Manufacturers & Laboratories
Section 1: Organization Quality Standard
- All manufacturers agree to be ISO 9001:2015 certified by end of year 2018
- All manufacturers to be compliant with GMP within 12 months of standards being published by the FDA
- All internal and external analytical labs to be ISO17025 certified by end of year 2017
Section 2: Design Standards
Devices and Batteries
- Preferred that devices are designed for non-removal batteries only by end-of-year 2017.
- If design calls for removable batteries, then additional protective housing or reinforcement must be used or provided at time to sale to prevent damage or short.
- All devices to incorporate the "Core-4" battery safety features:
- Chip/fuse on devices at charging port to prevent surges
- PCB feature to detect short/surges
- Protective fuse feature for overheating
- Chip on battery to detect surges and prevent energy flow
- Limits of 200 watts on all devices by 2019.
- All manufacturers agree to use battery that is UL Certified and/or IEC Certified by 2018.
- Devices will incorporate a minimum of one safety locking function(s), such as “five click” to lock, etc. by 2017 to mitigate false-firing.
- Tanks will be of a child proof design by 2018.
- Devices will include individualized serial numbers that link to manufacturing quality records
- Devices will include traceability / anti-counterfeiting feature(s) (verification system to ensure authenticity and compliance).
Section 3: Youth Access Prevention
- Advertising and Promotional restrictions based on those in place for US Tobacco Products to ensure that no vaping products are marketed to those below 18 years of age.
Section 4: Incident Reporting
- All members to carry minimum liability insurance of $1 million.
- Organization will setup and operate a consolidated adverse event reporting channel for consumers.
- Collaborate with FDA on Voluntary Withdrawal Process for all products that FDA deems as potential safety hazards.
- Agreement to phase out manufacturing of non-compliant designs by end of 2018, and retailers agree to stop selling residual inventory of non-compliant product by end of 2019.
- The Organization will setup a protocol and system to facilitate voluntary withdrawals by its members by end of 2018.
Section 1: Organization Registration
- All retailers agree to register with FDA and other regulatory authorities as such registration requirement become applicable.
Section 2: Vendor Selections
- All retailers agree to only carry products that are approved by FDA PMTA process, or alternatively, are produced according to the guideline established by GVSA by EOY 2019.
Section 3: Youth Access Prevention
- All retailers agree to the advertising and promotional restrictions to ensure that no vaping products are marketed to those below 18 years of age.
- No nicotine containing materials are to be sold in vending machines.
- All brick and mortar as well as web retailers to implement a robust age verification process to ensure minimum age of 18 for any vaping product sales and/or sampling.
- No free samples will be given out, regardless of age.
- No vaping products will be sold in vending machines.
- Incident Reporting System
- The GVSA will setup and operate a consolidated adverse event reporting channel for consumers.
- The GVSA will collaborate with FDA and CPSC on a Voluntary Withdrawal Process for all products that FDA or CPSC deems as potential safety hazards.
- An Association program will be setup by 2019 to provide for member audits to ensure continued compliance with the agreed Standards.