Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, March 2, 2012

Graphic Cigarette Warning Labels and Big Tobacco's Stall Tactics

Earlier this week, a federal judge ruled the FDA’s new graphic warning labels on cigarette packages violate Big Tobacco’s freedom of speech.


The decision is only one step in the legal process – the case will go on to appeal. But it is a small victory for Big Tobacco, awarding the industry’s continued aggressive and deceitful efforts to conceal the fatal health effects of smoking.

It's clear that Big Tobacco is using the courts as a stall tactic to keep effective new cigarette warning labels off their products as long as possible.

Starting this September, the FDA will require graphic warning labels to cover 50% of the front and 50% of the back of cigarette packages. The truthful, appalling labels will also be prominently featured in tobacco ads. The warnings will replace the small text-only cigarette warning labels that have not been updated since 1984.

This idea is not new. Many other countries, from Brazil to Russia, require similar graphic warnings on their cigarettes. Research from these countries shows these labels are an effective way to educate about the risks of smoking and discourage smoking. 

We need all the tools possible to further educate people about this deadly addiction and counteract the hundreds of millions of dollars the tobacco industry spends peddling their products to new and existing customers.

In Wisconsin alone, tobacco companies spend $233 million a year to market their lethal products to kids and adults – more than 40 times what the state spends on the Tobacco Prevention and Control Program ($5.3 million/year).

In case you forgot, smoking is still the leading cause of preventable death in Wisconsin and nearly 8,000 residents die each year from tobacco-related causes. Tobacco costs us over $4.5 billion a year in health care costs and lost productivity. That’s almost $2,000 per Wisconsin household!

The new cigarette warning labels will help relieve this tremendous burden on our kids, families, businesses and communities.

Let’s get these warning labels on our cigarette packages. In doing so, we’ll help the 70 percent of adult smokers who want to quit and we’ll prevent our kids from picking up this lifetime addiction. 

Wednesday, January 12, 2011

New FDA Regulations Announced for Tobacco Companies

There's been talk about the new FDA regulations announced last week for tobacco companies, so I thought I'd make it the topic for today's blog post. It's a complex topic, but an important one so I'd like to highlight some of what these new regulations will hopefully mean both short-term and long-term.

As of March 22, 2011 tobacco companies must report any changes to existing products or any new products to the FDA or submit a report showing that the changes or the new product are "substantially equivalent" to products that were on the market before February 15, 2007. This means these products cannot be more harmful than products that existed on the market as of that date. Tobacco companies that made any changes to products or created new products between these dates are being asked to submit reports on these products by March 22, 2011.

This "unprecedented disclosure requirement" is similar to what food and pharmaceutical companies have had in place for a long time. It is meant to ensure that all tobacco products made or changed are evaluated by the FDA. Until this time, changes could be made to tobacco products secretly, without the millions of consumers in America even knowing what is in the product they are using.

If these new or changed products raise question of public health by being worse than existing products, they can be pulled from the market if already on the market today or the FDA can keep these products from being marketed in America. To meet this requirement, tobacco companies cannot simply prove the products are less harmful. That requirement will be balanced with the risk and benefit to the population as a whole, including those trying to quit who may get hooked on this new product, or those who are not currently using tobacco products that may become addicted as a result of this new product being marketed.

What this could potentially mean:

In the immediate future, the impact of this will mostly be seen by the tobacco companies themselves, but the long-term potential these regulations have is that fewer products that attract our youth and turn them into  lifetime, addicted, tobacco customers will be seen on the market. Because every new or changed product must go through a review process, tobacco companies will likely have to be more selective in what products they attempt to push through.

For more information on the new FDA regulations from the FDA's web site click here

For The Campaign for Tobacco-Free Kids' Press Statement on the FDA regulations click here.

Wednesday, June 16, 2010

AMA: E-cigarettes are drug delivery devices



The American Medical Association released a statement earlier this week stating that electronic cigarettes or "e-cigarettes" should be classified as drug delivery devices and should be subject to FDA regulation. When e-cigs first emerged on the market, it was unclear what to classify these products as. The manufacturers state that the product is non-tobacco and a way to quit smoking. Folks who use e-cigarettes say they have quit smoking and have a "smoke-free" life. However you see the product, e-cigarettes do deliver nicotine, not unlike inhalers, lozenges, or gum. All cessation products are regulated by the FDA either as over-the-counter or by prescription. 
The article contains a quote which is quite poignant:
“Because e-cigarettes have not been thoroughly tested, one cannot conclude that they are less harmful or less dangerous than conventional cigarettes,” said Dr. Langston. “The fact that they come in fruit and candy flavors gives them the potential to entice new nicotine users, especially teens.”
FDA regulation of e-cigarettes is something we can all support.

