Administrative Agency Updates

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Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more

NRDC Files Petition for Review To Ban Flea Collars and Pet Products Containing Pesticides

On January 5, 2015, the Natural Resources Defense Council (NRDC) filed a petition for review in the U.S. Court of Appeals for the Ninth Circuit challenging the November 6, 2014, decision of the U.S. Environmental Protection...more

Communications Network Transitions and Next Generation 911: What You Need to Know About the FCC’s Proposed New Federal Framework

As part of its unrealized effort to bring policy coherence to the migration of traditional switch-based telephone networks towards all IP-based architectures, the Federal Communications Commission (FCC) recently commenced a...more

SEC Files Prime Bank Fraud and Offering Fraud Actions as Administrative Proceedings

The trend of selecting administrative proceedings rather than Federal court by the SEC appears to be continuing. Since last September, for example, the SEC has filed at least seven insider trading cases as administrative...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

The SEC Totally Cares about Its Injunctions

Last week I wrote a post discussing the injunctions the SEC typically obtains against defendants in federal court. I noted the oddity of these obey-the-law injunctions and wondered aloud why the Commission never pursues...more

Federal Circuit Review | January 2015

RAND Commitment Relevant to Damages - In ERICSSON, INC. v. D-LINK SYSTEMS, INC., Appeal Nos. 2013-1625, -1631, -1632, and -1633, the Federal Circuit affirmed-in-part and reversed-in-part the district court’s judgment...more

Pension News - December 2014

In This Issue: - Budget Reforms - Pension Protection Fund - Department for Work and Pensions - Legislation - Case Law - HMRC - Public service pension schemes - On the Horizon - Excerpt from...more

EPA Responds to Petition for Writ of Mandamus Relating to Chlorpyrifos

Along with the release of the revised human health risk assessment for chlorpyrifos, in late December 2014, the U.S. Environmental Protection Agency (EPA) filed a Response to the Petition for a Writ of Mandamus that the...more

SEC & AGs Fine & Suspended S&P for MBS Rating Violations

The SEC and the Attorneys General of New York and Massachusetts this week fined Standard & Poor’s almost $77 million, suspended S&P from conduit-fusion CMBS ratings work for a year and imposed other undertakings, for...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Prepacked caramel apples tied to four deaths from listeria. Listeria from...more

A Municipal Ordinance Requiring Registration and Maintenance of Vacant or Foreclosed Properties Preempted under Chapter 21E

A municipal ordinance imposing registration and maintenance obligations upon owners and secured lenders of buildings that are vacant or undergoing foreclosure was preempted by the Massachusetts remediation and clean-up...more

FRANCHISEE 101: Complying with the FDA's New Menu Labeling Requirement

On November 25, 2014, the Food and Drug Administration (FDA) released final rules governing menu and vending machine labeling to implement some of the Affordable Care Act's nutrition labeling requirements. The final...more

MassDEP Finalizes Underground Storage Tank Regulations

MassDEP’s new regulations governing Underground Storage Tanks (USTs) became effective January 2, 2015.  MassDEP took responsibility for USTs from the Department of Fire Services in 2009 and initially relied on existing...more

MEPA Climate Change Adaptation and Resiliency Policy Available for Public Comment

The Massachusetts Executive Office of Energy and Environmental Affairs (EEA) is accepting public comments on its proposed draft Massachusetts Environmental Policy Act (MEPA) Climate Change Adaptation and Resiliency Policy...more

California Environmental Law and Policy Update - January 2015

Environmental and Policy Focus: U.S. Supreme Court keeps in place protections for California's delta smelt - The U.S. Supreme Court last week kept in place environmental orders in California that protect the...more

CT Law of the Land

Week of January 12 - On January 7, 2015, the Planning & Zoning Section of the Connecticut Bar Association met in Cromwell, CT with special guest Judge Marshall Berger. The main focus of the meeting was Practice Book...more

Proposed Rule Would Allow Contractors’ Employees To File Whistleblower Disclosures With OSC

Last week, the U.S. Office of Special Counsel (“OSC”), an independent federal investigative and prosecutorial agency that handles claims of wrongdoing within the executive branch of the federal government, proposed revising...more

The SEC’s Telling Enforcement Shift

The Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 made numerous, and significant, changes to the Securities and Exchange Commission’s regulatory powers particularly with respect to regulated professionals...more

CFPB announces leadership additions and changes

Last Friday, the CFPB announced the following additions to its senior leadership team: In its announcement, the CFPB confirmed that Anthony Alexis will become the CFPB’s Assistant Director of Enforcement. Mr. Alexis...more

January 2015: EU Litigation Update

Second Helping—The EPO’s Enlarged Board of Appeals Hears Tomatoes/Broccoli II. On October 27, 2014 the Enlarged Board of Appeals of the European Patent Office (EBoA) heard the two appeals against the Opposition Division’s...more

Mississippi Microbrewery Modernization Act of 2015

Representative Toby Barker recently introduced House Bill 1158, the Mississippi Microbrewery Modernization Act of 2015. This bill would allow certain breweries in Mississippi to sell products on the brewery premises and...more

SHREDDING TRADE SECRETS: Heli-Ski Operators Fret over FOIA Disclosures Releasing a Blizzard of Confidential Information

Heli-skiing: it’s the holy grail for thrill-seeking skiers and snowboarders.   Ride to the roof of the world aboard a helicopter. Descend thousands of vertical feet through fresh, untracked powder.  No lift lines, no ski...more

Standard & Poor’s Resolves Three SEC Actions, Makes Admissions

Standard & Poor’s Ratings Services was named as a Respondent in three settled administrative proceedings by the SEC. Each is tied to the Rating Services’ role in the conduit/fusion Commercial Mortgage Backed Securities market...more

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