The FDA evoked the sale of four cigarette products manufactured by R.J. Reynolds.

The FDA, recently tightening its regulatory grip on cigarette manufactures, banned the sale of four kinds of cigarettes on Sept. 15.

Manufactured by R.J. Reynolds, the banned brands include Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. The action was taken because the manufacturer failed to prove the cigarettes were not more harmful than comparable tobacco products.

The FDA Pulls Cigarettes Off The Shelves

The FDA ordered that four cigarette brands be removed from retails stores because they failed to achieve substantial equivalence status.
Image: Pipes Magazine

The Family Smoking Prevention and Tobacco Control Act of 2009 was passed to allow the FDA to deny cigarettes and other tobacco products that may pose a greater public health risk than comparable products on the market.

R.J. Reynolds released new products that were commercially marketed as of Feb. 15, 2007. In 2011, the company applied for substantial equivalence status.

To receive that status, R.J. Reynolds would have to provide evidence that the products didn’t raise new questions for public health. The company could also receive the status by proving the new products had the same characteristics as an existing product.

The FDA found that the four banned brands were not the same as their predecessors and questioned if the newer versions could be more harmful.

In the announcement, the FDA said that ingredients, engineering and chemistry of the products were analyzed. The agency also measured how these factors could influence cigarette toxicity, addictiveness and appeal to smokers.

For example, Camel Crush Bold cigarettes have a small menthol capsule in the filter, which might make the cigarette more appealing to consumers.

Matthew Myers, the president of Campaign for Tobacco-Free Kids, said the products “deliver menthol differently and at higher levels, have added sugars and other sweeteners, new filters, and tested differently for harmful and potentially harmful constituents.”

Retailers have been told to immediately stop the sale of banned brands and dispose of them within 30 days. The consequence of noncompliance is financial penalties or criminal prosecution.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, the director of the Center for Tobacco Products at the agency, said in statement.

A Response From R.J. Reynolds

R.J. Reynolds claims that the FDA ban is unjust because the company successfully proved the substantial equivalence of their products.
Image: CBS News

The company gave a statement that asserted a strong disagreement with the decision.

“Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence,” according to Jeffery S. Gentry, the company’s executive vice president for operations and chief scientific officer.

R.J. Reynolds is currently examining options for moving forward.

Financial services firm Cowen and Company said in a research note that the four banned products accounted for less than 1 percent of the company’s sales. It’s not likely that the action will have a serious impact on R.J. Reynolds.

The firm predicts that the company will file a legal injunction to suspend the action. The other option would be to pull the products before legally contesting the findings.

As the FDA increasingly wields its power, it’s interesting to reflect on the nation’s tobacco history. Gone are the days when cigarette companies could alter existing products and introduce new ones as they pleased.

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The FDA has issued letters to three tobacco manufactures urging them to alter the advertising tactics used on natural and additive-free cigarettes. The FDA believes the wording will lead consumers to believe that some kinds of cigarettes are safer than others.

You’re a dedicated cigarette smoker, but this year you want to make an effort to be more health conscious. When shopping for cigarettes, you may see a product that has the words ‘natural’ or ‘additive-free’ written on the label. You compare the packaging and choose the brand that seems the healthiest.

In a recent crackdown, the FDA has demanded three tobacco companies stop advertising their cigarettes with wording that may be misleading to consumers.

This is the first time the FDA has taken action to enforce a law that was created six years ago. The historic move will change the way tobacco products are labeled.

Steps For Stricter Regulation

American spirit cigarette advertisements feature the standard surgeon general’s warning and an additional warning for cigarettes with no additives.
Via: Flickr

An FDA ruling in 2000 compelled cigarette companies that claimed their products use natural tobacco had to include “no additives in our tobacco does NOT mean a safer cigarette” on the labeling, along with the standard surgeon general’s warning.

But in 2009, legislators passed the Tobacco Control Act, which gave the FDA the authority to “regulate the manufacture, distribution, and marketing of tobacco products to help all Americans, especially young people, live longer, healthier lives.”

The law allowed the FDA to:

• Require new and more effective warning labels on tobacco products
• Establish and enforce restrictions on tobacco advertising and promotions
• Require tobacco companies to disclose what is in their products
• Review tobacco manufacturers’ claims of “modified risk” products to prevent misleading claims
• Educate consumers about the dangers of tobacco use, among other powers

The FDA first exercised the law by sending a warning to Santa Fe Natural Tobacco Co.,  ITG Brands and Sherman’s 1400 Broadway N.Y.C. about the advertising tactics used to sell their cigarettes. The brands sell American Spirits, Winston cigarettes and Nat Sherman cigarettes, respectively.

The warning letters discuss violations of section 911 of the Federal Food, Drug, and Cosmetic Act, urging the companies to alter their labeling to make sure that it doesn’t present “a lower risk of tobacco-related disease” that makes their product appear “less harmful than one or more other commercially marketed tobacco products.”

Setting An Example

The FDA is waiting for a response from three companies that have been asked to alter the advertising on their cigarette packages.
Via: Viral Sneak

The press release detailing the offense was issued on August 27. The three companies were contacted by the FDA and must respond to the letters in no more than 15 business days with an explanation of how they plan to remedy the issue.

The FDA believes these companies are not in compliance with the law. The companies have the option to give an explanation and  provide evidence if they believe they are not in violation of the law. If they fail to respond, the FDA may initiate civil financial penalties, criminal prosecution, seizure and/or injunctions.

ITG has responded in a statement that its product complies with the state and federal regulations. According to the representatives, “while we disagree with the FDA’s position on this issue, we intend to engage with the FDA and respond to their letter in the coming days.”

According to a statement from Mitch Zeller, director of the FDA’s Center for Tobacco Products, the agency is just doing its job.

“The FDA’s job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like ‘additive-free’ and ‘natural’ pose fewer health risks than other cigarettes, unless the claims have been scientifically supported,” he said.

“This action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use.”

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