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Deeming regulations published – the key points

deeming regulations news package - key points 900x540

The U.S. Food and Drug Administration (FDA) today published its long-awaited deeming rule, which brings e-cigarettes under federal regulation for the first time.

Key provisions of the new rule, which comes into effect in about 90 days, include:

  • E-cigarette makers will be required to submit for regulatory review any products that were not on the market as of 15th February 2007 – in other words, effectively all e-cigarettes.
  • But they will have up to two years to submit those applications, and can continue to sell the products concerned during the review period, which could last a year.
  • Companies will also have to register manufacturing facilities with the FDA.
  • Many vape stores will be considered manufacturers.
  • Products will have to carry health warnings.
  • E-cigarette sales to under-18s will be prohibited, and photo ID will be required for purchasing.
  • Free sampling will be banned.
  • Despite some fears, there is no ban on flavours.
  • Zero-nicotine e-liquid and e-liquid based on synthetic nicotine are also regulated.
  • Said Mitch Zeller, director of the FDA’s Center for Tobacco Products: “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

The deeming rule brings e-cigarettes – as well as cigars and some other tobacco products such as gels not hitherto regulated by the FDA – under the ambit of the Family Smoking Prevention and Tobacco Control Act of 2009.

First released in draft form more than two years ago, it seems to have undergone little change in substance during a long period of consultation with the industry and other stakeholders, followed by a review in the White House’s Office of Management and Budget (OMB).

 

What This Means: The ECigIntelligence regulatory, news, market analysis and Washington teams will be exploring the full implications of the new regulations in detail over the next days.

At first glance, the news appears to be mixed – there is no relaxation on the grandfather data, so all e-cigarettes introduced since 2007 will require approval; on the other hand, there is no regulation of flavours as some had feared (and some had called for).

 

– ECigIntelligence staff

Graphic: Carl Gamble

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