PMTA - VITRO

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WARNING: This product is intended to be used with nicotine containing e-liquids. Nicotine is an addictive chemical. Do NOT use with nicotine salt e-liquids. Only use with FDA-authorized e-liquids with nicotine (≤12 mg/ml).

PMTA Overview

A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration (FDA) before new or currently marketed tobacco products can be legally marketed and sold in the United States. Electronic Nicotine Delivery Systems (ENDS) are subject to the PMTA requirements according to Federal Food, Drug, and Cosmetic Act (FD&C Act) section 910(a). Through a comprehensive science and evidence-based approach, PMTA shall demonstrate that the new tobacco product to be marketed would be appropriate for the protection of the public health (APPH). The following key components must be included in a PMTA submission:

Full Reports of Investigations of Health Risks

Full Statement of All Components, Ingredients, Additives, and Properties, and of the Principle or Principles of Operation of the New Tobacco Product

Full Description of Methods of Manufacturing and Processing

Compliance with Tobacco Product Standards

Samples and Components

Proposed Labeling

Our commitment to PMTA

We have a team with experts from various fields including regulations, toxicology, chemistry, clinical research. We are now working with FDA-accredited global testing laboratories and the world's leading CROs to ensure full compliance with PMTA regulations. We’re committed to be responsible for our customers, distributors, and the community.

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The sale of tobacco products to minors is prohibited by law.
Warning:
This product contains nicotine. Nicotine is an addictive chemical.
California Proposition 65 Warning:
This product contains chemicals known to the state of California to cause cancer and birth defects or other reproductive harm.