The countdown begins
August 8 is Deeming Day. It’s when the FDA asserts its authority to treat e-cigarettes and vapor as tobacco products (along with pipe and hookah tobacco, cigars, nicotine gels and some dissolvables). It might be the beginning of the (legal) end — if our legal and legislative efforts all fail — but it’s just the beginning. There will be additional rules to follow. FDA Center for Tobacco Products chief Mitch Zeller is fond of saying that the deeming regs are “foundational.”
Today’s historic rule serves as the foundation for future FDA regulations.
Since there are so many misconceptions about the deeming regulations, and exactly what happens when, perhaps a step-by-step rundown is in order. We took the best FDA deeming document, and separated the events into a chronological format that makes it all a little clearer. Now you can be an expert on the regulations every vaper in the US is talking about.
August 8, 2016 - Deeming Day
- No new products can enter the market unless authorized by an FDA marketing order. A marketing order requires approval of a Premarket Tobacco Application (PMTA) or Substantial Equivalence approval.
- Retailers that mix or prepare e-liquids, or create or modify any device, are considered tobacco product manufacturers. All manufacturers must comply with the specific legal requirements FDA has created for them. Facilities must be sanitary, to prevent contamination of products that could pose a public health risk beyond the inherent risks of using the products. Businesses that choose to operate as manufacturers (rather than just retailers) will have to register by December 31 as manufacturers and provide a full list of products to the FDA.
- Retailers may only sell to customers age 18 or older (states may have stricter age requirements), and must check photo ID of everyone under age 27. Online sales require proper age verification. (All states except Michigan and Pennsylvania already prohibit sales to minors.)
Young people’s lungs shouldn’t be exposed to the aerosol and vapor that contains nicotine.
- Free samples are not allowed. Most interpretations of this say that retailers must charge a “reasonable” fee, and many suggest creating a paper trail of compliance, creating a SKU and ringing a sale for each sample. Some vape shops are turning this into an advocacy effort, offering to donate money to advocacy groups like CASAA or the AVA to match each sample fee.
- Selling products in a vending machine is not allowed, unless it is in a facility where those under 18 years of age are neither present nor permitted at any time.
- FDA will begin enforcing the prohibition on “misbranding,” including false and misleading claims on labels and advertising. Manufacturers and retailers are not allowed to make claims to customers in advertising or public statements that products are less harmful or pose fewer risks than other tobacco products. Such claims require a modified risk tobacco product order.
June 30, 2017
- Establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product must register with the FDA. Future regulation will require registration of foreign establishments.
- Provide the FDA a list of all products. The list must include all labeling and advertising. Product listings are updated every June and December.
The Agency has concluded, based on scientific data, that the newly deemed products should be regulated due to their potential for public harm and regulation is necessary to learn more about that potential.
August 8, 2017
- Manufacturers (except “small-scale” manufacturers) must provide ingredient listings and Tobacco Health Documents. (FDA considers “small-scale tobacco product manufacturers” to be manufacturers of any regulated tobacco product with 150 or fewer employees, and annual total revenues of $5 million or less.) Small-scale manufacturers will have until Feb. 8, 2018, to submit ingredient listings.
- “All required label and labeling statements must be prominent and in such terms that render it likely to be read and understood”
- Prohibition on the manufacture of products that contain “light,” “low,” “mild,” or other similar descriptors in the label, labeling, or advertising of such products without a modified risk tobacco product order in effect (and no distribution is allowed after September 8)
- Compliance period for manufacturers to submit a substantial equivalence exemption request. (This will almost certainly not apply to any vapor products.)
February 8, 2018
- “Small-scale” manufacturers must provide ingredient listings and Tobacco Health Documents.
- Compliance period for manufacturers to submit a substantial equivalence application. (This is unlikely to apply to any vapor products, unless a predicate product is approved through the PMTA pathway first.)
The direct benefits of making each of the newly deemed tobacco products subject to the requirements of the FD&C Act are difficult to quantify, and we cannot predict the size of these benefits at this time.
May 10, 2018
- Tobacco products will be considered misbranded unless they bear a label containing the following information:
The name and place of business
Quantity of the contents
Percentage of domestic and foreign-grown tobacco
The statement: “Sale only allowed in the United States” on labels, packaging, and shipping containers of tobacco products
- Product packages and ads must contain the addictiveness warning statement “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” The warning must follow size and format requirements. Manufacturers cannot manufacture products with non-compliant packages beginning May 10, 2018 and cannot distribute such products beginning June 11, 2018.
- Product packages and ads of covered tobacco products that do not contain nicotine may bear an alternative warning statement: “This product is made from tobacco.” Manufacturers must submit to FDA a self-certification.
August 8, 2018 - Doomsday
- Last day to submit PMTA’s for products that were on the market on August 8, 2016. Products may remain on the market for one year, or until the FDA denies the application.
August 8, 2019
- No products remain on the market that haven’t been issued a marketing order by the FDA.
- Manufacturers must report all harmful and potentially harmful constituents (HPHCs) for their approved products.
FDA authority over the newly deemed tobacco products will give it means to determine which products are legally on the market and which are counterfeit or otherwise illegally marketed and to take enforcement action against manufacturers who sell and distribute illegal products.
The end? Let's not give up just yet!
What can we do? The clock is ticking for real now, but we can still take action. Check out our recent suggestions for vapers looking for ways to fight back. Do something. We need each other.
- Visit August8th.org – It’s fast and easy. Bother your members of Congress until they start listening. Tell your vaping story, and explain how many small businesses in your area and state will close, and how many people will lose their jobs. Express your concern that thousands will return to smoking.
- Call them too! – Sending letters is great, but making a phone call to your elected officials is even better. The staff member you talk to will note that you are urging your Senators or Representative to support HR 2058 and the Cole-Bishop amendment. Both of those change the predicate date, preventing the FDA from forcing every product currently on the market from being forced into the PMTA pathway.Be sure to remind them that the Royal College of Physicians’ 200-page comprehensive review of the available evidence concluded that e-cigs are likely to pose no more than five percent the risk of smoking.
Never underestimate the power of a small group of committed people to change the world. In fact, it is the only thing that ever has.
- Talk to everyone you know – Are your friends and family members happy you quit smoking? Sure they are, and they ought to support your efforts to keep livesaving vapor products available to help smokers in the future.
- Join CASAA – It’s free, and every additional member makes us all stronger!
- Support the Right to be Smoke-Free Coalition lawsuit
- Support the businesses that fight for all of us – These regs are aimed at business owners, not vapers. Sure, we’re hurt in the end, but vape shops and online businesses will be destroyed if we lose this fight. Vendors who put money and time into this fight deserve loyalty, thanks, and your continued patronage.