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 August 17, the US Food and Drug Administration (FDA) published a Final Rule on the Generally Recognized as Safe (GRAS) notification program, a voluntary premarket notification program for products used in food substances. This Final Rule comes 19 years after the FDA proposed the GRAS notification program in a Proposed Rule, which was intended to shift the premarket program from the GRAS petition process, which involved formal rulemaking, to the less burdensome GRAS notice process. Although the Final Rule is extensive, human food manufacturers can rest assured that the changes to the GRAS notice are not.

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.”

Recently, the US Food and Drug Administration (FDA) announced its plan to redefine the implied nutrient content claim “healthy” by issuing a new guidance document—Use of the Term “Healthy” in the Labeling of Human Food Products1 (Guidance).

The Guidance is effective immediately and states that FDA will exercise enforcement discretion when the claim “healthy” is used on the labeling of certain food products. Specifically, FDA will exercise enforcement discretion for food labels that display the “healthy” implied nutrient content claim and that

  • are not low in fat, provided that the amounts of mono and polyunsaturated fats are declared on the label, and the amounts declared constitute the majority of the fat content; or
  • contain at least 10% of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

On September 19, the FDA Foods and Veterinary Programs held a webinar to discuss FDA’s recent issuance of the preventive controls hazard analysis and risk-based draft guidance (Draft Guidance), which became available for public comment on August 24, 2016.1 The Draft Guidance provides the first five chapters of a 14-part guidance designed to help businesses comply with the Preventive Controls for Human Food Final Rule2 by the compliance date of September 19, 2016.

The Draft Guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls, and includes discussions on establishing a food safety plan, what a hazard analysis entails, appropriate preventive controls for certain food categories, monitoring, corrective actions based on a hazard analysis, verification, and records requirements.

FDA recently released an updated version of its draft guidance on new dietary ingredients (NDIs), Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.1 The lengthy draft guidance details FDA’s thinking on determining whether an NDI notification is required, including how to determine if a substance is an NDI, exceptions to the notification requirement, NDI notification procedures and timeframes, what to include in an NDI notification, and a decision tree for NDI notification that helps companies determine whether an ingredient is an NDI and if notification is necessary.

A “dietary ingredient” is an ingredient used in a dietary supplement. NDIs are a subset of dietary ingredients that were not in the US food supply as dietary ingredients before October 15, 1994. The new draft guidance represents the FDA’s current thinking on NDIs and amends and supersedes the original 2011 draft guidance.

On August 24, the US Food and Drug Administration (FDA or Agency) issued a final rule (Final Rule) that extends and clarifies the compliance dates for a limited subset of Food Safety Modernization Act (FSMA) requirements in four of the seven foundational rules part of FDA’s FSMA implementation.1 The four rules include

  • Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (Preventive Control Rules) for Human and Animal Foods;2
  • Foreign Supplier Verification Programs (FSVP);3 and
  • Produce Safety.4

On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying bioengineered foods and food ingredients, known colloquially as “GMO” (genetically modified organism) or “GE” (genetically engineered) foods. The disclosure requirement will apply to foods subject to labeling requirements under the Federal Food, Drug, and Cosmetic Act. Please see our LawFlash, New GMO Legislation Signed Into Law, for more information.

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 www.data.gov.1

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.