Regulatory Update: March 1 – March 31, 2023

This update includes FDA updates, USDA updates, and FDA warning letters, including the issuance of a notice announcing the status of COVID-19 guidance documents, proposed updated rules governing voluntary “Product of USA” claims, and more.

FDA Updates

FDA Issues Draft Guidance About Dietary Guidance Statements in Food Labeling
March 27: FDA issued a draft guidance for industry titled “Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry.” The draft guidance will provide information and FDA’s current thinking on the use of Dietary Guidance Statements on packaged food labels and more broadly in the labeling of foods, including any written, printed, or graphic material accompanying a food, such as labeling on websites. In general, Dietary Guidance Statements are statements relating a food or food group to a nutritious dietary pattern, with such statements based on key or principal recommendations from consensus reports. The draft guidance can be found here. The deadline to submit public comments has been extended to September 25, 2023.

FDA Issues Notice Announcing the Status of COVID-19 Guidance Documents
March 13: The FDA issued a notice in the Federal Register to explain how the end of the federal Public Health Emergency (PHE) associated with COVID-19 impacts the agency’s pandemic-era guidance documents. As of the expiration of the PHE on May 11, 2023, many of the guidance documents are no longer in effect or will expire shortly after the PHE ends, while FDA has indicated that other guidance will continue to be effective. A list of affected guidance documents and their current status can be found here.

FDA Warning Letters

RTE Product: Upon inspection, a Florida food manufacturer of ready-to-eat (RTE) sandwiches received a warning letter after FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. During this inspection, FDA collected environmental samples from various areas and found the presence of Listeria monocytogenes.

Soft Cheese: A Michigan soft and semi-soft cheese producer was inspected after a multistate outbreak of Listeria was linked to RTE soft cheese products supplied by the facility. FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulations leading to a warning letter.

Pretzels: During an inspection of a Michigan RTE seasoned hard pretzels producer, inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

A full list of warning letters can be found here.

USDA Updates

FSIS Proposes Updated Rules Governing Voluntary “Product of USA” Claims
March 6: UDA’s Food Safety and Inspection Service (FSIS) proposed to amend its regulations to define the conditions under which the labeling of meat, poultry, and egg products, as well as voluntarily inspected products, may bear voluntary label claims indicating that the product is of United States origin. View the Federal Register notice here.

Other Developments

Fourth Circuit Affirms Gruyere Certification Mark Rejection
The federal Court of Appeals for the Fourth Circuit affirmed a lower court’s grant of summary judgment in favor of the opposers of a certification mark (a type of trademark used to show consumers that certain standards have been met by a product) for “GRUYERE” to designate cheese that originates in the Gruyère region of Switzerland and France. The three-judge panel concluded that “cheese consumers in the US understand ‘GRUYERE’ to refer to a type of cheese, which renders the term generic,” and thus deemed the term unregistrable as a certification mark. This ruling is a win for cheese producers that make cheeses with names associated with physical places such as Gruyere, Havarti, Cheddar, and Swiss.

This Regulatory Update covers information for March 2023. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, visit

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