FDA Q&A Webinar

May 25, 2016

The FDA hosted a special Q&A webinar today specifically targeted towards retailers. (A separate webinar tailored toward manufacturers will be announced at a later date.) This webinar was supposed to answer questions but many participants walked away more confused and concerned than ever. Hopefully, this will clear up some of the confusion and once again, light a fire under everyone to get on the phones and spread the word.

To summarize:

  • Stores may no longer offer free samples and/or testers. There must be a charge; however, there is no mandatory charge specified. Some stores have discussed perhaps charging a $2 tester fee and then crediting that $2 to the customer’s purchase. This ban on free samples also pertains to all parts and components.
  • Zero nicotine liquid, cotton, wire, batteries, and the like are all now considered tobacco products. It does not matter to the FDA that they do not in fact contain tobacco or even nicotine. The qualifier here is that they could potentially deliver nicotine, and so they are all classified as tobacco products.
  • DIY is safe for now. As long as you are making it for personal consumption and that alone, you are not subject to the regulations and also will not require any kind of licensing to buy or use nicotine.
  • Stores can no longer advertise and/or perform coil builds for customers. Doing so would immediately classify the store as a manufacturer. Some stores have suggested coil “repairs” as a way around this, but it remains to be seen.
  • If a person sells any vape-related device or product, then he/she is immediately considered a retailer. You do not have to own a B&M or even a business to be considered a retailer; it is the exchange of goods for money that now classifies you as a retailer.
  • If you choose to give away a device or product for free, you are no longer a retailer but you now are subject to the ban on free samples.
  • By this December, all manufacturers must register their businesses with the FDA. There is no cost to do this, but the document with the instructions is 104 pages long so it is not recommended that you delay this task. Shops do NOT have to register unless they make their own e-liquid. (Note: I have the instructions and am happy to share them if you email me at lena@bumblebeevapor.com.)
  • Age verification of 18 and older is required for all B&M and online retails. The FDA will begin sending secret shoppers in to check both age verification and no free samples as soon as August 8, 2016. When asked about the specific parameters concerning age verification guidelines, the FDA representatives did not answer the question.
  • May 8, 2018 is when new warnings will take effect.
  • Multi-pack promotions such as “Buy 1, Get 2 Free” are allowed.
  • On August 8, 2016, you may continue to manufacture products that were already on the marketing prior to the effective date while you prepare, submit, and await response on your application/s. The approval period can take up to 36 months.
  • Pre-market authorization will be required before releasing any new products after August 8, 2016.

The webinar will be edited and then posted to the FDA website. I will let you know when it is available for viewing on the site.

Personally, I think there was a lot of tap dancing going on. Beyond the infuriating saccharine smiles on their faces, their refusal to acknowledge some of the more detailed, upfront questions made the entire experience that much more frustrating. I can hardly wait (note the heavy sarcasm) to see what they do with the manufacturer’s webinar. It was glaringly obvious to me that instead of taking our questions and comments as legitimate, educated responses, they instead used our thoughts and ideas as further ammo to obliterate what few loopholes the regulations had afforded us. We fed them the very details that could be used against us, and it was very difficult to keep up hope while we awaited their return from their many “breaks” throughout the webinar.

This only further demonstrates the need to hold our elected leaders accountable. Passing legislation is not enough; they need to explain themselves and the reasoning that led them to these laws, and when they do not make sense and do not fit the needs of the people they represent, well then by God they need to be changed.

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PETA Joins the Fight!

 

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We have a new ally in PETA (People for the Ethical Treatment of Animals). They have spoken out against the FDA regs, stating that they were adversely affect animals through heightened animal testing.

In their press release, PETA states the following:

“To obtain FDA approval, tobacco manufacturers will be required to show that their products reduce the risk to current tobacco users and do not increase the risk to non-users. In a guidance document accompanying the rule, the FDA encourages manufacturers of electronic nicotine-delivery systems to meet with its Center for Tobacco Products (CTP) early in the development process to discuss what, if any, animal testing the agency considers ‘appropriate’ or whether non-animal tests may be acceptable.

The FDA has stated that animal tests will still be required for toxicological issues that it claims cannot be addressed by non-animal approaches—even though we know that the link between tobacco and lung cancer in humans was obscured for years because animal tests did not demonstrate this relationship.

