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Controversial FDA Regulations on E-Cigarettes

  • August 10, 2016
  • RPh on the Go

FDA regulations on e cigarettesVaping has become more popular since it’s been on the market. However, the more prominent it is in the marketplace, the more it can be watched and regulated. Manufacturers of vaping products have begun filing lawsuits against the FDA for what they allege is an overstepping of the authority granted them in the Tobacco Control Act of 2009. On August 8, the first portions of the final rule, delivered in May, will go into effect.

What Happens in August?

Beginning August 8, no retailer will be allowed to sell e-cigarettes to individuals under the age of 18. This will only have practical application in Pennsylvania and Michigan who have not previously instituted age requirements. Additionally, manufacturers will no longer be able to offer free samples of their products and they will only be able to utilize vending machines for sales in establishments that are restricted to adults. Furthermore, retailers will be required to request photo identification for those consumers who wish to purchase vaping products.

Manufacturers will also have to place warning labels on their products notifying consumers of the inclusion of nicotine. They will begin reporting the total list of ingredients within their product to the FDA and must register themselves as manufacturers. The majority of the regulations related to disclosure and manufacturing are to have a slower implementation rate.

E-Cigarettes and Lung Health

According to the American Lung Association, there is cause to be concerned about the ways in which public health is being effected by various vaping products. The increase of youth vaping has been substantial, and it appears as though the makers of these products target that demographic aggressively. The reported benefits of using e-cigarettes, for example the claim that they can assist in the cessation of smoking traditional tobacco products, has not been substantiated satisfactorily.

The full list of ingredients used in the various vaping products are not revealed by their manufacturers. This makes it impossible to effectively determine the potential health threat they may pose. However, it is known that nicotine is one of the ingredients that is almost universally used. Nicotine has been shown to be harmful to fetuses, pregnant women, and adolescent brain development. The other ingredients are equally worrisome and have been associated with poisonings.

It is not surprising that the manufacturers of these products would wish to challenge the ruling that allows the FDA to oversee and limit their freedom. The companies have enjoyed free reign in regards to creation and marketing, and the limitation of that freedom could have a negative impact on the financial status of the companies. In response many manufacturers of vaping products are challenging the process in court. It will take months if not years to determine the legal standing of the industry. Until that time, consumers and retailers, along with pharmacists and physicians, will need to be vigilant in following the progress of the cases, FDA authority and recommendations, and the available health data as it emerges.

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