Breaking News: The FDA Has Published the Deeming Rule
Today will go down as one of, if not the most significant days in the history of the vaping industry, as The Food and Drug Administration (FDA) has announced the highly anticipated deeming rule.
At Nicopure Labs, we are fully supportive of science-based and reasonable regulation of the vaping industry, and will continue taking the necessary steps in advancing the conversation.
What Does this Mean?
Essentially, the deeming rule declares that ALL electronic cigarettes and vaping products, including devices, cigars, hookahs, and other tobacco-derived nicotine or tobacco-containing products are to be regulated the same way as traditional cigarettes under the 2009 Tobacco Control Act.
Deeming Rule Summary:
“The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency’s “tobacco product” authorities in the FD&C Act to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of “covered tobacco products” to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.”
Although effective as of 90 days from its May 10, 2016 official publication in the Federal Register (August 8, 2016), look for additional compliance requirements to be met gradually over the next 24 months. The rule places very rigorous requirements on all manufacturers, and industry leaders will be called upon to contribute to prompt compliance as needed.
As an industry leading, premium e-liquid manufacturer, we have spent years preparing for the deeming rule and have always placed a strong emphasis on good manufacturing practices. Our American made e-liquid is carefully blended, using independently tested ingredients, in an ISO-rated cleanroom environment. We employ stringent quality control guidelines and our products are made under the direction of experienced lab technicians, flavorists, and chemists. We work hard to stay ahead of the regulatory environment. We are prepared and ready for this regulation.
As the news breaks today, the Cole-Bishop Amendment, which was approved by a 31-19 vote a few weeks ago, is moving through the house to appropriations legislation which calls for a “date change” to the predicate date.
Stay tuned for all the latest industry news and webinars by visiting www.halocigs.com
Click here for the complete summary of the FDA’s ruling.
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