JUUL LABS’ COMMITMENT TO HIGH MANUFACTURING AND QUALITY STANDARDS

Company News

August 23, 2019

At JUUL Labs product quality and safety are of paramount importance. As part of our commitment to improve the lives of adult smokers by eliminating cigarettes, we maintain robust quality controls and manufacturing standards. Our Regulatory and Quality executive leaders have decades of experience and they leverage their expertise to measure, manage and continuously improve JUUL Labs’ quality system. We are committed to meeting exacting quality standards for our products. 

E-Liquid: Subject to High Product Quality Standards

We fill the e-liquid for all JUULpods in the United States. While our products are regulated in the United States as “tobacco products,” for which good manufacturing practice (GMP) requirements have not yet been established, our e-liquid production facilities are certified against international manufacturing standards (ISO 9001). We also perform chemical testing and chemical release on every lot of e-liquid.

In addition to enforcing stringent manufacturing controls, we conduct extensive preclinical and toxicological testing of the ingredients and analytes in JUUL e-liquids and aerosols, including testing for harmful and potentially harmful constituents (HPHCs). Our testing is conducted through reputable, independent third-party laboratories and we provide the results of these tests to regulatory bodies.

JUUL is a closed system vapor product, designed to prevent someone from altering the product, including by refilling the cartridge with other substances (which would be an open system). We do not sell any products that contain THC, which is a Schedule 1 controlled substance. 

Device and Pod Manufacturing:  Rigorous Design Standards, Supplier Audits, and Extensive Product Testing

Both our devices and our manufacturing facilities are subject to numerous quality and certification standards. JUUL products are manufactured in China, Hungary, Mexico, and several locations in the United States. We require our global device manufacturing plants to have quality systems compliant with international medical device standards (ISO 13485), as verified by third-party auditors.

Additionally, all JUUL products have received a CE Mark, meaning they meet the health, safety, and environmental protection standards of the European market (a designation that is recognized worldwide). Our devices and JUULpods are inspected before leaving our manufacturing facilities, undergoing rigorous testing in a wide variety of scenarios, and are specifically designed with multiple protections, while charging and in use.

We conduct reliability tests to simulate the effects of stress under actual use over time, and also involve routine hardware tests for reliability and safety in real-world scenarios, such as impact and drop testing. Additionally, our contracts with suppliers contain stringent quality requirements and we regularly audit them to ensure compliance. 

Battery Safety: Exacting Product Specifications and Rigorous Testing

Battery safety begins with the product specifications, so that the battery itself, its current requirements, and the circuitry design it works within, are designed with fail-safes to make it very unlikely that safety issues could ever occur. Our captive batteries cannot be removed or altered by the consumer and have limited charging capacity, which mitigates the risks associated with a removable battery. JUUL device batteries also store a fraction of the energy of common open-system vaporizers.

We test for reliability and operational consistency in both individual battery packs and at the system level — at each stage of the design process — including impact and drop testing as well as forced failure, all according to international safety standards. We put the actual batteries and finished devices through rigorous testing to confirm our specifications are met.

Industry-wide Regulation: Protecting Adult Smokers and Combating Underage Use

JUUL Labs strongly supports industry-wide regulation to establish uniform quality control and manufacturing standards for all vapor products.  We believe the standards we have voluntarily implemented are industry-leading and are critical to pursuing our mission to improve the lives of adult smokers by eliminating cigarettes.

We also strongly support regulations aimed at combating underage use of all vapor products and we support FDA’s draft guidance modifying its compliance policy for certain deemed products, including vapor, to address this. Youth use of vapor products remains an urgent issue, and JUUL Labs shares public concerns over the reported increase in use among youth, which is why we have initiated meaningful measures to limit access and appeal of JUUL products to minors.

Any reports of incidents involving underage use of vapor products reaffirm the need to keep all tobacco products out of the hands of youth through significant regulation on access and enforcement. We must also ensure illegal products, such as counterfeit, copycat, and those that deliver controlled substances, stay out of the market. These products, often marketed in violation of FDA laws, regulations, and policies, represent a pressing public health threat: they may be made with unknown ingredients and under unknown manufacturing and quality standards.

Moreover, these products are marketed in overtly youth-appealing flavors and packaging and often sold online with little to no age verification. JUUL Labs is aggressively enforcing our intellectual property rights against manufacturers of counterfeit and pod-compatible vapor products who flood the market with unauthorized and unregulated items.