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You are Here: Home >> News >> Industry News >> NicoPure Sues FDA Over Deeming Regulations
NicoPure Sues FDA Over Deeming Regulations

The first lawsuit against the deeming regulations the FDA will be putting into place has been filed, and it is NicoPure that is leading the way.

NicoPure Labs LLC is an American manufacturer of e-liquids that was established in 2009 and is a founding member of the Vapor Trade Association. They filed their lawsuit in the federal district court in Washington, D.C., alleging that the FDA’s move to regulating the vaping industry under the 2009 Smoking Prevention and Tobacco Control Act is unconstitutional.

The ruling to allow FDA jurisdiction over the vaping industry was handed down last Thursday, and it is being reported by The Hill that vape companies like NicoPure see the rule-making process as a violation both the First Amendment and the Administrative Procedure Act. This act is the federal statute that dictates the process in which administrative agencies, like the FDA, can propose and establish regulations that fall within their realm of expertise.

“We are committed to responsible manufacturing based on superior product standards and stringent quality requirements. FDA’s rule does not protect the consumer from low-quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies such as ourselves, who are determined to drive the industry to the highest standards of quality and innovation,” said Jason del Giudice, the CTO and co-founder of NicoPure, said in a statement released earlier this week.

Most of the provisions of the coming regulations are welcome by the vaping industry. This includes health warnings on product pages, ingredient lists for e-juices, and the prohibiting the sale of vape products to anyone under the age of 18, which is already standard practice in the industry.

But there is one rule that has the entire industry worried, and is the main reason that NicoPure filed its lawsuit. The FDA has a rule that stipulates that any vape product that was sold after February 15, 2007, must go through a costly approval process that takes up to two years for review and can cost upwards of $2 million.

Because the vape industry wasn’t fully formed until around 2009, this means that all the products currently on the market will have to undergo this process, including new products that will be introduced from this point on. This causes a problem for vape companies, as most are small businesses that cannot afford multi-product review process — and the FDA requires each individual product be reviewed separately — and will subsequently be put out of business.

NicoPure’s lawsuit against the FDA is thought to be one of many companies considering possible legal action. Fortem Ventures hasn’t ruled out the possibility of a lawsuit, but many are sitting tight to see what the outcome of the NicoPure lawsuit might be. We will keep you updated with more information on how this affects you as a vaper as this story develops.