We all knew it was coming. The Deeming Rule is now here, and there’s no question it represents a major paradigm shift for the vaping industry. The “Wild West” days are gone for good.
So what is the new normal, and what does the future hold?
Retailers and manufacturers now have a slew of new rules to follow. While some are common-sense rules, there are onerous ones that require significant investments of both time and capital — and ultimately limit your customers’ choices.
The most substantial new requirement is for manufacturers to submit a pre-market tobacco application (PMTA) for each e-liquid and device to the FDA by August 8, 2018. While the application itself is free, the PMTA must include a significant amount of information drawn from independent testing and human research, a time-consuming undertaking that, by the FDA’s own estimates, can exceed $300,000 per product and according to the industry, it will exceed $3 million. Paying that sum to consultants doesn’t guarantee approval. To date, the FDA only approved one PMTA in seven years, so they don’t have much experience with it.
Before you say, “I’m not a manufacturer,” be warned that the FDA’s definition of manufacturer is very broad. According to their website, “If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any ‘tobacco product,’ then you are considered a tobacco product manufacturer.”
Following are some guidelines that can help you stay in compliance with the Deeming Rule. Please keep in mind, this information does not constitute legal advice.
Follow Age Restrictions
The FDA set the national minimum age for purchasing or using vaping products at 18. However, if your state has a higher minimum age, you must abide by the more restrictive requirement. In addition, you must ask for proof of age by means of a government issued photo ID from any customer who appears to be under 27. Instruct your staff to do this without exception.
Don’t Give Away Free Samples
You can sell samples to eligible adults at whatever price you decide. The FDA does not specify a minimum amount, though it likely should not be a trivial sum. You can take that amount off the purchase price if a sale is made. Membership clubs may be viable as long as the membership isn’t free.
Limit Vending Machines
Vending machines are permitted only in locations where all patrons and staff are at least 18 years of age. Children may enter your store accompanied by a parent, except if a vending machine is present. You do not need to keep products behind the counter.
Cooperate With Inspectors
You are not likely to get a visit from a federal inspector, as the FDA contracts with state and local inspectors, unless you are a manufacturer. Whatever the case, you should always fully cooperate with these officials.
Sometimes an inspector will send in a person under the legal smoking age who will attempt to make a purchase without showing proof of age. Most inspections happen discreetly, and you may not know you were inspected unless a violation is found. If this happens, you will receive a warning letter. Beyond this, you may incur financial penalties for noncompliance.
Sell Legal Products
Vaping products that were in market on August 8, 2016 are legal for sale for the time being. However, those that were not introduced by that date must go through the PMTA process before being allowed on the market, which can take years.
Keep in mind that the FDA does not provide a letter of approval or proof of compliance to manufacturers for products on the market as of August 8, 2016. Work with a trusted supplier to ensure you are selling legal products.
Don’t Mix or Relabel E-Liquids
Retail shop owners that mix or relabel products are designated as manufacturers under the Tobacco Control Act of 2009.
Don’t Tamper or Reassemble
Do not open bottles of e-liquids or hardware packages as much for liability reasons as for regulatory ones. Sell products as they came to you from the manufacturer.
Break Open Multi-Packs, With a Caveat
Just as you can sell a pack or a carton of cigarettes, you can sell a bottle of e-juice that came in a larger pack, because you are not creating a new product. However, do not rebundle bottles into a new pack, or relabel them, as that is considered “manufacturing” under the FDA’s onerous rules.
Continue to Sell Online — With Age Verification
You can still sell vaping products online, as long as you have adequate age verification measures in place. Be sure that the mobile version of your site has the same functionality.
Continue to Educate and Assist Customers
You can describe how products work. However, if you are going to show a customer how to assemble a device or one of its components, they must first purchase that product. Some customers may believe that you are simply trying to push a sale, but it is in fact protecting them under the law.
The best policy is to keep an open display model at the counter. Remember, this cannot be sold, as it is considered to have been “tampered” with.
You cannot say one product is less harmful or healthier than another, whether verbally, on your website, or on your packaging. All advertising must be truthful. No product is currently “approved by the FDA,” and none will be for some time. Whatever you do, do not even appear to appeal to minors.
Continue Exporting, for Now
As long as you follow all of the laws of the jurisdiction in which you are selling, you can continue to sell outside the United States. The FDA will likely issue additional guidance on this in the future.
Join the Fight
All is not lost. A number of pending legislative and legal actions may still help the vaping industry.
The Cole-Bishop Amendment aims to move the grandfather date of deemed products from the current February 15, 2007 — when few vaping products were actually available — to August 8, 2016, when the Deeming Rule went into effect. This would allow vaping products on the market by that date to forego a PMTA. We encourage you to read about this amendment to see all the ways it may benefit our industry.
Contact your congressional representatives and encourage them to support the Cole-Bishop Amendment and other measures that will help our burgeoning industry stay alive. Explain how such rules will make it difficult for you to continue operating and supporting your local economy through jobs and tax revenue.
My company, Nicopure Labs, LLC, was the first to file a challenge in federal court against the FDA’s rule on the very day the rule was published. Others in the industry soon joined the fight. Our case is ongoing and on an accelerated schedule. Stay tuned.
We highly recommend joining an advocacy organization such as the Vapor Technology Association (VTA), which is one of many actively working to get the Deeming Rule, or at least sections of it, changed.
Though the Deeming Rule is now enforced, the final outcome of this story has not been written. Let’s work together to steer it in a more favorable direction for the vaping industry. SVBS
Jeff Stamler is a co-founder of NicoPure Labs, the parent company of Halo and eVo. After starting the company in 2009 he has overseen its growth into one of the leaders of the vaping industry. Today he presides over NicoPure from its headquarters in Trinity, Florida. He can be reached at [email protected], or by phone at 888 270 2449, or visit their website at www.nicopure.com.