Everyone knows vape manufacturers aren’t allowed to sell new products after 8/8 — that is, August 8, 2016. But look at the shelves in your local vape shop, and you’ll see lots of products that weren’t there before that date. How does that work?
Most manufacturers are banking on the FDA’s own rules from 2009 applying to the current situation. While there is no specific information from the FDA on the procedures required to qualify newly deemed “tobacco products” as being available pre-8/8, they did issue guidance for products sold before the original tobacco products predicate date: Feb. 15, 2007. All tobacco products available before that date were “grandfathered” into the market.
That happened in 2009, when the Family Smoking Prevention and Tobacco Control Act went into effect. The congressional act specified that date as the cutoff after which new products would have to receive a marketing order from the FDA through either the substantial equivalence (SE) or premarket tobacco application (PMTA) pathway.
Manufacturers back then had to prove that their products had been “commercially marketed” before that date. In other words, they didn’t necessarily have to be available to retail customers yet, but they had to at least have been available for businesses to buy from the manufacturer. Remember, it’s the manufacturer who bears the burden of proof, not the retailer.
The FDA “Guidance For Industry” document offered a variety of documents the manufacturer might use to prove their product’s pre-Feb. 15 presence in the market:
- Dated copies of advertisements
- Dated catalog pages
- Dated promotional material
- Dated trade publications
- Dated bills of lading
- Dated freight bills
- Dated waybills
- Dated invoices
- Dated purchase orders
- Dated customer receipts
- Dated manufacturing documents
- Dated distributor or retailer inventory lists
- Any other document you believe demonstrates that the tobacco product was commercially
marketed (other than exclusively in test markets) in the United States as of February 15,
Manufacturers in 2016 are using the same guidance for vapor products. So if, say, a new atomizer was in the pipeline to U.S. distributors on August 8, that qualifies the atty as “commercially marketed.” There is no requirement that the products must be on retail shelves and available to the public on August 8.
What does that mean for vapers now? Well, it may mean a large number of products are still waiting in the shadows to be unveiled to the public — even though there is ample evidence for the FDA to consider them grandfathered. You may see a stream of “new” products for weeks or even months still.
They will all be gone on August 8, 2018 though, unless their manufacturers receive a tobacco marketing order from the FDA — or if the deeming regs are thrown out or modified by a federal court judge, or Congress changes the 2007 predicate date by amending the Tobacco Control Act (which made the deeming rule possible). Rewriting the Tobacco Control Act is the holy grail for vape industry advocates. It’s their only long-term hope for survival.