LexisNexis® Legal Newsroom
Keller and Heckman: N.J. District Court Refuses to Dismiss False Advertising Suit

On June 12, 2013, the U.S. District Court for the District of New Jersey denied Tropicana’s motion to dismiss a false advertising suit. In Lynch v. Tropicana Products, Inc. , the plaintiffs alleged that the juice’s label falsely claimed that its modified “not-from-concentrate”...

Fungal Meningitis Outbreak Spurs FDA Oversight Of Drug Compounders

In 2012, a major outbreak of fungal meningitis was traced to drugs compounded by New England Compounding Centers . The outbreak included approximately 750 confirmed cases and has resulted in 64 deaths to date. Tragedies of this scale have often been the impetus for major changes to federal food and drug...

FDA Declines to Define "Natural"

In a much anticipated letter response, FDA has officially declined the opportunity to administratively determine whether foods containing bioengineered ingredients may be labeled as “Natural,” “All Natural” or “100% Natural,” and more generally, declined the opportunity...

FDA Issues Final Guidance Distinguishing Liquid Dietary Supplements from Beverages

The Food and Drug Administration (FDA) has issued a long-awaited and much anticipated, revised and now, final Guidance for Industry entitled, “Distinguishing Liquid Dietary Supplements from Beverages.” The FDA had previously issued a Draft Guidance for Industry entitled, “Factors that...

FDA Announces Major Revisions to the Nutrition and Supplement Facts Labels

On February 27th, the Food and Drug Administration (FDA) announced the availability of three proposed rules that would revise the Nutrition Facts label requirements. These proposals were published in the Federal Register on Monday, March 3. Food Labeling: Revision to the Nutrition and Supplement Facts...

Food and Beverage News and Trends: Labeling of GMOs, Honey, Sugar, Cane Juice

By Stefanie Jill Fogel , Mary B. Langowski , and Tiffani V. Williams • Federal GMO labeling legislation introduced . On April 9, Representative Mike Pompeo (R-KS) introduced The Safe and Accurate Food Labeling Act of 2014 (H.R. 4432) [ enhanced version available to lexis.com subscribers ]...

FSMA Update: FDA Seeks Input on Reportable Food Registry Requirements

FDA has issued an Advanced Notice of Proposed Rulemaking (ANPRM) to seek comments, data, and information from stakeholders that will assist the Agency with implementing amendments to the Reportable Food Registry (RFR) requirements that were enacted as part of the FDA Food Safety Modernization Act (FSMA...

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which sets forth FDA's current thinking on the annual...

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To accomplish this, the U.S. Food and Drug Administration (FDA) is required...

FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for Omega-3 Fatty Acids

On April 28, 2014, the Food and Drug Administration (FDA) published a final rule that will prohibit certain nutrient content claims for foods and dietary supplements containing the omega-3 fatty acids docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and alpha-linolenic acid (ALA).[1] As identified...

FDA Issues Guidance on Submission of Petitions and Notifications for Exemption from Allergen Labeling

Last month the Food and Drug Administration (FDA) released draft guidance for industry with instructions on how to obtain a food allergen labeling exemption through submission of a petition or notification to FDA.[1] The Food Allergen Labeling and Consumer Protection Act of 2004 (FACLPA) amended the...

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers , which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability...

FDA Issues Draft Guidance for Identification and Notification of Suspect Products

As discussed in our April 11, 2014 Alert , the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." Recently, the U.S. Food and Drug Administration...

Food Safety Modernization Act: FDA Operational Strategy, Sanitary Transportation Rule, Congressional Advice

FDA Publishes Operational Strategy for Implementing FSMA The FDA has published its “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA),” which will be considered the Agency’s launching pad for all food safety efforts moving forward. The strategy is...

FDA Gives Guidance on Compounding for Human Use

Last month, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use. These documents are: · Draft Interim Guidance setting forth FDA's...

Twenty-Nine States Urge FDA To Strengthen Proposed Regulation Of E-Cigarettes To Protect Kids

States Propose Restrictions On Advertising To Youth, Bans On Flavored E-Cigarettes Current FDA Proposal Falls Far Short Of What Is Needed To Protect Our Youth The attorneys general of Illinois, Indiana, Massachussetts, and New York, have co-sponsored a letter submitted to the Food and Drug Administration...

FDA Issues Two Final Rules to Help Consumers Keep Track of Calories

The U.S. Food and Drug Administration (FDA) recently finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments, as well as on certain vending machines. In announcing the finalization of the two rules, FDA Commissioner...

Navigating FDA and USDA Reporting/Notification Requirements for Adulterated and Misbranded Food

When incidents of adulterated or misbranded food arise that trigger a need to report to or notify a federal agency, food companies face a number of somewhat confusing, and not always congruent, requirements. Both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture, Food...

FDA Opens Plan to Let Generic Drug Manufacturers Update Labels to Debate

In response to the U.S. Supreme Court's holding in Pliva v. Mensing , 131 S. Ct. 2567 (2011), [ enhanced version available to lexis.com subscribers ], that federal laws and regulations preempted state failure-to-warn claims, the U.S. Food and Drug Administration (FDA) in 2013 proposed to allow generic...

FDA Announces Plan to Streamline Animal Food Regulation

On March 27, 2015, FDA announced a strategy to establish ingredient definitions and standards for animal food. The goal of FDA’s strategy is to promote consistency in the Agency’s regulatory review and clearance of animal food ingredients. Currently, ingredients used in animal feed and...

No Decision by FDA Until Next Year On Whether Evaporated Cane Juice is Misleading

By Stefanie Jill Fogel , Kathleen Smith Ruhland , and Maggie Craig FDA will not issue further guidance on evaporated cane juice until 2016. In a July 8, 2015 letter response to a Northern District of California federal judge (filed July 13, 2015), the FDA stated that it will not issue further guidance...