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Headlines Tagged with FDA 8,666 headlines found

13 Views

[USA] E-cigarette regulations set to go into effect

“The bad news is that August 8th … marks the beginning of a two-year countdown to FDA prohibition of 99.9%+ of vapor products on the market,” Greg Conley, president of the American Vaping Association, wrote Friday on the group’s website. “If we do not su
USA Today
added Aug 7, 2016 23:08
15 Views

Deciphering Smoke Signals — FDA’s New Tobacco Product Rules and Their Impact on the Cannabis Industry (PDF)

Dual-use cannabis consumption products and their off-label uses may cause those products to fall within the new FDA rules governing tobacco products. Manufacturers and retailers of vape pens and atomizers will face a brave new world come August 8 when
JD Supra, LLC
added Aug 9, 2016 16:08
14 Views

FDA Rule Describes Acceptance Threshold for Tobacco Product Applications

Types of tobacco product applications include: requests for exemption from demonstrating substantial equivalence (SE), SE reports, premarket tobacco applications (PMTAs), and modified risk tobacco product (MRTP) applications.
FDA - Food and Drug Administration
added Aug 8, 2016 21:01
8 Views

8 Insights From Day 2 of the Total Nicotine Conference

Roll With It / Pipe Packs a Punch / SKU-ing Cigars / A 'Slippery Slope' / The Price Of Compliance / Whom Does CTP Answer To? / Just the Beginning / The White House Wants to Know
Convenience Store/Petroleum (CSPNet)
added Aug 7, 2016 05:04
8 Views

Tobacco Deeming Regulations Set to Go into Effect

"We absolutely share the public health concern that flavored e-cigarettes remain quite popular with kids," Zeller said. "But we still need to sort out what the right policy is for regulating flavors in e-cigarettes now that we have completed the monumenta
MedPage Today
added Aug 7, 2016 03:59
24 Views

CICELSKI: FDA Claims Jurisdiction Over All Tobacco Products ($$)

The parties subject to these new regulations should be sure to familiarize themselves with the rule’s requirements... broadcast stations and other media outlets should now become even more vigilant in vetting such advertisements prior to their release.
Law360
added Aug 5, 2016 20:23
7 Views

FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” s
FDA - Food and Drug Administration
added Aug 5, 2016 19:59
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FDA tightening tobacco review process

Tobacco manufacturers are facing new roadblocks from the Obama administration... The FDA says tightening up its review process will allow it to focus on “quality submissions” from other tobacco companies.
The Hill
added Aug 5, 2016 19:58
4 Views

[Michigan] E-cigarettes facing new regulations starting next week

"We've seen people in their 50s, 60s, and 70s and older coming off of half a century of cigarette use," Cesnick said. Regardless of what he thinks, the FDA will now have the final say and control over the industry. "Come Monday no new products will ent
WJBK FOX 2 (Southfield, MI)
added Aug 5, 2016 14:44
7 Views

E-Cigarette Makers Contending With New CPSC And FDA Regulations

Even entities not directly affected by the new rules should consider, for example, whether they need to add more specific reps and warranties related to regulatory compliance in their supply agreements with ENDS manufacturers.
Mondaq
added Aug 8, 2016 18:12
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