2 Steps Closer to Liquid Approval

January 7, 2017

So if you’re all wondering, what do you have to do to get my liquids approved? What is the PMTA process? How long does it take? What does it cost? Those are excellent questions that nobody in the market seems to know the exact answers or have the same answers. That’s because no one has actually done this process. We’ve been calling around to all kinds of different companies out of curiosity, and we’ve gotten answers all over the grid. The people who actually have the answers, the FDA, never returned our call—shocking I know.

Here’s what we know: Two things are going to have to happen for you to get your liquids approved. One–You have to have a clean and proper environment up to ISO standards (also called GMP: Good Manufacturing Practices). If you aren’t a white coat/white glove type of person and don’t have a facility like this, you can make friends with a modern day “Doc” Brown and outsource your manufacturing by paying someone else to mix the liquids with your formula and ingredients. Ah—ingredients. That’s our number two.

If each of your liquid ingredients has a CAS (Chemical Abstract Service) Registry number, it seems it will be much easier for you to get your liquids approved. From what we understand, having a CAS number means that the necessary clinical testing has already been done on that ingredient. If your ingredients don’t already have CAS numbers, you may have to do your own clinical testing, which can get expensive. Call your product manufacturers to see if they have CAS numbers.

How much does all this cost? What a GREAT question. Again, we have gotten answers all over the place. One source told us if you didn’t have $10 million dollars to hang it up. I think he was having a bad day. Another source said that coming into compliance with ISO standards could cost $1 million in and of itself.  It seems clear that the clinical testing costs are going to depend on how many flavors you have and how many chemicals are in each flavor. Only one chemical testing facility has given us a quote on testing and that was $250 per chemical. For example, if there are 40 chemicals in your bubblegum flavor, you’re looking at $10,000 for that flavor to do the testing.  We’ve also heard the whole process could cost $600,000 to $1 million per flavor. Like I said—all over the place.

Moral of the story for small companies that want to stay in business: you may need to contract out your manufacturing and re-formulate your flavors to include ingredients with CAS numbers to avoid clinical testing costs. Or just pick your favorite flavor and ‘sayonara’ to the rest of them!

Win $500.00 Amazon gift card by Lobbying – start the challenge!

October 18, 2016

Did you know that you are very powerful?  Maybe you are one with the force like Luke Skywalker or you have super powers like Superman.  Maybe you are just an awesome, rich vigilante like Batman?  Maybe you are hot like Superwoman.  Maybe you can just write letters, make a call or two, and send some emails.

The challenge: Lobby to make a difference.  Change the estimate of 1% to 100% that H.R. 2058 will pass.

Why:

  1. Because it matters.  And….
  2. The person who writes the best letters and emails and makes the most difference towards H.R. 2058 moving out of committee and passing will win a $500.00 Amazon gift card on December 15, 2016 (at midnight we will pick a winner) right in time for Christmas!

Here are the steps to take between now and December 15, 2016 (read carefully):

  1. Contact your congressional delegate from both the House of Representatives and the Senate and ask them to vote for, promote, and lobby for H.R. 2058 from the 114th Congress which is called the FDA Deeming Authority Clarification Act of 2015.
  2. Contact the members of the House Committee on Energy and Commerce Subcommittee on Health.
  3. Send letters/emails/telephone calls to the Sponsor and Co-Sponsors thanking them for promoting H.R. 2058.
  4. Go to www.popvox.com to show your support for H.R. 2058.  (I was only the 53rd person to weigh in on the law).  Let’s turn the map green on this page.
  5. Comment below with any additional ideas on how to get our congress working for us!

Tomorrow I will put up very clear directives on how to provide us with proof of your efforts, ideas for letter/email/call content, and more information on what we can all do.

You are powerful.  Now, be a superhero and demonstrate your power to your congressional delegates (and win a $500.00 Amazon gift card).

 

-Janet

Register to Vote

October 17, 2016

Before I go any further – let me be clear – you need to be a registered voter.  Okay, if you are not you can still do the challenge starting tomorrow.  We will not need a copy of your voter registration.  However, I will tell you this – if you want to have some power in your lobbying efforts – register to vote and put your vote to work.

Not sure what to do next – here it is: http://rtvote.com/2dpWIUz

Lobbying for H.R. 2058 – Step One

October 17, 2016

Step one in lobbying for H.R. 2058 is a two fold process.  You must understand the current status in Congress of the bill and then start to make contacts.  We are going to start a challenge here tomorrow so that we can redirect American politics and ways of thinking about H.R. 2058.  Whether you are a vaper, a vape store owner, a vape store employee, a liquid producer, a coil maker, an ends designer, an entrepreneur, or someone who loves free enterprise this bill is important to all of us.  If this bill does not pass, the current estimate is that within the next 2 years ninety-nine percent (99%) of all vape stores and vape suppliers will close.  Permanently.

