Good morning Girls and Boys
If the following has already been discussed please humor me. From where I sit and that's IMHO, I see a lot of discussion about the two year period starting on 8-8-16 where IDENTICAL vaping stuff can still be sold and of course compliance with the other terms of this calendar at
FDA Deeming Regulation Compliance Calendar prepared by VTA (Vapor Technology Association)..pdf for a 2 year sell timeline. After a bit of research from available data I think the 2 year issue is far more complex and fraught with serious doses of danger. Let me explain:
12-31-16 - Register with the FDA. Includes Product Listings. Annually. Not yet available for ENDS but from medical device a ball park cost is 2K+
2/8/17 - Ingredient listings
Given the above two deadlines I asked myself, what if a given Tobacco Manufacterer decides not to comply with the above two dates. Maybe they have the money but see no need for submission since they have no desire or means to acquire a PMTA. Maybe they hate the FDA and plan to ignore these two dates. BUT still plan to comply with all of the other terms for a two year can sell period.
Here comes the FDA! Nothing yet posted on ENDS that I could find BUT the following applies to Medical Devices which is reasonable to expect for ENDS:
"(c) Failure to submit required information. Failure to submit any of the required information on time, as specified in paragraphs (a) and (b) of this section, will put the establishment in a "failed to register" or "failed to list" status as applicable. The establishment will not be considered active and the establishment registration and device listing information may not appear on the FDA Web site until such time as the owner or operator submits and FDA processes the required information." Source:
CFR - Code of Federal Regulations Title 21
So exactly what is the regulatory enforcement action for "failed to register" or "failed to list" status:
"2.OTHER LEGAL SANCTIONS
If issuance of the *Warning* Letter does not achieve correction, one of the following legal actions should be recommended to *CVM,* Division of Compliance, HFV-236 within one week after the response period expires:
Seizure
When failure to register *and/or drug list* is the only actionable violation and a firm fails to comply with the *Warning* Letter,
seizure of all products whose manufacture necessitates registration and/or in the non-registered firm's possession, is the recommended action. Applicable raw materials may be included to bring a small lot up to seizable size. Do not recommend seizure of lots otherwise believed to be in compliance in the possession of consignees. *An inventory* of the drugs manufactured, repacked, or relabeled should be submitted with the regulatory action request
Source:
CPG Sec. 625.500 Failure to Register *and/or Drug List*
Stay Strong! Fight! Stock Up!