people educational travel general license. This means that U.S. persons can freely travel to Cuba to engage in educational exchange activities that enhance contact with the Cuban people, support civil society in Cuba, or promote Cubans’ independence from their government, as long as they keep records of the travel transactions and full-time schedule of activities.

  • Financial Transactions. The regulations enable U.S. banks to process U.S. dollars and travelers’ checks from Cuban banks, to conduct U-turn transactions in which Cubans have an interest, and to allow Cuban nationals to open bank accounts to receive payments in the U.S.

  • Business Presence. In addition, the regulations allow certain carrier and travel services providers to maintain a business presence in Cuba under a general license.  This means that travel-service providers are authorized to establish and maintain subsidiaries, branches, offices, joint ventures, franchises, and other business relationships with any Cuban national, and enter into all necessary agreements or arrangements with such entity or individual.

These changes encourage much more travel between Cuba and the United States, ease restrictions that affect the ability to operate hotels and hospitality services in Cuba, and demonstrate a policy shift in favor of facilitating business, particularly in the travel sector, in Cuba.

Checking In: President Obama’s Historic Visit.  In late March 2016, President Obama visited Cuba as the first sitting U.S. president to visit Cuba since Calvin Coolidge visited in 1928.  Not only was President Obama’s visit a diplomatic feat as he quoted Cuban independence poet Jose Marti’s line: “Cultivo una rosa blanca” (“Cultivate a white rose”) in a live address on Cuban television, but it was also a marked invitation for more American business involvement in the island nation.  Notably, Marriott CEO Arne Sorenson accompanied President Obama on his visit.  According to media reports, Marriott is pursuing business opportunities to run or develop hotels on the island, and to provide training and opportunities for Cuban nationals to supply hotel needs.

Enjoy Your Stay: A Suite of Opportunities.  As a result of the steady changes in the travel regulations, many hotels and hospitality companies are eager to take advantage of the opportunities that await in Cuba.  Even before the most recent updates announced this year, Airbnb announced its presence in Cuba to provide bookings for U.S. travelers in the authorized travel categories.  More recently, the company announced it has received permission from OFAC to open its doors to non-U.S. travelers as well.  Starwood has reportedly signed three deals to open properties in Havana, apparently being the first hospitality company to obtain specific authorization from OFAC to operate hotels in Cuba.  We think this signals OFAC’s willingness to use its licensing authority favorably for hotel and hospitality companies looking to develop in Cuba.

Earlier this month, a trade fair in Havana hosted a hall full of companies in the construction industry eager to get in on the ground floor of real estate and hotel projects that seem to be on the horizon.  U.S. travel to Cuba reportedly increased between 77 percent in 2015, and this upward trend is expected to continue as a result of the recent regulatory changes.  As the travel restrictions ease, travel-related businesses may gain greater latitude to develop the infrastructure to support such travelers and provide economic benefits to the Cuban people.

Check All Your Belongings: Compliance Challenges to Consider

  • Working under General Licenses. Though there is a general license authorizing certain travel services, providing lodging services is still prohibited unless specifically licensed by OFAC. Tourist travel is still prohibited by statute. Businesses that wish to operate under the general licenses must put together procedures that comply with these restrictions.

  • Getting Authorization. In order to effectively negotiate and finalize agreements with Cuban counterparties for the provision of services outside the general licenses, U.S. companies must receive authorization from OFAC.  This makes doing business difficult because putting in the resources and time to apply and receive authorization may not make business sense unless companies have concrete opportunities.  OFAC is currently inundated with applications and Cuba questions.  Hotel and hospitality companies looking to expand in Cuba should plan as early as possible and be prepared for the license application process and approval to take several months.

  • Restrictions on Property and Development. The inability to own property outright under Cuban law is an obstacle for many hotel companies that seek to invest in facilities that will maintain and build their brands.  It is a challenge to find an existing property to develop or property on which to build. It can be an even greater challenge to import the materials needed to develop and maintain the property.  Even if a company acquires authorization to build and develop a hotel, there will be a plethora of suppliers who may also need to seek authorization.  S. businesses must plan accordingly when seeking authority to develop properties.

  • Dealing with the Cuban Government. S. businesses will have to learn quickly about negotiating with the Cuban government and getting government approvals because most potential counterparties are state-owned, and each step in the development process will likely include government involvement. This also raises corruption risks (Don’t forget the FCPA!) as companies wine and dine potential counterparties and work toward getting permits.

