House Bill 1432 authored by an Indiana Representative Kevin Mahan is turning heads. The Bill is looking to set a legal definition of an e-liquid, and require manufacturers of e-liquids to undergo rigorous standardization lest incurring civil or criminal penalties. Portions of the bill have passed and are slated to go into effect in July of this year. Hoosier Vapers, Inc., an Indiana based advocacy group, has filed a lawsuit with their county Superior Court. Their claim is that the bill has anti-competitive aspects, and seek to remedy that.
The bill (full write up here) would require the manufacturer to:
- Obtain a permit from the alcohol & tobacco commission prior to manufacture, distribution, or sale of e-liquids
- The purpose of the permit would require e-liquid manufacturers to:
o Limit ingredients used in manufacture
o Requires a “clean room” to prevent contamination in the facility
o Containers must have certain features such as child-proof caps, nicotine content labels, etc.
o All production steps during manufacturing (mixing, bottling, packaging) must take place in the designated “clean room”
o monitor facilities 24/7
o Manufacturers must take 3 milliliter samples from each batch over 2 liters
o Samples must be stored for at least 3 years
o Penalty for violations: fine up to $10,000 and suspension of their permit for up to 1 year
- The application for this permit must include:
o Plans for the manufacturing facility
o Security certification that the facility meets surveillance standards
o Application fee ($1000)
o Permits will last for 5 years
Currently, the industry has not been required to adhere to any regulations. The FDA sent its final rule to regulate the industry to the White House back in October 2015. Typically the review process runs 90 days, but can be lengthened or shortened based on the need for further discussion. There haven’t been any updates, and based off of an article from NPR, they are still discussing the regulations. Based on our past experience with FDA regulations in other industries, we expect the federal government is going to deem e-liquids as tobacco products and will regulate them as such by 2018.
These events are major and the community is outraged, but we’ve seen it unfold in the dietary supplement industry. Their regulations require material specifications, lot traceability, vendor qualification, quality controls, and batch records. InstantGMP provides solutions for manufacturers at every step, from Standard Operating Procedures to consulting and to compliance software. E-Liquid manufacturers should expect the same to happen to them.
We invite you to get in touch with us, we’ll help you through the compliance transition.