May 6, 2015
“Even though the FDA already has this authority, the legislation I introduce today will underscore that FDA should choose a new grandfather/predicate date each time the agency deems new tobacco products.”
On April 28th, Representative Tom Cole (R-OK04) introduced HR 2058 which would change the February 15, 2007 “grandfather date” currently in the Tobacco Control Act (TCA). If the bill is passed (and that’s a really big if), it would be difficult to overstate the implications for the vaping community and indeed, the entire vaping industry in the U.S.
As it stands right now
- Tobacco products on the market prior to February 2007 are grandfathered under the TCA. Those products will be permitted to stay on the market without filing applications for FDA approval.
- Products introduced to the market between February 15, 2007 and March 22, 2011, would also be permitted to stay on the market. But manufacturers would be required to file a “substantial equivalence” (SE) application with the FDA.
- An SE application proposes to the FDA that a given product is substantially equivalent to a product that was on the market prior to February 15, 2007. Since there were almost no substantially equivalent products on the market prior to February 2007, 99% of current vaping products would be eliminated.
- All tobacco products not meeting those criteria would be required to file a “premarket tobacco product application” (PMTA). The FDA estimates the cost of a PMTA application at more than 5,000 man hours and approximately $300,000. Per product. An estimated 16,000 vape shops across the country would be out of business.
If HR 2058 becomes law
HR 2058 would replace all references to February 15, 2007 in the TCA with “the effective date of the regulation under which a tobacco product is deemed subject to the requirements of” the TCA. So:
- The “new” grandfather date would be based on whatever date the FDA makes current, or future, deeming regulations effective.
- If the FDA finalizes the currently proposed deeming regulations on June 15, 2015 – all vaping products on the market as of that date would be grandfathered, permitted to stay on the market, and no FDA application would be required.
- Future vaping products would require substantial equivalent applications be filed. But manufacturers would have thousands of grandfathered products on which they could base their SE applications.
Will HR 2058 pass? Probably not. There’s a good chance it will never make it out of committee. If it does, it would then go before the full House of Representatives for a vote. If it passes the House vote, it would then go on to the Senate. Where it would likely first go to another committee. Then to a full vote of the Senate. Both the House and the Senate must approve an identical version of the bill before it goes to the President to be signed into law.
Even if HR 2058 fails, the introduction of the bill to the House will strengthen lawsuits almost certain to follow if the grandfather date is not changed, one way or another. We’ll examine what the basis of those lawsuits might be in my next blog.
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Dave Coggin has a Master’s Degree in business and spent 35 years in corporate America. He is a co-founder and partner in DIYELS. He has spent the last five years actively researching and following the evolution of the e-cigarette industry. He is a strong proponent of e-cigarettes as the most promising option currently known for tobacco harm reduction. He may be contacted directly at firstname.lastname@example.org .