Category Archives: Foods and Beverages

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San Francisco Backpedals on Ad Ban for Sugary Drinks, but Maintains Warnings Requirements

In June 2015, the San Francisco Board of Supervisors passed two sweeping ordinances concerning sugar-sweetened beverages designed to “inform the public of the presence of added sugars” and restrict certain advertising for these products.  The first ordinance requires warnings on certain advertisements for sugar-sweetened beverages to advise consumers about the “harmful health effects of consuming … Continue Reading

FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon.  The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the new animal … Continue Reading

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients. The proposed rule builds on the FDA’s 2013 final rule defining the term “gluten-free” for voluntary use in labeling of foods. … Continue Reading

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants.  The final guidance updates the FDA draft guidance originally issued on January 18, 2001.  Under the guidance, food manufacturers may voluntarily label their foods with … Continue Reading

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal agencies, and academia, and also to “remind manufacturers of this policy.”  FDA’s “fortification policy” was first published in a 1980 Federal Register … Continue Reading

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register.  In particular, FDA seeks information and public comment relating to a number of specific issues, including the following: Should FDA define the … Continue Reading

WLF Working Paper Assesses Ninth Circuit Preemption Decision

In Reid v. Johnson & Johnson, the Ninth Circuit heard an appeal of one of the many state law-based consumer class actions over food labeling. A new Washington Legal Foundation Working Paper by Sarah Roller assesses the Ninth Circuit’s refusal in Reid to grant preemptive effect to a 2003 FDA letter of enforcement discretion. Johnson & … Continue Reading

“The White Sauce” Decision (International Custom Products, Inc. v. United States) Highlights Importance of Administrative Procedures for Food Importers

The Court of Appeals for the Federal Circuit decision, International Custom Products, Inc. v. United States, 2015 U.S. App. LEXIS 11170 (Fed. Cir. June 30, 2015), was ten years in the making and provides a stern lesson for importers of food products to follow U.S. Customs and Border Protection’s administrative procedures carefully.  If not, importers … Continue Reading

FDA Extends Menu Labeling Deadline

Responding to input from stakeholders, the FDA has decided to extend the deadline for complying with its Menu Labeling Final Rule from December 1, 2015 to December 1, 2016.  In general, the Rule requires chain restaurants and other food service establishments to provide calorie information on menus and menu boards.  We discussed the specific requirements … Continue Reading

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA).  The draft guidance describes how FDA intends to determine eligibility to participate in the program, along with the benefits of participating, instructions for completing … Continue Reading

FDA Issues Final Rules Prescribing Broad Labeling Requirements for Menus and Vending Machines

The FDA recently released two long-awaited final rules that establish detailed requirements for calorie labeling on menus and menu boards and vending machines. Promulgated pursuant to provisions of the Affordable Care Act (ACA) that amended the Federal Food, Drug & Cosmetic Act, the final rule broadly defines “similar retail food establishments” such that many non-restaurants … Continue Reading

Not So Happy Meals? New York City Council Moves to Ban Free Toys Offered with Certain Food and Beverage Products

The New York City Council introduced a bill last week that would prohibit restaurants from offering free toys or other giveaways aimed at children in connection with certain meals and food and beverage products. The legislation would only permit restaurants to offer “incentive items” if the meal, food or beverage which with the item is … Continue Reading

Sysco Agrees to Pay $19.4M to Settle California Enforcement Challenging the Company’s Food Safety Practices and Related Public Statements

The world’s largest food distributor, Sysco Corp., has entered into a settlement with the California Department of Public Health to resolve allegations that the company had engaged in unlawful food transportation and storage practices and had misrepresented its practices on the company’s website.  The Department alleged that the company held “perishable food and other food … Continue Reading

FDA on UGC

A recent warning letter suggests that FDA, in regulating user generated content (“UGC”) on social media pages, will likely treat all companies the same. Earlier this year, FDA released two guidance documents for drug and medical device companies on social media. Those documents provided the following stance on UGC: “[A] firm generally is not responsible for UGC … Continue Reading

