Comments in support still needed

[Vocalek]

Comments are still needed in support of the two petitions submitted to the FDA by the American Association of Public Health Physicians.

FDA-2010-P-0093 – Asks the FDA to correct the erroneous information provided in the July 22, 2009 press conference. [Currently there are only 44 comments in support of this. Do we really want the FDA to get away with telling great big whoppers?]

FDA-2010-P-0095 – Asks the FDA to stop trying to regulate (i.e. ban) electronic cigarettes as drug-delivery devices and reclassify electronic cigarettes as tobacco products. [See *NOTE at the end of this post]

To comment,

1. Click this link
http://www.regulations.gov/search/Regs/home.html#home
2. Copy one of the two document numbers and paste into the field labeled “Enter Keyword or ID:” Press Enter.
FDA-2010-P-0093
FDA-2010-P-0095
3. Make sure that the correct Document number is displayed in the ID column.
4. Click “Open Docket Folder” link in the Actions column.
5. Locate the title “American Association of Public Health Physicians, tobacco Control Task Force (AAPHP) - Citizen Petition” and click it.
6. On the Document Details page, click Submit Comment.
7. Complete the fields. Note for Submitter Category, select “Consumer Group – B0003”. If you select “Individual Consumer”, your comment will not be displayed unless you contact FDA to specifically request that it be displayed.

Repeat the above steps, commenting on the other Document.

Make sure that your comments reflect the topic.

Comments on FDA-2010-P-0093 should ask FDA to correct the erroneous information regarding the July 2009 cress conference.

Suggested talking points:
- the FDA Electronic Cigarettes grossly mispresented its own laboratory test findings on two brands of e-cigarettes http://www.fda.gov/downloads/Drugs/S.../UCM173250.pdf
- in contrast to claims made at the FDA's press conference, there is no evidence that e-cigarettes have ever harmed any user or nonuser, and there is no evidence that e-cigarettes are marketed to youth,
- the FDA failed to acknowledge any evidence (sent to the agency) that e-cigarettes are far less hazardous alternatives to tobacco cigarettes, and that thousands of e-cigarette users informed the agency they had quit smoking by switching to the products,
- cigarette smokers have a human right to truthful information about, and legal access to, less hazardous alternatives,
- FDA officials have an ethical duty to protect consumer health and to provide truthful health risk information,
- if applicable, describe your personal experience using e-cigarettes

Comments on FDA-2010-P-0093 should support why FDA should classify the electronic cigarette as a tobacco product.

Suggested talking points
- since e-cigarettes (nicotine vaporizers) are derived from tobacco, the FDA can legally reclassify and regulate them as "tobacco products",
- by choosing to classify e-cigarettes as "drugs" or "devices", the FDA was/is attempting to ban the products,
- hundreds of thousands of smokers already have significantly reduced their health risks by switching to e-cigarettes,
- by reclassifying e-cigarettes as tobacco products, the FDA would ban their sale to minors, can establish other reasonable and responsible product regulations, would help to reduce (instead of maintain) cigarette consumption, and would save taxpayers money that FDA continues to waste,
- in SE vs FDA, federal Judge Richard Leon has ruled that the FDA can regulate e-cigarettes as "tobacco products", but not as "drugs" or "devices",
- sales and use of e-cigarettes have continued to sharply increase despite the FDA's ongoing attempt to ban the products,
- banning e-cigarettes would primarily protect cigarette markets at the expense of consumer and public health,
- if applicable, describe your personal experience using e-cigarettes

*NOTE: At this point in the U.S., there are only two legal classifications open. The products can be regulated as drug-delivery combination devices under the Food Drug and Cosmetics Act (FDCA), or as tobacco products under The Family Smoking Prevention and Tobacco Control Act (Tobacco Act). There is no third option, much as we would prefer.

The court case Smoking Everywhere v. FDA will decide the matter one way or the other. If FDA wins the court case, they will immediately step up seizures of shipments and confiscate productd from retail outlets. Their grouds will be that they have affirmed that the product is a new, unapproved drug under FDCA. The burden will be on manufacturers to file New Drug Applications and then go through the long, expensive process to conduct randomized clinical trials to prove safety and effectiveness. Odds are, the products as we know them will be gone forever.

Under the Tobacco Act, FDA is not allowed to remove a product from the market simply because they don’t like it. They can impose reasonable regulations with regard to safety.

AAPHP’s petition asks FDA to stop trying to ban the products and get on with the job of coming up with reasonable safety regulations under the Tobacco Act. We can wait for this to make its way through the court system, but meanwhile some of the smaller supplliers can't take much more of paying thousands of dollars for shipments that never arrive, thanks to FDA.

(The above isn't really quoting anyone but myself. I just wanted to set the text off visually.)

 

[Janetda]

Bump, bump, bump

 

[Vocalek]

Thanks, Janet. I already submitted my personal comments. Now I have to get cracking on drafting the official CASAA organization comments. *nudge* *nudge*

 

[D103]

I submitted again Elaine, even though I submitted to these petitions months ago I could not find my posts anywhere-I don't know if I was censured or not, the site did not say so and it indicated at the time my submission was accepted- anyway it allowed me to submit again, so I will see if I actually make it "on" this time.

 

[Vocalek]

Reminder: If you selected "Individual Consumer" FDA's practice is to not display the comments, supposedly to protect your privacy. There is a number (I'd have to search through the other posts) that you can phone and request that FDA find and post your comment. We are recommending that people select "Consumer Group" as their Submitter Category when they post a comments. Those do get displayed without having to make a phone call to FDA.

 

[D103]

I did follow your instructions this time and posted under Consumer Group-B0003, so hopefully it will make it.

 

[Vocalek]

For some reason, there is no Edit button on the OP.

The document number needs to be corrected. The correct statement should read:

Comments on FDA-2010-P-0095 should support why FDA should classify the electronic cigarette as a tobacco product.

 

[mikecyber]

The FDA can legally reclassify and regulate them as "tobacco products"

What would happen to all of the non-tobacco flavors? The FDA has banned all flavored cigarettes, except menthol. What would stop them from outlawing non-tobacco flavored juice?

I can't tolerate tobacco flavors. I put up with it in analogs because that was my only viable option for nicotine intake. I would hate to see them ruin a huge appeal to ecigs.

 

[Vocalek]

You would need to order unflavored juice and add your own flavoring. I have stocked up on food flavorings.

 

[Janetda]

bump bump bump