FDA Seeking Public Comment on Tobacco Regulation

[IsxFun]

I found this on the ASH website: "TELL THE FDA What YOU Think Should Be Done About E-Cigs, Etc." with the following link:

FDA Seeking Public Comment on Tobacco Regulation

FDA Seeking Public Comment on tobacco Regulation

The Food and Drug Administration (FDA) established a public docket to obtain information on the implementation of the Family Smoking Prevention and tobacco Control Act. FDA is establishing this docket to provide an opportunity for all interested parties to provide information and share views on the implementation of the new law.

The period for comments on the implementation of the Family Smoking Prevention and tobacco Control Act has been extended until December 28, 2009 to allow interested persons additional time to submit comments.

..... I hope that you will tell the FDA your opinion.

 

[tdwave]

What sub category do you suggest. That is a must. I went there and do not know what to put in.. Any Ideas?

 

[IsxFun]

I used "individual consumer"

 

[instantinlaw]

Hello,
Don't get mad at me, but I don't see how this could affect the e cig in a negative manner...
Please explain.

What will the Family Smoking Prevention and Tobacco Control Act do?
The FSTPC Act gives FDA the authority to regulate tobacco products. The authority given FDA includes how tobacco products are manufactured, marketed, and distributed. Some of the key elements of the FSPTC Act are:

• Requiring companies who manufacture or import tobacco products to provide FDA with a listing of the amounts of all ingredients in the tobacco products they produce.
• Giving FDA the authority to require companies to provide information about the amount of nicotine in their products to FDA and the public.
• Giving FDA the authority, when appropriate for protecting public health, to adopt standards for nicotine yields and for the reduction or elimination of other harmful substances that may be present in tobacco products.
• Requiring that FDA must review an application and determine the product meets certain standards before tobacco products can be marketed and promoted as being "light", "mild" or "low". Premarket review by FDA is also required for tobacco products that were not commercially marketed as of February 15, 2007, or were modified after that date.
• Requiring the warnings on tobacco products to cover 50 percent of the front and back panels of the package and that text be large and legible.
• Requiring FDA to issue regulations regarding the advertising of, and access to, tobacco products.
• Establishing a Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations to FDA, such as on safety, dependence, or other health issues related to tobacco products.

 

[IsxFun]

Requiring FDA to issue regulations regarding the advertising of, and access to, tobacco products.

I thought the FDA had the ability to classify the E-cig (or juice) a tobacco product and could therefore deny their use?

 

[tdwave]

This is my comment to the FDA:
As you must know already, a big issue facing you is e-cigs. Please consider this. My wife and i were smokers for 30+ years. I to did start on the e-cig and since Sept. 24th both my wife and i have totally stopped smoking real cigs. I can only hope that someone can truly see the potential in this product. I never thought i was capable of not smoking. And as far as the nicotine levels, we are adults and yes the regulating of nicotine might be a consideration. But such regulations are in place with the patches correct? Please tell me what is stopping someone from putting 2, or more patches on at the same time? Also the patch didn't work for me. The function of the e-cig, helps me simulate the actions and feel of cigarette smoking and maybe that is what truly helped me and my wife get over smoking.
I know the FDA is in place to protect my wife and I from harmful products, so please, you have to know that if you are letting people smoke a known killer like a cigarette than just with common sense, why wouldn't the e-cigarette be a safer alternative... you must know that it is.
Being a small voice for similar people like me, i would be willing to answer or even testify on any questions you might have on this subject. All i know for sure is that from what coverage i have seen on this product there seems to be no one telling the public that there are success stories like mine, and plenty of others but in fact to many negatives. It makes me believe that the people that are making the decisions for us seem not to have done enough homework on this subject. So my summary is this: The E-Cig does not cater to children. Adults like flavors to, does not cause deaths or cancer, will in fact help the health care system by having less cancer patients in the future. Please, i am not a writer, but just take the time to look at the positives on this product and let people know you care.
Thank You All.

And after all that they say:
There is a problem with your comments and:
Your comment has been sent to the agency and will be available on Regulations.gov once it has been processed. Given certain regulations may have thousands of comments, processing may take several weeks before it can be viewed online. We value your comment, and encourage you to contact the agency directly for additional questions related to your specific comment.

Wonderful World we live in... Ha..

 

[Shadowdr]

• Requiring that FDA must review an application and determine the product meets certain standards before tobacco products can be marketed and promoted as being "light", "mild" or "low". Premarket review by FDA is also required for tobacco products that were not commercially marketed as of February 15, 2007, or were modified after that date.

In other words, no more cheap cigarettes. No competition to established name brands, no alternatives.
The addition of FSC to cigarettes is a clear indication that the health of smokers is the least of their concerns. Premarket reviews are an oppertunity for FDA officials to receive massive bribes to bring new and established product to market.

