Search Results Archives: October 2013

October 31, 2013

Regulatory Stars Aligning for E-Cigs?

From: CSPNet  The Source for Convenience Store and Fuel News

Herzog optimistic after attending Food and Drug Law Institute tobacco regulation conference 

Melissa Vonder Haar, Tobacco Editor

WASHINGTON — On Oct. 28, the Food and Drug Law Institute (FDLI) hosted a conference on FDA regulation of tobacco, featuring a number of industry speakers including director of the FDA’s Center for Tobacco Products (CTP), Mitch Zeller. According to Wells Fargo Securities analyst Bonnie Herzog, Zeller and other speakers echoed the sentiments famously expressed by Professor Michael Russell that “people smoke for nicotine, but they die from tar.”

October 29, 2013

Why PRA Review is Important

Editor’s Note:  The following article illustrates why proposed information collections need to undergo a thorough review, conducted with appropriate resources, under the Paperwork Reduction Act.

From: Washington Free Beacon

HHS Predicted Obamacare Exchange Sign Up Would Take 28 Minutes

White House approved HHS 28 minute estimate for Obamacare exchange application time in April 

BY: Elizabeth Harrington

The Department of Health and Human Services (HHS) estimated consumers would take an average of 28 minutes to sign up for Obamacare, according to a notice the agency sent to the White House in February.

Indian Supreme Court Demands Regulation of Clinical Trials

Editor’s Note: CRE maintains an ongoing interest in international regulatory developments affecting American businesses.

From: RegBlog

Pooja Agarwal

More than 2,600 people reportedly died during clinical trials for new drugs in India between 2005 and 2012.  It is perhaps no surprise that the Indian Supreme Court recently demanded that the government create a strict regulatory plan before the end of the year for clinical trials to ensure the safety of the human subjects who participate in them.

October 28, 2013

FDA: No Surprises Planned for E-Cigarette Regs

From: MedPageToday

By Crystal Phend, Senior Staff Writer

When the FDA finally issues its proposed regulations on electronic cigarettes, which may be as soon as the end of the month, what will they look like? Probably pretty familiar, experts said.

The first step is likely to be just bringing the nicotine-vapor devices officially under the agency’s tobacco control authority and up to speed with the age, marketing, and packaging restrictions that have long been in place for conventional cigarettes.

October 25, 2013

The Continuing Debate Over Regulatory Incorporation

Editor’s Note:  Please see RegBlog’s Thee-Part Series on Regulatory Incorporation here.

From: RegBlog

RegBlog is pleased to publish this week’s series facilitating further debate over the practice of federal agencies incorporating private standards into binding government regulations.  Our previous series, Regulating by Reference, chronicled the surprising reality that “some legally binding rules also originate within private organizations – not the government.”

This practice, known as “incorporation by reference,” takes advantage of industry expertise, but also is perceived to come into tension with general principles of open government because the private standards an agency incorporates by reference are not always readily available to the public.  Despite this alleged tension, Congress passed a law in 1996 requiring federal agencies to incorporate private standards by reference whenever appropriate and practical.

October 24, 2013

Unmanned Aircraft Finding Their Way Into Airspace System

From: AINOnline

Slowly but surely, unmanned aircraft systems (UAS) are entering the U.S. National Airspace System (NAS) despite a regulatory regime that was previously considered prohibitive to all but government agencies and research institutions. Unmanned aircraft have flown for the first time commercially in remote Arctic airspace, and companies are considering or have already begun the process of obtaining FAA airworthiness certification of their UAS designs.

Heretofore, the FAA has required that private entities obtain a special airworthiness certificate in the experimental category to operate UASs, a status that prohibits them from being used commercially. Military services and public organizations require a certificate of authorization (COA).

October 21, 2013

White House FSMA/Foreign Supplier Verification Program Rules Redline

From: Politico

The FDA Friday quietly posted the White House’s redline version of the proposed Foreign Supplier Verification Program and third party auditor accreditation rules to the regulatory docket, offering the first look at what exactly what the Office of Management and Budget changed during the two years it was reviewing these provisions.

October 20, 2013

Understanding the Social Cost of Carbon

From: Montana Energy Review

By Jennifer Owen


October 18, 2013

Oil lobby threatens lawsuit against the EPA

From: RegWatch/The Hill’s Regulation Blog

By Julian Hattem

The oil and gas lobby is threatening to sue the Obama administration if environmental regulators do not release a biofuel regulation by the end of November.

The American Petroleum Institute (API) on Thursday sent a letter notifying the Environmental Protection Agency that it should prepare for a lawsuit if the final 2014 renewable fuel standard is not released on time.

The fuel standard calls for refiners to mix increasing amounts of biofuel in with conventional gasoline.

October 17, 2013

E-Cigarette Marketing Seen Threatened by FDA Scrutiny

From: Bloomberg

By Anna Edney

The $1.5 billion U.S. electronic-cigarette industry has tripled sales this year with the help of TV ads, Nascar sponsorships and product giveaways. Government regulation may now threaten those marketing tactics.

The Food and Drug Administration is set to decide this month whether to lump e-cigarettes in with conventional smokes as part of its oversight of the $90 billion U.S. tobacco market. Such a step would set the stage for greater restrictions on production, advertising, flavorings and online sales.