Read the full release here: http://www.ama-assn.org/ama/pub/news/news/electronic-cigarettes-policy.shtml

Friday, May 7, 2010

Looking at Tobacco Through a Microscope: FDA Tobacco Products Scientific Advisory Committee


CAMEL (TM) Tobacco Flakes 10X by spike55151.
Photo Credit: spike55151CAMEL (TM) Tobacco Flakes 10X

The Family Smoking Prevention and Tobacco Control Act or FDA regulation of tobacco (or authority over tobacco) requires that a scientific advisory committee is set-up to investigate a number of issues related to tobacco. The Scientific Advisory Committee is perhaps one of the more controversial elements of the FDA regulations, both from public health, but also from Big Tobacco. This committee is charged with investigating the following areas:

  • The impact of the use of menthol in cigarettes on the public health, including such use among children, African Americans, Latinos, and other racial and ethnic minorities
  • The nature and impact of the use of dissolvable tobacco products on the public health, including such use on children
  • The effects of the alteration of nicotine yields from tobacco products and whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved
  • Any application submitted by a manufacturer for a modified risk tobacco product
The first three tasks are fairly straightforward and are certainly hot button issues in tobacco control right now. The last area of inquiry is more broad and delves into the recent trend that the industry has made in creating "reduced harm products." The application for modified risk could be something like the use of the word "light." The committee must find that the product does indeed carry less risk in order to use words which previously could simply be applied without any scientific backing. 


Just last week the FDA denied a request from Phillip Morris (Altria, Inc.) to remove certain panelists due to financial conflicts and "irreconcilable biases." Admittedly Big Tobacco requesting the removal of certain "biased" scientists is ironic given there will also be three tobacco industry representatives. Are industry representatives not biased?

At any rate, Altria was concerned about the appointment of Neal Benowitz, Gregory Connolly, Jack Henningfield and Jonathan Samet. Some concerns raised were related to panelists being paid for expert witness testimony in tobacco related litigation, or potential ties to pharmaceutical companies. 
While tobacco industry representatives will be non-voting, according the the FDA's own FAQ about this advisory committee, it is common to have industry representatives present on these types of committees. 


To learn more about the group of scientists brought together by the FDA to explore the issues outlined above click here. 


To learn more about the committee and its roles click here

Wednesday, May 5, 2010

Spotlight: FDA Provisions effective in June



As part of the compromise brokered between health advocates and Big Tobacco, certain elements of the FDA Regulation of Tobacco had phase in periods. Starting June 22 this year a number of different regulations will go into effect. 

As previously discussed on our blog terms like "light," "mild," and  "low" are prohibited from packaging.

Other provisions include:
  • Larger, stronger warnings on smokeless tobacco product packaging and advertisements.   
  • The removal of vending machines in facilities where youth under 18 are present. Vending machines would still be allowable in businesses which cater to adults only. 
  • Product branded t-shirts, hats, and other swag are prohibited from being sold along with a tobacco product- say good bye to packs of Marlboro with a free T-shirt!
  • Cigarettes may not be sold in packages fewer than 20. (Smaller packages are rare, now they will be completely eliminated.)
  • All advertising for both cigarettes and smokeless products must be in plain black text on a white background. Magazine ads must be placed in  publications with fewer than 2 million youth readers.  
  • Commercials for tobacco will change too- they can only be spoken words no music or jingles. Adult only facilities may allow audio ads with jingles or the like. 
  • No billboards or other outdoor advertisements are permitted within 1000 feet of schools, parks or playgrounds. 
  • Sponsoring cultural and athletic events is a thing of the past as well. No smokeless at the rodeo and no Phillip Morris at the baseball game. 
  • No free samples of tobacco, except smokeless in adult-only venues which meet certain restrictions. 

