The Food and Drug Administration is responsible for protecting the public health, but strict regulations that were set to go into effect in mid-2017 could have also been responsible for wiping out the U.S. vaping industry. Changes to those regulations, however, have given the vaping industry a break while suggesting the FDA is coming around to understand that vaping may be an integral part of its overall mission. 

Original FDA Regulations

Original deeming regulations set forth by the FDA would have required vaping product manufacturers to submit an extremely lengthy and even more costly application for their products to remain on the market. 

The deadline to comply had been in August 2017, which could have also been the date a multitude of companies went out of business. Not many independent vaping companies would have been able to afford the time, effort, or estimated cost of $400,000 per application each product would require.

FDA Changes

With about two weeks to go before the deadline hit, the FDA announced a new comprehensive plan for tobacco and nicotine regulation. That plan can be considered a huge win for the vaping industry, as it suggests the FDA is moving toward working with the vaping industry, rather than enacting unreasonable regulations against it. 

Plan points that specifically benefit the vaping industry include:

  • Extension of the product application deadline to 2022
  • Plans to issue “foundational rules” to make the product review process more predictable, transparent and efficient for manufacturers
  • Ability for vaping manufacturers to continue to market products while awaiting review

The FDA said the changes pertaining to vaping products were made to ensure the agency is “striking an appropriate balance” between regulating new tobacco products and encouraging the development of products that may be less hazardous than traditional cigarettes. Those new products, of course, can refer to those in the vaping industry

Change of Focus

While the FDA noted that nicotine was highly addictive, the agency also said that nicotine was most harmful when delivered through smoke particles in traditional cigarettes. Vaping produces no smoke particles. E-liquid is likewise free of the thousands of toxic chemicals found in their combustible counterparts.

If nicotine addiction is a concern, most e-juice manufacturers already offer a range of nicotine levels in their products, from as high as 24 mg and as low as 0 mg. This allows smokers to gradually wean themselves off nicotine to reduce the severity of withdrawal symptoms. 

The Bottom Line

The FDA’s new plan is definitely promising for the vaping industry, as well as the general public as a whole. What’s most promising of all is the revised attitude the FDA has appeared to take with the vaping industry, no longer targeting it for demise but rather considering it as an ally. The vaping industry and the FDA finally appear to be on common ground, as both aim to provide less harmful alternatives to smoking that can ultimately reduce tobacco-related deaths and disease.

 

SOURCES:

https://cei.org/blog/how-fda-commissioner-gottlieb-can-save-e-cigarettes-and-lives

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm


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