LexisNexis® Legal Newsroom
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...

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices

By Cori Annapolen Goldberg and Lidia Niecko-Najjum In efforts to ensure that in vitro diagnostic devices 1 provide accurate, consistent and reliable results, the US Food and Drug Administration ("FDA" or "the Agency") 1) issued a final guidance on the development, review and approval...

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...

Norton Rose Fulbright: Breadth Of Primary Jurisdiction Expanded In Class Actions

By Matthew Gurvitz The doctrine of primary jurisdiction gained ground in false advertising litigation, as Judge Sammartino of the Southern District of California dismissed a putative class action against Kashi Company because FDA signaled that it was reevaluating draft guidance that served as a partial...

Norton Rose Fulbright Consumer Products Law Blog: Formula For Disaster: FTC Sues Gerber For Falsely Advertising Baby Formula As ‘’FDA Approved’

By Julie Glazer Last week the FTC sued Gerber Products Co., alleging that it has no basis for asserting that its Good Start Gentle baby formula reduces the risk of infant allergy development and that these health claims were falsely advertised as “FDA Approved.” Whether to identify...

Failure-To-Update Claims For Generic Drugs Not Preempted In New Jersey, Court Says

TRENTON, N.J. — (Mealey’s) A New Jersey state appeals court panel on Nov. 12 affirmed a lower court ruling that generic drug manufacturers can be sued for failure to update their labels with warnings added to the labels of the predecessor drug ( In Re: Reglan Litigation , No. A-2014-13T4...

FDA’s New Menu Labeling and Vending Machine Requirements: 10 Key Answers For Food Businesses

by Scott W. Pink and Barry M. Heller The Food and Drug Administration has finalized its rules requiring that calorie information be listed on menus and menu boards of chains with at least 20 units operating under the same name and in connection with vending machines with at least 20 locations. The...

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...

Opioids – The Grand Debate

An examination of ACOEM’s newly revised opioid practice guidelines for treatment of pain By Robert G. Rassp, Esq. We hate statistics but policymakers can’t live without them. For example, 100 million residents of the United States have chronic pain according to a 2011 report from...

Generic Drug Failure-To-Update Preemption Ruling Won’t Be Reviewed By High Court

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on Jan. 20 denied review of a California appeals court ruling that a drug company may be liable for failure to update a generic drug’s warning label ( Teva Pharmaceuticals USA Inc., et al. v. Superior Court of California, et al. ...

Compounding Pharmacy Co-Owner Pleads Guilty to Misdemeanor Criminal Violations of the Food, Drug, and Cosmetic Act

The U.S. Food and Drug Administration, acting through the U.S. Department of Justice appears to have relied on the Park Doctrine, [ enhanced version available to lexis.com subscribers ], to hold a corporate officer of a compounding pharmacy criminally responsible for the pharmacy's violations of...

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...

Barnes & Thornburg LLP: Amarin Pharma Preemptively Sues FDA over 1st Amendment Rights

On Thursday, May 7, Amarin Pharma took the unprecedented step of proactively suing the U.S. Food and Drug Administration (FDA) over the agency’s alleged infringement of the company’s First Amendment Rights. The case arises from Amarin’s desire to market its product, Vascepa, for uses...

Keller And Heckman LLP: Consumer Claims Targeting Trans Fat In Instant Noodles Case Survive Motion To Dismiss

Last month we wrote about FDA's determination that trans fat will no longer be generally recognized as safe ("GRAS") and that the agency's decision could open the door for consumers wishing to attack food products containing trans fat. 1 Perhaps in a sign of things to come, the "Food...

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...

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory

. . . A federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the traditional compliance analysis regarding the legality...

Cadwalader: Pharmaceutical Manufacturer's Preemptive Suit Secures Preliminary 1st Amendment Protection for Script to Promote Off-Label Use

On August 7, 2015, the U.S. District Court for the Southern District of New York invoked the First Amendment, granting Amarin Pharma, Inc. ( Amarin ) preliminary protection against federal criminal prosecution for misbranding and allowing Amarin to promote its drug, Vascepa, for off-label use through...

FDA is Keeping up with Kim Kardashian

by Cori Goldberg and Saul Perloff Kim Kardashian’s recent Instagram post yielded 466,000 “likes” and one FDA Warning Letter . In her social media post, also posted on Facebook, Kardashian discussed the drug DICLEGIS and the positive effect she claims it has had on her morning sickness...

Kim Kardashian Posts Corrective Ad on Instagram

Kim Kardashian is promoting Diclegis® on social media once again. But this time, she is posting about the drug to correct her prior actions. On August 12, we discussed Kim Kardashian’s Instagram and Facebook post in which she discussed the drug Diclegis® and the positive effect that...

Duane Morris LLP: FDA Publishes Revised Guidance on Product Tracing Requirements for Dispensers

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States.” This year, trading partners were required...

Duane Morris LLP: FDA Publishes Draft Guidance Documents on Compounding Using Bulk Drug Substances

On October 27, 2015, the U.S. Food and Drug Administration (FDA) published notice of two draft guidance documents in the Federal Register [1] : “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act” [2] and “Interim...

National and State-by-State Workers' Comp News Powered by Larson's (5/15/2016)

WCRI Publishes New Study on Ambulatory Surgery Centers . FDA Issues Three New Draft Guidances for Compound Drugs . EEOC Issues New Guidance on Employer-Provided Leave, ADA . AK: WCB Discusses Budget, HB 214 Workers Comp Appeals Commission . AZ: ICA to Hold Hearing on One-Half Percent Assessment...