Over the next few days check back on our blog to learn a little bit more about some of these provisions. Tobacco control waited a long time to finally rein in Big Tobacco in more meaningful ways. Despite compromises and delays this is a landmark piece of legislation which will ultimately reduce the burden of tobacco for generations to come. It looks like the hammer has finally dropped on Big Tobacco. 

Tuesday, February 23, 2010

Does changing the name and keeping the branding change public opinion?

Back in October we talked about the evidence which supports that labels like light and mild are deceptive. We also discussed the provisions of the FDA Regulation of Tobacco with regards to labels like light and mild. Numerous companies have re-branded their products to exclude labels like "light" or "mild." They have opted to keep the colors commonly associated with the word like light blue of gold in the case of Marlboro Lights. Big Tobacco might remove the words, but maintaining the branding commonly associated with the words is not doing consumers any favors. The branding plays into what consumers believe. Consumers will still have an easily recognizable package which they associate with light and with less risk than full flavor cigarettes. While the FDA has begun research about color coding and could possibly change these regulations in the future, for now, they stand.



To read more about the debate on this issue click here. 

Wednesday, February 10, 2010

FDA: Worried about R. J. Reynold's new products

File:Worry dolls.jpg
In the new regulatory capacity of the FDA, they have requested research about  new Camel (R. J. Reynolds) products such as orbs, sticks, and strips. While only being test marketed in a few places nationwide, the hope is these products will be nationwide. The FDA is worried that these products will appeal to youth and young people. With bright packaging, small size, and affordable price, these products are likely to make their way into the hands of young people. FDA is requesting information about how people under 25 perceive dissolvable products. They are likely to find that young people view these products as safer then cigarettes. 
While the Master Settlement Agreement prohibits the marketing of products directly to minors, it is clear that these products are a cause for concern. 
As many people know, Wisconsin was not chosen as a test market for the sticks, strips, and orbs. However we have tried to keep the good people of Wisconsin in the know about these products. Hopefully the FDA finds out some good information and we can use to that to prevent youth from picking up these products. We don't know if these products are safer than cigarettes. We do know that these products carry different risks than cigarettes, most likely more like chewing tobacco. Time and the FDA will tell...... 

Tuesday, January 19, 2010

Spotlight: FDA to study what is in a cigarette?

While the FDA has been able to tell you what is in a tube of lipstick, they have not been able to tell you what is in a cigarette. The wait is finally over. According to an article today on WKOW Channel 27 Madison and an AP article announced that cigarette manufacturers will have to disclose their ingredients to the Food and Drug Administration. Starting in June Big Tobacco will need to turn over their ingredients and studies they have conducted on their products.
This is a huge step forward for public health. It has been a great mystery as to what addictive chemicals are added to cigarettes. Finally the public will know the truth!
While general ingredients have been published by some of Big Tobacco, by and large the contents of these products has been unknown. With FDA in charge, determining and eliminating additives will be much easier.
This will mean people all across the nation and in Wisconsin will better know what is in these products.

Monday, January 11, 2010

Court Ruling

A while back we posted about a pending lawsuit that deals with FDA regulatory provisions eliminating the use of light or mild on cigarette packaging (See post on light and mild). Last week a U.S. Judge struck down portions of the new FDA law which restricts tobacco product advertising. However many of the provisions of the FDA law have stood up in the court challenge by Big Tobacco. The ruling states that FDA can't block tobacco companies from using colors and graphics- they also can't say their product is safer because it has been regulated by the FDA.

The important provisions that still stand are: the requirement to use large graphic health warnings on tobacco products, the elimination sponsorships of athletic, social and cultural events using brand names, and the elimination of using branding and logos on merchandise.

All sides, Big Tobacco, Advertising Folks, and Public Health all call this a victory.

Read the full article about the ruling.

Read the full ruling.

Campaign for Tobacco-Free Kids release

Monday, November 16, 2009

Federal Judge Rejects Tobacco Companies’ Effort to Block Key Provisions of New Tobacco Regulation Law

On November 5th, 2009 there was a victory for public health's continued fight with Big Tobacco. A federal judge in Kentucky rejected a motion by tobacco companies trying to block provisions of the FDA legislation. The decision strongly support the authority of the Federal Government to prevent the industry from making health claims about its products without approval from the FDA. 


