I am a California business attorney and my firm specializes in assisting small businesses with their legal needs. Frequently, my e-cigarette and vape merchant clients tell me of the pains they have figuring out how to get and/or stay compliant with the seemingly yearly changes in the laws regulating their products. Their frustration is completely understandable as the information they need is often scattered throughout multiple sources.
Therefore, I have decided to write some articles to assist e-cigarette and vape retailers and/or manufacturers to more easily navigate the complex and ever-evolving rules and regulations of their industry. This article provides information specifically regarding the U.S. Food and Drug Administration (FDA). I hope it is of use.
If you have any questions about the following information, or have any other business needs, please do not hesitate to contact me.
Electronic Nicotine Delivery Systems (ENDS)
As of 2016, the FDA, through the Center for Tobacco Products, regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS1. Including components and parts but not accessories.
Components include “software or an assembly of materials intended or reasonably expected to alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or to be used with or for the human consumption of a tobacco product.”
In English that means, for example:
- A glass or plastic vial container of e-liquid;
- Certain batteries;
- Cartomizers and clearomizers;
- Digital display or lights to adjust settings;
- Tank systems;
- Drip tips;
- Flavorings for ENDS; and
- Programmable software etc.
You are considered a retailer if you sell ENDS and/or their components or parts. If the FDA classifies you as a retailer, you must satisfy the following requirements:
- Check photo ID of everyone under age 27 who attempts to purchase e-cigarettes and other ENDS;
- Only sell e-cigarettes and other ENDS to customers age 18 or older;
- Cannot sell e-cigarettes and other ENDS in a vending machine or self-service display unless in an adult-only facility;
- Cannot give away free samples of e-cigarettes and other ENDS, including any of their components or parts;
- Beginning on May 10, 2018, additional laws come into effect for example:
- Cannot sell of distribute e-cigarettes or other ENDS without a health warning statement on the package;
- Cannot display advertisements for e-cigarettes and other ENDS without a health warning statement etc.
You are considered a manufacturer if you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, re-label, or import any, ENDS and/or their components or parts. *Keep in mind you can be both a retailer and manufacturer.* If the FDA classifies you as a manufacturer, you must satisfy the following requirements:
- Report user fee information;
- Pay user fees;
- Register your establishment and submit list of products, including labeling and advertisements;
- Submit tobacco health documents;
- Submit ingredient listing;
- Apply to market your tobacco product via one of three pathways;
- Substantial Equivalent (SE); SE Exemption; or Premarket Tobacco Product Application (PMTA)
- Include required warning statements on packages and advertisements;
- Submit warning plans for smokeless tobacco and warning plans for cigars
- Submit quantities of harmful and potentially harmful constituents;
- Submit a modified risk tobacco product application if you would like to market your product as having reduced risk or harm.
As you can see, there are numerous regulations just to become compliant with the FDA, and the above is not an exhaustive list. Additionally, be sure to seek guidance in satisfying the requirements of your local state government agencies, which may vary by jurisdiction. If you are in need of a secure e-commerce payment gateway, contact our friends at Tasker Payment Gateways and they can get you set up!
Disclaimer: The information above is for informational purposes only and should not be construed as legal advice. It is not privileged and does not create any attorney-client relationship.
1 If your product is marketed for therapeutic purposes (eg. to help people quit smoking) then it is regulated through the Center of Drug Evaluation and Research (CDER), which has different rules. Please click here for more information.
This post originally appeared at http://taskerpaymentgateways.com/vape-regulations-am-i-complaint