Not just E-liquid - It's Viquid™
8 steps for an E-Liquid to Become a Viquid
Most eCig liquids are either made in China with substandard ingredients and little or no testing, or in cottage industries here in the US by people with minimal or no experience in pharmaceutical production. In fact, the media has crushed the e-cigarette industry, stating that no one knows what is in the E-Liquid they are vaping....until now.
Viquid™ is the first liquid that is manufactured in a Pharmaceutical facility located in the United States. The facility is FDA-registered and DEA-certified. Viquid™ is made with only US-sourced ingredients that have achieved USP (United States Pharmacopoeia) designation and manufactured using cGMP (Current Good Manufacturing Process), processes.
For an ordinary e-liquid to be designated as a Viquid™, eight strict standards must be met. If just one of the eight criteria is not met, it cannot be called a Viquid™.
1) Manufactured in a United States Pharmaceutical Facility
that is FDA-Registered and DEA-Certified
This is the foundation needed for the best e-liquid. Because Pharmaceutical facilities based in the USA have such stringent testing, quality, consistency, safety, and purity are ensured.
2) Use USA-sourced ingredients that have achieved US Pharmacopeia (USP) designation where possible*
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
USP standards are developed and revised by more than 900 volunteer experts, including international participants, who work with USP under strict conflict-of-interest rules.. Since its founding in 1820, USP has helped secure the quality of the American drug supply. Building on that legacy, USP today works with scientists, practitioners, and regulators of many nations to help protect public health worldwide.
*Note that there are no Manufacturers of pure Nicotine in the United States, so it is impossible to have Nicotine sourced in the US at this time. Our Nicotine is sourced from India. All other ingredients are US-Sourced. Our hope is that we will soon have a US-based manufacturer of Nicotine when one becomes available.
3) Manufactured in a Pharmaceutical facility that abides by current Good Manufacturing Processes (cGMP)
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls helps to prevent instances of contamination, mix-ups, deviations, failures, and errors.
4)Have official Certificates of Analysis (COA) from an FDA-Registered and DEA-Approved Pharmaceutical Facility
A Certificate of Analysis, or COA, is issued for each batch of liquids produced. Information on a typical COA includes, its grade, the batch number, the date of release, and the liquid’s expiration date. The Certificates will be dated and signed by authorized personnel and show the manufacturer information.
The key piece of information on the Certificate of Analysis is the list of ingredients. The e-cigarette industry has come under fire in recent months. The media has blasted the industry for not disclosing, (in many cases because of lack of knowledge), what is in e-liquids. By having an e-liquid produced in a US Pharmaceutical facility, COA’s are credible because they are from the most reliable source.
Under the Bioterrorism Act of 2002, manufacturing facilities must register with the FDA. These plants are inspected by the FDA on a cyclical basis to determine compliance. This ensures that the manufacturing facilities are constantly maintained at the highest levels.
DEA Approved means that the facility is registered with the DEA and is approved to handle Schedule II - V controlled substances.
5) Liquid must pass all FDA Pharmaceutical Stability Tests
A Stability Test is a documented, ongoing program that monitors the stability characteristics of the e-liquid. The results confirm the appropriate storage conditions and expiration dates for the e-liquid. The samples are stored and tested in the same containers that are sold to the consumers. At least one batch per year should be added annually to the stability monitoring program and tested to confirm the stability. By undergoing the stability tests, you are assured that Viquid™ will always be the same purity, consistency,and flavor that you expect.
6) Liquids must have a minimum shelf life of 2 years
Why is this so important? Most e-liquids have a shelf life of 6-months to a year. Some have even less than that. This means they are volatile and subject to changes in such things as their consistency, flavor, and vapor production. By having a 2-year shelf life, Viquid™ sets the standard in this category and provides you with the ultimate consistency, flavor, and vapor production.
7) All labeling and packaging must abide by FDA Pharmaceutical Compliance Standards
As part of their compliance and regulatory standards, the Pharmaceutical Facility must abide by all FDA Pharmaceutical Compliance Standards in order to maintain their status. This ensures the safety of consumers.
8) Packaging must be double-sealed with child-resistant caps and boxed in tamper-evident boxes
One of our goals is to not only ensure that you enjoy your Viquid™, but that children and pets are kept safe. That is why we insist on taking the extra steps providing child resistant caps on the Viquid™ bottles and putting them in a tamper evident box. The opaque bottles used also ensure the stability of the liquid.
A benefit to doing all of this is that your Viquid™ will remain protected from the sunlight, which oxidizes the Nicotine in the liquid over time. Also, the plastic will not absorb into the ingredients, changing the properties of the liquid, also known as leaching.
As you can see, the standards are pretty high. But with the impending FDA regulation, we anticipate these standards to be the baseline of e-Liquid regulation. It will certainly be interesting to see what happens.
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