Judge McKinley forcefully backed the government’s interest in protecting consumers from misleading claims about tobacco products with supposedly reduced health risks. The judge agreed with the key argument that  “given the significant health risks associated with the use of tobacco products and the history of marketing ‘low tar’ and ‘light’ cigarettes,” the government  “has a substantial interest in protecting consumers from misleading tobacco industry claims about allegedly reduced risk tobacco products.”


Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association among others released the following statement about this land mark decision. 


We applaud the federal court’s decision to quickly and decisively reject the latest attempt by Big Tobacco to frustrate the intent of the new FDA law and allow the agency to get on with its role in putting an end to deceptive and dangerous tobacco marketing.

Friday, November 13, 2009

Graphic Warnings



These are images taken of graphic warnings on cigarette packs from Mauritius. These packs show the type of death and disease that cigarette smoking can cause. If the US had these types of warnings how many lives would be saved?

With the passage of FDA Regulation of Tobacco, hopefully someday we too will have the types of warnings that will make people stop in their tracks and think about the risk they are taking with their health.

Monday, November 9, 2009

FDA: moving into a new era in tobacco control research

Dr. Cathy L. Backinger of the National Cancer Institute (NCI)- Tobacco Control Research Branch wrote an important release about tobacco control research. She outlines some of the important areas that the FDA will regulate including candy flavored cigarettes and mild and light labels. She also highlights some important funded research initiatives: improving effectiveness of smoking cessation interventions among low-income adults and preventing and reducing smokeless tobacco use. In 2010 continued efforts to expand our knowledge through an ever expanding body of research about tobacco and how to help people quit. NCI intends to move into funding research that examines state and community tobacco control and exploring media  relations. 


Continued research that helps to improve the effectiveness of tobacco control is extremely important. Any new studies that are released will ultimately help Wisconsin better address the number one cause of preventable death and disease in our state. Wisconsin citizens are not as educated about new product innovations, like Camel Snus, as they are about the hazards of smoking. As the FDA's new regulation over tobacco continues, improved research will emerge. The overall effectiveness of Wisconsin's tobacco control efforts will improve and more research is released.  



Friday, October 23, 2009

Dangerously Smooth Clove Smoke




Late last month the FDA outlawed the sale of cigarettes with flavors like clove, strawberry or vanilla.   While there were some push back from smokers of clove cigarettes a recent report shows how important this restriction is to public health. There is a chemical in cloves that is responsible for numbing the throat and giving smokers the impression that these cigarettes are less harsh than others. The burning cloves releases a chemical called eugenol, a topical anesthetic used by dentists to numb the mouth. For smokers, inhaling clove smoke means numbing the throat, which allows them to breathe the smoke in more deeply. "Most officials agree that when young people smoke cloves, they can get hooked faster because of the anesthetic, eugenol, in the cloves," said Richard Hurt, director of the Nicotine Dependence Center at the Mayo Clinic. "In many respects, clove cigarettes are more dangerous" than other flavored cigarettes, he said.

What you need to know:

  • Clove cigarettes are a thing of the past thanks to the FDA
  • Manufacturers of cloves are exploiting a loophole to keep their product on the market (creating little clove cigars)
  • The burning of cloves releases  a dangerous chemical, eugenol
  • Eugenol is a dangerous additive that numbs the throat and increases the likelihood of addiction 

Monday, October 12, 2009

Evidence supports light and mild labels are deceptive


A 2009 study features in the Journal of Public Health shows that research participants were more likely to rate cigarette packages with the terms light, mild, smooth, and silver as having a smoother taste, pose a lower risk to health and deliver less tar than packages that used words like regular or full flavor. Also, participants rated packages with lighter colors or those that featured pictures of filters as a smoother, lower tar, and lower risk product. Smokers were more likely to believe the the reduced risk than non-smokers. Of note, smokers of light or mild cigarettes were much more likely to believe that their brand was smoother and carried less risk.


The fact is all cigarettes pose the same health risks no matter how Big Tobacco dresses them up. This study points out what Big Tobacco has known for a long time: smokers, especially light or mild smokers believe the product they use poses less risk to their health and will have a smoother flavor. This study is timely and relevant because the FDA will outlaw these words next year but Big Tobacco is already moving its branding and labeling into compliance while still maintaining the myth that light is some how less harmful. More than 40 countries do not allow the use of light or mild because these terms are misleading. The study points to the fact that removing light or mild is not going to be enough- color and a larger list of words must be outlawed to ensure that Big Tobacco can't continue to mislead people with bogus health claims.

