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 In a March 2018 unpublished opinion, the court affirmed the dismissal of lawsuits filed over the labeling of dog food and treats as “made in the USA” when they contained tapioca starch,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.
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.
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.
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.
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.
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.
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.
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics:
- Guidance on application of the Foreign Supplier Verification Programs (FSVP) regulation to the importation of certain live animals;
- Draft Guidance on the definition of “small business” for purposes of the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) regulations;
- A letter to the winegrape and hops growing industries regarding possible modifications to written assurances in the Produce Safety Rule; and
- A report from the Government Accountability Office (GAO) scrutinizing FDA’s progress and implementation of key food safety-related activities.
Also, as a reminder, March 19, 2018 was the compliance date for supplier verification under the PCHF (Subpart G) and FSVP regulations when a supplier is a “small business” required to comply with the PCHF regulation. Additionally, April 6, 2018 is the compliance date for small businesses for the Sanitary Food Transportation regulation.
Join us in London for a food seminar, “New U.S. food manufacturing, labeling, and inspection requirements – What you need to know to export foods ”
On 19 April, Hogan Lovells will offer a seminar on recent developments in U.S. food law that affect all food companies exporting food to the U.S.
U.S. partners Maile Hermida and Elizabeth Fawell will be visiting London from Washington, DC to discuss the latest U.S. food law developments that affect foreign companies that sell food in the U.S. This session will address recent changes for food safety, nutrition labeling, import filings, and facility inspections, addressing what these developments mean for exporters and how they are affected by the political climate in the United States. Both Maile and Elizabeth have extensive experience helping companies navigate these new requirements and developing effective business solutions for managing compliance.
Topics for this two hour seminar include:
— New U.S. Food Safety Requirements (FSMA)
— New Nutrition Labeling Rules
— Impacts from and Forecast for Trump Administration
— Inspections and Enforcement
On March 1, 2018, Food and Drug Administration (FDA or the agency) Commissioner Dr. Scott Gottlieb, M.D., announced new efforts to advance implementation of the new consumer Nutrition Facts label for foods, and with it a plethora of guidance documents on dietary fiber, Reference Amounts Customarily Consumed (RACCs) for product categories, declaration of added sugars on honey and similar products, and proper labeling of honey and honey products. We briefly discuss each of the following guidance documents further below:
- Final Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category
- Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Small Entity Compliance Guide
- Final Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)
- Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products
- Final Guidance for Industry: Proper Labeling of Honey and Honey Products
The deadline for submitting comments on the Draft Guidance concerning the declaration of added sugars for honey, maple syrup, and certain cranberry products is May 1, 2018. Comments should be submitted to Docket No. FDA-2018-D-0075. The other documents are Final Guidance, on which comments can be submitted at any time.