You may have noticed some changes to Mt Baker Vapor in the last couple of months. It is no coincidence that the FDA Deeming Regulations went into effect in this timeframe. Mt Baker Vapor has had to adjust our services to comply with the FDA. Here is our official statement on automation and solar panels.
When it comes to Federal Regulation, you do not want to take any chances. The cost of violating FDA regulations is devastating. Mt Baker Vapor is putting its best foot forward to be compliant with the FDA, while fighting a legal battle against the FDA via the Right 2 Be Smoke-Free Coalition. In the interest of FDA compliance, we have made changes to our manufacturing, flavor options, and customer incentives.
The Cost of Business:
In the past years, Mt Baker Vapor e liquid was hand-mixed, within minutes of the order being processed. This enabled us to make almost unlimited combinations of e liquids at your command. Unfortunately, this was not a sustainable practice for the era of regulation. Each combination of flavor, blend, flavor shots, and bottle size would be subject to premarket tobacco application (PMTA), with each application costing somewhere between $300,000 and 3,000,000 each.
For each individual product, in each combination, a PMTA would be filed. In the old Mt Baker Vapor manufacturing method, thousands upon thousands of products would be scrutinized, each costing hundreds of thousands of dollars. As you can imagine, a five-year-old business like Mt Baker Vapor does not have 8 billion dollars to dedicate to our original business model. We made a decisive pivot to feature our best-selling e liquids, with fewer options, with the PMTAs in mind.
Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, states,
“Companies must apply to the FDA first, and then the FDA uses a rigorous scientific review to determine if new tobacco products should come to market under this pathway. Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected… As other manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law.”
By Mr. Zeller’s statement, it is clear the vape industry has an uphill battle ahead. Vape manufactures must do everything in their power to ensure quality, consistency, and safety.
Mt Baker Vapor switched from the classic white-label, hand-mixed manufacturing to Blue Bottle E Liquid, which uses automated machinery to manufacture e liquid with surgical precision. Automated production of e liquid also means we can batch our e liquids, which allows us to pre-steep e liquid.
The FDA directly mandates certain regulations to our company, while others are peripheral. Direct regulations include the huge warning label on our bottles that read, “WARNING: THIS PRODUCT CONTAINS NICOTINE. NICOTINE IS AN ADDICTIVE CHEMICAL.” No sales to minors, age verification, child-proof bottles, and a prohibition on “freebies” and giveaways are all clear restrictions in the FDA’s language.
Though not specifically mandated, many of the changes to Mt Baker Vapor have been made in anticipation of FDA regulation. 236 mL bottles have been discontinued with FDA assessment in mind, since consistency is compromised with larger bottle sizes. Flavor shots, DIY options, BYOJ, and some flavors have been discontinued to reduce the number of product permutations that will be subject to PMTAs.
Mt Baker Vapor understands that cutting options for the customer can be upsetting. Keep in mind that these changes were made in the interest of compliance and keeping our doors open for the long haul.
Mt Baker Vapor has installed solar panels on our headquarters in Mesa, Arizona, to reduce our environmental impact, and to set a precedent for the future of the vaping industry.
Since the installation of our solar panels, Mt Baker Vapor has produced 63,651 kilowatt hours of energy, which is the environmental equivalent of 104,010 passenger car miles driven, 31,676 gallons of water used by a coal-powered plant, and planting 1,120 trees. Nearly year-round sunshine in Arizona, the mind reels to imagine how much solar energy will be produced in the coming years!