The FDA looks ready to begin enforcing the most restrictive of the existing regulations written into its Deeming Rule: the ban on innovation of products after the grandfather date.
Most vapers know the date by heart: Aug. 8, 2016.
That’s the date after which no new vapor product can come to market without first successfully going through one of the three pathways the agency offers: substantial equivalence (SE), premarket tobacco application (PMTA), or modified risk tobacco product (MRTP). Getting approval to market new products through those routes is probably impossible for the vast majority of independent vaping companies.
The prohibition on new products includes any changes to existing products — even minor changes. Inconsequential modifications like firmware upgrades or minor alterations to e-liquid recipes count as violations of the marketing prohibition.
Until now, the FDA has apparently decided not to enforce the rule against selling new products after that date. But that may be about to change.
The FDA has asked for bids on a contract to provide “Vape Inspection” services. The agency is prepared to spend $23 million over a five-year period to verify compliance, and has published a detailed list of items inspectors will be searching for.
The contract specifies inspections of manufacturers (which also includes any vape shop that makes e-liquid on site), but the Tobacco Control Act allows gives the FDA authority to inspect all “establishments engaged in the retail sale of FDA-regulated tobacco products.” That could include any vape shop or online seller.
One of the tasks inspectors will have is checking to see if “Establishment is potentially in violation of Section 910 of the FD&C Act, which prohibits introducing or delivering for introduction into interstate commerce any ‘new tobacco product’ without an order from FDA authorizing the marketing of the product.”
Responsibility for proving that products were available before the Aug. 8, 2016 cutoff belongs to manufacturers and wholesale/importers, but non-compliant products could be seized from retailers. The FDA could even confiscate shipments to individuals from China or other countries after mail inspections.
The news about the FDA call for inspection bids was first reported by ECigIntelligence. The vape market analysts say there is evidence that some non-compliant products are being sold currently.
“There appears to be some disconnect between product authorisation and product availability,” said ECigIntelligence managing director Tim Phillips in an email to subscribers. “It could be that manufacturers and importers are gambling on non-enforcement or even a rollback of the FDA regulations governing e-cigarettes,” he added.
There are a variety of ways manufacturers can prove a product was “commercially marketed” before the Aug. 8 grandfather date. According to an FDA guidance document, these are some examples:
- 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
Many vape manufacturers documented technical compliance with the rules by selling products once before the Aug. 8 cutoff, then immediately removing them from the market.
The inspectors will be gathering other information during visits to vape businesses too, including searching for products with “ false or misleading labeling.” The FDA contractors will also be taking photographs of any evidence discovered during inspections.
A complete list of tasks that will be completed during inspections is provided in a document linked in the call for bids:
- Complete and present to the establishment an original, properly executed, and signed Form FDA 482 (Notice of Inspection). The Contractor shall retain a copy of the signed Form FDA 482 for submission to FDA.
- Complete an inspectional form provided by FDA. An inspectional form shall contain at least fifteen questions pertaining to the following categories of information:
- Administrative information about the establishment, potentially including but not limited to the following information: name, address, city, state, size of establishment, hours of operation.
- Inspectional questions related to all applicable provisions of the Food, Drug and Cosmetic Act, including but not limited to: Sections 903(a)(1), 903(a)(7)(A), 910, and 911 of the FD&C Act, potentially including but not limited to the following topics:
- Establishment is a retailer, manufacturer, or both.
- Products the establishment manufactures.
- Establishment imports or exports regulated tobacco products.
- Establishment is potentially in violation of Sections 903(a)(1) or 903(a)(7)(A) of the FD&C Act, which prohibit false or misleading labeling and advertising for regulated tobacco products.
- Establishment is potentially in violation of Section 910 of the FD&C Act, which prohibits introducing or delivering for introduction into interstate commerce any “new tobacco product” without an order from FDA authorizing the marketing of the product.
- Establishment is potentially in violation of Section 911 of the FD&C Act, which prohibits introducing or delivering for introduction into interstate commerce any “modified risk tobacco product” without an FDA order in effect.
The Contractor shall observe, review, request, or otherwise obtain access to all information necessary to complete the inspectional form and provide FDA with all information requested therein.
FDA may generate multiple versions of the inspectional form, but all versions shall conform to the parameters of this section.
- Take photographs of evidence pertaining to the information requested in the inspectional form. The Contractor may be required to photograph evidence including but not limited to documents, written procedures, brochures, products, signage, advertising, and labeling. All photographs must be clear, any inspector’s writing in the photograph must be legible (if applicable), and the photograph must fully capture the required information.
The FDA plan to crack down on non-compliant manufacturers could cause chaos in the vaping retail sector. And although it wouldn’t be as damaging to businesses as the imminent FDA war on e-liquid flavors, it would create enough uncertainty about the future that many small businesses might reconsider their plans.