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Headlines Tagged with FDA 9,049 headlines found


Submission of Warning Plans for Cigars; Guidance for Industry; Availability A Notice by the Food and Drug Administration on 12/29/2016

(FDA) is announcing the availability of a guidance for industry entitled “Submission of Warning Plans for Cigars.” The guidance will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar wa
Federal Register
added Dec 30, 2016 06:09

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

Q&A: Modified Risk Tobacco Products

Modified risk tobacco products (MRTPs) are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
FDA - Food and Drug Administration
added May 24, 2017 22:16

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

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

Vaping Measure Fails to Pass Senate

The fight to ease looming FDA requirements over e-cigarette and vaping manufacturers were put on hold at least until spring, with the so-called Cole-Bishop Amendment failing to get into federal budget legislation passed last month. The bill from U.S. Re
Convenience Store/Petroleum (CSPNet)
added Dec 30, 2016 06:03

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

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

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

BOEHM: Safer Alternative to Smoking Can’t Call Itself a Safer Alternative to Smoking

Approving Swedish Match's application to pitch snus as a safer alternative to smoking would probably save American lives, but it would create more competition for Nicorette gum and other pharmaceutical stop-smoking products like Chantix. It's worth noting
Reason Magazine
added Dec 21, 2016 22:40
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