Food Labeling

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The U.S. Food and Drug Administration (FDA) recently issued two guidance documents to assist establishments in determining whether they have an obligation to register as a food facility. The first document is the finalized seventh edition of FDA’s Questions and Answers Regarding Food Facility Registration (Final Guidance). The second document is a supplemental draft guidance to the seventh edition (Supplemental Draft Guidance), which addresses which parties must register in situations where multiple entities share a physical space (e.g., a food manufacturer leases a building). The Supplemental Draft Guidance is open for comments through October 19, 2018. This memorandum summarizes the changes made in the Final Guidance since it was originally proposed in draft form in December 2016 and the new content in the Supplemental Draft Guidance.

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Key considerations for food companies considering a package refresh or new product launch – an integrated legal team approach

Launching a new food product? Revising your label? On September 13, the Hogan Lovells Food and Beverage team will offer a free webinar on key considerations for food and beverage packaging and labeling.  Food regulatory partners Maile Hermida and Elizabeth Fawell will be joined by trademark partner Julia Matheson to discuss what you need to know if you are refreshing your product’s packaging and labels – either on your own initiative or to comply with new labeling requirements – or launching a new product.

Maile and Elizabeth will discuss key labeling considerations facing food companies, including new nutrition labeling requirements, GMO disclosures, and class action litigation.  Julia will provide an overview on trademark, trade dress, and unfair competition claims.

Topics for this one hour webinar include:
•           Labeling hot issues
•           False advertising claims
•           Trademark
•           Trade dress
•           Unfair competition

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On July 26, 2018, the FDA held a public meeting to discuss issues related to the agency’s comprehensive multi-year Nutrition Innovation Strategy. This public meeting and comment period follows FDA Commissioner Dr. Scott Gottlieb’s unveiling of the Nutrition Innovation Strategy in a policy address on March 29, 2018 as a way to help Americans improve their nutrition as a step towards reducing chronic disease. This post provides a high-level summary of the issues that were raised at the public meeting.

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The U.S. Appeals Court for the 9th Circuit issued a favorable decision earlier this year interpreting the California “made in the USA” statute. In a March 2018 unpublished opinion, the court affirmed the dismissal of lawsuits filed over the labeling of dog food and treats as “made in the USA” when they contained tapioca starch, an ingredient derived from a plant not commercially grown in the U.S. The appeals court decision confirms that a plaintiff cannot bring a lawsuit to challenge a “made in the USA” claim under the old, stricter version of the California “made in the USA” statute.  Instead, such claims would be governed by the more permissive version of the statute that permits a made in the USA claim when a product contains certain small amounts of foreign-sourced ingredients consistent with one of two exemptions. The case did not address how the claim should be viewed under the Federal Trade Commission (FTC) standard for U.S. origin claims.

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The Food and Drug Administration (FDA) is proposing to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The proposed rule would require such calorie declarations to be at least 150% the size of the net quantity of contents statement (i.e., 1.5 x the size of the net weight). This proposed change was prompted by industry concerns that the current type size requirement for FOP calorie declarations – of at least 50% of the size of the largest printed matter on the label – is impractical, needlessly burdensome, and would disrupt existing voluntary industry front-of-pack nutrition labeling programs. The existing programs require FOP calorie declarations to appear in a type size ranging from 100 to 150% of the size of the net quantity of contents statement.

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The Food and Drug Administration (FDA) has issued a guidance document that identifies eight ingredients that the agency has determined meet the regulatory definition of “dietary fiber.” Specifically, FDA has recognized the following ingredients as meeting the dietary fiber definition: (1) mixed plant cell wall fibers; (2) arabinoxylan; (3) alginate; (4) inulin and inulin-type fructans; (5) high amylose starch (resistant starch 2); (6) galactooligosaccharide; (7) polydextrose; and (8) resistant maltodextrin/dextrin. In this guidance document, FDA also announced that it intends to extend enforcement discretion regarding the declaration of these eight isolated or synthetic nondigestible carbohydrates (NDCs) as a dietary fiber on Nutrition Facts and Supplement Facts labels pending completion of a formal rulemaking to revise the dietary fiber regulation to reflect these ingredients. In addition to the guidance document, FDA has also published a review of the scientific evidence on the physiological effects of these NDCs, and has issued responses to several citizen petitions requesting that certain NDCs be added to the “dietary fiber” definition.

This post provides a brief overview of FDA’s dietary fiber definition, and summarizes the key aspects of the guidance related to FDA’s determination that these eight ingredients meet the dietary fiber definition.

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The Office of Management and Budget (OMB) recently released the Spring 2018 Unified Agenda of Regulatory Actions for federal agencies, which outlines the rulemaking actions currently under development in each federal agency. This post summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS). After highlighting the most significant priorities, we provide charts for each agency that provide additional details on their plans.

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Food product labels are under intense scrutiny from consumers, regulators, class action lawyers, and non-governmental organizations (NGOs). Demands for more information, as well as changes to or prohibitions on labels’ use of certain terminology, are on the rise. But do label-reform advocates fully appreciate the legal and regulatory complexities and burdens food-labeling revisions impose on the industry, especially when those changes involve state-specific rules? Martin Hahn and Samantha Dietle discuss in the Washington Legal Foundation’s Legal Backgrounder.

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As the June 18, 2018 compliance date for the Food and Drug Administration’s (FDA’s) final determination that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) approaches, the food industry has undertaken efforts to obtain clarification and flexibility from FDA on several issues related to the compliance date, including (1) clarifying the regulatory status of PHO-containing products on the market after the compliance date, (2) requesting an extension of the compliance date to accommodate the time needed for the agency to respond to the pending food additive petition on PHOs, and (3) seeking enforcement discretion to use existing label inventory that declares PHOs as an ingredient after the ingredient has been removed from product formulations.

This post summarizes recent developments and statements from the agency on these issues.

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Food companies and retailers doing business in California should take note of the recent proposed statement of decision in the case challenging the coffee industry’s failure to warn of the presence of acrylamide in coffee under Proposition 65. On March 28, 2018, the Superior Court of California at Los Angeles County issued a proposed statement of decision ruling the coffee industry failed to meet their burden of proof on their alternative significant risk level (ASRL) affirmative defense. To the extent the ruling is not overturned on appeal, it would set the precedent for applying the ASRL for other listed substances that form during the cooking of food.

Acrylamide is not intentionally added to coffee. Instead, when coffee beans are roasted, a chemical reaction (the Maillard reaction) occurs causing the asparagine and sugars in coffee beans to form the chemical. FDA reports “acrylamide is found mainly in foods made from plants, such as potato products, grain products, or coffee” and that generally it is “more likely to accumulate when cooking is done for longer periods or at higher temperatures.” In the past few years, bounty hunters have filed multiple actions against companies marketing foods in California that contain acrylamide and do not bear the Proposition 65 warning. In light of the recent ruling, it would be prudent for companies that manufacture or market food products that contain acrylamide to reexamine their obligations under Proposition 65.

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