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New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

New GMO Legislation Signed into Law

With Congress’s freshly enacted GMO labeling bill, the devil is in the implementing details. On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying...more

Update: Unraveling the Toxic Substances Control Act Reform Bill

In June, the U.S. Senate and House of Representatives passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals. The bill...more

Congress Passes GE Labeling Bill, President Obama Expected to Sign Bill Into Law

On July 14, 2016, after more than a year of on-and-off debate and failed attempts at legislative compromise, Congress finally passed a bill to require the creation of a federal labeling standard for bioengineered food within...more

Congress Passes National GMO Disclosure Law

On Thursday the U.S. House of Representatives passed S. 764, a Senate-initiated bill establishing a national uniform standard for labeling of bioengineered foods, sometimes referred to as genetically modified foods or GMOs....more

Congress Passes GMO Labeling Bill, President Obama To Sign into Law

On July 14th, Congress passed a GMO labeling bill by a vote of 306-117 that would preempt Vermont’s mandatory labeling act that went into effect on July 1st. The White House said President Obama will sign the bill into...more

One Step Closer to a National GMO Labeling Law

The Vermont GMO Labeling Law is currently in effect, but it may soon be preempted by federal legislation making its way through Congress. On July 7, by a vote of 63-30, the US Senate passed a measure (Senate Bill)...more

Industry, NGOs, Republicans, and Democrats Bond over Chemistry

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed in the House by an overwhelming vote of 403 – 12. After passing the Senate, it was signed into law by President Obama on June 22, 2016. The...more

Toxic Substances Control Act Overhauled Chemical Risk Regulation in the U.S. Joins the 21st Century

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act). Passed with significant bipartisan support, the Act is the first major update to a federal...more

Federal Toxics Law Grows Up: Congress Strengthens the Toxic Substances Control Act

OVERVIEW - President Obama has signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA) for the first time since it was enacted in 1976. The compromise...more

Vermont Act 120 and Beyond: Genetically Engineered Foods, Where Are We Now?

On July 1, 2016, Vermont’s genetically engineered food labeling law is set to become effective. Act 120 and its implementing rule (Vermont Consumer Protection Rule 121) require food manufacturers to label food products that...more

“GMO” Labeling Food Fight: How Vermont’s Act 120 Is Pressuring An Entire Industry

On July 1, 2016, Vermont’s Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE). Unless Congress acts...more

Privacy Regulation Regime Change: Bad or Good for ISPs?

The Federal Communications Commission (“FCC”) is on the verge of proposing new federal privacy regulations for internet broadband service providers (“ISPs”). ISPs were previously policed by the Federal Trade Commission...more

Drone on Drones: Arizona Bill Would Preclude Local Government Drone Regulation

The Arizona Senate has introduced new legislation creating a comprehensive state policy on drone use that would preempt cities from enacting their own regulations. While the bill is likely to see major changes before becoming...more

California AG Proposes State Consensus on Breach Laws

Businesses scrambling to comply with the dozens of varying state laws governing data privacy and security breaches may have a new ally in California Attorney General Kamala Harris, but they shouldn’t expect her to relax any...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

House Panel Approves Data Breach Bill

On Wednesday, Dec. 9, the House Financial Services Committee approved a bill that would require companies to notify consumers and the government when a data breach compromises certain unencrypted consumer information. The...more

Treasury Request for Public Input on Expanding Access to Credit through Online Marketplace Lending

On July 20, the Department of the Treasury published a Notice and Request for Information (“RFI”) seeking comment on various aspects of online marketplace lending, including – - the business models and products offered...more

State Attorneys General Ask Congress Not To Preempt Breach Notification Laws

In the wake of recent, large-scale data breaches, several pieces of legislation have been introduced in Congress to establish a national data breach notification law, including a House bill that would preempt the current...more

Financial Services Weekly News Roundup - May 2015 #4

CFPB Fines Bank $7.5M for Overdraft Violations, With $49M More in Redress - Why it matters: In its first action targeting overdraft fees, the Consumer Financial Protection Bureau (CFPB) fined Regions Bank $7.5...more

New Federal Bill Would Preempt State Data Security Breach Notification Laws

Rep. Marsha Blackburn (R-Tenn) recently introduced H.R. 1770, legislation intended to establish a framework of national data security breach laws, to the House Energy and Commerce Committee. The bill, called the Data Security...more

First Circuit Decision Strengthens Preemption Defense in Name-Brand Pharmaceutical Litigation

On February 20, 2015, the U.S. Court of Appeals for the First Circuit affirmed the dismissal of plaintiffs’ state-law consumer protection claims against a name-brand pharmaceutical manufacturer, concluding they were impliedly...more

First Steps Taken to Establish Federal Law Requiring Companies to Secure Consumer Data; Will Congress Pass Something This Year?

The U.S. House Energy & Commerce Committee took the first steps recently to establish a federal law that would cover actions that companies need to take to secure consumer data. ...more

Data Security and Breach Notification Act of 2015 Making its Way through Congress

On March 25, 2015, a Congressional Subcommittee approved a draft of the “Data Security and Breach Notification Act of 2015,” a statute intended to create a national standard for data security and reporting data breaches. ...more

Financial Industry Backs Cybersecurity, Data Breach Notification Legislation

Why it matters - The financial industry has thrown its support behind data breach notification legislation as well as passage of a law that would encourage businesses to share cyberthreat information. Data security...more

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