FDA ENDS Regulations Extension

FDA Announces Extension for Their Ends Regulations

What are the FDA ENDS regulations

Electronic Nicotine Delivery Systems, known as ENDS, are taking the world by storm. From vaporizers to E-Cigarettes plus all other forms of cigarette alternatives(this includes e juice), ENDS have been raising questions and concerns regarding the safety and health ramifications. With a new announcement about the FDA ENDS regulations, ENDS will be facing new rules in the face of changing laws.

FDA ENDS Regulations: The Good and the Bad

There are eight recognized electronic nicotine delivery systems. These include hookah pens, vaporizers, vape pens, electronic cigarettes, and e-pipes. Each of these various products has liquid that contains nicotine, flavoring, glycerin, propylene glycol and other similar ingredients. The user heats the liquid just enough, that it produces vapor to inhale. The ENDS of today are made to look like typical cigars, pipes, and cigarettes. Others look like pens or any similar everyday object. These regulations now apply to mods and tank systems as well.

ENDS are gaining the majority of their popularity among children. Over 3 million students are currently using of vaping products. That makes e-cigarettes the most popular tobacco among teenagers and young adults for the second year in a row.

Adding More Products to The List

The FDA finalized a new rule in 2016 regarding ENDS. They extended their regulatory authority to include vaporizers, hookah pens, vape pens, electronic cigarettes, e-pipes and any other ENDS. Now they will regulate the import, manufacturing, labeling, packaging, promotion, advertising, distribution and sale of ENDS.

The products that have been marketed for specific therapeutic purposes, including products that are expected to help people end their smoking addiction, will be regulated by the CDER or Center for Drug Evaluation and Research, by the FDA.

The FDA will regulate all components; this includes the software and materials that are integral to the product’s characteristics, performance, and composition. Other parts and elements of ENDS include the containers, atomizers, cartomizers, vape coils, tanks, and more…

Creating and Selling ENDS

For businesses that manufacture, or process ENDS products need to comply with and all requirements of the FDA. The CTP Office for Small Business Assistance will answer any questions that businesses may have about the regulations.

Nicotine Warning Statement

Starting in 2018, advertisements and product packages for regulated tobacco products will need a warning label. This warning statement includes stating that the product contains nicotine.  The warning statement needs to state that nicotine is addictive.

The manufacturer of tobacco products can submit a statement of self-certification to the FDA. This statement should state that their product has no nicotine in it, along with sufficient data to back the statement. The manufacturer can print a statement that asserts the product is made from tobacco. For businesses that are interested in a complete breakdown of the rules and regulations and full list can check this out. Through the FDA website, manufacturers can find more information guidance, regulations and more.

Mixing Manufacturing E-Liquids and Modifying Products

A vape shop that sells or mixes e-liquid or any other modified ENDS will be considered to be a manufacturer. Companies that are considered manufacturers in this manner have legal responsibilities for retailers and manufacturers of tobacco products. Business owners should review all regulations regarding compliance with labels and the requirements.

Importing ENDS and Similar Products

The importation of tobacco products into the country has to comply with any and all of the rules and regulations set forth by the FD&C Act. For any specific questions regarding importing tobacco products, businesses should contact the FDA.

Product Violations and Reporting Negative Experiences

Anyone that has experienced unexpected safety or health issues with tobacco products, can file a report with the FDA. The FDA will use these reports to help understand these issues. If you or any business owner knows of ENDS being sold to a minor or any other violation of FD&C Act is witnessed, the violation should be reported to the FDA. The reports of adverse experiences that have already been voluntarily submitted can be reviewed as well.

Protection Against ENDS Abuse

These guidelines serve as a way to help prevent the abuse of ENDS and tobacco products.  The regulations focus on addiction and nicotine as the primary impetus for the FDA’s regulation efforts. The new guidelines will work to encourage the development of new products.

The use of tobacco is one of the leading causes of death and disease in the U.S. Over 480,000 adults, and young people die from smoking every year. Lost productivity and health care add to the losses that result in almost $300 billion lost each year. To circumvent the negative impact caused by tobacco, the FDA hopes to bring better awareness to the consequences of nicotine.

The goal is to promote a better understanding and awareness of tobacco products that are addictive and harmful. With the regulation of ENDS products, the FDA is working to encourage a healthier alternative to cigarettes.

What are your thoughts about the FDA ENDS Regulations?

We’d love to get your thought and opinions about the extension and how it will affect things down the road. Don’t be afraid to use the comments section below to voice your opinion.

Thank you, and keep vaping.

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