“restricted flow requirement” states that an opened bottle, when inverted and squeezed continuously for five seconds by a five-year-old child, must dispense no more than two milliliters of e-liquid
New compliance standard for container’s with nicotine may be imposed causing all
those glass bottles and many others to be non-compliant then recalled or destroyed.
The FDA Deeming Rule prohibits manufacturers from changing the packaging of a product (except labels) introduced before Aug. 8, 2016. Any alteration to the product — including new bottles — would make a deemed product non-compliant and subject to the requirement for an approved premarket tobacco application before it can be legally sold.
a PMTA could cost over $1 million, and there is no guarantee it will be accepted and approved by the FDA. That’s why not a single application has yet been submitted for any vaping product, nearly three years after the Deeming Rule was finalized.
E-liquid sellers could be caught in a terrible Catch-22: comply with one federal rule and be out of compliance with another. If both agencies enforce their rules, the entire independent industry could be flattened - vaping360