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FDA Regulates E-cigarettes (ENDS) and Other Tobacco Products (OTP)

VaporB2B Aug 08, 2016
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The Food and Drug Administration Today on Monday, August 8, 2016 FDA will begin regulating e-cigarettes and other tobacco products like hookahs and premium cigars in the same way it regulates conventional cigarettes and smokeless tobacco — making it more troublesome for minors to vape, and requiring scientific reviews of some products.

fda-regulates-ecigarettesThe FDA officially made the announcement back in May.

The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency’s “tobacco product” authorities in the FD&C Act to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of “covered tobacco products” to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.

The “last rule” broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products.

“This action is a milestone in consumer protection. Going forward, the FDA will be able to review new tobacco products not yet on the market, help prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate the potential risks of tobacco products,” the FDA said in announcing the extension of its authority.

The FDA held three open workshops to gather information about the devices and the potential effect on general health. The general population comment period closed July second, and soon thereafter the agency began a review of approximately 130,000 comments that informed the last rule.

The purpose of those workshops was to figure out what the risks of e-cigarettes are when used properly and what number of chemicals and nicotine are inhaled when someone uses them. The FDA also wanted to think about any potential health benefit.

Some studies have showed that using e-cigarettes would be a decent approach to help a person quit smoking.

In 2014, the Royal College of Physicians published a statement that suggested they were an effective and affordable alternative to conventional cigarettes and could “make hurt reduction a reality for smokers.”

On the other end of the spectrum, the American Lung Association heralded the news as a “long-awaited step to protect public health.”

“At last the Food and Drug Administration will have basic authority to make science-based decisions that will protect our nation’s youth and the public health from all tobacco products, including e-cigarettes, cigars and hookah,” Harold Wimmer, president and CEO of the association, said in a statement in May.

E-cigarette use among adults has gone up around 12.6%, as indicated by Centers for Disease Control and Prevention information from 2014.

Among the adults who tried to stop smoking that year, more than a half had tried e-cigarettes as an alternative, and more than 20% started using them. Just a little more than 3% of people who had never smoked tried them, however what has troubled general health leaders is the news that people between ages 18 and 24 had the highest number of new users.

With the new regulations, people under the age of 18 won’t be able to purchase these products.

Research has showed that e-cigarettes have become a problem for children. This year, the CDC found that e-cigarette use had tripled among teens in just one year, and recent research found that teens who used them were more than three times as likely to smoke conventional cigarettes a year later. It’s a phenomenon CDC Director Dr. Tom Frieden characterized as “deeply disturbing.”

The American Academy of Pediatrics also said it welcomed the new rule.

“An historic step forward in helping to alleviate the threat of lifelong nicotine addiction for our youth,” said its president, Dr. Benard Dreyer.

The products will also have to come in child-resistant packaging.

In 2014, the CDC found that the number of calls to poison centers about e-cigarettes had skyrocketed. Most of those calls involved children under the age of five ingesting the fluid or getting it at them or on their skin.

E-cigarettes come in child friendly flavors like sticky bear, nuclear fireball confection, and cookies and cream.

The new regulations also mean that the government can have a say in what goes into the products.

Previously there was no law commanding that manufacturers tell you what you are breathing in when you attempt one of their products.

The market has been called a “complete unregulated Wild West.”

“This important final regulation puts several strong provisions in place that will serve to protect the public health and rein in an unscrupulous industry,” said Chris Hansen, president of the American Cancer Society Cancer Action Network.

“There are tens of thousands of products on the market.”

The new rule will require companies to show what is in their products, excluding those that have been on the market since before 2007.

FDA – Previous Attempts to Regulate Vapor Products

  • In 2008 FDA attempted to regulate e-cigarettes as a drug or drug delivery device under the Federal Food, Drug, and Cosmetic Act (FDCA) ; blocked shipment of e-cigarettes into the US
  • In 2009, Sottera, distributor of NJOY e-cigarettes, sued for an injunction to allow the entry of their e-cigarettes, claiming that e-cigarettes cannot be regulated under the FDCA
  • The US District Court of the District of Columbia ruled that e-cigarettes cannot be regulated as a drug or drug delivery device and so FDA lacked authority to block the shipment
  • The FDA appealed to the US Court of Appeals

The new rules will also require companies to register with the FDA and put health warnings on their packages and in their ads. It gives the agency the power to evaluate the potential health effect of these ingredients on users.

“This is a big blow to public health,” said Ray Story. “When you see everyone switching back to conventional tobacco, the pharmaceutical industry will be happy, since they will now have an endless supply of new customers.”

The FDA said it has been preparing to enforce the law with state-and neighborhood level experts and will add inspectors to be sure retail stores are not selling to minors.


Vapor B2B Investigates is a way we share our research and does not express the opinions of Vapor B2B, LLC. “the Vapor B2B Guide”, Vapor B2B or it’s affiliates.

Vapor B2B Sources |  Federal Register May 10, 2016 (https://www.federalregister.gov/documents/2016/05/10/2016-10685/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the)   FDA (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf) FDA Economic Analysis (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf)

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