To read the full article click here. 

Friday, October 9, 2009

FDA: No more light, ultra light, or other similiar descriptors

For many years Big Tobacco has used language light, ultra light, low tar, mild, and other descriptors of their products, mostly cigarettes. Typically Big Tobacco uses color association as well as descriptors. For example Marlboro Milds uses a blue package and the language of mild invoking a sense of reduced harm and potentially a safer product. Many smokers believe that lights or milds are not as harmful as other products.




Not to be outdone by Phillip Morris, R.J. Reynolds changed the packaging of Camel Lights to reflect the belief that smokers perceive the language of lights and blue colors as possibly safer. Pall Mall (also owned by R.J. Reynolds) uses blue for their Pall Mall Brand Lights. These changes were made prior to the FDA regulation of tobacco. In the minds of smokers the connect has already been between the colors and language of lights and milds. Pall Mall will be changing their brand language from Light to Blues in order to comply with the new FDA regulation. This example further shows smoker's association between light and blue packaging. These colors will be what convey the message of safer or potentially healthier to smokers, the words aren't as important as the marketing and packaging that comes with it.  
More below the break

Thursday, October 8, 2009

FDA Spotlight Series


As the various provisions of the FDA regulation begin to come into effect SmokeFree Wisconsin believes it is important to keep are readers updated on the various components of the law. We will also be talking about the dubious and deceptive ways that Big Tobacco will try to avoid these regulations.

Our first post about flavored cigarettes can be read here: CLICK HERE

We hope you are as excited about the possibilities of learning more about the FDA regulation as well as the always dubious ways of Big Tobacco.

Friday, October 2, 2009

Now you can report the sale of candy flavored tobacco products!

The FDA has launched a whole new website dedicated to its important work of regulated tobacco products.
As many of you know candy flavored cigarettes are a thing of the past as of September 22, 2009. If you see a retailer stocking these products or are able to purchase these products you should report that retailer to the FDA. It is important that we make sure retailers are aware of the changes to the law about flavored cigarettes like clove, vanilla, grape, or strawberry.

To report a retailer who is selling or still stocking these products visit the FDA website.

To read more about flavored tobacco products see the FDA's Factsheet.

Wednesday, September 23, 2009

FDA: No more candy flavored cigarettes



Earlier this month the Food and Drug Administration (FDA) sent a letter to  the tobacco industry, manufacturers, and distributors. Specifically the letter states, 
"The FSPTCA provides FDA with regulatory authority over the manufacture, marketing, and distribution of tobacco products. Specifically, section 907(a)(1)(A) of the Act, as amended by the FSPTCA, establishes a tobacco product standard special rule for cigarettes that states in part:
…a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.
This standard applies to all tobacco products that meet the definition of a “cigarette” in section 900(3) of the Act even if they are not labeled as “cigarettes” or are labeled as cigars or as some other product."
More below the break

Friday, September 18, 2009

Light, Low, Mild a thing of the past


Light, low, mild, and other descriptors have long been a Big Tobacco marketing gimmick to define their products.  Some customers believe they are doing themselves a favor by smoking a light or low tar product. Nothing could be further from the truth.

The FDA regulation of tobacco seeks to protect consumers from the lies and myths of an industry that has been unregulated for far too long. Light does not mean a safer cigarette! Behind all that marketing and branding is the same cancer causing substances found in regular cigarettes. There is also evidence that Big Tobacco puts additional chemicals into light cigarettes to make them "smoother" or to hind the harsh-ness of the smoke.




Twelve months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, tobacco manufacturers and others will be prohibited from using descriptors, such as "light", "mild", "low" or "other similar descriptors" in the label, labeling or advertising of tobacco products without an order from the FDA because of the scientific evidence that these products do not reduce the risk of disease. 

Earlier a letter was submitted to the FDA by the American Cancer Society Cancer Action Network, the American Heart Association, the American Legacy Foundation, the American Lung Association, and the Campaign for Tobacco Free Kids alerting the FDA of possible industry efforts to get around the ban. (To learn more CLICK HERE)
If you see evidence of these efforts in your community, comments can be submitted to the FDA on this and other issues at www.regulations.gov