However, H.R. 2058 is one giant step in the right direction to ensure this does not happen. What can you do right now?

  1. Understand what the bill says (see prior blog post).
  2. Understand the current status of the bill.  You can go to the following link and even get the people at govtrack.us to send you alerts.  https://www.govtrack.us/congress/bills/114/hr2058
  3. Understand the current odds of passage.  predictgov.com is giving the bill 1% (sound familiar?)  http://predictgov.com/projects/congress/
  4. Find out who represents you in the U.S. Congress through this super easy site: http://www.whoismyrepresentative.com
  5. Get ready to take action.  Our challenge will start tomorrow!

The health implications of e-cigs according to U.S. agency experts. — Vaping Links And More

October 16, 2016

Prestigious “non-profit agencies” such as the American Cancer Society, American Lung Association, American Heart Association, Campaign for Tobacco Free Kids and all of their state and local “affiliates” are unwilling to stand up for the public, placing their fiscal priorities before public health. Joining them are government agencies like the Centers for Disease Control & […]

via The health implications of e-cigs according to U.S. agency experts. — Vaping Links And More

Lobbying for Change – get ready! H.R. 2058

October 16, 2016

Here are some links that reference a bill ( the FDA Deeming Authority Clarification Act of 2015) that has been introduced for the purpose of changing the date for the deeming rule from February 15, 2007 (the grandfather date) to sometime after the finalization of the currently proposed deeming regulations (which were due out on June 15, 2015).

 

Remarks from Hon. Tom Cole of Oklahoma to the House of Representatives on Tuesday, April 28, 2015:

https://www.congress.gov/congressional-record/2015/04/28/extensions-of-remarks-section/article/E596-1

Text of H.R. 2058

https://www.congress.gov/bill/114th-congress/house-bill/2058/text

 

Also some great posts from others on this topic:

  1.  From DIY E-Liquid Supplies: http://diye-liquidsupplies.com/blog/the-grandfather-date-question-is-hr-2058-the-answer/
  2. From The Dailey Caller: http://dailycaller.com/2016/04/19/vapers-win-big-house-committee-passes-amendment-to-save-e-cigarettes/
  3. From GrimmGreen: http://www.grimmgreen.com/post/136957696213/the-future-of-vaping-is-hr-2058

 

Staying Alive – Deadline 12/31/2016

September 26, 2016

Step one in this crazy process, for any person at all concerned about this Deeming Rule, has to be to go to the source and get some actually information, right? So that would be the FDA website, no problem. Do some basic searches and everything says they are committed to helping people through the process, they have set up videos and special web sites and even put out guidance documents! This seems great! At first glance…

Then you click on one link, looking for an answer, and it takes you to a page you were already at. OK, surely I did something wrong, handy little back arrow puts me back where I was. Click. Nope. OK, back up. Fast forward twenty minutes later. I have my answer! Well, mostly…actually just kinda sorta. They still keep using terms like PMTA, Master List, and user fees but I cannot get any concrete answers about this. Surely they know exactly what has to go into this process. Why isn’t there just a check list?

An hour later I finally find an outline of dates! I’m doing a happy dance through my house as my dogs look on at me like I’m crazy – maybe I am since I am looking at the FDA website for hours. Then I really look at the document. One form claims it is due February 8, 2017 OR August 8, 2017. What does that mean? How do I know which date to use?

Deep breath. Surely I can figure this out.  I am an Attorney (hear the bells and whistles). FDA said, somewhere in the labyrinth I got stuck in (that didn’t even have a talking worm with a British accent, mind you) that they would help, that this process would be laid out for me. There I sat, hours later, still unsure of where to start.

That is why we are here to help. We have already gone through the frustration that is the FDA web site, along with the actual regulations, and lived to tell the tale. We have answers for your questions, at least the answers that are available. The truth of the matter is the FDA has only updated ONE, yes I said, ONE, form that is tailored for vape and ENDS products. The more you muddle through their web site you get the feeling maybe this whole thing was rolled out a little too quickly, but here we are. They hold the keys to the castle and they are trying to hide the fact that the castle isn’t even fully built.

Still the first real deadline, with the only document tailored to this unique and specialized product, is fast approaching. December 31, 2016 is the first deadline, with the only form we are sure about. This is not the type of form you sit down during your copious amounts of down time as a small business owner and fill out. (Could you feel the sarcasm?) There are attachments and DUNS numbers that have to be attached. Let us help and let you actually enjoy the limited free time you have. As more information becomes available we will keep you up to date and and as in the know as possible.

-Jessica