YOUR SOURCE ON FOOD LITIGATION AND REGULATION

On November 2, the Food Safety and Inspection Service (FSIS or the Agency) released its Fiscal Year (FY) 2017–2021 Strategic Plan,1 which provides a framework for FSIS to address continual challenges with inspection modernization and articulates FSIS’s goals for meeting its public health mission over the next four years.

FSIS strongly asserts that it has successfully implemented the 2011–2016 Strategic Plan with the collaborative assistance of industry, Agency employees, and the public. The FSIS Constituent Update indicates that these efforts have culminated in the Agency’s system of food safety inspection continuing to be one of the most reliable and well-documented in the world.2

On October 5, the US Department of Agriculture’s (USDA’s or the Agency’s) Food Safety and Inspection Service (FSIS) released an updated version of its Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submission (the Guidance).1 All labels with special claims, including animal-raising claims, must be submitted to FSIS prior to being used on a product under 9 CFR 412.1(c)(3). Examples of animal-raising claims include “grass-fed,” “raised without antibiotics,” and “free-range.”

After initial delays that we covered in our previous post, FDA Delaying Enforcement (Again) for Menu Labeling Final Rule,1 we now report that on April 29, FDA issued its Final Guidance on Menu Labeling (Final Guidance).2,3 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)4 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The 58-page Final Guidance is largely a reprint of the previous draft guidance of the same name. The Final Guidance contains many nonsubstantive changes from the draft guidance and provides additional examples (as well as several new, revised, and/or reformatted questions and answers on topics such as covered establishments, alcoholic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).

To view the more notable changes in the Final Guidance, read our LawFlash: FDA Issues Menu Labeling Final Guidance.

In a decision that will impact numerous lawsuits in the lower courts, in Kane v. Chobani (No. 14-15670 (9th Cir. Mar. 24, 2016)) the US Court of Appeals for the Ninth Circuit stayed proceedings in a class action regarding the alleged misuse of the term “natural” on food labels until the US Food and Drug Administration (FDA) has completed its review of the term.

Background

The case arises from Chobani’s use of the terms “only natural ingredients” and “all natural” on the labels of its yogurt products. Plaintiffs originally brought suit in the Northern District of California (see Kane, et al v. Chobani, LLC, No. 5:12-cv-02425-LHK (N.D. Cal.)) claiming, among other things, that characterizing the yogurt as “natural” was misleading because the product included color additives that were not natural, and the fruit and vegetable juices in the product “were highly processed unnatural substances.” To establish standing, a plaintiff must prove actual reliance on the defendant’s misrepresentations—here, that the plaintiff purchased the Chobani yogurt that he or she otherwise would not have purchased (or would not have spent as much money on) in reliance on the fact that the yogurt was “natural.” The lower court dismissed the case on the ground that plaintiffs failed to plead sufficient reliance on the term.

On February 26, two cheese companies and one of their corporate officers, Michelle Myrter, pleaded guilty in federal court for selling “real parmesan and romano cheese” that contained high amounts of cellulose and other improper fillers. The companies, Universal Cheese & Drying Inc. and International Packing LLC, each pleaded guilty in federal court to one count of conspiring to introduce misbranded and adulterated cheese products into interstate commerce and to commit money laundering. Each company also forfeited to the United States $500,000.1 Myrter pleaded guilty as a responsible corporate officer to one misdemeanor count of aiding and abetting. She faces up to one year in prison and/or a $100,000 fine.

The recipe for parmesan and romano cheeses are standardized (also called a product’s “standard of identity”) and regulated by the US Food and Drug Administration (FDA). The investigation into the two cheese companies was instigated after a fired plant manager tipped off the FDA that the companies’ cheeses contained improper fillers. The US Department of Justice (DOJ) alleged that Myrter and the companies knew that the cheese they sold did not meet the standards of identity for parmesan and romano cheese, but they nevertheless marked the products as real parmesan and romano cheese. Notably, the DOJ acknowledged that the adulterated products never posed a threat to the health or safety of consumers.

On February 23, the US Food and Drug Administration (FDA) issued a guidance document titled Guidance for Industry: Nutrient Content Claims; Alpha-Linolenic Acid (ALA), Eicosapentaenoic Acid (EPA), and Docosahexaenoic Acid (DHA) Omega-3 Fatty Acids; Small Entity Compliance Guide1 (Guidance). The Guidance was issued pursuant to the Final Rule regarding omega-3 nutrient content claims issued in 2014, which took effect on January 1, 2016.2 Thus, this Guidance was issued after the compliance date. The Final Rule was issued in response to three notifications from seafood and fish oil producers that wished to make nutrient content claims for ALA, DHA, and EPA on their product labels. Specifically, two of the producers manufactured fish oil–based dietary supplements.

The Guidance clarifies food producers’ responsibilities with regard to ALA, EPA, and DHA nutrient content claims and prohibits certain claims. The prohibition on certain claims has wide implications for foods that previously made DHA, EPA, and certain ALA claims. Possible products affected include seafood, eggs, pasta, dairy products, juices, baby food, cooking oil, certain meats, and fat-based spreads.