PETA fears that despite the existence of robust human-relevant animal-free tests, the number of animals suffering and dying in tobacco-related testing will rise dramatically. In the most common tests, rats are immobilized inside tubes and test substances are pumped directly into their noses for up to six hours each day.

‘The CTP will expect manufacturers to conduct animal tests in support of marketing applications, and CTP is funding dozens of its own animal studies at universities and the National Center for Toxicological Research,’ says Joseph Manuppello, senior research associate for People for the Ethical Treatment of Animals. ‘However, history has shown us that animal tests will not result in safer tobacco products.’

Animal tests for tobacco products have already been banned in Belgium, Estonia, Germany, Slovakia and the United Kingdom.”

RICO Charges Against Former FDA Commissioner Hamburg

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Former FDA Commissioner Margaret Hamburg

And the plot thickens.

Yesterday an article published by Blasting News United States blasted former FDA Commissioner Margaret Hamburg for her pending RICO (Racketeer Influenced and Corrupt Organizations) charges. Hamburg served as the Commissioner from May 2009 until March 2015. She has been charged for accepting kickbacks from Johnson & Johnson for concealing the deadly risks associated with the company’s drug Levaquin. Also charged is her husband Peter Brown, a hedge fund manager for Renaissance Technologies.

Prior to these charges, Hamburg was actually celebrated in the medical community for her many public achievements. Stat News reported the following in an article glamorizing Hamburg: “Named the youngest-ever health commissioner for New York City in 1992, at age 36, Hamburg helped slow the spread of AIDS, boosted childhood immunization rates, and reversed a crippling tuberculosis epidemic. Seventeen years later, as commissioner of the US Food and Drug Administration, Hamburg inherited an agency battered by a series of drug scandals and food poisoning outbreaks. And although her tenure wasn’t without controversy, when she left last April, after a nearly six-year stint, she was widely seen as having cleaned up the FDA and laid the groundwork for speedier drug and device approvals, more oversight of tobacco products, and a modernized food safety system.”

While Hamburg may have effectively concealed her corruption during her term as Commissioner, the cat is out of the bag now.

Blasting News USA reports: “While Hamburg was acting Commissioner, she was instrumental in forming e-cigarette regulations before she left the FDA. Her replacement, Dr. Robert Califf also has financial ties to pharmaceutical giants AstraZeneca, Johnson & Johnson, GlaxoSmithKline and more. While he was the director of the Duke Translational Medicine Institute (DTMI) he received a consulting payment from Johnson & Johnson of $87,500.”

While these charges may not have a direct effect on the FDA’s regulations on the vape industry, they certainly go a long way in undermining the credibility of these appointed officials who are supposed to treat legislature with honor and integrity.

It appears that Califf was not only heavily influenced by his predecessor Hamburg, but he is continuing her shameful legacy through his attempts to shut down the vape industry. Thankfully Senator Johnson is all for accountability, and he is calling the FDA down to the carpet.

For more information, the article can be found in its entirety here.

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Current FDA Commissioner Dr. Robert Califf

 

Updated: 54 Co-Sponsors for HR 2058

We now have 54 co-sponsors for HR 2058!!!!

