On March 31, FDA published a final guidance document on acceptable unique facility identifiers (UFIs) for Foreign Supplier Verification Programs (FSVPs). FDA states in the guidance that it now formally recognizes the Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.
In the last few years, food and beverage companies have been defending against a new trend of claims related not to the products they manufacture, but the packages in which the products are sold. Recently filed class action complaints allege that food and beverage manufacturers are reducing the amount of product inside opaque containers but not reducing the size of the containers, or that the manufacturers do not adequately fill the containers. Classic examples include bags of chips or boxes of rice with extra container space that is only visible once the package is open.
This extra space is known as “slack-fill.” The US Food and Drug Administration (FDA) defines slack-fill as the difference between the actual capacity of a container and the volume of the product contained therein. 21 C.F.R. § 100.100. Under the FDA’s regulations, a “container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill.” Id. The FDA recognizes that some slack-fill does have a purpose. Thus, functional slack-fill, such as the extra space that is intended to help protect the contents of the package or that is the result of unavoidable product settling, is exempt from the FDA’s regulations. See id. The State of California also prohibits nonfunctional slack-fill in food packaging, but defines “nonfunctional slack-fill” as the empty space in a package that is filled to “substantially” less than its capacity. Cal. Bus. & Prof. Code §§ 12606, 12606.2.
Food Chemical News spoke with Bob Hibbert about his thoughts on what the regulatory climate under the Trump administration means for the food industry—particularly for USDA’s Food Safety and Inspection Service (FSIS) and the meat and poultry industry the agency oversees.
Read the full interview >>
(reproduced with permission)
Recent public controversy surrounding an issue many readers would probably rather not hear about—whether it is acceptable to use heart meat in products labeled as “ground beef”—has raised a series of questions involving not simply what might wind up on your grill this summer, but also how USDA’s Food Safety and Inspection Service (FSIS) goes about developing, changing, and publicly announcing policy developments and changes in the labelling of the meat and poultry products it regulates.
A bit of personal history is in order: This author, formerly in government service, signed off on the FSIS policy memo in 1981, which unequivocally stated that “heart meats were not to be allowed as a constituent of [a ground beef] product so labeled.”
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.
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:
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Human PC Final Rule)
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal PC Final Rule)
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Product Safety Final Rule)
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (FSVP Final Rule)
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.