Food, Drug and Cosmetic Act

The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set... more +
The Food, Drug and Cosmetic Act is a United States federal law enacted in 1938 in response to deaths following the legal marketing of a toxic elixir. The FDCA authorized the  Federal Drug Administration to set standards for food and drug safety, and to conduct factory inspections.  The FDCA was amended in 1962 to strengthen drug safety policies and implement new efficacy requirements. In 1976, Congress further amended the FDCA to apply safety and efficacy standards to new medical devices. less -
News & Analysis as of

C.D. Cal. Dismisses Infusion Pump Complaint

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing... - FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

Blowing the Whistle on Food Safety: OSHA Issues a Final Rule Related to FDCA Complaints

On April 18, 2016, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) announced that it has issued procedural rules for enforcement of whistleblower complaints alleging violations of the...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Regulators Offer Guidance on Privacy and Security for Health App Developers

This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

POM Wonderful LLC v. Coca Cola Co.: legal battle nearly over, but industry litigation landscape forever changed…

On March 18, 2016, Pom Wonderful LLC made closing arguments in its trial against Coca-Cola for the alleged misleading marketing of a pomegranate-blueberry juice which contained only trace amounts of either pomegranate or...more

Comment K Case by Case – Falling Out of Favor?

When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away...more

Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims

Last November we blogged about "specialized" preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a...more

Coca-Cola Wrings the Last Drops out of POM’s False Advertising Litigation Campaign

Seven crops of pomegranates (and other fruits) have grown, ripened, been picked, pulped and processed. A river of juice has flowed. After seven years of litigation, the last overripe fruit of the Lanham Act campaign launched...more

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

Food Safety Criminal Prosecutions: When Compliance is a Matter of Life and Death

Over the last ten to twenty years, we have witnessed the expansion of federal criminal prosecution of health and safety matters. Environmental and food and drug regulatory enforcement has been supplemented by aggressive...more

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat...more

2015 Food Industry Decisions With Bite

Food for Thought is a review of significant court decisions affecting the food, beverage, dietary supplements and personal care products industry. Although many cases in this edition focus on class certification, others...more

Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more

FDA Approves First Genetically Modified Food-Producing Animal

On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of the AquAdvantage Salmon, a genetically modified Atlantic salmon. In...more

Blame Flows Downhill: All the Way to Sales Clerks

What if a store clerk sells a product that, unbeknownst to him, is illegal? Can the clerk be convicted of a crime, despite not knowing the product was illegal and not intending to sell an illegal product? On January 14,...more

The Other Shoe Drops in Estes

Last month, we discussed Estes v. Lanx, Inc., 2015 WL 9462964 (N.D. Miss. Dec. 23, 2015), and mentioned that the court had left a bit of unfinished business behind – having raised sua sponte the question of whether the...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

First Amendment Follow-Up

The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion. In that post we asked, “Has...more

Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around?

As we mentioned before (when we provided a discount) Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label...more

California Supreme Court – Presumption Against Preemption Still Around

Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) –...more

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