Rep. Rouzer, David [R-NC-7] 04/29/2015
Rep. Guthrie, Brett [R-KY-2] 04/29/2015
Rep. Rooney, Thomas J. [R-FL-17] 04/29/2015
Rep. Hunter, Duncan D. [R-CA-50] 05/01/2015
Rep. Amodei, Mark E. [R-NV-2] 05/14/2015
Rep. Harris, Andy [R-MD-1] 05/14/2015
Rep. Jones, Walter B., Jr. [R-NC-3] 05/14/2015
Rep. Ellmers, Renee L. [R-NC-2] 05/14/2015
Rep. Pompeo, Mike [R-KS-4] 05/18/2015
Rep. Long, Billy [R-MO-7] 05/21/2015
Rep. Graves, Tom [R-GA-14] 05/21/2015
Rep. Valadao, David G. [R-CA-21] 05/21/2015
Rep. Yoder, Kevin [R-KS-3] 06/09/2015
Rep. Whitfield, Ed [R-KY-1] 06/09/2015
Rep. Hurt, Robert [R-VA-5] 06/09/2015
Rep. Brat, Dave [R-VA-7] 06/15/2015
Rep. Griffith, H. Morgan [R-VA-9] 06/15/2015
Rep. Fleischmann, Charles J. “Chuck” [R-TN-3] 06/15/2015
Rep. Rigell, E. Scott [R-VA-2] 06/15/2015
Rep. Kinzinger, Adam [R-IL-16] 06/25/2015
Rep. Barletta, Lou [R-PA-11] 07/09/2015
Rep. Shimkus, John [R-IL-15] 07/09/2015
Rep. Flores, Bill [R-TX-17] 07/09/2015
Rep. Walker, Mark [R-NC-6] 07/22/2015
Rep. Wittman, Robert J. [R-VA-1] 07/28/2015
Rep. Forbes, J. Randy [R-VA-4] 07/28/2015
Rep. Blum, Rod [R-IA-1] 11/02/2015
Rep. Hudson, Richard [R-NC-8] 11/04/2015
Rep. Kline, John [R-MN-2] 11/05/2015
Rep. Blackburn, Marsha [R-TN-7] 11/18/2015
Rep. Neugebauer, Randy [R-TX-19] 12/01/2015
Rep. Sanford, Mark [R-SC-1] 12/01/2015
Rep. Mooney, Alexander X. [R-WV-2] 12/03/2015
Rep. Goodlatte, Bob [R-VA-6] 12/10/2015
Rep. Holding, George [R-NC-13] 12/10/2015
Rep. Zinke, Ryan K. [R-MT-At Large] 12/11/2015
Rep. Emmer, Tom [R-MN-6] 01/05/2016
Rep. Collins, Chris [R-NY-27] 01/05/2016
Rep. Ribble, Reid J. [R-WI-8] 01/11/2016
Rep. Thornberry, Mac [R-TX-13] 01/11/2016
Rep. Young, Don [R-AK-At Large] 01/13/2016
Rep. Stivers, Steve [R-OH-15] 02/03/2016
Rep. Byrne, Bradley [R-AL-1] 02/03/2016
Rep. Rogers, Harold [R-KY-5] 02/03/2016
Rep. Heck, Joseph J. [R-NV-3] 02/03/2016
Rep. Murphy, Tim [R-PA-18] 02/11/2016
Rep. Grothman, Glenn [R-WI-6] 02/11/2016
Rep. Kelly, Mike [R-PA-3] 02/11/2016
Rep. Johnson, Bill [R-OH-6] 02/24/2016
Rep. Boustany, Charles W., Jr. [R-LA-3] 02/24/2016
Rep. Womack, Steve [R-AR-3] 03/02/2016
Rep. Massie, Thomas [R-KY-4] 05/12/2016
Rep. Westerman, Bruce [R-AR-4] 05/13/2016
Rep. Marchant, Kenny [R-TX-24] 05/16/2016

Please be sure to thank them for supporting us!

If your district is missing, take action here!!!

Sen. Ron Johnson is Officially Our Hero

 

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That’s right. We have another friend in Congress!

On May 18, 2016, Sen. Ron Johnson (R-Wis) wrote a letter to FDA Commissioner Robert Califf challenging the FDA’s entire stance on the e-cigarette regulations. Sen. Johnson is the chairman of the Senate Homeland Security and Government Affairs Committee, so he is well within his rights to challenge the FDA and demand answers.

Not only does he call the regulations premature given the lack of “sufficient data” proving negative health risks from e-cigarettes, but he asks if the FDA will reverse their ruling if science proves otherwise. He also demands that the FDA account for the thousands of businesses and jobs that will be lost due to these regulations.

More details can be found here. Please be sure to visit Sen. Johnson’s page to thank him for his support!

Lost Art Liquids Files 2nd Lawsuit Against FDA

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Today, Lost Art Liquids, LLC of Los Angeles, California filed the second lawsuit against the FDA. Filed in the Central District of California, the suit challenges the FDA’s authority to regulate the vaping industry and their ability to deem e-cigaretttes as “tobacco products.” Furthermore, the suit claims that the FDA has violated the 1st and 5th Amendments, the Regulatory Flexibility Act, and the Administrative Procedures Act.

