On, Tuesday, June 11th, 2019, the FDA issued a final guidance document entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” The guidance was published less than a month after a federal judge ordered the Agency to speed up its review of vaping products and provides Sponsors with recommendations regarding the submission of premarket tobacco product applications (PMTAs) for e-cigarette products.
Furthermore, on July 12, 2019, District Judge Paul Grimm of the U.S. District Court for the District of Maryland ruled that the deadline for manufacturers to submit PMTAs for ENDS products will be May 12, 2020.
On June 22, 2009, the Tobacco Control Act was signed into law, amending the Federal Food, Drug, & Cosmetics (FD&C) Act to grant FDA with authority over tobacco products. At the time, this included all cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco and “any other products that the Secretary of Health and Human Services by regulation deems to be subject to this matter.”
In May 2016, FDA published a final deeming rule to extend FDA’s authority to all products that meet the statutory definition of a “tobacco product.” Specifically, the rule extended FDA’s authority to all electronic nicotine delivery systems (ENDS), which comprises the components and parts of ENDS products (whether sold as a unit or separately), including a variety of products such as vape pens or personal vaporizers, cigalikes, e-pens, e-hookahs, e-cigars, e-pipes, e-liquids, atomizers, batteries, cartomizers (atomizer plus replaceable fluid-filled cartridge), digital display/lights to adjust settings, clearomizers (refillable e-liquid cartridges with built-in atomizer and wicking system), tank systems, flavors, and programmable software. With the 2016 deeming rule, these products became subject to the same premarket review requirements and adulteration and misbranding provisions as all other tobacco products.
FDA Recommendations Regarding PMTAs for ENDS
On May 5, 2016, the FDA issued a draft guidance to assist Sponsors in improving the efficiency of application submission and review for PMTAs for ENDS products. Last month, the Agency finalized this guidance, which consists of recommendations that are “substantially similar to those set forth in the draft guidance.” As such, the FDA states that “if you have taken measures consistent with the draft guidance, they will generally be consistent with the recommendations herein.”
The document contains a number of definitions including the term new tobacco product, which it states “is defined in section 910(a)(1) of the FD&C Act as:
- any tobacco product (including those products in test markets) that was not commercially marketed in the U.S. as of February 15, 2007; or
- 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 U.S. after February 5, 2007.”
Under section 910 of the FD&C Act, individuals seeking to market a new tobacco product are required to submit a PMTA to the FDA to obtain a marketing authorization order, unless the Agency “has issued an order that the new tobacco product is substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, or the new tobacco product is exempt from demonstrating substantial equivalence pursuant to the reasons outlined in section 905(j)(3) of the FD&C Act.”
The guidance document also includes definitions for accessory, additive, component or part, covered tobacco product, e-cigarette, e-liquid, finished tobacco product, and tobacco product.
Among other things, the guidance document touches on the following:
- “Products to which this guidance applies
- When a PMTA is required under the statute and regulations
- General procedures for review of an ENDS PMTA
- What information the FD&C Act requires you to submit in a PMTA
- What information FDA recommends you submit in an ENDS PMTA to show that permitting your new tobacco product to be marketed would be appropriate for the protection of the public health (APPH).”
FDA notes that the guidance document applies to all components and parts of ENDS products (as listed above), but not their related accessories. For additional details or more information, view the full guidance document.
ProPharma Group Can Help with your PMTA Submissions
Do you manufacture or are you in the process of developing an ENDS product? Navigating these new regulatory requirements can be confusing and stressful, but that is why we are here to help. ProPharma Group has a track record of successful interactions with the FDA and we can help you throughout the regulatory process.
Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.
We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.
Interested in gaining an industry edge? Let us help you stay up to date.
Gain an Industry Edge With Expertise From ProPharma Group
Get the latest insights and top tips from our experts, delivered right to your inbox.
Have a complex challenge?