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

Food for Thought: A Review of 2016 Litigation

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

Food industry sees one of first whistleblower suits under FSMA

As part of the massive overhaul of food safety regulations under the Food Safety Modernization Act, Life Sciences Decoded reported in August on new whistleblower protections for food industry employees. On Feb. 9, six months...more

Food contact goods and the FSVP: Deciphering the FDA’s stance

The last 18 months have seen a flurry of regulatory activity as the FDA has finalized and begun enforcing a number of new regulations based on the Food Safety Modernization Act (FSMA). Among these regulatory schemes is the...more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

Marketing Genetically Engineered Crops Just Got Easier: CRISPR Deletion Mutant Crops May Face Reduced Regulatory Hurdles

From the earliest days of recombinant DNA technology, there has been worry in the policy community and among the public about the release and consumption of genetically engineered (GE) crops, especially crops for human...more

Supreme Court Hears Argument on Stale Claims and FDCPA

As reported on our blog, the Eleventh Circuit ruled that filing a time barred proof of claim does not violate the Fair Debt Collection Practices Act, an issue which has divided courts and Courts of Appeals. The Supreme Court...more

Iran and Russia Sanctions Programs Under a Trump Administration–What to Expect

In the final weeks of December, President Obama amended sanctions to both the Iran and Russia programs. These changes further relaxed sanctions on Iran while they tightened sanctions on Russia. Yet, just three days from the...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

FDA bans powdered gloves in human, animal medicine

Effective Jan. 18, 2017, the federal Food and Drug Administration has, by implementation of a final rule, banned the use of powdered gloves by a physician when treating humans or animals. Powdered gloves are now added to the...more

When the Strength of the Facts Cannot be Lifted – SDNY Dismisses Muscle Maker Slack-Fill Class Action

The Southern District of New York recently dismissed a putative class action against Cytosport, the maker of Muscle Milk protein powder. The plaintiff, Orlando Bautista, alleged that he bought a container of Muscle Milk...more

The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions

Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more

Medical Software and the 21st Century Cures Act

The 21St Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033, was signed into law on December 13, 2016. This expansive statute addresses topics ranging from investigational drug clinical trial design, mental health...more

The Peaks – The Ten Best Prescription Drug/Medical Device Decisions of 2016

Today we’re going peak bagging – no, not to the Canadian Rockies or Patagonia (we leave that to Bexis) – for the high points in this year’s drug/medical device product liability jurisprudence. Last week, we visited the...more

DeCoster Rehearing Denied—Food and Beverage Company Executives Face Risks of Prosecution as Responsible Corporate Officers

A recent Eighth Circuit decision that two corporate officers must serve jail time for failing to prevent the distribution of contaminated eggs despite the fact that they did not know the eggs were infected reaffirms...more

Slack-fill lawsuits filling up state court dockets

The uptick in “slack-fill” litigation that we have previously covered in this blog shows no signs of abating — and a spate of recent filings in Missouri state court show that the trend may be expanding....more

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

The Food Safety Modernization Act (FSMA) became law in 2011, signaling a sea change in U.S. food safety regulation and making prevention the cornerstone of safety measures. To achieve its lofty goals, while providing time for...more

Basaglar (Insulin Glargine Injection) Launches in US

Eli Lilly and Boehringer Ingelheim announced today that their insulin glargine injection product, Basaglar® (a follow-on biologic for Sanofi’s Lantus®), is now available by prescription in the U.S. Although Basaglar is...more

Update on Second Circuit Ruling in Church & Dwight v. SPD Swiss Precision Diagnostics “Weeks Estimator” Home Pregnancy Test...

Last month we summarized the Second Circuit’s important decision in a dispute between plaintiff-appellee Church & Dwight and its principal competitor, defendant-appellant SPD Swiss Precision Diagnostics, concerning SPD’s...more

FDA Is Evolving on Qualifications for 'New Chemical Entity'

The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more

Expansion of Liability in Product Labeling Cases

An unprecedented surge in consumer fraud lawsuits over the last several years has consumers and lawyers closely scrutinizing product labels and advertisements. While many of these claims challenge the veracity of “Organic,”...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action

Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. ...more

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

Navigating the Maze of E-Cig Marketing Regulations

Federal regulators, and states, counties and cities throughout the country, are enacting new laws, rules and regulations in the e-cigarette marketing space. How can e-cig manufacturers and related marketing affiliates...more

Washington Healthcare Update

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

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