Our hearts go out to all of those suffering from the effects of the coronavirus pandemic. During these unprecedented times, we offer our wishes for your, and your families, good health and well-being.
OUR COVID19 RESPONSE
We do want our customers to know how we have, and are continuing to adhere to the highest possible standards of cleanliness in our packaging and shipping operations. Being a small business with a relatively small staff, we have been able to implement additional safety precautions extremely quickly and effectively.
As many of our customers might already know, we produce all of our e-liquids in AEMSA-Certified clean rooms. This means we adhere to a strict set of standards for cleanliness, handling, and packaging for all of our products. Liquids never come into contact with employee hands or skin, and all employees are required to wear face masks, hairnets, and gloves at all times. Additionally, we have added a strict set of guidelines for employees in packaging and shipping to further reduce any contact with our products.
Due to the COVID-19 pandemic, the United States District Court has granted the FDA’s request for a PMTA deadline extension. E-liquid manufacturers were originally required to submit a Pre-Market Tobacco Application to the FDA by May 12, 2020. At the urging of many companies requesting an extension to the burdensome application process, the FDA submitted a request to the courts to extend the deadline by 120 days. On April 3, 2020 Judge Paul Grimm of the United States District Court in Maryland approved the request. Companies will now have until September 9, 2020 to submit their applications.
Many of us in the industry have criticized the PMTA process altogether, citing it as a ploy by big tobacco (and their lobbying efforts) to push small e-liquid companies out of business. In short, the application requires extremely expensive testing and reporting on a company’s products. One of the most controversial components is a human health study requirement that is only possible with large sums of money and high-end lab equipment. It’s been estimated per the FDA’s own Deeming Rule that each sku that a company wishes to file an application for could cost between $28,000 and $2,500,000.
Despite the controversial aspects of the PMTA process, we appreciate the FDA – and the courts’ decision to extend the deadline. Additional time will undoubtedly allow more small businesses like ourselves to take part in the process and submit timely applications. We hope to stay in business for many more years, provided a much needed organic option for the vaping community.