Overnight Regulation: FDA e-cig rule hit with first lawsuit

Welcome to Overnight Regulations, your daily rundown of news from the federal agencies, Capitol Hill and beyond. It’s Tuesday evening here in Washington and we can’t believe how bad D.C. Metro has become. It might be time to join a bike share. Here’s the latest.

 

THE BIG STORY

A company has filed the first legal challenge to the Food and Drug Administration’s (FDA) move to regulate e-cigarettes and cigars like traditional tobacco products.

Nicopure Labs LLC, a leading manufacturer of American made e-liquids, announced Tuesday that it has filed a lawsuit in federal district court in Washington, D.C., challenging the “deeming” rule.

{mosads}The rule finalized last Thursday allows the FDA, for the first time, to regulate cigars, e-cigarettes, hookahs, personal vaporizers and electronic pipes under the 2009 Family Smoking Prevention and Tobacco Control Act.

Nicopure Labs argues in its filing that FDA’s rulemaking process violated the Administrative Procedure Act and that the regulation violates the First Amendment.

“FDA’s rule does not protect the consumer from low quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies such as ourselves, who are determined to drive the industry to the highest standards of quality and innovation,” Jason del Giudice, the company’s chief technology officer and co-founder, said in a statement.

FDA’s rule forces manufactures to put health warnings on product packaging and on advertisements, and prohibits sales to anyone under the age of 18, but it’s the provision requiring any product that hit store shelves after February 2007 to go through a costly approval process that has companies most distressed.

Industry leaders claim that provision alone will wipe them out of business since most of their products came out in 2009.

“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness” Nicopure’s general counsel and chief compliance officer Patricia Kovacevic said in a statement. “The government’s role is not to regulate for the sake of regulation; regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”

Other companies are reviewing what options they have to fight back against a rule they say will stifle product innovation even if the 2007 predicate date is changed.

When asked if Fortem Ventures, which makes the e-cigarette brand blu, would also challenge the rule in court, the company’s senior vice president Marc Michelsen said, “we’re not going to rule anything out.”

“We have to look at what our options are,” he added. http://bit.ly/1qchbPQ

 

WATCH LIVE: 

Tune in Wednesday, May 11 at 8:45 am for Targeted Cures: A Policy Discussion on Treating Patients with Rare Diseases. Featuring:

-Energy & Committee Chairman Fred Upton (R-Mich.)

-Senator Bob Casey (D-Pa.)

-Biogen CEO Dr. George A. Scangos

-PhRMA President & CEO Stephen J. Ubl

Topics of discussion include: the cutting-edge science & medicine driving rare disease advances, public-private partnerships for developing and delivering treatments, and the path to making care accessible to the patients who need it most. 

Click here.

 

ON TAP FOR WEDNESDAY

The Senate Small Business & Entrepreneurship Committee will hold a hearing to discuss how the administration’s overtime rule will impact businesses. http://1.usa.gov/21U1fzv

The Senate Judiciary Committee will hold a hearing to discuss the Federal Communications Commission’s proposed privacy rules. http://1.usa.gov/1T0EQNi

The House Oversight and Government Reform Committee will hold a hearing to discuss how to reform the postal service. http://1.usa.gov/1TDkUgA

The House Energy and Commerce Committee will hold a hearing to discuss issues with daily fantasy sports. http://1.usa.gov/24BWfBf

 

TOMORROW’S REGS TODAY

The Obama administration will publish 200 new regulations, proposed rules, notices and other administrative actions in Wednesday’s edition of the Federal Register.

–The Department of the Army will propose new rules for military cemeteries.

The changes would update burial eligibility, cemetery management structure, and the name of the cemeteries.

The public has 60 days to comment. http://bit.ly/1rS8I5o

–The Fish and Wildlife Service (FWS) will issue new protections for the Oregon spotted frog.

The FWS will designate a critical habitat for the Oregon spotted frog. The new habitat ranges 65,000 acres and 20 river miles across Oregon and Washington.

The protections go into effect in 30 days. http://bit.ly/1qceQ7m

–The Federal Reserve will propose new rules for systemically-important banks under the Dodd-Frank financial reform law.

These banks would face “restrictions regarding the terms of their non-cleared qualified financial contracts (QFCs).”

The public has until Aug. 5 to comment. http://bit.ly/1Omvwiy

 

NEWS RIGHT NOW

Oil companies abandon Arctic drilling rights. http://bit.ly/1VROFRp

This stings: Winter death rate for America’s bees jumps (AP). http://bit.ly/1rF2VAo

Pesticide regs could solve honeybee decline, experts say. http://bit.ly/24LBCWC

FDA to evaluate ‘healthy’ food labels. http://bit.ly/21TYnCz

Report: 73 percent of consumers misled by ‘natural’ labels. http://bit.ly/1sa0M02

Frozen vegetable recall expands to more than 40 brands. http://bit.ly/24LvE8a

AAA: Pot-related traffic deaths a concern. http://bit.ly/1QXI4gf

Maple Match: Dating service helps Trump-fleeing Americans find love in Canada (The Guardian). http://bit.ly/1ZCnWGt

FCC order offers merger details on Charter-Time Warner Cable deal. http://bit.ly/1WmHn8j

Company files first lawsuit against FDA e-cig rule. http://bit.ly/1qchbPQ

States, Chamber back Keystone lawsuit against Obama. http://bit.ly/1TzoB7v

Senate Dems to airlines: Stop charging baggage fees. http://bit.ly/1sbhegy

EPA settles with Wyoming farmer over man-made pond. http://bit.ly/1T9FW9x

 

BY THE NUMBERS

73 percent: Customers being misled by food labeled as “natural,” according to a Consumer Reports survey. http://bit.ly/1sa0M02

44 percent: Decline last year in the honeybee population, according to a USDA survey. http://bit.ly/24LBCWC
 

QUOTE OF THE DAY 

“Whether the use of marijuana is legal or not, all motorists should avoid driving while impaired. Just because a drug is legal does not mean it is safe to use while operating a motor vehicle. Drivers who get behind the wheel while impaired put themselves and others on the road at risk,” –The American Automobile Association (AAA).

Marijuana-related traffic accidents are becoming a growing concern in states that have legalized pot, according to a new study from AAA released Tuesday. http://bit.ly/1QXI4gf

 

We’ll work to stay on top of these and other stories throughout the week, so check The Hill’s Regulation page (http://digital-staging.thehill.com/regulation) early and often for the latest. And send any comments, complaints or regulatory news tips our way, tdevaney@digital-staging.thehill.com or lwheeler@digital-staging.thehill.com. And follow us at @timdevaney and @wheelerlydia.

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