  • Employee Base. For foreign companies seeking to establish a brand in the market, restrictions on hiring may pose extreme challenges.  Employment in Cuba is not left to market dynamics. Hiring Cuban employees involves working with the Cuban government and hiring the personnel designated by the government.  Generally the employer is required to pay the Cuban government directly, and the government pays the employees.  Complying with such Cuban laws may fly directly in the face of a company’s business model and may compound the U.S. law compliance challenges.

  • Cuban Law. Having counsel who understand the Cuban legal landscape and regulatory challenges will be crucial for U.S. companies.  Structuring deals in Cuba that comply with Cuban law can be tricky.  The legal infrastructure in Cuba for foreign investment is not well developed, so U.S. companies will face a steep learning curve to successfully finalize and implement deals in Cuba.  Moreover, Cuban lawyers have very different ethical obligations than U.S. clients may be used to (including a virtual complete lack of attorney-client privilege).

Even with the host of challenges, exploring the Cuban market presents an intriguing opportunity for hotel and hospitality companies.  With the right compliance strategy and the right team, U.S. businesses could enjoy their stay in Cuba for years to come.

Article By Fatema K. Merchant & Lisa C. Mays of Sheppard, Mullin, Richter & Hampton LLP

© 2016, Sheppard Mullin Richter & Hampton LLP.

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

Solazyme Becomes TerraVia, Shifts Focus To Food And Specialty Ingredients

On March 11, 2016, Solazyme announced a name change to reflect a new focus on food, nutrition, and specialty ingredients instead of biofuels. TerraVia™ (TerraVia), as Solazyme is now known, will create value in plant-based food through a transformational algae innovation platform. TerraVia will focus on developing AlgaVia® Whole Algae ingredients (lipid rich powder and protein) and AlgaWise™ Algae Oils, as well as consumer food products that currently include Thrive® Culinary Algae Oil. The Company will also focus on animal nutrition ingredients and personal care ingredients, including AlgaPur Oils. The fuels, industrial oils, and Encapso™ business previously run by Solazyme have been moved to a unit called Solazyme Industrials, which is likely to be sold off. This shift towards high-value, low volume product areas is not surprising given the current low oil prices that are hurting biofuel profits, and is a key component in the continued success of the biobased industry.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.
©2016 Bergeson & Campbell, P.C.

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

Agriculture, Food, and Health Issues to Watch for 2016

Label Food Organic.jpgAs the agriculture and food industries head into the new year, a number of important cases and regulatory issues that have the potential to dramatically affect the industry are front and center. Below, an overview of the status of several of the key cases and issues that related industries should keep an eye on during 2016.

Waters of the United States

On October 9, 2015, following an earlier ruling by the U.S. District Court for the District of North Dakota, the United States Circuit Court for the Sixth Circuit issued a nationwide stay of the so-called “Waters of the United States” or “WOTUS” rule. The stay halted implementation of the WOTUS rule, pending resolution of jurisdictional issues that were the subject of oral argument on December 8, 2015. Those jurisdictional issues are focused on whether the Sixth Circuit is the proper venue to hear challenges to the rule. A ruling is expected in 2016.

A number of district court cases across the country also remain pending, and the District of North Dakota’s earlier injunction against implementation of the WOTUS rule in 13 states, including Missouri, remains in place.

Vermont Act 120

On October 8, 2015, the U.S. Circuit Court of Appeals for the Second Circuit heard oral argument of an appeal filed by the Grocery Manufacturers Association and other plaintiffs seeking review of the U.S. District Court for the District of Vermont’s denial of their Motion for Preliminary Injunction on April 27, 2015. The motion sought a preliminary injunction enjoining implementation of Vermont Act 120, passed on May 8, 2014, with an effective date of July 1, 2016. Act 120 would, among numerous provisions, mandate new labeling requirements on the part of manufacturers and other food processors for any food that is “produced with genetic engineering,” “partially produced with genetic engineering,” or “may be produced with genetic engineering.” Violators of Act 120 are subject to civil penalties of up to $1,000 per day, per product.

A decision is expected in the first two quarters of 2016 in advance of the July 1, 2016, effective date of the law.

