PMTA - SPRK Vapors

PMTA Submission

Overview of PMTAs

A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers, among other things:

Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available;
The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.

Products Affected

Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007.
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.
Any tobacco product that was commercially marketed after February 15, 2007, must comply with the premarket review requirements of the Food and Drug Administration (FDA). This means manufacturers must submit an application to the FDA and receive authorization before marketing these products. The application should demonstrate that the new or modified tobacco product is appropriate for the protection of public health.

PMTA Review Process

Deficiency Letter

If the application lacks necessary information, the FDA issues a deficiency letter requesting additional data or clarification from the manufacturer.

Post-Market Reporting

Manufacturers must comply with post-market reporting requirements, including submitting annual reports and any new information about the product’s health effects.

Filing Review

The FDA performs a more detailed review to determine if the application contains sufficient data for a substantive scientific evaluation.

Substantive Review

The FDA thoroughly evaluates the scientific data in the PMTA, including studies on the product’s health impacts and potential benefits and risks to the public.

Marketing Order

If the FDA determines that the product is appropriate for the protection of public health, it issues a marketing order allowing the product to be legally marketed.

Our PMTA Commitment

To achieve world leadership status in presenting tobacco users with a desirable alternative to combustible cigarettes, we are fully committed to the current PMTA process and are confident in the content and quality of the materials we submitted with our application by Sep 2020.

On February 24th, 2021, SPRK had received an FDA acceptance letter regarding the PMTA applications for our Electronic Cigarettes and E-Liquids. According to US cooperative agents, the FDA has provided positive comments on the SPRK products application. In the near future, SPRK anticipates being able to provide US customers with viable products. The range of products will provide customers with a strategic step-down program, which we believe will enable smokers and vapers alike to more easily eliminate their habitual use, or alternatively minimize nicotine consumption.

FDA – SPRK VAPE, INC PMTA ACCEPTANCE

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SPRK is committed to preventing illegal sales to minors which involves a 21+ Age Verification process upon checkout, and an adult (21+) signature confirmation upon delivery for ALL SPRK sales.California Proposition 65 Warning: This product can expose you to chemicals and nicotine which is known to the State of California to cause cancer, birth defects or other reproductive harm. For more information please see www.p65warnings.ca.gov SPRK name, logo, and tag lines are trademarks of SPRK Vape, U.S. and International Patents Pending

NOT FOR SALE TO MINORS: This product may be hazardous to health and is intended for use by adult smokers. Keep out of reach of children or pets. SPRK products with nicotine e-liquid are not suitable for use by: persons under the age of 21, pregnant or breastfeeding women, or persons who are sensitive or allergic to nicotine, and should be used with caution by persons with or at a risk of an unstable heart condition or high blood pressure.

WARNING: This product contains nicotine. Nicotine is an addictive chemical.