Will the New FDA Rules Affect Vapo Devices? NO!

Posted on January 03 2020

Will the New FDA Rules Affect Vapo Devices?  NO!

From everything we heard from the FDA and also reading the Definitions of the new rules as you can see below the vapo would not be affected.

 

New FDA Rules Definitions

For purposes of this guidance, FDA intends to use the following definitions: 

Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system. (20) See below 

Electronic nicotine delivery systems (or ENDS) include devices, components, and/or parts that deliver aerosolized e-liquid when inhaled. For example, FDA considers vapes or vape pens, personal vaporizers, e-cigarettes, cigalikes, e-pens, e-hookahs, e-cigars, and e-pipes to be ENDS. 

E-liquids are a type of ENDS product and generally refer to liquid nicotine and nicotine containing e-liquids (i.e., liquid nicotine combined with colorings, flavorings, and/or other ingredients). Liquids that do not contain nicotine or other material made or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control authorities. 

Label means a display of written, printed, or graphic matter upon the immediate container of any article. Section 201(k) of the FD&C Act. 

Labeling means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. Section 201(m) of the FD&C Act. 

New tobacco product means (1) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (2) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. Section 910(a) of the FD&C Act. 

Tobacco product means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). The term “tobacco product” does not mean an article that under the FD&C Act is a drug (section 201(g)(1) (21 U.S.C 321(g)(1))), a device (section 201(h)), or a combination product (section 503(g) (21 U.S.C 353(g))). Section 201(rr) of the FD&C Act.

 

(20) An example of products that would not be captured by this definition include completely self-contained, disposable products.

Here is the new rule in case you wanted to read it:

Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization

 

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