FDA New Regulation to Penalize Freedom of Speech About Vaping Products and Consumer Opinion

“To CRA or not to CRA?  

CRA you say?  What the heck is that?  The Congressional Review Act is a law enacted in 1996, which basically creates an opportunity for Congress to negate or invalidate a regulation put forth by an executive branch agency.  Do I have your attention now?

The Congressional Review Act (CRA) states that before a rule can take effect, an agency must submit the rule to Congress with a statement on its impact and whether it is a major rule.  Upon receipt of this report, Congress will have 60 legislative days in which to take action on a joint resolution of disapproval of the rule.  If the joint resolution of disapproval is submitted within the CRA specified deadline, and signed by the president, the “rule shall not take effect (or continue).”  Such rule would be deemed not to have any effect at any time – even provisions that had become effective would be retroactively negated.

What’s more, if enacted with regard to a rule, the CRA prohibits that agency from issuing any rule that is substantially the same in the future, and prohibits judicial review of this action!

I know what you are thinking…. THE FDA DEEMING RULE!  Unfortunately, the 60 legislative day limit – looking back 60 days in which Congress was in session and doing legislative business – only takes us back to early July. And, the FDA final deeming rule was submitted to Congress in May. Basically, the deeming rule was too long ago to exercise CRA option on it. So, we will have to use other tools at our disposal to address the deeming rule – including changing the predicate date and working with the new administration, etc.

However, there is another very important rule to which Congress could – and should – apply the CRA process.  I refer to the rule made final earlier this month by FDA, which I call the “Intended Use” rule.

The Intended Use rule is nefarious because it is how FDA will extend its prohibition on free speech and possibly hold manufacturers accountable for what OTHERS say about their products. That is, they prohibit you and anyone who sells vapor products from making truthful statements about relative risks of vapor products and smoking. This rule prohibits you from even citing peer reviewed scientific studies such as the Royal College of Physicians or Public Health England studies in conjunction with your business. Click here to read the rule.


Not only does this rule prohibit manufacturers and retailers from making certain truthful statements regarding risk, smoking cessation, and health issues, but it goes even further. The FDA is giving itself the authority to use not only statements made by you to determine whether prohibited health claims are being made, it also says FDA may consider other evidence of intended use, which may include “circumstantial evidence.”

FDA could use this as justification to force products off the market as unapproved medicine, medical devices, or combination products. Remember, this is the same justification the FDA used to seize vapor products several years ago before the federal court system told them (Sottera v. FDA) that they could not do this because the manufacturers who sued the FDA were not making health claims in marketing e-cigarettes.

This new restriction and enforcement power really bothers me. Because, once freedom of speech is so severely restricted, open debate about our products and public health can be critically harmed. Truthful statements should be allowed and their veracity can be tested through other mechanisms.

If this rule remains in effect, we will not only be keeping life-saving facts from the public.  We will also be left fighting this battle without being able to state facts to public audiences whose opinions sway the will of elected officials. 

In any case, NO governmental organization should be permitted to use “circumstantial evidence” (presumably what consumers are saying about cessation online??) to stop a product from being sold.

How are we, as a society, going to have an honest and open discussion of tobacco harm reduction if one side is prohibited from educating customers and the public while the other is constantly pumping out ridiculous propaganda?

Congress should consider submitting a resolution of disapproval on this new FDA “intended use” rule. If you agree, please call or email your Congressmen and urge them to apply the CRA to this rule promptly, before it does irreversible damage.”

 

Article Made Available by SFATA – www.sfata.org

A Brief Look at the History of Electronic Cigarettes and Vaping

If you’re a vaper, do you owe a huge debt to Mr. Hon Lik?  Yes we all do, though many think Mr. Lik, Chinese pharmacist, was the first to invent the concept of the electronic cigarette, he was not!

The honor of the first concept of the electronic cigarette goes to Herbert A Gilbert, who submitted a patent application in 1963!  Gilbert’s design included all the elements we’re familiar with today – a battery, a reservoir for flavored liquid and a heating element. He made a few prototypes but these were never deemed marketable in the culture of the 60’s, where smoking cigarettes was much more widely acceptable than today.

Though Mr. Lik wasn’t the first to conceptualize the electronic cigarette, was the first one to turn the vision into a reality, inventing a real device that actually worked.  He came up with his own idea independently and outside of Gilbert’s design, motivated by his father’s death from lung cancer and his own struggle to quit smoking with nicotine patches. Initially he used ultrasound technology to create the vapor, but it was found that the droplets were too large and didn’t have the same feel as cigarette smoke. When he hit on the idea of using a resistance heater, much better results were created, and paved the way for electronic cigarettes as they exist in today’s vaping market.  

In 2003, Mr. Lik registered a patent for the familiar modern design, and the first devices hit the Chinese market the next year.  By 2006 electronic cigarettes were becoming available outside of China and to date; China still remains the largest manufacturer of vaping technology products in the world.

