FDA Exemption to E-Cigarette Deeming Rule

FDA Exemption to E-Cigarette Deeming Rule

***UPDATE December 16, 2016*** The draft text of the Omnibus Bill does not include the FDA exemption to e-cigarette deeming rule. If this is confirmed, then the rule will go into effect as originally planned.

A potential FDA exemption to the E-Cigarette Deeming Rule may pass Congress before the end of 2015. A rider has been discussed as part of the must pass Omnibus spending bill. According to Roll Call the rider proposes grandfathering in e-cigarette products on the market prior to Feb. 15, 2007.

Under the proposal, e-cigarettes that were on the market as of Feb. 15, 2007, are exempt or “grandfathered” from the agency’s review process. FDA officials stated they don’t have the authority to change that date, which was in the 2009 Tobacco Control Act.

The potential FDA exemption to the e-cigarette deeming rule would be a significant change. As previously discussed the FDA e-cigarette deeming rule sweeps in a host of changes including a new approval process for ingredients, such as flavors and coloring. The risks, safety concerns, and warnings for traditional tobacco or nicotine e-cigarette products is well established. The inhalation of other ingredients, traditionally viewed as dietary ingredients, may not be well studied. This could make the FDA exemption to the e-cigarette deeming rule a cost-saver for small companies, but potentially leave consumers exposed to unknown or understudied risks.

FDA Exemption to E-Cigarette Deeming Rule – Timing

The FDA exemption to the e-cigarette deeming rule would comes just as the rule is finalized. The FDA submitted the e-cigarette deeming rule to the the Office of Management and Budget for revision and approval in October. Once the OMB released the rule it is published in the Federal Register. At that time the rule would be subject to a 90-day countdown before becoming effective. An optimistic estimate would place the FDA e-cigarette deeming rule in effect by the summer of 2016. The FDA exemption to the e-cigarette rule if passed in the Omnibus bill would not delay or change the release of the rule. It would, however, dramatically reduce the number of companies impacted by the rule. The rider, whose text is not yet known, would likely set a cut-off date with all new companies after the passage of the rider subject to the FDA e-cigarette deeming rule.

Stay tuned to this space as the Omnibus bill, riders and all, is expected to be released by December 14, 2015.

 

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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