Monday, August 8th, 2016 set a new and deadly precedent after years of patiently waiting on the FDA to make up their minds on e-cigs and related products. They set forth new rules regarding restrictions on sales and marketing of all vaping products, which appear to be a joke but they are not joking.
The regulations also encompass all of the required compliance, agency filing, and the approval processes that must be done prior to such sales. At present, there are upwards of over 35,000 vaping related businesses and thousands more products on the market. If these laws go into full effect, there will be a huge ripple effect for thousands of families, destroying their lives and free commerce.
Here are how the changes will affect such businesses and their products.
How Does The FDA Have The Authority To Regulate Vaping?
The FDA is limited in their capacity to regulate vaping. However, they do have the ability to reinterpret the existing laws in order to strategize how the established control over vaping products and the market work. Per their claim that the Tobacco Control Act of 2009 was enacted in Congress to allow the FDA the right to regulate cigarettes and to give them the authority to regulate vaping products. Per the deeming rule of 2014, they have the rights to do this.
What Is A Deeming Rule?
The FDA directed the United States Customs in rejecting the importation of all e-cigs into the U.S., insisting that it had the authority to regulate all medical devices. This happened in 2009. Just as in the 90s, when they tried to regulate cigarettes, the FDA claimed that the vaporizers were for the delivery of medical drugs and noted nicotine as the drug that they could regulate.
Of course, it should come as no surprise that the manufacturers sued and the courts agreed with them, reaching a verdict in 2011. The FDA could only regulate the vaping products as tobacco products under the TCA or Tobacco Control Act. Just three years later, they issued new proposals on rules to regulate the market. Today, the ruling is that the FDA has the right to regulate the non-traditional products including the following:
- e-cigs, e-cigars, e-hookah, e-pipes
- e-liquids, flavors, e-juice bottles
- vape pens, cartomizers
- atomizers, clearomizers, tank systems
- digital display lights to adjust settings
- software, firmware
Accordingly, deadlines will be staggered with some of the rules and regulations requiring compliance early on and others will have up to two years to comply.
The new rules will go as follows:
Sales of all vape products, including hookahs, pipe tobacco, cigars, and vapes shall not be sold to those under the age of 18 years.
All buyers, under the age of 27, shall be required to show Identification prior to sales.
No products shall be sold in vending machines where minors may be present or permitted on the premises.
No free samples shall be given for any vape liquids or any other tobacco products.
As of May of 2018, the following rules will take affect:
All packaging and advertising must contain a warning regarding the dangers of nicotine being addictive.
All products that contain tobacco shall have a warning that the product is made of tobacco.
All manufacturers and importers shall be required to submit premarket tobacco product applications or PMTA or show why they should be given an exemption.
Premarket approval is long and costly and all companies will have to file this for each separate component.
Per the FDA, preparing a single PMTA can take up to 5000 hours and approximately $333,000 per application. This is a nearly insurmountable hurdle for all but the very largest of corporations.
It's estimated that up to 99 percent of the current products on the vaping market today won't even apply for the approval.
Another means of gaining approval is to file a “substantial equivalence exception” and request that since the company meets or exceeds the requirements that they are grandfathered in. To qualify, they will be required to prove that their products are the same as or similar to predicate products that were on the market as of February 2007.
Predicate Date and Grandfather Clause
A grandfather clause or a predicate date allows the products that were already on the market, and met the stringent requirements, to be bypassed for the premarket approval process. Keep in mind, however, that there weren't any vapes on the market prior to February of 2007. So there is nothing technically to measure the comparison to. According to the FDA, there were no vape products that would qualify for such an exemption. It's pure trickery and politics.
As the new rules have bee proposed, many are rushing to ask the FDA if they could push the predicate date from August of 2007 to August of 2016. If this request were granted, it would give the current product line the ability to remain available for us.
The FDA, however, states that they don't have the authority to change the date in spite of the fact that the TCA gives the FDA a flexible authority to change dates and ensure that their oversight is allowing for the tobacco industry to comply with all regulations. In order to fully address the issue, the lawmakers have proposed more legislation that would amend the TCA laws and set the predicate date at 2016.
The FDA would like to regulate the vaping market in an effort to “protect the health of the public.” That's their job description at least, but I'm not really seeing banning vapes as protecting our health. They want vapes and e liquids to be “safe” but need to settle for “safer than tobacco.” There is no way to know at this point in time exactly how harmful vaping could be for us, but studies have revealed nothing to be concerned about so far. We know for a fact that it's not as harmful as smoking. However, they have plenty of statistics and data to show that the traditional tobacco products are harmful to health and that up to fifty percent of users have had serious medical issues including death from such products.
There is plenty of data to show that vaping is 95 percent less harmful than smoking cigarettes. More costly products are going to be on the market and there will be less availability due to the regulations. Fewer smokers are going to make the switch and more will continue with their deadly trend of smoking regular cigarettes.