In 2007 British entrepreneurs Umer and Tariq Sheikh invented the cartomizer, which is a mechanism that integrates the heating coil into the liquid chamber.  This invention revolutionized electronic cigarettes. They launched this new device in the United Kingdom in 2008 under their Gamucci brand, and the design is now widely adopted by most “cig-a-like” brands.

The first mod to replace the e-cigarette’s case to accommodate a longer-lasting battery, dubbed the “screwdriver”, was developed by Ted and Matt Rogers in 2008.  And in 2009, Joyetech developed the eGo series, which offered the power of the “screwdriver” model and a user-activated switch to the growing electronic cigarette world market.  

The clearomizer was invented in 2009, originating from the cartomizer design; it contained the wicking material, an e-liquid chamber, and an atomizer or heating coil within a single clear component.  The clearomizer allowed the user to monitor the liquid level in the device.  Soon after the clearomizer reached the market, replaceable atomizer coils and variable voltage batteries were introduced.  Clearomizers and eGo batteries became the best-selling customizable e-cigarette components in early 2012.  

Clearomizers paved the way to what is currently known today as tanks and coils in varying sizes, shapes, and colors.  Batteries or Mods have also evolved in size, shape, color and technological varieties ranging from variable voltage to temperature control models, as well as internal and external battery options.

The culture of vaping has expanded in leaps and bounds since Mr. Gilbert and Mr. Lik’s original concept; it is no wonder that in November 2015 the CDC data stated there were more than 9 million vapers in the US.  And in April of 2016 the French Inter-professional Vaping Federation estimates the number of vapers at 25 million worldwide.

Ocean State Vapes Legal Age Requirements

A Reminder for all of our Customers

As the vaping industry moves forward, and Governmental, State and Local Laws of enforcement become more stringent regarding selling vaping products to or purchasing vaping products for minors, we want to remind all of our customers that Ocean State Vapes follows age requirement laws to the letter!  We follow these requirements not as a “punishment” for anyone, but to ensure that the Vaping Community as a whole obtains and maintains a good reputation for adhering to the legal standards set forth by our government.

“With the new FDA rules and enforcement procedures now rolling out all across the 50 states, it is more important than ever that your staff knows how to properly age-verify your potential customers.  The penalties are pricey and the “no sale orders” are no joke.  Here are some statistics that may be eye-opening for many in our industry, as these FDA secret shops are a new experience for most vapor retailers.

The “FDA has undertaken nationwide law enforcement checks and in FFY 2016 alone conducted more than 134,000 compliance checks. Since 2010, FDA has conducted 640,000 retailer compliance checks covering every state, Washington, DC and U.S. territories and issued nearly 8,200 civil money penalties against retailers ranging from $250 to $11,000. In October 2015, FDA began issuing no tobacco sale orders (NTSO) against repeat violators.”  (Article: New FDA Tobacco Regulations Means Retailer Commitment to Compliance- We Card)

When coming to the shop please keep in mind the following:

  • If you look under the age of 27 years old, you will be asked for your ID.
  • Remember to bring your ID with you every time you come to the shop.
  • If you do not have your ID when asked, you will be asked to leave the shop.
  • If you should be in the shop with friends, whether purchasing items or not, and look under the age of 27 years old, you will be asked for your ID.
  • If you have children with you under the age of 18 years old, without ID, they will be not be allowed in the shop.
  • If you tell any sales associates that your intent is to purchase items for friends or family members under the age of 18 years old, the sale will be refused.

We appreciate all of our customers understanding and assistance in helping our Vaping Community remain strong, grow and thrive during these times of ever changing regulations!

What is an RDA?

An “RDA” is a Rebuildable Dripping Atomizer. The basic components of an RDA are the “deck”, or platform, posts, cap and “drip tip” or “chuff cap”.  The posts are anchored to the deck allowing the coils to be inserted, and provides the electrical connections to the battery (mod) that heats the coils. The “deck” is covered with the cap (outer housing) that typically slides on with O-rings. The most common style of RDA’s will have a removable “drip tip” or “chuff cap” allowing the user to have easier access to the coils and/or wicking material.  RDAs have no “tank” section to hold e-liquid, and are designed for e-liquid to be dripped from a bottle directly onto the coils and/or wicks.  Most RDA’s are designed where you only have to remove the drip tip or chuff cap, as opposed to removing the entire cap after “dripping”.  Some are made with the deck having a small “well” under the coils that holds a minimal amount of e-liquid, usually less than 1ml, but allowing there to be less frequent “dripping”.

 

A commonly held opinion in the vaping community is that RDA’s produce a cleaner and more intense flavor than any other method of vaping. Thus for some, RDA’s are the top choice and present the standard for which all other types of atomizers are measured.  RDA’s can produce astonishing amounts of vapor, especially when outfitted with coil builds with ultra-low resistance (0.05-0.2 Ohms) and vaped at a sufficient rate of power (100+ watts).  Most avid RDA users will typically chose to build their own coils, however there are also many companies that produce high quality pre-built coils ready for use.  Wicking materials used for RDA’s vary from organic cotton, synthetic blended materials, to even quartz crystals.

RI Vaping Interview

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