FDA and Tobacco Industry - The Tension & Next Steps

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FDA's New Tobacco Scheme, and its Legislative Underpinnings, May Go Up in Smoke - Forbes:

"Several years ago, the federal government entered into a Faustian bargain with the tobacco industry — and the cigarette makers with the government. It was legislation borne of mutual antipathy.

Under the scheme, Washington brought the tobacco industry under the thumb of federal regulation. FDA now oversees everything from the way cigarettes are marketed, to the manner in which they are made. In exchange, the tobacco industry was promised a regulatory track out of their current (declining) business model.

FDA was to create a path to enable cigarette makers to transition away from smoked tobacco and win government approval of consumable products that used tobacco but presumably harbored less, and perhaps even none of the health risks posed by smoking. "

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Learn more about an upcoming March 2013 workshop:
FDA - Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

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FDA Asked About Mobile Apps and the FDA 510K Process

Congress asks FDA if “actual use” is factor in medical app regulation | mobihealthnews:

". . . The letter also asks whether the FDA will consider the “actual use” of a mobile medical app in addition to the “intended use” when making its determination about whether an app needs to go through the 510(K) process. Finally, the letter closes with a series of questions related to the final guidance document and the committee wants answers by March 15th."

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Read the Letter Sent to FDA Commissioner Margaret Hamburg (pdf)

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• FDA Free Tips - Don't Fall for Health Fraud Scams (video) (drughealth.blogspot.com)

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• Trusted and respected FDA GMP online training courses, programs, and classes offered by SkillsPlus International Inc.

Consumer Updates > 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams:

"In this video, FDA Commissioner Margaret A. Hamburg, M.D., and FDA National Health Fraud Coordinator Gary Coody, R.Ph., discuss health fraud and tips for avoiding scams."

[embedded video removed]

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Learn more about health fraud scams from the FDA:  Health Fraud Scams (FDA)
"Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment. They can also cause serious or even fatal injuries."

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FDA Intro To The FSMA (video)

• FDA cGMP QSR GMP Training - popular online training courses by SkillsPlus International Inc.

The FDA Food Safety Modernization Act (FSMA) video explains how the new law makes prevention from farm to table the basis of food safety.



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• FDA cGMP QSR GMP Training - popular online training courses by SkillsPlus International Inc.

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• FDA - Proposed Rules To Implement FSMA (skillsplusinfo.blogspot.com)

FDA Facts About Current Good Manufacturing Practices (cGMPs)

If you're new to the FDA's cGMPs, then follow the link below, to their website. It explains what the cGMPs are all about:

Manufacturing > Facts About Current Good Manufacturing Practices (cGMPs):

"Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American.  Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.  Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.  This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

What are cGMPs?" . . .

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