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Submission of Warning Plans for Cigars: Guidance for Industry (PDF)

This guidance document discusses, among other things: •The regulatory requirements to submit warning plans Definitions Who submits a warning plan The scope of a warning plan When to submit a warning plan What information should be submitted in a warning p
FDA - Food and Drug Administration
added Dec 29, 2016 12:42
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Submission of Warning Plans for Cigars

This guidance document is intended to assist persons submitting warning plans for cigars, as required by Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143). This guidance document discusses, among other things: The regulatory requi
FDA - Food and Drug Administration
added Dec 29, 2016 12:39
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FDA discloses warning labels for cigars

it is moving forward on requiring warning labels on cigars even though it is in the midst of lawsuits addressing similar labels for cigarettes. The agency said a rotating group of six warning statements will be required of cigar manufacturers beginning o
Winston-Salem (NC) Journal
added Dec 29, 2016 12:37
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Who Will Trump Pick to Helm the FDA? Health policy experts discuss rumored contenders

A group of cardiologists have lobbied for Califf to stay on-board....Nancy Brown, CEO of the American Heart Association agreed...."he has been instrumental to the FDA's success in curbing tobacco use and ensuring food safety," she stated.
MedPage Today
added Dec 28, 2016 13:50
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RODU: FDA Rejects Plea to Correct Smokeless Tobacco Warnings; A Closer Look at Flawed Interpretations

nter for Tobacco Products rejected Swedish Match’s request... The FDA justified its rejections in a six-page letter to the company (here) in a 115-page supporting document (here), and subsequently in an announcement proclaiming, “FDA Issues Science-Based
Tobacco Truth (Brad Rodu blog)
added Dec 23, 2016 14:07
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LETTER to SWEDISH MATCH from FDA (PDF)

we are not issuing modified risk orders...with respect to your requests to remove the mouth cancer warning and revise the “not a safe alternative” warning. We have determined that in their present form, the applications do not contain sufficient evidence
FDA - Food and Drug Administration
added Dec 23, 2016 14:06
22 Views

Under Trump, Florida's premium cigar industry could escape job-killing FDA regulations

could save thousands of jobs by stripping the [FDA] of its ability to regulate premium cigars like cigarettes. Late last week, U.S. Rep. Mark Meadows, R-N.C., the incoming chairman of the conservative House Freedom Caucus, met with President-elect Donald
Watchdog.org (Franklin Center for Government & Public Integrity)
added Dec 23, 2016 00:34
17 Views

FDA Checks Reveal Stores Illegally Sell Tobacco to Minors

“We’re helping protect the health of America’s youth by enforcing restrictions that make it illegal to sell tobacco products to minors – including e-cigarettes, e-liquids and cigars,” the FDA’s Mitch Zeller said in a press release titled “FDA protects ki
JD Supra, LLC
added Dec 23, 2016 00:31
14 Views

FDA Extends Cigar Registration Period By Six Months

Cigarmakers seeking approval under the U.S. Food and Drug Administration's new premium cigar regulations are getting a bit of extra breathing room. The FDA recently issued an extension for newly-regulated tobacco manufacturers, pushing back the agency's
Cigar Aficionado
added Dec 23, 2016 00:28
46 Views

SATEL/SWEANOR: Dear Surgeon General and public health agencies, anti-vaping polices are bad for public health

Our lead public health agencies – CDC, FDA, and the Surgeon General’s office – have been shamefully derelict in their duty to protect the health of smokers and empower them. Many of the nation’s millions of smokers would surely switch to reduced harm al
American Enterprise Institute
added Dec 21, 2016 22:40
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