Here’s an excellent post by our Of Counsel Ashley Franco:
As new technologies appear, so do laws that regulate them. Changes in technology usually outpace laws put in place to regulate them; as a result, there is usually a gap between the time the technology emerges and time a law is enacted to regulate it. Until recently, the increasingly popular e-cigarette went without regulation. On May 5, 2016, the U.S. Food and Drug Administration finalized a rule extending its authority to include e-cigarettes as part of the tobacco products it can regulate. The new rule, effective August 8, 2016, imposes disclosure requirements to companies selling and/or manufacturing the e-cigarettes and/or any of its affiliated products.
One major implication of the new rule is that e-cigarette manufacturers will have to undergo a premarket review in which they must disclose the ingredients in the e-liquids used in the e-cigarette. The FDA stated the new requirements are in the interest of the consumers who should have the opportunity to evaluate the potential risks associated with consuming the e-cigarette liquids, which usually contain nicotine derived from tobacco.
It comes as no surprise that the FDA has decided to regulate e-cigarettes, since there are obvious health risks associated with consuming tobacco products. Since the e-cigarette’s introduction, it has gone under the radar with little to no regulation. You will most likely find individuals smoking e-cigarettes in the non-smoking sections of restaurants and bars. It has become a way for smokers to get their nicotine fix in areas where the common cigarette is banned by regulation. That seems to be heading to an end with the new regulation because under the new rule the FDA will be able to evaluate the dangers of the e-cigarette.
Under the new rule’s premarket review requirement, the FDA will be able to evaluate the dangers of the e-cigarette. For example, tobacco smokers are prohibited from smoking regular cigarettes in certain areas because of the known health risks associated with second hand smoke. The effects of e-cigarette second hand smoke is not certain as of yet, but will be investigated as part of the new rule and will most likely have an affect on where e-cigarette smokers can enjoy their e-cigarettes.
Who should worry about the outcomes of the new rule? Small businesses should certainly start looking into the impact this new rule will have on them. The new disclosure requirements will most likely have a negative effect on small businesses that may not be able to cover the costs of the additional disclosure requirements. The premarket review requirement imposes a great costs to all businesses that sell and/or manufacturer e-cigarettes and affiliated products.
If you manufacture e-cigarettes the rule requires you to:
- Submit an application and obtain FDA authorization to market the e-cigarette
- Register establishment(s) an submit the product listing to FDA by December 31, 2016
- Submit a list of the ingredients associated with your e-cigarette and affiliated products
- Submit information on the harmful and potentially harmful constituents (HPHCs)
- Submit tobacco health documents
- Manufacture your tobacco product with the required warning statement on packaging and advertisements
- Market your tobacco product in compliance with the other applicable statutory requirements, rules and regulations.
If you sell e-cigarettes or their component parts that are made or derived from tobacco you are also subject to certain FDA requirements.
Complying with the law may be a long and complex process. We recommend you consult with a lawyer to help you understand and comply with the FDA regulations and policies.