Over Its 111-Year History, This Approval Marks a First for the FDA

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Since the passage of the Pure Food and Drugs Act back in 1906, the U.S. Food and Drug Administration (FDA) has been the regulatory agency that's stood between drug developers and pharmacy shelves. Over those 111 years, more than 1,500 drugs have been approved for sale by the agency to treat a variety of ailments, including cancer, diabetes, and heart disease, to name a few. 

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The leading cause of preventable death

The Centers for Disease Control and Prevention (CDC) lists some of the most common causes of death, such as cancer, diabetes, and heart disease, as being among the most preventable of all health problems. For instance, getting regular health checkups, eating right, and exercising may lower your chances of developing these diseases. But at the very top of the list when it comes to preventable health problems is smoking. Smoking increases the risk of developing all three of these ailments, and is responsible for more than 480,000 deaths in the U.S. each year, including more than 41,000 due to secondhand smoke. 

Throughout the FDA's history, it's approved a number of smoking cessation products designed to wean consumers off tobacco products. These have included nicotine-replacement products, such as lozenges, chewing gum, and skin patches, as well as medicines that don't contain nicotine, like Chantix or Zyban. 

The CDC has also done its part by educating the public about the dangers of smoking. More than 50 years ago, Surgeon General Luther Terry released a report that undeniably linked smoking to life-threatening diseases like lung cancer and heart disease. The adult smoking rate was at 42% in the mid-1960s, and it's fallen to just 15.1% as of 2015.

While the CDC's war on tobacco has resulted in a solid step in the right direction, 36.5 million U.S. adults are still smoking cigarettes. This represents a large pool of people that could be at high risk of developing preventable life-threatening diseases. The FDA is hoping that its latest approval will continue to push smoking cessation figures higher.

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A one-of-a-kind FDA approval

Earlier this week, the FDA gave a green light to the very first smartphone app designed to help people quit smoking. Developed by start-up company Carrot, the smartphone app combines a mobile coaching program known as Pivot with an FDA-cleared carbon monoxide breath sensor that can be used at home, according to CNBC.

The app provides a personal dashboard that logs carbon monoxide levels and displays other metrics to raise user awareness and allows the user to track their smoking behavior over time. Pivot also delivers evidence-based counseling and quit strategies recommended by the Department of Health and Human Services and medical community, along with personal coaching over the year-plus program. 

Carrot CEO David Utley noted in an interview with CNBC that the app is designed to motivate smokers rather than admonish them, and that it's targeted at all smokers, not just those who depend on cigarettes daily. Also, he believes that smokers will use their carbon monoxide levels, which are higher in smokers compared to nonsmokers, as motivation to quit. Carbon monoxide poisoning leads to approximately 50,000 deaths annually, so the FDA-approved breath sensor is viewed as one extra push in the right direction for smokers. 

While not the only game in town when it comes to smoking cessation apps, Carrot holds the distinction of being the only one to have the FDA's backing.

Tobacco companies have no choice but to adapt

Between continued pressure from the CDC and this one-of-a-kind approval by the FDA, it's all the more apparent that the tobacco industry has to be creative in looking for new ways to attract customers.

Overseas giants like Philip Morris International (NYSE: PM) have it somewhat easy. While it's facing tougher tobacco laws in countries like Australia, it has a burgeoning middle class in India and China to thank for growing demand. Philip Morris can lean on its geographic diversity and more than 180 markets instead of being overly concerned about the future of its product line. Nonetheless, it has been investing heavily in cigarette alternatives.

On the other hand, U.S.-based tobacco companies like Altria (NYSE: MO) have a lot of work to do to ensure they can survive for decades to come. One of the more intriguing solutions is Altria licensing Philip Morris' iQOS device in the states. This device heats tobacco without setting it on fire, releasing nicotine and its accompanying flavors. It could represent a multibillion-dollar market for Altria and help the company preserve what seems to be a dwindling consumer pool.  

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