You know if I missed the deadline for three reports at my job, well it wouldn't be my job anymore.
Here's an e-mail the FDA sent to a news reporter who inquired about the agency's report on Section 918 (whose deadline was today).
From: Haliski, Jennifer [mailto:Jennifer.Haliski@fda.hhs.gov]
Sent: Monday, April 01, 2013 12:38 PM
To:
Subject:
FDA is missing the other statutory deadlines related to the three reports to Congress and the two items on harmful and potentially harmful constituents. Below are the two statements from the Agency on those issues:
FDA statement related to missing April 01, 2013 Report to Congress deadlines
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires the Secretary of the Department of Health and Human Services to submit to Congress three reports dealing with specific tobacco-related issues by April 1, 2013. These reports are near completion and will be submitted to Congress in the near future. The subjects of the required reports are:
Examining how to best regulate, promote, and encourage the development of innovative products and treatments to reduce or eliminate tobacco dependence and harm (section 918(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the TCA);
Reporting on the implementation of the Tobacco Control Act (TCA section 106(a)); and
Reporting on U.S. tobacco product exports that do not conform to tobacco product standards (section 801(p)(1) of the FD&C Act, as amended by the TCA).
FDA Statement on HPHC Statutory Deadlines
The Family Smoking Prevention and Tobacco Control Act gives the FDA an extraordinary opportunity to improve the health of all Americans, whether they use tobacco or not. One of the goals of the law is to improve consumer understanding of tobacco products and their related harms, as tobacco use continues to be the leading cause of preventable death and disease in the United States.
Part of the law requires the FDA to publicly display information about harmful and potentially harmful constituents (HPHCs), chemicals in tobacco products and tobacco smoke that cause harm, or could cause harm, to users and non-users. The FDA is required by law to provide this information to the public, including the amount of each chemical present in specific brands and sub-brands of tobacco products, in a way that is understandable and not misleading by April 1, 2013.
The FDA is currently not ready to make this information available by the upcoming deadline, but will do so once the Agency is confident that the information is accurate, understandable and not misleading to the public. Currently, the Agency is still evaluating the data it has received from manufacturers, including verifying its accuracy. In addition, FDA is planning to conduct scientific studies to assess consumer understanding of how the Agency presents information about HPHCs. Upon completion of these important activities, FDA intends to publish the HPHC information so that consumers can make more informed decisions about tobacco products.
Section 915 of the Federal Food, Drug and Cosmetic Act requires the FDA to issue regulations by April 1, 2013 requiring the testing and reporting of tobacco product constituents, ingredients, and additives that the FDA determines should be tested to protect the public health. The FDA intends to follow notice and comment rulemaking procedures and issue a proposed rule. FDA will publish a proposed date in the Unified Agenda, which semi-annually lists all of the Agencys projected publication dates.
The FDA provides harm. I say let's abolish them.
A good first step in the many federal agencies that should be abolished.
Selling an inferior product is a business model destined to fail.
100% agree. It's very easy to generalize and think the FDA as a whole is evil, or BP, or BT. We have to step back and realize there are always good and bad people in an organization, it's never as black & white as 'they're all evil scumbags'. I think we absolutely can make a difference.
I know that seems like a naive statement to some, but consider this: Didn't a good judge shut down the FDA last time? If we generalize and think every person in a group is bad or against our best interest, how will we ever gain support from those who would side with us?
Just look at all the whistleblowers who have risked their lives by speaking out against powerful organizations and institutions. Many have been suicided. We have to always remember that there are good souls in every group of people. We have to band together. There is strength in numbers, and there are more of us than there are of them. "Them" being sociopaths in powerful positions, and "people" who put money before human life. Yes WE CAN! LOL
In Corporate america, failure is rewarded. Look at CEOs from worldcom, etc. They take their golden parachute after either failing or picking the bones clean like a vulture, then move on to another start-up or company, as CEOs again.....then rinse and repeat.
That's how you end up retiring early into the best gated communities, with a coupla "properties" in the islands......
In Corporate america, failure is rewarded. Look at CEOs from worldcom, etc. They take their golden parachute after either failing or picking the bones clean like a vulture, then move on to another start-up or company, as CEOs again.....then rinse and repeat.
That's how you end up retiring early into the best gated communities, with a coupla "properties" in the islands......
This is all so freaking fascinating...
But what I'm getting out of all of this is that "we" vapers have upset the apple cart.
And the FDA, due to our incredible showing of over 5000 official comments, is now in back-to-the-drawing-board mode.
Those that think the FDA doesn't care about what we have to say perhaps should reconsider the impact our actions might be having.
Depends on who your reporting to. Say it's a report to your professor, well he or she will read it and scour the data to check your conclusions.As pleasant as it would be for the FDA to actually care about what we have to say, I'm still skeptical. The delay could be a result of "we" vapers pushing so much science and research through their official channels, and our show of public force against the direction the were leaning towards, that a majority of the data in the report goes against their claims I'm the report.
How can you submit a report where your data contradicts your statements?
Depends on who your reporting to. Say it's a report to your professor, well he or she will read it and scour the data to check your conclusions.
Now if otoh it to some political type , what you do is bury the data in a 20 page tightly typed 'report' and stick your conclusions in a big typeface cover letter. The only bit they will read is the conclusion and recommendation. After all thats what your payed for.