Nutrient Content Claims Generally
Nutrient content claims are labeling claims that characterize the level of a nutrient in a food. The Food, Drug, and Cosmetic Act (FD&C Act) requires that companies notify FDA of a nutrient content claim at least 120 days before a food that bears the claim is introduced into interstate commerce. Among other requirements, nutrient content claims must 1) be based on an authoritative statement that identifies a nutrient level to which the claims refer and 2) be stated in a manner in which the public can understand the relative significance of the nutrient in the context of daily diet. In the Final Rule, FDA prohibited the claims set forth in the notifications for DHA and EPA and some ALA claims because they did not meet these requirements.

On January 29, the US Food and Drug Administration (FDA or the Agency) issued Import Alert 99-40: Genetically Engineered (GE) Salmon, which bans the import of any human or animal food containing GE salmon until the FDA publishes final labeling guidelines for informing consumers of such content.1

The import alert was issued to comply with language introduced in the Consolidated and Further Continuing Appropriations Act by Senator Lisa Murkowski (R-AK), an act signed into law by President Barack Obama in December 2015. The bill ordered the FDA to block imports of GE salmon until the FDA issued final guidance requiring food derived from GE salmon to be labeled as such. Currently, Alaska is the only state that requires labeling of genetically modified fish.

The mandate in the omnibus bill states, “[d]uring FY16 the FDA shall not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon until FDA publishes final labeling guidelines for informing consumers of such content.” The law also requires the FDA to allocate at least $150,000 of its funding to developing and implementing guidance to disclose to consumers whether salmon is genetically engineered.

On November 12, 2015, the Food and Drug Administration (FDA) announced the establishment of a docket (Docket No. FDA–2014–N–1207) to receive information and comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering.1 In direct response to subsequent requests from the public, FDA extended the closing date for the relevant original comment period from February 10, 2016 to May 10, 2016.2

To date, FDA has not developed an official definition for the term “natural,” although it has made public statements indicating the uses of the term that it accepts. For example, in a proposed rule published in 1991, FDA stated that the word ‘‘natural’’ was often used to describe a food that is composed only of substances that are not manmade and is, therefore, somehow more wholesome. In the same proposed rule, FDA stated that their informal policy considered “natural” to mean that nothing artificial or synthetic is included in, or has been added to, a product that a consumer would not normally expect. However, as a result of unclear direction from public comments, in the final rule published in 1993, FDA stated that it would not define the term “natural” but would instead maintain its policy of interpreting the term as meaning that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.”

The National Oceanic and Atmospheric Administration (NOAA) published a final rule on January 13 that implements the Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico (Gulf Aquaculture Plan). The plan allows for the first time the commercial farming and harvesting of seafood fish in federal waters off the Gulf of Mexico.1 It is intended to encourage commercial farming and harvesting of seafood in federal waters and has the potential to significantly expand US seafood production and trade. The Gulf Aquaculture Plan took effect on September 3, 2009, and this final rule implementing it will take effect on February 12, 2016.

Aquaculture or aquafarming is the practice of raising marine species in controlled environments rather than harvesting them in the wild. According to NOAA, US aquaculture production yields approximately $1.3 billion annually, which is several times less than the $5 billion annual production of wild-capture fisheries.2 Nevertheless, global aquaculture supplies half of the world’s seafood, and the aquaculture industry is expected to increase significantly in the next decade.3

Currently, there are no commercial aquaculture operations in US federal waters, which begin three to nine nautical miles off the state coasts and extend offshore for 200 miles, although there are such operations in state waters. Prior to the Gulf Aquaculture Plan, an exempted fishing permit was required to conduct aquaculture in federal waters, and the permit was valid for only one year. NOAA concluded that the limited permit duration was not a viable option for many commercial aquaculture operations.

Updated nutritional guidelines emphasize holistic eating patterns over the course of a lifespan.

On January 7, the US Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) jointly issued the 2015-2020 Dietary Guidelines for Americans (Guidelines),[1]

The Guidelines are based largely on the recommendations from the Dietary Guidelines Advisory Committee (Advisory Committee), which is comprised of expert researchers in the fields of nutrition, health, and medicine.[2] The HHS and USDA stated that the updated Guidelines are intended to “reduce obesity and prevent chronic diseases like Type 2 diabetes, hypertension, and heart disease.” Importantly, the Guidelines emphasize healthy eating patterns to increase population health, rather than focusing on individual nutrients or foods. The Guidelines state that Americans should focus on maintaining healthy body weight through nutrient adequacy over their lifespan. Reading between the lines, the Guidelines seem to advocate that Americans should avoid so-called “fad diets” that can lead to “yo-yo” weight fluctuations.

1US Department of Health and Human Services and US Department of Agriculture, Dietary Guidelines for Americans 2015-2010, 8th ed. (Dec. 2015) [hereinafter Dietary Guidelines] http://health.gov/dietaryguidelines/2015/guidelines/; United States Dept. of Agriculture, HHS and USDA Release New Dietary Guidelines to Encourage Healthy Eating Patterns to Prevent Chronic Diseases (Jan, 7, 2016) http://www.usda.gov/wps/portal/usda/usdahome?contentid=2016/01/0005.xml&contentidonly=true.

2 See Health.gov, Advisory Committee Members (Jan. 11, 2016) http://health.gov/dietaryguidelines/committee/; United States Dept. of Agriculture, Scientific Report of the 2015 Dietary Guidelines: Advisory Report to the Secretary of Health and Human Services and the Secretary of Agriculture (Feb. 2015) http://health.gov/dietaryguidelines/2015-scientific-report/PDFs/Scientific-Report-of-the-2015-Dietary-Guidelines-Advisory-Committee.pdf.