Ryan Thomas, co-founder and COO of Lost Art Liquids, says: “The FDA has introduced one of the most burdensome, misguided and harmful regulations in its history without adequately sound science, or adhering to required, lawful procedures. These regulations will harm Lost Art Liquids’ business and customers by eliminating vapor products from the market, forcing consumers to resort to more harmful products like cigarettes and cigars.”

Amen, brother! They have shared the complete suit on their Facebook page here.

 

SEVIA Joins the Fight

Last week, Dimitris Agrafiotis made an official announcement introducing the Shenzhen Electronic Vaporizer Industry Association (SEVIA) USA. This organization, led by Dimitris as the chairman and Phil Busardo as the Executive Assistant, is the nation’s only association of Chinese vendors and brings together Aspire, Innokin, Kanger, and SMOK. Their support will undoubtedly add another layer of pressure on the FDA and American government as a whole, given our strong partnership with Chinese manufacturing and imports.

SEVIA USA will be partnering with the Right 2 Be Smoke Free Coalition. They encourage you to donate to their cause here!

Thank you Dimitris, Phil, and our Chinese friends for all you do to help save the vaping industry!!!

Once Again, The U.K. Has Our Back!

On April 28,  2016, the Royal College of Physicians (RCP) released a 200 paged report debunking vaping myths and showing overwhelming support for vaping as a tool to quit smoking. The RCP is the most respected and reputable medical institution in the UK, and their 1964 report linking smoking to lung disease and bronchitis actually prompted the U.S. Surgeon General to publish the historic report finally acknowledging the risks associated with smoking. Hopefully, the RCP still has the U.S. Surgeon General’s ear, since this new report states the following:

“None of these products has to date attracted significant use among adult never-smokers, or demonstrated evidence of significant gateway progression into smoking among young people.”

“Among smokers, e-cigarette use is likely to lead to quit attempts that would not otherwise have happened, and in a proportion of these to successful cessation. In this way, e-cigarettes can act as a gateway from smoking.”

Risks from vaping are “very small, and substantially smaller than that arising from tobacco smoking.”

 

For more information, visit the RCP’s website.

NJ S298 & HR2058

Hey guys!!! It has been a wicked busy Monday in the vaping world with a lot taking place today!

First, let’s address NJ S298 since that’s the latest topic at hand. Today at the New Jersey Statehouse in Trenton, the New Jersey State Legislature Senate Health and Human Services Committee met to vote on S. 298, a bill which would ban ALL flavors with the exception of tobacco, clove, and menthol flavors. Supporters claim that this bill would help reduce the FDA’s estimated “3 million middle and high school students” who are now using some form of e-cigs. The bill in its entirety can be found here.

Several industry insiders, including Gregory Conley of AVA/CASAA and New Jersey’s Gorilla Vapes, were there to protest and even picked up local media coverage. Sadly, consumers did not come out in droves despite extensive promotion on social media. Committee members were said to have commented on the lack of consumers present at the hearing, taking their absence as support for the ban.

The bill passed after a 6-2 vote; however, the fight is far from over. From here, the bill will advance to a House vote and will be subject to a few additional steps before landing in the Governor’s office.

CASAA has issued a Call to Action link here. Please spread this along social media and send to friends, family members, and coworkers regardless of your place of residence. It is imperative that we defeat this bill and send a message to all states that we have a voice and message!!!!

Speaking of CASAA, the organization has posted on its Facebook page that CASAA representatives will be joining Congressman Tom Cole for a second meeting on June 1st to discuss the FDA’s misuse of legislative power and HR 2058.

Lately, there’s been a lot of talk regarding HR 2058 and rightfully so. This bill is our saving grace, so to speak.

When HR 2058 was initially rejected in December 2015, Representative Cole stood before the committee and argued that his amendment is necessary. His office released a statement on May 5th to coincide with the FDA Deeming Regulations, stating the following:

“The FDA’s announcement today that it plans to regulate all tobacco products is just another example of the Obama Administration’s regulatory overreach and nanny-state mentality,” said Cole. “This regulation takes an overly-broad approach to regulating these products. While we can all agree that tobacco products should not be marketed to children, I still believe that my bipartisan amendment, recently approved by the Appropriations Committee in the Agriculture Appropriations bill, provides the same framework for new tobacco products without needlessly subjecting small businesses to unnecessary regulations and without treating law abiding adults like naïve children.”