Federal Activity Regarding GMOs and the Safe and Accurate Food Labeling Act

The U.S. House of Representatives passed the Safe & Accurate Food Labeling Act (SAFL) on July 23, 2015. The SAFL Act would, among other things, serve to pre-empt any state laws governing labeling of GMO-containing food products, including Vermont’s Act 120 due to become effective on July 1, 2016. Despite pressure on the U.S. Senate to address the SAFL Act and pass a companion or similar bill before the end of 2015, efforts to include any such bill or related provisions in the year-end omnibus spending bill were unsuccessful. Senate Agricultural Committee Group leaders, including Sen. Debbie Stabenow, D-Mich., have pledged to make the issue a top priority in January 2016, and many expect Sen. John Hoeven, R-N.D., to play a role in trying to secure passage of a bipartisan bill.

Food Safety Modernization Act Roll-Out

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, and represents the most comprehensive overhaul of the U.S. food safety regulatory scheme since the passage of the Food, Drug and Cosmetic Act in 1938. For nearly five years, the U.S. Food and Drug Administration (FDA) has been developing the seven final rules that implement FSMA. Each final rule impacts a different fundamental area of the U.S. food system.

In September and November 2015, the FDA issued the first five of the seven final rules: (1) Preventive Controls for Human Food; (2) Preventive Controls for Animal Food; (3) Foreign Supplier Verification Program; (4) Standards for Produce Safety; and (5) Accredited Third-Party Certification. The issuance of these rules initiates the countdown for the relevant compliance deadlines for covered entities.

It is anticipated that the final two FSMA rules regarding Sanitary Transportation and Intentional Adulteration will be issued on March 31, 2016. The Sanitary Transportation final rule will establish criteria for the sanitary transportation of food, including criteria targeted at shipping conditions and practices, employee training, and record keeping. The Intentional Adulteration final rule will require domestic and foreign food processing facilities to address vulnerabilities in their operations to prevent acts on the food supply intended to cause large-scale public harm. In 2016, the FDA will also be working with certain alliance groups to further develop FSMA compliance and enforcement guidance.

FDA Menu Labeling Requirements

Section 4205 of the Affordable Care Act charges the FDA with establishing labeling requirements for certain retail food establishments and vending machines. On December 1, 2014, the FDA issued two rules requiring calorie information to be listed on menus and menu boards at retail food establishments if they are a part of a chain of twenty or more locations operating under the same name and offering for sale substantially the same restaurant-type food items.

In July 2015, the FDA announced that the compliance deadline for the menu labeling rule was being extended by one year. All covered establishments (e.g., restaurants, grocery stores, and gas station convenience stores) now have until December 1, 2016, to identify calorie count and other information on their menus and menu boards as required by the FDA menu labeling rules.

Article By Laura A. Bentele, Scott K.G. Kozak & Jonathan D. Valentino of Armstrong Teasdale
© Copyright 2016 Armstrong Teasdale LLP. All rights reserved

2015 FDA Wrap-Up and 2016 Regulatory Priorities

Happy New Year! This article will revisit and update the status of significant regulatory issues in 2015 and assess 2016 FDA priorities in the food area.

2015 Overview

  • Office of Dietary Supplement Programs

    On December 21, 2015, the FDA announced the creation of the Office of Dietary Supplement Programs (ODSP).1 The program was formerly a division under the Office of Nutrition Labeling and Dietary Supplements, now known as the Office of Nutrition and Food Labeling. The Department of Justice brought a significant number of civil and criminal cases against the makers of dietary supplements in 2015. The creation of ODSP supports the mission of monitoring the safety of dietary supplements and taking action against entities that present a risk of harm to the consumer.

  • “Natural” Label Claims

    In 2015, the FDA received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling. The term “natural” has been the subject of many food labeling lawsuits. In direct response to requests from the public, the FDA has extended the comment period on the use of the term “natural” in food labeling to May 10, 2016.2 The Morgan Lewis FDA team is currently working on an analysis of the comments submitted to date. Please contact the FDA team if you are interested in submitting a comment.

  • Food Safety and Modernization Act (FSMA) Regulations

    As discussed in our November 16 post, in late 2015, the FDA published three final rules under FSMA: the Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule),3 the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule),4 and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Accredited Third-Party Certification rule).5 These rules implement sections of FSMA geared toward protecting the US food supply. As discussed below, the FDA plans to take further action to implement sections of FSMA in 2016.

