United States - FDA Vaping Regulations
National Legal landscape for vaping in the U.S.
The most important laws and bills and will update this page regularly so all vapers can stay up to date and can do their part.
On the U.S. side the Cole-bishop amendment and bill, H.R.1136, and the new Cigarette Smoking Reduction and Electronic Vapor Alternatives Act introduced by California Rep. Duncan Hunter on April 27th 2017.
Introduced on Feb 17 2017 to challenge the FDA's deeming rule that will crush the vape industry. Cole-Bishop would challenge it by moving the grandfather date from 2007 to 2017, hence saving thousands of products that are already on the market from the agency’s extraordinary and outlandish fees for the licensing process which would put most vape companies out of business.
All the products on the market could continue to be sold if the passed the agency standards. Cole-Bishop was a rider on the budget bill and was stripped out on the budget vote along with 159 other riders. This was bad news but it will have another chance in the next budget vote in a few months.
Rep. Hunter's bill goes a step further than Cole-Bishop. “Cole-Bishop is like gaining the inch, and Hunter’s legislation the yard.” Joe Kasper, Rep. Duncan Hunter's chief of staff.
Here is how Gregory Conley, who is president of the American Vaping Association felt about it: “the FDA’s deeming ban is set to take effect less than three months before Senate Democrats have some of their toughest election fights in years. Just as vapers helped re-elect Senator Ron Johnson, vapers will vote out Senators who stand by idly as harm reduction products are yanked from shelves.” He went further: “Democrats are setting themselves up to experience a reality check on vaping in the November 2018 mid-term elections.”
Rep. Hunter's new bill-Cigarette Smoking Reduction and Electronic Vapor Alternatives Act
One step further than the Cole-Bishop bill
The bill is known as HR2194- The Hunter bill. The bill was formally introduced on April 27. Rep Hunter's bill would exempt vaping devices from FDA regulations by proposing regulating vape products as NRT's for harm reduction (what they actually are) instead of regulating them like horrible cigarettes.
It is a rewrite of the Family Smoking Prevention and Tobacco Control Act (TCA) and goes further than any other congressional effort to separate vaping from tobacco regulation. That is the main focus of the bill but here are some other features of it:
- Change the name of the FDA Center for Tobacco Products (CTP) to the Center for Tobacco Products and Tobacco Harm Reduction.
- Requires the FDA to recommend harm reduction strategies for nicotine and tobacco users
- Requires the FDA to rank nicotine products by comparative risk, and report to Congress on the the comparative risk
- Authorizes the FDA to inspect manufacturing facilities, and impose penalties on manufacturers not in compliance with rules
- Prevents states and municipalities from defining e-cigarettes as tobacco products and creating more stringent restrictions than those in the federal rules
- Authorizes the FDA to prohibit advertising and marketing to minors
- Requires products to have serial or lot numbers
- Requires device manufacturers to follow strict electronics and battery standards
- Requires e-liquid manufacturers to follow existing standards of the American E-liquid Manufacturers Standards Association (AEMSA) until permanent standards are created by the American National Standards Institute (ANSI)
Scott Gottlieb confirmed as new FDA Commissioner
Scott Gottlieb was confirmed May 9th,he is a medical doctor, venture capitalist, consultant and cancer survivor.
This looks like a big win for the vaping industry. Dr. Scott Gottlieb is familiar with vaping as he has done business in the industry. New FDA head Dr. Scott Gottlieb, has so far maintained an open attitude towards vaping. He also stated that it is imperative that the matter of e-liquid flavors is viewed from all angles as the products may be inappropriate in one context, but relevant in another. Four years ago he wrote:
“FDA was to create a path to enable cigarette makers to transition away from smoked tobacco and win government approval of consumable products that used tobacco but presumably harbored less, and perhaps even none of the health risks posed by smoking. When this quid pro quo was pushed through Congress, the industry’s critics and allies each positioned it as a win-win. But it was dependent on FDA being able to establish – and maintain – a regulatory path that let tobacco get approval for new products that posed a “reduced harm” over traditional smoked cigarettes.”
It looks the new FDA head will be open to dialogue instead of the FDA's vaping is forbidden stance of the past. The former Surgeon General who has been incessantly campaigning against vape products, has also been recently dismissed. These two personnel changes are a step in the right direction for vaping in the U.S.A.
UK Vaping Laws and Regulations
Article 20 and The Current Situation for EU Vapers
After a long fight against article 20 of the Tobacco Products Directive (TPD) Totally Wicked lost its challenge and Big Tobacco along with similar vested interests won. Article 20 of the UK TPD is now in full effect.