 

[BardicDruid]

I just wonder what Larry will do when ecig users out number the anti-smokers. That melt down would be so fun to watch.

 

[yvilla]

Here is a short list of suggestions from CASAA for comments to the FDA:

"We encourage you to submit a comment expressing, for example: Your experience with e-cigarettes helping you switch to them instead of tobacco cigarettes; your dilemma of whether to return to smoking cigarettes if e-cigarettes aren't accessible; your outrage at the FDA's misrepresentations of scientific evidence about e-cigarettes; and/or your recommendation that the FDA redefine e-cigarettes as a new category of harm reducing tobacco product, and reasonably regulate them as such."

 

[KermieD]

Hopefully CASAA consulted with an attorney before making that list. I can see where it would be very easy to turn that last statement into regulating PVs as they do inhalers or other NRTs. While volume of replies is certainly imperative in any request for comment prior to rulemaking by a federal agency, the content of those replies is just as important.

 

[yvilla]

Hopefully CASAA consulted with an attorney before making that list. I can see where it would be very easy to turn that last statement into regulating PVs as they do inhalers or other NRTs. While volume of replies is certainly imperative in any request for comment prior to rulemaking by a federal agency, the content of those replies is just as important.

Actually that last statement is precisely an argument against the FDA's current position regarding the ecig as a drug/device combination, requiring prior approval under Chapter V of the FD&C Act .

The new tobacco legislation (now a new chapter of FD&C Act) does contain a new category of "modified risk" tobacco products. Here is their definition in the new law:

SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
(a) IN GENERAL.—No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco
product unless an order issued pursuant to subsection (g) is effective
with respect to such product.
(b) DEFINITIONS.—In this section:
(1) MODIFIED RISK TOBACCO PRODUCT.—The term ‘modified
risk tobacco product’ means any tobacco product that is sold
or distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
(2) SOLD OR DISTRIBUTED.—
(A) IN GENERAL.—With respect to a tobacco product,
the term ‘sold or distributed for use to reduce harm or
the risk of tobacco-related disease associated with commer-
cially marketed tobacco products’ means a tobacco
product—
(i) the label, labeling, or advertising of which rep-
resents explicitly or implicitly that—
(I) the tobacco product presents a lower risk
of tobacco-related disease or is less harmful than
one or more other commercially marketed tobacco
products;
(II) the tobacco product or its smoke contains
a reduced level of a substance or presents a
reduced exposure to a substance; or
(III) the tobacco product or its smoke does
not contain or is free of a substance;
(ii) the label, labeling, or advertising of which
uses the descriptors ‘light’, ‘mild’, or ‘low’ or similar
descriptors; or
(iii) the tobacco product manufacturer of which
has taken any action directed to consumers through
the media or otherwise, other than by means of the
tobacco product’s label, labeling, or advertising, after
the date of enactment of the Family Smoking Preven-
tion and Tobacco Control Act, respecting the product
that would be reasonably expected to result in con-
sumers believing that the tobacco product or its smoke
may present a lower risk of disease or is less harmful
than one or more commercially marketed tobacco prod-
ucts, or presents a reduced exposure to, or does not
contain or is free of, a substance or substances.

***************************************

(g) MARKETING.—
(1) MODIFIED RISK PRODUCTS.—Except as provided in para-
graph (2), the Secretary shall, with respect to an application
submitted under this section, issue an order that a modified
risk product may be commercially marketed only if the Sec-
retary determines that the applicant has demonstrated that
such product, as it is actually used by consumers, will—
(A) significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users; and
(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1256enr.txt.pdf (quote is from pages 37 and 38)

While the FDA may well not willingly back down from its position classifying ecigs as drug device products, it is still to be hoped that Judge Leon's decision in the SE & Njoy case may force it to do so. Thousands of comments urging the FDA in that direction certainly would be helpful as well; at the very least it would do no harm.

 

[IsxFun]

Shameless bump...... There is limited window for your voices to be heard. I hope everyone will tell the FDA your experiences and opinions. I believe they make a difference.

 

[rjmporter]

A number of users in this thread have reported that they would get an error message after typing out their comments on the FDA site. I got the same error and took a little time to investigate the cause. It seems the site (regulations.gov) has a very short session timeout (about 10 minutes). So if it took you longer than 10 minutes to type your comments, they were probably not submitted.

If you would like to comment, and you plan to write a significant amount of text, try to type it up in a Word Processor (MS Word, etc.) first and then copy/past into the comment field on the site. Doing so, you should not run out of session time.

RJ
"The Computer Doctor"

 

[IsxFun]

Let your voices be heard. The time is now!