FDA Submissions Here: Let the FDA Know What You Think

Click on the link below to let the Food and Drug Administration know what you think about the new Waxman-Kennedy law providing the FDA with regulatory authority over the tobacco industry.

http://www.regulations.gov/fdmspublic/component/main?main=SubmitComment&o=09000064809e74eb

This link takes you directly to Regulations.gov and the FDA’s Comment Page on this regulation. You can write whatever you want since a public comment period is indeed open to everyone equally: FDA does not look at who sent the comment only at the comment per se to see if it is useful to them as they plan their regulatory agenda.

As a reader on TobaccoToday, you are only too aware of the US Government’s evolving controls over the tobacco industry through FDA regulation and the role that Altria/Philip Morris USA has played in a process that saw them write this legislation alongside the Campaign for Tobacco-Free Kids. As a reader you are only too aware that the public health community has been divided over the merits of this law and that PM expects to become a major beneficiary given that the law is directed largely at youth initiation not at adult smokers. It raises the bar on Tobacco Harm Reduction so high that Marlboro has little to fear from new products such as eCigarettes effectively enabling the most used cigarette brand to gain from further point of use/sale practices given that advertising is virtually eliminated. Adult smokers, still faced with the “quit or die” mentality that both PM and Tobacco Control encourage, are now less likely to learn that alternative forms of tobacco consumption are less harmful.

After you fill out the comments on Regulations.gov, feel free to copy and paste your comments as a comment to this blog, so your fellow readers at TobaccoToday can follow the progression of comments AND perhaps get inspired to comment themselves.

7 comments ↓

#1 Tatler on 07.02.09 at 2:59 PM

This is a great idea for smokers to make comments on the regulation of the industry and to post them here at the same time so everyone can see what’s being said.

Keep up the good work guys.

#2 Joe on 07.02.09 at 7:24 PM

I believe the fda should be progressive towards harm-reduction rather than agressively against harm-reduction. E-cigs and Snus are two examples where the FDA shows it’s ignorance.

#3 jancascade on 07.25.09 at 7:22 PM

The government,/FDA are not showing their ignorance, they are showing their greed.

#4 Chris Crawley on 10.16.09 at 9:07 AM

I agree with Joe the FDA has an opportunity to provide real leadership in driving harm reduction in a controlled way into the product. This is particularly true for cigarettes.

Much of the harm reduction dialogue and development effort has migrated to smokeless tobacco products while smokers get almost no attention.

#5 Bill Godshall on 10.16.09 at 12:23 PM

In public comments, Smokefree Pennsylvania has urged the FDA to:

– truthfully inform smokers and the public that smokefree tobacco/nicotine products are less hazardous alternatives to cigarettes,

– eliminate the misleading “This product is not a safe alternative to cigarettes” warning on smokeless products,

– eliminate the unsubstantiated “This product may cause mouth cancer” warning from snus and other low nitrosamine smokeless products (as there is no scientific evidence these products cause mouth cancer),

– require a warning on all cigarette packs stating “Smokefree tobacco and nicotine products are less hazardous alternatives to cigarettes”,

– evaluate and publish the relative and comparable health risks of different tobacco/nicotine products,

– establish stricter standards for “modified risk” and “reduced exposure” claims for cigarettes than for smokefree tobacco products,

– require a warning on all cigarette packs stating “There is no such thing as a safer cigarette; all cigarettes are similarly hazardous”,

– not propose/approve cigarette emission standards for nicotine/tars/CO etc.,

– not propose/approve banning menthol cigarettes as it would create black market for untaxed menthol cigarettes,

– not propose/approve banning or restricting flavorings/additives in cigars or smokefree tobacco products,

– redefine e-cigarettes as a new category of smokefree tobacco products and develop reasonable product regulations,

– approve NY Health Cmsnr’s petition to make NRT products (i.e. gums, lozenges, patches, inhalers) more accessible (i.e. allow sales of $5-$10 daily dose packages, and in all stores that sell cigarettes), and to change mandatory warnings to state that NRT is less hazardous alternative to cigarettes and can be used concurrently with tobacco products (the current warnings are scarier than cigarette warnings and say not to use if tobacco is also being used),

– approve temporary and long term use of NRT products (FDA currently approves NRT only to be used for 10-12 weeks and only for tobacco cessation),

– inform smokers and the public that cold turkey is the most effective smoking cessation method (not NRT products, which have a 93% failure rate after 6 months and a 98% failure rate after 20 months),

– stop deceiving the public and misrepresenting scientific evidence (e.g. tobacco flavorings/additives, marketing to youth, e-cigarettes, NRT success rates for smoking cessation).

#6 Bill Godshall on 10.16.09 at 12:36 PM

Following are my suggested actions for folks in the industry to help promote tobacco harm reduction (and help convince the FDA do so as well).

– In public comments http://www.regulations.gov urge the FDA to truthfully inform tobacco consumers and the public about the vastly different comparable risks of different tobacco/nicotine products.

– Routinely inform media/public via noncommercial speech (press releases, op/eds, LTEs, media interviews, public testimony, litigation) that smokefree tobacco products are less hazardous alternatives to cigarettes.

– Target market smokefree tobacco products to smokers as cigarette substitutes.

– Aggressively defend smokefree tobacco products (including flavored brands) from unsubstantiated charges that they are target marketed to youth.

– In litigation challenging provisions of FDA statute for violating 1st amendment, emphasize that smokers have a human right to be informed smokefree tobacco products are less hazardous alternatives to cigarettes, that tobacco companies (and the FDA) have an ethical duty to inform smokers of this fact, and that the FDA statute violates the 1st amendment by prohibiting tobacco companies from truthfully informing smokers.

– Develop/introduce new smokefree tobacco brands and inform the FDA they are “substantially equivalent” to other similar smokefree tobacco products that were on the market before February, 2007.

– Submit applications to the FDA to make “modified risk” claims stating that a smokefree tobacco brand is a less hazardous alternative to cigarettes (and/or to cigarette brands).

– Submit applications to the FDA to make “modified risk” claims stating that pasteurized snus is not associated with oral cancer, unlike fermented smokefree tobacco products.

– Submit applications to the FDA to make “reduced exposure” claims stating that snus or other low nitrosamine tobacco products emit fewer carcinogens than chewing tobacco or moist snuff.

– Do NOT submit applications to the FDA to make “modified risk” or “reduced exposure” claims stating that a cigarette brand is less hazardous or contains fewer smoke constituents than other cigarettes (and/or other cigarette brands).

#7 OTP Kid on 10.28.09 at 11:24 AM

Bill,

I’m offended at the terminology used when you mentioned banning menthol flavorings and what this would create.

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