The FDA recently proposed rules on e-cigarettes, deeming them tobacco products, and asked for public comments within the next 75 days. Up to the release of this document, the regulation of e-cigarettes and other forms of nicotine containing products was ambiguous and not well defined. Now the FDA wants to regulate e-cigarettes just like tobacco cigarettes. They will use the term “deem” to make this happen as in e-cigarettes would be “deemed” to be subject to tobacco regulations.
Currently, regulated tobacco products must meet certain review and labeling restrictions and the proposed e-cigarette regulations would be similar to current tobacco product guidelines:
- Manufacturers will register with the FDA and report product and ingredient listings.
- New tobacco products could only be marketed after FDA review.
- Direct and implied claims of reduced risk could only be made if the FDA confirms that scientific evidence and that the product will benefit public health.
- Free samples cannot be distributed.
- There will be minimum age and identification restrictions to prevent sales to underage youth.
- Health warnings will be imposed.
- Vending machine sales will be prohibited expect in a facility that never admits youth.
The FDA has a track record of publishing draft rules and then taking years to collect and evaluate comments. For example, the Dietary Supplement Health and Education Act was put into law in 1994 to regulate the production and sale of dietary supplements. It took 16 years before the entire dietary supplement industry was held accountable to that law. While the new tobacco regulations are an important step in setting standards for a newly emerging industry, it may be many years before all e-cigarette manufacturers must comply with the new requirements.
Even after the regulations go into effect, there will not be any significant effort to control quality in manufacturing the e-liquids that go into e-cigarettes. There are private organizations that are trying to fill this gap in assuring consistency and quality in e-cigarette and e-liquid manufacturing. Organizations such as AEMSA (American E-Liquid Manufacturing Standards Association) are establishing manufacturing standards for their membership will have more impact than the FDA’s proposed new rule. Quality has to be built in through good manufacturing practices. We applaud this effort and will work to help all manufacturers establish manufacturing systems that use the best of good manufacturing practices in their operations.