YOUR SOURCE ON FOOD LITIGATION AND REGULATION

As our Canadian neighbors gaze south across the border, their minds are no doubt filled with countless questions over what can safely be described as the unusual political circumstances that currently prevail within the United States.

Read the Canadian Meat Business article >>

On December 1, the US Department of Agriculture's (USDA’s) Food Safety and Inspection Service (FSIS) issued a proposed rule to amend the nutrition labeling regulations for meat and poultry products (Proposed Rule). The revisions in the Proposed Rule are meant to parallel, to the extent possible, the US Food and Drug Administration’s (FDA’s) two similar final rules concerning nutrition fact labels (Nutrition Labeling Rules).1

Some notable similarities between provisions in the Proposed Rule and FDA’s Nutrition Labeling Rules include, but are not limited to, the following:

  • Updating the list of nutrients required or permitted to be declared (e.g., no longer requiring declaration of Vitamins A and C but requiring declarations for Vitamins D and Potassium) and updating Dietary Reference Values (DRVs) and Reference Daily Intakes (RDIs) that are based on current dietary recommendations2
  • Requiring the declaration of trans fat in the Nutrition Facts label
  • Requiring the declaration of added sugars
  • Establishing a new definition of “dietary fiber”
  • Modifying the nutritional labeling format for certain nutrition information (e.g., calories, serving size, and servings per container) prominence, and changing the order of the “Serving Size” and “Servings Per Container” declarations
  • Requiring mandatory dual-column labeling on certain packages of meat and poultry products (i.e., products that contain 200–300% of the applicable reference amounts customarily consumed (RACC))
  • Amending the requirements for foods represented or purported to be specifically for children under the age of four years, and pregnant and lactating women

The Final Rules implementing the Food Safety Modernization Act (FSMA) issued over the last several years contain numerous requirements, compliance dates, definitions, applicability guidelines, extensions, and related guidance. For your comprehensive reference, we’ve drafted a summary of the Final Rule information and requirements. We are continually monitoring FSMA developments and can assist you with questions regarding the items in the summary.

Read the Final Rule summary.

As part of its continuing implementation of the Food Safety Modernization Act (FSMA), on October 31, the FDA announced the availability of a draft guidance document titled “Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA” (Guidance).

The Guidance is meant to provide industry with more information on the content of the disclosure statements required by four of the seven foundational FSMA rules. Additionally, it identifies the types of documents that would and would not be appropriate vehicles for such disclosure statements.

The four relevant foundational FSMA rules are:

  1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Human PC Final Rule)[1]
  2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal PC Final Rule)[2]
  3. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Product Safety Final  Rule)[3]
  4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (FSVP Final Rule)[4]

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.