FDA Releases Draft Guidance on Proper Labeling of Honey and Honey Products

The FDA today released a Draft Guidance that offers a definition for “honey” without formally establishing a standard of identity and cites to existing laws and regulations to respond to questions regarding the proper labeling of honey and honey products. The Draft Guidance follows FDA’s 2011 denial of a petition for a standard of identity … Continue Reading

FDA Proposes to Revamp Nutrition Labeling Requirements for Conventional Foods and Dietary Supplements

On March 3, 2014, FDA published two notices of proposed rulemaking detailing the agency’s proposed revisions to its nutrition labeling requirements. The proposed rules: (1) update the list of nutrients required or permitted to be declared, the Daily Reference Values and Reference Daily Intake values of several nutrients, and the format and appearance of the … Continue Reading

FDA Proposes Significant Changes to RACCs and Serving Size Requirements

In conjunction with the proposed changes to the nutrition labeling requirements, the FDA is separately issuing a proposed rule that would make significant changes to “reference amounts customarily consumed” (“RACCs”) for certain foods, and existing requirements governing the declaration of serving sizes for nutrition labeling purposes.  Existing FDA regulations prescribe the “RACC” for foods on a … Continue Reading

FDA Reopens Comment Period on Final Guidance Requiring INDs for Certain Food, Dietary Supplement, and Cosmetic Studies

The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.” FDA published the IND guidance document in draft form in October 2010. FDA then released a significantly expanded version of the … Continue Reading

FDA Releases Long-Awaited Proposed Rule Prescribing Sanitary Transportation Practices for Human and Animal Food

FDA today released a proposed rule that would prescribe sanitary transportation practices for shippers, receivers, motor and rail carriers, and other companies that are engaged in the transportation of food in the United States. The proposed rule is designed to implement the amendments to the Federal Food, Drug and Cosmetic Act (FDCA) that were made … Continue Reading

FDA Publishes Guidance on Food, Beverage, and Dietary Supplement Additives

On January 14, the Food and Drug Administration (“FDA”) published a guidance document entitled Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, with the goal of reminding industry: (1) about the Federal Food, Drug and Cosmetic Act’s requirements governing substances added to conventional foods, including beverages; and (2) that those same requirements … Continue Reading

FDA Issues Proposed Rule to Combat Intentional Adulteration under FSMA

FDA recently issued a new proposed rule under the Food Safety Modernization Act (FSMA) that would require domestic and foreign food facilities to identify and implement focused mitigation strategies to reduce the risk of intentional adulteration. The rule is scheduled to be published tomorrow in the Federal Register and interested parties will have until March … Continue Reading

Highlights of FDA’s Implementation of the Food Safety Modernization Act in 2013

President Obama signed into law the Food Safety Modernization Act (FSMA) nearly three years ago. After significant delays, the FDA has made significant progress this year towards implementing this act and published five key proposed FSMA implementing regulations. These proposed regulations and related FDA enforcement policies will have far-reaching implications for how food for both … Continue Reading

Court’s Decision Over “Spreadable Butter” Claims Upheld On Appeal

The 2nd District Court of Appeals agreed with the lower court’s decision that no reasonable consumer would be misled into thinking that a product labeled as spreadable butter with canola oil was not 100% butter.  Mary Simpson sued Kelley Drye clients Kroger Corp. and Challenge Dairy Products alleging that the labeling of Challenge’s “Spreadable Butter … Continue Reading

Honeygate II Highlights Supply Chain Risks For U.S. Buyers Of Imported Goods

Still buying imports of dubious foreign origin from unrelated U.S. importers? Consider the case of Groeb Farms, Inc., which recently accepted criminal responsibility for fraudulently entered Chinese honey that had avoided $79 million in duties – despite not being directly involved in the honey’s importation. The takeaway: Not being the importer of record for fraudulently … Continue Reading
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