E-cigarettes and Vape Might be Worth a Try, says the FDA
Alternative smoking methods and products like e-cigarettes, vaping pens and e-liquids are not something very recent. They have been around for a while. The manufacturers, wholesalers, and retailers had been flourishing very well in this trade. But since this industry needs the sanction of a couple of regulatory authorities which the state law has put in place to ensure to deterrence the illegal sale, and unwise consumption of these alternative methods of smoking, it may be facing a gamut of challenges in the two years to come.
Also Read :
- Are Electronic Cigarettes Safe? The short answer is yes
- What is the difference between Disposable vs. Rechargeable E-cigs
- Looking For Alternatives to Smoking? E-cigarettes and Vape
The fact that must be understood here is that all the products related to tobacco, the ones that have been deemed by the laws as tobacco products, must comply with the rules that bodies like FDA (the US Food and Drug Administration), or what is popularly known as “the Agency”, prescribe for these products.
Looking For Alternatives to Smoking?
While FDA feels that the steps it has taken were necessary to discourage the use of tobacco and vaping products among children and teenagers, a majority of Americans have come to stand against it, especially the against the proposed bill of raising the age of vaping to 21 years. The vaping industry, that has now come under the scanner, for it is now controlled by federal laws which can be exercised on it by the FDA, the debate has gone even more terse.
On the one side are the health concerns of smokers as well as of the non-smokers that arise due to the use of tobacco and products; on the the other hand is the vast vaping industry that, due to the new Deeming Rule by FDA, can go to the dogs. Even if they manage to survive, the costs are so much so, that it may not be a profitable deal at all. While the Agency is being true to its aims for safeguarding the health of the American public, for the Californian Orange county it could be a spell of death, a slow poison, indeed.
This article lets you know what exactly this revolutionary bill is doing, what the repercussions will be, and what options the vaping industry has given the regulations.
The Tobacco Act and the FDA
On June 22nd, 2009, the Tobacco Contol Act, also known as the Family Smoking Prevention and Tobacco Control Act was made a law. It simply authorizes the FDA to exercise control over the production, distribution, and marketing of tobacco and products. Its direct aim is to safeguard the public and create a better and a healthier future for the people of America.
Here is, in brief, what the Tobacco Control Acts does:
Exercises restriction of over the marketing of tobacco, and its sale to the youth
- Necessitates warning labels for smokeless tobacco products
- It makes sure that the claims for “Modified Risks” are supported by sound scientific evidence
- It mandataries the disclosure of all the ingredients used in tobacco products
- It preserves and endorses the power the local, state as well as tribal authorities
And here are some things that you may think it does but it actually doesn’t:
- It does not require prescriptions for the purchase of tobacco products
- It does not necessitate the reduction of nicotine content to zero
- It does not prohibit in-person sales in any particular category of retail vendors
- It does not any particular category of tobacco
Looking at it closely, all that the act means to do is, make tobacco products less available as well as less alluring to the youth. The traditional standard of evaluation that the FDA follows for examining and marking medical products cannot be applied to tobacco products. The newer available tobacco products are evaluated on the basis of the benefits and threats that they pose for the health standards of the public of America. And this public includes both users as well as non-users. These regulations, as a matter of fact, are considered federal laws.
Now, for the success of these regulations largely depends on the comprehension of the manufacturers and retailers. To this purpose, the FDA or the Agency issues guidance documents that help them understand the all the important aspect of the Tobacco Control Act. Though these documents are not legally binding, yet they extend major help to the producers and the retailers understand what exactly the FDA prescribes them to do, or stops them from doing. It helps them in:
- Determining the period of a no-tobacco-sale order as well as the compliance with the same
- Complying with the regulations that restrict the distribution and sale of cigarettes and smokeless tobacco products to adolescents as well as children
- Implementing the policies concerning particular regulations that restrict the distribution and sale of cigarettes and smokeless tobacco products
- Providing frequently asked questions and the answers relating to the ban of cigarettes containing certain characterizing flavors (Edition 2)
- Training program for retailers
- No-tobacco sale orders and civil money penalties that can be levied on tobacco retailers smoking.
- Frequently asked questions and answers pertaining to these penalties
FDA Retailer Training and Enforcement Programs
The Agency makes every possible effort it can to aid the retailers in complying with the federal tobacco regulations, enforcement as well as with the compliance checks.
- Webinars for tobacco compliance
- Videos for retailer training
- Guidance through retailer training in person
- Education sources for retailers
Our no.2 concern here is the FDA Deeming Regulations Analysis. No matter how complicated it may sound, it must be understood nonetheless.
FDA Deeming Regulations Analysis from Smoking-Free Alternatives Trade Organization
On May 5, 2016, the Agency issued forward a republication version of the Final Deeming Rule that was to come out shortly. This rule authorizes FDA to extend and exercise control over all tobacco products, along with the ones that are derived from tobacco, as well as the devices in which tobacco products are used (accessories excepted). This simply meant that the FDA, effective from the date of the issuance of the rule will have direct control over te following products:
- Liquids that contain nicotine (vaping and e-liquids)
- Digital Displays
- Device Software
*the liquids which do not have nicotine do not fall under FDA’s authority.
Subsequently, in the May 10, 2016, edition of the Federal Register, the rule was ultimately published. To all the manufacturers’ and retailers good luck, it becomes effective within 90 days from the date of publication. And that is 8th August 2016.
Also, when we talk of retailers and manufacturers, it is important to know how the Agency differentiates between the two.
FDA’s Definition of Retailers:
- Any person who is directly involved in the sale of tobacco to individuals for their personal consumption
- Any person who operates a facility, or an outlet where it is permitted to have vending machines or self-service displays
FDA’s Definition of Manufacturers:
- Any person who directly fabricates, manufactures, processes, or labels the tobacco product that is finished. This also includes the re-packer or re-labeler.
- Any establishment or person that mixes or makes e-juices; prepares or modifies apparatuses for aerosolization (for selling to the public directly)
- Any business organization that rebuilds the devices or coils that need more than simple repair
- the number of employees and the annual revenue may also be used to further categorize the manufacturer as “small scale tobacco product manufacturer.” This qualification does not reduce any burden of compliance but does buy the manufacturer extra time to comply.
This means that probably none involved in the industry one way or the other can escape from it. As a result, all who fall under any of these categories need to fulfill requirements in order to operate legally.
How Can this Authorization be Bagged?
The direct way to getting FDA authorization for these newly deemed products (“new tobacco products”) is clearly through three following ways:
SE – Substantial Equivalence
it requires manufacturers to prove that the new product that he/she is dealing with, is substantially equivalent to any product already existing in the market as on February 15, 2007. To be honest, the probability is very little that you find such a product as similar, and draw an SE comparison because of the big difference in products then and now. You can make this kind of submission within 18 months after the effective date of the regulation.
Relief from SE
This certainly cannot help the vapor products and may have been intended to be used primarily for cigars. These applications are due within 12 months after the effective date.
PMTAs – Premarket Tobacco Product (Smoking) Application
Almost all vapor products can go this way. Both liquids as well as device manufacturers have 24 months at their disposal for the submission of a PMTA application. Once that has been done, they have an additional one year time to market the products. After the close of this 3-year span, FDA enforcement shall be done, unless the products have a grandfathered status or if they are subject to market authorization order.
One pointer for you is that all this costs money, a few hundred thousand dollars per product as the cost of compiling a PMTA. The testing cost to generate the required data is over and above this cost, and could reach at $1 million in the least, that too for just one product.