FDA ENDS Regulations Extension

FDA Announces Extension for Their Ends Regulations

What is ENDS

Electronic Nicotine Delivery Systems, also known as ENDS, are taking the world by storm. From vaporizers to E-Cigarettes and all other form of cigarette alternatives, ENDS have been raising questions and concerns regarding the safety and health ramifications. With a new announcement of FDA regulation, ENDS will be facing a new rules in the face of changing laws.

ENDS: The Good and the Bad

Currently 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 have liquid that contains nicotine, in addition to different compositions of flavors, glycerin, propylene glycol and other similar ingredients. The liquid will then be heated as an aerosol that the user will inhale. The ENDS of today are made to look like typical cigars, pipes and cigarettes. Others look like pens or any similar everyday object. There are ENDS that are created as mods or tank systems as well.

ENDS are gaining the majority of their popularity amongst students in middle and high school. In fact, over 3 million students are current users of ENDS like e-cigarettes. That makes e-cigarettes the most popular tobacco among teenagers and young adults for second year in a row.

The FDA finalized a new rule in 2016 regarding ENDS. The FDA extended their regulatory authority to include vaporizers, hookah pens, vape pens, electronic cigarettes, e-pipes and any other ENDS. The FDA will now 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 through the CDER or Center for Drug Evaluation and Research, by the FDA. The FDA proposed a rule recently to clarify the FDA’s jurisdiction covering drugs, devices and tobacco products.

All components of ENDS are also regulated by the FDA. This includes the software and materials that are integral to the product’s characteristics, performance, composition of constituents. Other parts and components of ENDS include the plastic or glass container for the e-liquid, atomizers, cartridges, batteries, clearomizers, cartomizers, drip tips, tank systems, flavorings as well as programmable software.

Creating and Selling ENDS

For businesses that manufacture, mix, modify, make, assemble, label, fabricate, relabel, import or process ENDS, the products need to comply with and all requirements of the FDA for ENDS manufacturers. The CTP Office for Small Business Assistance will answer any specific questions that business owners may have for compliance with all rules and regulations of ENDS.

Nicotine Warning Statement

Starting in 2018, advertisements and product packages for newly regulated tobacco products have to have the standard warning for all products containing nicotine. This includes stating that the product contains nicotine as well as bearing the warning statement that nicotine is addictive.

The manufacturer of the tobacco product can submit a statement of self certification to the FDA, stating that their product has no nicotine in it, along with sufficient data to back the statement. In this case, 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 of ENDS and similar products by the FDA, a full list can be found in the “Deeming Tobacco Products…” Act. Through the FDA website, manufacturers can also find more information guidance, regulations and more.

Mixing Manufacturing E-Liquids and Modifying Products

An business and vape shop that sell mixes, modified or prepared liquid nicotine that have e-liquid or any other modified ENDS will be considered to be a manufacturer. Businesses that are considered manufacturers in this manner have legal responsibilities for retailers and manufacturers of tobacco products. These business owners should review all drafts of regulation regarding compliance with labels and the requirements of certain federal drug, food and cosmetic acts.

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 that is in the district of where the product is intended to be imported.

Product Violations and Reporting Negative Experiences

For those that have experienced unexpected safety or health issues with any tobacco product, a report can be filed with he FDA. This knowledge about negative or adverse experiences will help the FDA to identify safety or health issues that are not normally connected with the use of ENDS. Additionally, 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

Ultimately, these guidelines serve as a way to help prevent the abuse of ENDS and tobacco products , specifically in regards to children and teenagers. The regulations focus on addiction and nicotine as the primary impetus for the FDA’s regulation efforts. While working to regulate existing tobacco products, the new guidelines also work to encourage the development of new products like ENDS that promote the use of products that are significantly less harmful than tobacco heavy products like cigarettes.

The use of tobacco is still one of the leading causes of death and disease in the U.S. Over 480,000 adults and young people die from tobacco addiction every year. Lost productivity and health care adds to the losses that result in almost $300 billion lost each year. In order to try to circumvent the large monetary and human toll caused by tobacco products, the FDA hopes to bring a better awareness to the consequences of nicotine.

With FDA’s regulations, the goal is to promote a better understanding and awareness of the particular tobacco products that are the most addictive and the most harmful. Additionally, with the regulation of ENDS and similar products, the FDA is working to encourage a healthier alternative to cigarettes and the like.

 

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death