A recent Food and Drug Administration Request for Proposal indicates that the agency is poised to more aggressively ensure that vape shops are satisfying their obligations under the Family Smoking Prevention and Tobacco Control Act. The FDA has asked for bids on a third-party contract to inspect vape shops and other companies that manufacture components of electronic nicotine delivery systems (ENDS). The agency is apparently prepared to spend $23 million over a five-year period for these services.
The inspectors will be tasked with a number of duties, including specifically ensuring that companies have not impermissibly introduced so-called “new tobacco products.” Under the Tobacco Control Act, companies generally are not permitted to introduce “new tobacco products” (defined as any product introduced after February 15, 2007 or changed in any way since then) without FDA permission. However, under the Deeming Regulations, ENDS were given limited relief, such that if the product was introduced by August 8, 2016 (the effective date of the regulations) the product could continue to be sold until 2022, provided that the manufacturer submits a request for FDA premarket authorization, pending FDA approval or rejection. The inspections apparently will focus on whether a manufacturer’s products were in fact introduced by August 8, 2016, and have not been changed in any way since then.
Manufacturers must be prepared to document that their products are not “new tobacco products”, and the burden of proof is on the manufacturer. There are a variety of ways to show that a product was on the market before August 8, 2016, including:
- Dated invoices
- Dated manufacturing records
- Dated promotional material
- Dated trade publications
- Dated advertisements
- Dated catalog pages
- Dated purchase orders
- Dated inventory lists
Most fundamentally, however, manufacturers and merchants must be prepared to demonstrate that a product is produced the same way, with the same ingredients and specifications, as the pre-August 2016 version of the product.
The inspectors also will be tasked with ensuring that establishments and products are properly registered, ingredient submissions have been made in accordance with FDA guidelines, and the products’ labeling accords with FDA regulations, including whether labels are “false or misleading” in any way. The inspectors also will evaluate whether manufacturers and other regulated parties are making impermissible “modified risk” claims without requisite FDA approval.