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 The second document is a supplemental draft guidance to the seventh edition (Supplemental Draft Guidance), which addresses which parties must register in situations where multiple entities share a physical space (e.g., a food manufacturer leases a building). The Supplemental Draft Guidance is open for comments through October 19, 2018.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Final Guidance since it was originally proposed in draft form in December 2016 and the new content in the Supplemental Draft Guidance.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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China announced a second round of American products that could be subject to retaliatory tariffs between 10 to 25 percent. The proposed list would target $60 billion worth of additional United States products, including many food products. China has not yet identified the effective date in the event it implements these tariffs.

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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 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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On June 15, 2018, the Office of the United States Trade Representative (USTR) released a list of products imported from China that will be subject to additional tariffs as part of the United States response to China’s alleged unfair trade practices related to technology and intellectual property. The tariffs will pose an additional duty of 25 percent on approximately $50 billion worth of Chinese imports containing industrially significant technologies. The announcement follows a Section 301 investigation in which the USTR found that China’s acts, policies and practices related to technology transfer, intellectual property, and innovation are unreasonable and discriminatory, and burden United States commerce. United States Customs and Border Protection will begin to collect the additional duties from China on July 6, 2018 on an initial list of products affecting $36 billion in imports.

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On Friday, June 15th, the California Office of Environmental Health Hazard Assessment (OEHHA) announced a proposed regulation clarifying that exposures to Proposition 65 chemicals in coffee do not pose a significant cancer risk. The proposal follows a recent California Superior Court ruling that the coffee industry failed to meet its burden of proof on its alternative significant risk level (ASRL) affirmative defense to its failure to warn of the presence of acrylamide in coffee under Proposition 65. The proposed regulation is significant as, if adopted, it would effectively exempt coffee products from Proposition 65 carcinogen warning requirements.

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