Choose Site

On July 14, FDA issued a final rule amending the requirements for the registration of food facilities (Final Rule).1 The Final Rule was issued as part of the implementation of the Food Safety Modernization Act (FSMA) to help improve the accuracy of the food facility registration database.

Background of FSMA

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.

Adopting a practice with the potential for considerable long-term significance, USDA’s Food Safety and Inspection Service (FSIS) recently announced that it will soon begin sharing more food safety data regarding slaughter and processing facilities on

FSIS inspects meat, poultry, and processed-egg-product establishments to ensure that the food produced therein is safe, wholesome, and properly labeled. Its inspections generate a large volume of data that is mainly made public in aggregated and/or summary format or through requests for data pursuant to the Freedom of Information Act (FOIA). Citing several motivating factors (including the policies of the Obama administration and the Office of Management and Budget that have called for increased data sharing and greater transparency), FSIS began exploring in 2010 how to share establishment-specific data with the public. That effort resulted in FSIS’s Establishment-Specific Data Release Plan,2 published on July 11, which details the framework for release of the safety data that FSIS collects.

On June 1, FDA issued draft guidance for voluntary sodium reduction goals for food manufacturers and restaurants.1 According to the guidance, approximately three-quarters of sodium consumed by the US population is added during food manufacturing and commercial food preparation. The new goals are therefore intended to encourage food manufacturers, restaurants, and food service operations to reduce the amount of sodium they add to food to reduce overall salt consumption by about 50% throughout the next 10 years.

FDA states in the guidance that Americans consume too much sodium, and broad sodium reductions are necessary to achieve health benefits. The average sodium intake in the US is approximately 3,400 mg/day, about 50% more than the 2,300 mg/day recommended in the 2015-2020 Dietary Guidelines for Americans. According to FDA, a diet high in sodium contributes to the development of hypertension, a leading cause of heart disease and stroke. Excessive sodium intake has also been linked to high blood pressure, another risk factor for heart disease and stroke.

On May 27, the US Food and Drug Administration (FDA or Agency) published a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule).1 The Final Rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA) and requires food facilities to prepare and implement a food defense plan, conduct a vulnerability assessment, and implement mitigation strategies with food defense monitoring procedures to minimize or prevent significant vulnerabilities.

The Final Rule applies to both domestic and foreign facilities required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is targeting larger businesses with this Final Rule because its purpose is to protect the food supply against individuals or organizations with intent to cause large-scale public health harm.

On May 13, FDA announced the publication of a draft guidance to assist “qualified facilities” (i.e., very small or low-grossing businesses) in complying with the Preventive Controls for Human or Animal Food Rules (PC Final Rules) under the FDA Food Safety Modernization Act (FSMA) (Draft Guidance). 1,2

On May 10, FDA announced that it will reevaluate regulations concerning nutrient content claims (NCCs), including the definition of “healthy.”

An NCC is a claim on a food product label that directly or by implication characterizes the level of a nutrient in a food (e.g., “low fat,” “high in fiber,” “healthy”). A food with a “healthy” NCC claim must contain specific low levels of total fat, saturated fat, cholesterol, and other nutrients. However, members of the food industry have pointed to current nutrition guidance that state that a healthy diet includes foods that are high in certain fats, such as almonds, avocados, and salmon.

If you have been down a pet food aisle recently, you may have noticed dog and cat foods that claim to treat various conditions, making claims to treat urinary tract disease in cats or “control blood glucose” in dogs. Products with these types of claims have been marketed for more than 50 years; however, because of the potential for consumers to misuse or misunderstand these products as effective treatments for disease conditions in pets, the FDA’s Center for Veterinary Medicine (CVM) recently outlined its policies for enforcement on the topic of disease claims in dog and cat foods.

On April 29, 2016, CVM released Compliance Policy Guide (CPG) 690.150: Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.1 The CPG describes situations when CVM intends to take enforcement action against dog and cat foods that are labeled as intended to diagnose, cure, mitigate, treat, or prevent diseases (disease claims). These products may be regulated as a food, drug, or both. A product is an animal drug if it makes disease claims, and otherwise is an animal food.

On January 4, 2011, US President Barack Obama signed the Food Safety Modernization Act (FSMA).[1] The law’s aim is to shift the focus on food safety from responding to problems to preventing them. FSMA accomplishes this by providing new enforcement authorities to the FDA to help it achieve higher rates of compliance through risk-based, prevention-oriented safety standards to better respond to and contain problems when they do occur. The law also contains important new tools to better ensure the safety of imported foods and encourages partnerships with state, local, tribal, and territorial authorities.

Since 2013, the FDA has published in the Federal Register those FSMA-required regulations that provide the framework for the law’s preventive-oriented approach. On April 6, 2016, the FDA published the final rule on Sanitary Transportation of Human and Animal Food (Final Rule).[2] The Final Rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. Because of limitations in the laws, the requirements do not apply to transportation by air or ship. As compared to the proposed rule[3], the Final Rule made some notable changes to the scope of covered entities and the definition of “transportation operations” and added clarifying language to the new requirements.

For a more detailed analysis, please see our LawFlash on the sanitary transportation of human and animal food Final Rule.

The FDA is planning a webinar on April 25 from 11:00 a.m. to 12:00 p.m. eastern time to present key pieces of the Final Rule. More information on the webinar can be found on the FSMA website.


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.


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.

The FDA issued a statement on March 9 indicating that, as a result of language in the Omnibus Appropriations Bill enacted December 18, 2015,1 it is delaying enforcement of the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Rule (Menu Labeling Final Rule).2 Importantly, the compliance date was originally set to be December 1, 2015. However, in July 2015, FDA extended the compliance date for covered entities to December 1, 2016.3

Now, FDA has extended the compliance date even further to an undetermined date that is “one year after it issues a Final Level-1 guidance on menu labeling.”

The Menu Labeling Draft Level 1 Guidance was only issued on Sept. 11, 2015.4 FDA stated that it has received extensive input from stakeholders to aid in further developing the guidance and that it will issue the final guidance “as soon as possible.”