The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based products. This action arose from the agency’s Nutrition Innovation Strategy, one tenet of which is a focus on modernizing food standards. During Commissioner Gottlieb’s remarks at the Nutrition Innovation Strategy public meeting, he stated that requests for the agency to take a closer look at the dairy standards of identity is one of many reasons why FDA is interested in modernizing the food standards, and that this would be the first area in which FDA is going to have an active public process for reviewing the standards and how consumers understand the use of terms like “milk” on both animal-derived and plant-based products.

This RFI aims to gather information on how consumers use plant-based products and how consumers understand the use of dairy terms, such as “milk,” or “yogurt” when they appear on the labels of plant-based products, as well as the nutritional attributes of these products and how these products can help consumers meet the recommendations in the Dietary Guidelines for Americans.

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On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety. Additionally, on September 27, 2018, FDA published a Federal Register Notice announcing availability of a draft guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls. Publication of the Draft Guidance is the second of a series of policy steps the agency is taking as part of a broader plan to improve oversight of food safety and the recall process.

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The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule under the FDA Food Safety Modernization Act (FSMA). Through a Notice to Industry, FDA is inviting food companies with multiple facilities that implement centrally developed supply-chain programs and recall plans to apply to participate in two-tier inspections. FDA plans to limit initial participation in the program to five businesses. FDA will consider the results of the two-tier inspections pilot to determine the feasibility of employing the two-tier approach to inspections on a broader scale. This post summarizes the program and FDA’s criteria for participation. Interested companies must notify FDA of their desire to participate no later than October 31, 2018.

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The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”) request process for certain records within FDA’s possession. The proposed rule would amend FDA’s regulations to reflect updated Federal requirements for information access, clarify certain provisions of FDA’s information access regulations, and make the FOIA process easier for the public to navigate. The agency anticipates that these changes, taken together, will enhance transparency for the public with regard to FDA activities.

FOIA is a law that gives the public the right to access information from the Federal government. There is a presumption that government records must be released under FOIA unless they are subject to an exemption. In this regard, FDA is proposing to amend its regulations to state explicitly that the agency would withhold information under FOIA only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption or disclosure is prohibited by law.

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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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A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning for acrylamide on these cereals would pose an obstacle to the federal scheme, and therefore is preempted by federal law. To support the ruling, the panel of appeals court judges referenced the advisory letters issued by the FDA to the California regulators and Attorney General with “persuasive reasoning why Proposition 65 acrylamide warnings on whole grain cereals would mislead consumers and lead to health detriments.” We do not know if the decision will be appealed to the California Supreme Court.

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The Food and Drug Administration (FDA) announced a public meeting and comment period on the agency’s comprehensive multi-year Nutrition Innovation Strategy. This public meeting and comment period follows FDA Commissioner 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 details the proposed topics to be discussed at the meeting, as well as the logistics for the meeting and comment period.

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The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and they must take steps to ensure those mitigation strategies are working. This first installment includes the first four chapters of the Draft Guidance, which provide FDA’s recommendations on how to develop a food defense plan, including one particular method for conducting a vulnerability assessment to identify significant vulnerabilities and actionable process steps, developing mitigation strategies for actionable process steps, and monitoring mitigation strategies. It also contains templates for various components of a food defense plan.

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