Many American e-cigarette companies are bracing for the FDA to release new regulations in 2014. While the FDA has been hesitant to make a move so far, rumors abound that this will be the year when e-cigarettes face new stringent guidelines. Some companies are taking a proactive approach by giving their manufacturing processes an overhaul just to insure they can keep business going when the FDA gets involved. This week, Bloog made a huge stride by releasing the first ever pharmaceutical grade e-liquid in the United States. The new “Viquid” is manufactured from start to finish in a FDA-registered facility that is also certified by the DEA to handle controlled substances.
Bloog is creating the new e-liquids with only American ingredients that undergo strenuous quality checks for purity and stability. By sending manufacturing processes to the pharmaceutical facility, they have insured that these new e-liquids meet United States Pharmacopoeia (USP) standards and adhere to good manufacturing process (cGMP) as defined by medication regulations. This is the type of rigorous testing that is required by the FDA and as such, there are 140 countries following USP practices.
On a practical level, this means that the e-liquid is manufactured in a series of very detailed steps. First, the nicotine is formulated and tested for purity. Then each individual ingredients undergoes quality checks as well. Finally, the ingredients are combined into an e-liquid and assigned a drug master file, which is turned over the FDA for record keeping.
Working in a pharmaceutical lab is a huge step for Bloog in manufacturing high quality e-liquids, but it also means the FDA will have a closer look at their processes. All FDA-approved facilities are routinely inspected so Bloog is ultimately submitting to the FDA’s standards before they ever officially exist. The chosen facility is also DEA-approved to handle Schedule II-V drugs, so there is a great deal of regulatory work and screening in place on a daily basis.
After the new e-liquids are mixed, they are assigned a certificate of analysis (COA) with a full list of ingredients, a batch number and grade, the release date, and an expiration date. They e-liquids will have a shelf life of two-years, which is much longer than the usual average of six months. Bloog has chosen to follow the FDA’s standards for packaging as well. The liquids are finalized with a double-sealed package and child resistant caps.
The new “Viquid” is a courageous move on behalf of Bloog, proving that this company is willing to do what it takes to make it for the long haul regardless of how the FDA acts in the future. This is a bold maneuver that could lead to more companies changing manufacturing practices in order to compete in the e-liquid marketplace. Do you think Bloog made a wise decision by moving e-liquid manufacturing to a pharmaceutical facility?