FDA Want Public Input on New Tobacco Labels
Posted by on November 12, 2010 - 10:56am

Federal regulators are testing the waters with the first proposed changes to cigarette packaging and advertisements in more than 25 years—bold health warnings with color images that show the tragic consequences of smoking.

On Nov. 10, the Food and Drug Administration (FDA) posted on the Internet 36 images showing the dangers of smoking. Federal health agencies hope the new warnings will discourage Americans from smoking by bringing them face-to-face with the cancers that plague smokers.

Under 2009’s Family Smoking Prevention and Tobacco Control Act, cigarette packages and advertisements must carry more pointed health warnings with color images after Sept. 12, 2012. FDA is beginning the process by publishing a proposal in the Federal Register that outlines new packaging and advertising requirements for cigarette makers.

FDA Invites Public Comment

FDA is asking the public to weigh-in on the images. When the public comment period ends on Jan. 9, 2011, FDA will use the comments, research results, and scientific research to pare the list to nine. The final set of images and the congressionally mandated health warnings will rotate on all cigarette packaging and in advertisements by fall 2012.

By law, the nine warnings that must appear on cigarette advertisements and packaging are:

  • WARNING: Cigarettes are addictive
  • WARNING: Tobacco smoke can harm your children
  • WARNING: Cigarettes cause fatal lung disease
  • WARNING: Cigarettes cause cancer
  • WARNING: Cigarettes cause strokes and heart disease
  • WARNING: Smoking during pregnancy can harm your baby
  • WARNING: Smoking can kill you
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers
  • WARNING: Quitting smoking now greatly reduces serious risks to your health

Once in place, each warning will accompany a color image, and they’ll be splashed over 50 percent of the front and rear panels of all cigarette packages and at least 20 percent of each advertisement.

Preventable Deaths

If the requirements seem tough, they’re intended to be. The Centers for Disease Control and Prevention says tobacco use is the single biggest cause of preventable death in the United States—killing more than 443,000 users and victims of secondhand smoke and causing serious illness in 8.6 million Americans.

The new warnings will be required on cigarette packages no later than Sept. 22, 2012

Where to See the Warnings and Where to Comment

Flickr LOGOTo view the warning labels, go to: www.flickr.com/photos/fdaphotos/collections/72157625232230587/

To submit comments on the warning labels and the proposed rule—between Friday, Nov. 12, 2010, through Tuesday, Jan. 11, 2011:

  • Go to www.regulations.gov and insert docket number FDA-2010-N-0568 into the “search” box and follow the prompts.
  • Send a fax, with your comments, to 301-827-6870.
  • Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

All comments should be identified by Docket ID No. FDA-2010-N-0568. It is only necessary to send one set of comments.

Women, Smoking and Weight Gain
Posted by on September 21, 2010 - 4:01pm

Today,more than 200 health professionals attended the Institute for Women's Health Research at Northwestern University's first educational research forum of the 2010-2011 school year that  featured Bonnie Spring, PhD, a behavioral psychologist at Northwestern.   Her lecture entitled  "Untangling the Web of Women, Smoking and Weight"  made me realize how much we still need to learn about the power of addiction.  Here are some interesting notes about smoking cessation and weight gain from her lecture:

  • Reasons women continue to smoke:   mood and stress management, addiction/craving, social network, weight management.
  • Fear of weight gain discourages 50% of women and 26% of men who smoke  from quitting.   The reality is that 80% of people who quit smoking gain weight but the actual weight gain is about 6-10 lbs. , not the 15 lbs. that people assume.
  • The major cause of post cessation weight gain:   decreased metabolism (from nicotine cessation) and increased energy intake from snacks. Evidently, when we take away something the body values or provides pleasure (e.g., nicotine), we tend to substitute it with something else that we value (e.g. food).
  • Education about the benefits of not smoking is not enough to change behavior;  exercise alone to keep weight off while quitting smoking does not work.
  • Drugs sometimes used during smoking cessation to keep weight down work while they are being used, but once they are stopped, the weight returns.
  • Several studies have been conducted to determine if weight loss programs should be done simultaneously during smoking cessation therapy; shortly after smoking cessation has begun;  or completely after the person quits.  The results vary and it is not yet clear what the best approach is.
  • A lot of controversy persists around the question:   Do weight management efforts undermine tobacco abstinence?  Despite several national guidelines that state so, there is no study that demonstrates that trying to prevent weight gain while trying to quit smoking makes it less likely that a woman will succeed at quitting smoking, according to Dr. Spring.

Some promising approaches that are being evaluated include:

  • Sequential behavioral treatment (cessation, then diet and activity change) more effective than simultaneous treatment because it is  less overwhelming to the patient.
  • Exercise alone does not suppress weigh gain
  • Bupropion, varenicline, NRT suppress weight gain in the short term, but not long-term (after medications discontinued)
  • Weight acceptance (but so far tested only among very weight concerned smokers)

So the jury is still out on the best way to quit smoking.  Dr. Spring also shared some of the early advertising campaigns that were highly successful in raising the number of women smokers.   She noted, "Perhaps the best way to get women to quit smoking is to hire the companies that have been so successful in getting women addicted!"

Tobacco Smoke Exposure Increases Chronic Disease in Children
Posted by on August 10, 2010 - 2:45pm

In July, a commentary in the journal Pediatrics discussed several new studies that have increased our knowledge of the  association between tobacco smoke exposure and childhood morbidity and mortality.  Collectively, these new reports demonstrate that in several categories of chronic childhood illness (asthma, obesity, and mental health disorders) there are small-to-moderate independent associations with tobacco smoke exposure either during pregnancy or in the postnatal period.   A moderate association with tobacco smoke and dental caries (cavities) in children was also reported.   One study found an association between smoke exposure of pregnant women and subsequent childhood overweight in offspring.   What was especially significant about the latter study was the fact that it was conducted in pregnant women who did NOT smoke but were exposed to smoke from the father.  Studies looking at mothers who smoke continue to show an association to their children's mental health status that affects their children's  ability to participate in social activities and make friends.

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