  • Menu Labeling Requirements

    As discussed in our post July 13, 2015, FDA released its final rule on menu labeling in restaurants on December 1, 2014, and later extended the date for compliance from December 1, 2015 to December 1, 2016. The rule will require restaurants and similar retail food establishments that (1) sell “restaurant-type food,” (2) are part of a chain of 20 or more locations, (3) do business under the same name or slight variations of each other, and (4) offer for sale substantially the same menu items as the other business locations, to disclose calorie information on menus and menu boards.

  • New York Sodium Warning

    AThe New York City Department of Health and Mental Hygiene Board of Health (Board of Health) Sodium Warning Label Rule went into effect on December 1, 2015. The Rule requires food service establishments in New York City with 15 or more locations nationwide to provide a warning for menu items that contain 2,300 mg or more of sodium. New York City is the first city in the United States to require chain restaurants to include sodium warnings on menus or menu boards. Chains with 15 or more locations have 90 days to comply with the new rule before they face a $200 fine. The rule elicited responses from the National Salt Institute and the National Restaurant Association. The National Restaurant Association filed suit against the Board of Health, claiming that it did not have the authority to require such a warning. We will monitor this lawsuit and provide updates in 2016.

2016 FDA Regulatory Publication Agenda

On December 15, 2015, the FDA released its Semiannual Regulatory Agenda.6 The Agenda outlines the following outstanding proposed and final rules for 2016 with respect to food:

  • Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods:7

    This proposed rule was published in late 2015. It would establish requirements concerning compliance for using a ‘‘gluten-free’’ labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million gluten in the food. FDA has acknowledged that it is difficult to scientifically detect gluten in fermented and hydrolyzed foods.8 Accordingly, the rule would require manufacturers to make and keep records to show that (1) the food meets the definition for “gluten-free” in 21 C.F.R. 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis; (2) the manufacturer adequately evaluated the processing for any potential for gluten cross-contact; and (3) where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. FDA is accepting comments until February 16, 2016.

  • Food Labeling: Revision of the Nutrition and Supplement Facts Labels:9

    Under the Food, Drug and Cosmetic Act (FD&C Act), this final rule would amend the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The rule would modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. The FDA reopened the comment period for this final rule in October 2015, and anticipates issuing a final rule in March 2016.10

  • Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed (RACCS):11

    Under the Nutrition Labeling and Education Act of 1990 and the FD&C Act, this final rule would modify labeling regulations for foods to provide updated RACCs for certain food categories to assist consumers in maintaining healthy dietary practices. The rule would also amend the definition of single-serving containers; the label serving size for breath mints; and provide for dual-column labeling, which would provide nutrition information per serving and per container or unit, as appropriate. The FDA anticipates releasing the final rule in March 2016.12

  • Focused Mitigation Strategies to Protect Food Against Intentional Adulteration:13

    Under FSMA, the final rule would require domestic and foreign food facilities that are required to register with the FDA to address hazards that may be intentionally introduced by acts of terrorism. Food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. The FDA anticipates releasing the final rule in June 2016.14

  • Sanitary Transportation of Human and Animal Food:15

    Under the 2005 Sanitary Food Transportation Act and FSMA, this final rule would establish requirements for parties and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. The FDA anticipates publication of the final rule in April 2016.

Article By Robert G. Hibbert & Heather A. Dorsey of Morgan, Lewis & Bockius LLP

Copyright © 2015 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

1 U.S. Food & Drug Admin., FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership (Dec. 21, 2015) http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm478303.htm.
2 80 Fed. Reg. 80178 (Dec. 28, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-12-28/pdf/2015-32471.pdf; 80 Fed. Reg. 69905 (Nov. 12, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-12/pdf/2015-28779.pdf.
3 80 Fed. Reg. 74354 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28159.pdf.
4 80 Fed. Reg. 74226 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28158.pdf.
5 80 Fed. Reg. 74570 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28160.pdf.
6 80 Fed. Reg. 77960 (Dec. 15, 2015).
7 Id. at 77963; 80 Fed. Reg. 71990 (Nov. 18, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-18/pdf/2015-29292.pdf.
8 78 Fed. Reg. 47154.
9 80 Fed. Reg. 77764, 77965 (Dec. 15, 2015).
10 Id. at 77764.
11 80 Fed. Reg. 77765, 77965 (Dec. 15, 2015).
12 Id. at 77765.
13 Id. at 77768.
14 Id.
15 Id. at 77771.