The Grandfather Date Question – Is HR 2058 the Answer

Vaper’s Vortex

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.


We are sincerely interested in your thoughts and comments! Please join the conversation and invite others by sharing this post! Thank you for visiting our site and we hope that you will come back often!

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 dave@diyels.com .

The opinions presented here are exclusively those of the author. Vaper’s Vortex is offered as a service to our customers and followers. Anyone considering e-cigarettes as an alternative to tobacco cigarettes should seek qualified advice from a medical professional.

9 thoughts on “The Grandfather Date Question – Is HR 2058 the Answer

  1. I have not researched SE applications since, as it stands right now, there are no (or minimal) products that were on the market prior to Feb 15, 2007 on which to base an SE application. You can get more information at http://www.fda.gov/tobaccoproducts/labeling/rulesregulationsguidance/ucm436462.htm.

    You also can subscribe to email notifications for tobacco related actions by the FDA which includes information on SE applications that have been approved, withdrawn or denied.

  2. I would like some clarification on this issue.
    I have researched and have not found answers to my questions

    how will hardware be effected?
    a battery pack and a heating coil are not “tobacco” products and they have been around way before 2007

    concentrated nicotine has been used in mixed drinks in NYC since they banned smoking indoors, therefore concentrated nicotine falls with in the grandfather date correct?

    Vaporizer flavoring (menthol) is added to room vaporizers to help clear sinuses again before the grandfather time period.

    food concentrates and extracts are constantly used in food preparation again long before the grandfather date.

    from my understanding of the bill if this does not pass a person can still walk into a shop purchase a mod, RDA/RTA, juice and nic all separately and commit no violation as the products sold individually cannot be defined as “new” tobacco product.

    1. We have to keep in mind that the final deeming proposal was only submitted to OMB on October 19th. OMB represents the White House and has the authority to change (override) FDA’s proposal. So we don’t yet know conclusively what the final rule will look like. With that said, I’ll try to answer at least some of your questions.

      Under the proposed rule, FDA defines “tobacco product” as “any product
      made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product) (see section 201(rr) of the FD&C Act). The term is not limited to products containing tobacco or tobacco derivatives, but also includes components, part, or accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, e-liquids, aerosolizing apparatus, atomizers, and batteries used in ENDS are tobacco products whether they are sold to consumers for use in an ENDS or are sold for further manufacturing into another product sold to a consumer.”

      As you can see, that is a very broad, sweeping definition of “tobacco product”. So how will hardware be affected? I am not an attorney but my interpretation of the definition in the draft proposal is that virtually all vaping hardware will be regulated as a “tobacco product.”

      Does nicotine fall outside the scope of the grandfather date. I believe the deciding factor will be “intended use”. If nicotine is sold for the intended use of an Electronic Nicotine Delivery System, then it falls under FDA regulatory authority as a “tobacco product”. If the intended use is in mixed drinks, I doubt that FDA would have (or exercise) regulatory authority.

      PG, sometimes with menthol as you point out, is used for a number of applications other than ENDS. It is used in a number of foods, in theater fog machines, etc. Again referring back to “intended use”, I doubt that FDA will regulate in those situations. But they will regulate PG and VG for intended use in ENDS and consumption by the user.

      Food concentrates and extracts – same story as above. Concentrates and extracts are GRAS by FDA for ingestion, not for inhalation. Flavor extracts and concentrates intended for ENDS use, will be regulated.

      If HR 2058 does not pass, customers will still be able to purchase all components from any manufacturer or retailer that is still in business. But those manufacturers and retailers will be required to register with the FDA and all newly defined “tobacco products” not on the market prior to February 15, 2007 will be subject to Premarket Tobacco Product Applications at an estimated cost of between $2 and $10 million dollars. The ONLY exceptions to that requirement would be products that came to market between February 15, 2007 and prior to March 22, 2011 will be allowed to stay on the market IF the manufacturer filed a Substantial Equivalence application that was subsequently approved by the FDA.

      My apologies for the “wall of text” but as you can see, these are not questions easily answered. The proposed regulation is virtually all encompassing and would decimate the vaping industry as we know it today.

      1. It’s a strange one. Because the batteries we use are for flashlights. The wires have always been on market. The liquids are used for food. So in the end no they cannot classify as tobacco not legally. That would be a long stretch. Kind of like saying fertilizer. Is for bombs and ending conversation at that. This would only really affect. The stores but even that would only come down to. How you market it because remove nicotine and none of it is tobacco. Not by any stretch

        1. Nope, the FDA has stated they consider anything that is sold for the intended purpose of vaperizing, or ENDS (Electronic Nicotine Delivery System) in their lingo, is considered a tobacco product. They have even stated that they consider liquid with no nicotine, therefore not containing any tobacco derived substance, is a tobacco product. I know it’s difficult to wrap your head around this idea, probably only over payed pencil pushing government bureaucrats could understand their reasoning and think it made sense.

  3. so how does this affect say 0% nicotine lines of juice? or better, how can they prove that anyone is or isnt using a non tobacco solution in thier vape stick?

    its a big wig move to bring people back to smoking and making cigarette manufacturers money again, while simultaneously shutting down private small businesses.

    they have the fda in thier pocket, the story of aspartame shows as much, so this happening isnt a big stretch of any imagination.

    1. The FDA considers 0% nicotine liquid to be a tobacco product, even though it contains no tobacco derived substance.

      Basically Big Tobacco hates that people are switching from their product to one they don’t control, and Big Pharma hates that people are using a product other than their ineffective ones to quit smoking. So Little Vape is up against two massive, lucrative, and politically connected industries.

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