Cole’s amendment would change the predicate date from 2007 to sometime in 2016. This means that only products created after this new date would be subject to the regulations and the rest would be grandfathered in. This would essentially preserve vaping as we know it while simultaneously saving countless businesses and jobs around the country. Cole was also careful when drafting the  amendment to include bipartisan language, so not to isolate any one side of the aisle and capturing both Republican and Democrat support.

The amendment will be presented to Congress as part of the Agricultural Appropriations bill. There is no indication yet of when voting will occur, so it is important that we all act now to spread the word and show our support. This bill will keep us in the game and give us more time to fight. If it does pass through Congress, it will then move to the President’s office.

CASAA has officially stated that their position is to support HR 2058 above all else. There are a few items within the Cole-Bishop amendment that CASAA would like to clarify before granting their whole-hearted support but have in the meantime issued a Call to Action for HR 2058 here.

I’ll keep you updated as things progress, but in the meantime, make sure you’re doing your part by calling, emailing, writing, and petitioning your lawmakers to support HR 2058 and save vaping!!!

Thank you for your support!

XOXO,

Lee

Texas Fights Back? I Think Not.

In a May 8, 2016 article published by US Chronicle and authored by user phoenix, Texas appears to be making moves. Texas Governor Greg Abbot is of the opinion that the United States government is out of control, and it is up to Congress to restore the checks and balances in our government by revising the Constitution to include a number of additions that would limit the power of the government and restore the balance of power in the U.S.

Note: I found this article slightly suspect at first, so I did do some outside research and found an official press release from Governor Abbot’s office here.

There is a total of nine proposed amendments, but there are specifically six that could feasibly relate to the vape industry:

  1. Prohibit Congress from regulating activity that occurs wholly within one State.
  2. Prohibit administrative agencies—and the unelected bureaucrats that staff them—from creating federal law. (FDA much??)
  3. Prohibit administrative agencies—and the unelected bureaucrats that staff them—from preempting state law.
  4. Allow a two-thirds majority of the States to override a U.S. Supreme Court decision.
  5. Give state officials the power to sue in federal court when federal officials overstep their bounds.
  6. Allow a two-thirds majority of the States to override a federal law or regulation.

The main idea here is to lessen the power of a power-hungry, irresponsible federal government and instead delegate greater legislative power to the states.

At first glance, it sounds like a great plan. Take power away from the FDA? Hell yeah! Empower the states to overrule even the Supreme Court? Awesome!

Only…it won’t help.

Maybe it’s just me, but I don’t trust ANY politician, regardless of whether they are on a state or federal level. Moreover, I don’t trust big tobacco, and really guys, who do you think is funding all these political campaigns? Even if we were to assume that some states were onboard with saving lives, the ability to sway 3/4 of states in our favor is going to be very difficult. You have to remember that many of these states have been trying to restrict vaping way before the regs came along, whether it is through heavy taxes, B2B restrictions, or even wholesale and e-commerce.

Then we have the great state of Virginia, my home state, born and bred. Unfortunately, I have the extreme displeasure of also sharing my home with Phillip Morris. In fact, every time I wanted to visit family or really go anywhere south, we get to drive by their huge plant. (We have many selfies proclaiming our affections with middle fingers out the window, but I digress.) With Phillip Morris in my state, I know Virginia’s state government isn’t going to step up for something as trivial as public health. Money and power trumps morality every time.

Now, I don’t want you to feel hopeless. I’m just saying be careful where you put your faith. I’ve seen this article floating around Facebook with a variety of colorful opinions, but the bottom line is that your energies are best focused on CASAA, SFATA, AVA, and Not Blowing Smoke. Don’t forget to visit this page  and follow all the links to show your support.

SFATA had a follow up webinar this week addressing a myriad of issues so I will follow up with my notes in the next few entries. There’s also a ton of material floating around Facebook that I’ve bookmarked, but Texas just happened to be the first one on my reading list. More to come soon.

Thanks for your support guys!

XOXO,

Lee