This effects the everyday vaper but it also harms current and future smokers looking for a safer alternative than tobacco. Every employee of any business involved in vaping in the UK also has their job threatened.
What is Article 20?
Article 20 is part of the Tobacco Products Directive also known as the TPD. Article 20 seeks to prohibit advertising and introduce several cumbersome restrictions across products and liquids which will reduce choice and competition while driving up prices.
New testing requirements and prohibiting advertising together will be financially crippling for manufacturers. Prices will have to go up to cover the testing and reporting requirements. Consumers will not be aware of products or suppliers through traditional means like advertising.
The only companies that will be able to meet the financial burden of the new law will be the Big Tobacco companies themselves or their subsidiaries.
Article 20 Legal Challenge
Failed in Court
The Article 20 Legal Challenge was brought forth by the Totally Wicked juice company based in the UK and supported by vapers worldwide.
It sought to prevent the implementation of Article 20 of the TPD but it was defeated in court in 2016. It's a terrible verdict for the citizens and also anybody in the vape business.
This is a bitterly disappointing end to a battle that has lasted more than two years. At its heart, was a fundamental dispute between those who recognize the public health potential vaping offers and therefore wish to see these products and their use flourish under a robust consumer regulatory regime, and those who either do not understand vaping or see it as a threat to established interests and therefore wish to see e-cigarettes subjected to disproportionate and inappropriate regulation.
New Rules and Requirements of the Tobacco Products Directive
TPD New Rules and Requirements List
The UK Tobacco and Related Products Regulations 2016 implement the TPD in the UK, and came into force on 20 May 2016. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the competent authority for the notification scheme for e-cigarettes and refill containers in the UK and is responsible for implementing the majority of provisions under Article 20.
The following lists are their words; notice how vague and broad the scope is of the new rules.
- Environment that protects children from starting these products
- Information is provided to customers so they can make educated choice
- Minimum standards for the safety and quality of all e cigarettes and e-liquids
- Require all e-liquids and e-cigarettes be notified to MHRA before they can be sold
- Ban certain ingredients including Taurine, Caffeine, and certain coloring's
- Include new labeling requirements and warnings
- Require nicotine-containing products and their packaging to be child-resistant and tamper evident
- Restrict e cigarettes to a capacity no more than 2 ml
- Restrict the maximum volume of E-liquid for sale in one refill container to 10 ml
- Restrict E-Liquids to a nicotine strength to no more than 20mg/ml
- While removing certain ingredients that may pose a health risk is good, companies were doing that on their own. Consumers are switching to vaping mostly due to health concerns and the marketplace was already forcing ingredient disclosures from manufacturers.
If you look at the restriction on devices as far as tank capacity goes, as well as E-Liquid container sizes and nicotine strength, doesn't that remind you of the cheap cig-a-likes that the tobacco companies were pushing years ago? Basically everyone in U.K. will eventually only be able to get high nic mouth to lung devices. Sorry U.K., no clouds bro.
Reactions from Around the U.K.
(about the failure of the Article 20 Legal Challenge)
Paul Nuttall of UKIP- “This ridiculous judgement may well mean some vapers will go back to tobacco, which is plainly not to be encouraged.”
The New Nicotine Alliance-“The resulting ruling from the CJEU places an undue burden on the industry that is predominantly made up of small business by enforcing a cumbersome, fragmented and expensive notification system for new and existing products that meet the stringent requirements of the Directive to reach the market.”
The Government’s own impact assessment of the directive showed that there is a very real risk that the provisions which relate to e-cigarettes will deter smokers from switching to vaping and may push some vapers back to smoking. It is a very sad day when a government is ‘forced’ to implement law which will harm the health of its citizens.
This Law Will Do More Harm Than Good
The TPD seems like a well timed gift to Big Tobacco manufacturers. People switching to vaping from cigarettes is threatening Big Tobacco profits and they need to crush their biggest competition by advocating for these laws to get passed.
These new rules make it harder for people to quit smoking and actually works to keep them smoking. Everything will cost more and vapers will get less. Arguably worse products will cost more and a decline in innovation will occur.
Small to medium independent operators will be effected most and will probably be unable to stay in business.
Everyone must do their part in fighting these new rules and regulations worldwide. This was just a battle the war is still going on. All products not meeting the new regulations or requirements must be sold by and not after May 20th 2017.