FDA Calls For Workshop on Electronic Cigarettes
The Food & Drug Administration (FDA) has called for a workshop to review electronic cigarettes and their relation to public health to be held in December of 2014. The workshop comes as many organizations and businesses are looking to the FDA for what to do next when it comes to electronic cigarettes and their regulation, or rather lack there of.
According to the FDA’s official release for the workshop, taking place December 10th and 11th in Maryland, the purpose is “to gather scientific information and stimulate discussion among scientists about electronic cigarettes.” This workshop is the first of a series of workshops from the FDA that are intended to obtain information on e-cigarettes and how they affect public health. The agency is calling for scientists, manufacturers, and health care professionals to present information they have compiled on e-cigarettes in order to provide the most current information to other researchers in the field.
The workshop will focus on five major aspects of electronic cigarettes: device design and design characteristics, e-liquid and aerosol constituents, device design and e-liquid and aerosol interactions, packaging and constituent labeling, and environmental impact. Presenters for the device design and characteristics portion of the workshop will focus on the potential risks associated with different devices characteristics, material hazards, and manipulations by the users. Researchers will also delve into product standards and long-term product evaluation.
Research on e-liquids will focus on the ingredients, including nicotine, their effects, and how they are measured and regulated by the manufacturer. Presenters will also focus on the reasons for preferring or avoiding a specific ingredient, for example, using propylene glycol vs. glycerin in e-liquid. Presenters will question these issues, as well as query about the stability of e-liquids, their shelf life and packaging procedures and restrictions. They will also talk about the relationship between the device and the liquid and present any data on potential risks.
Regulation is often presented to the public through a product’s packaging, and the workshop intends to discuss packaging for e-cigarettes and e-liquids as well. Finally, the workshop will focus on environmental impact. While many studies have already shown that our overall public health would be improved with the use of e-cigarettes that is not all that the FDA workshop is concerned with. Presenters will focus on the presence, if any, of hazardous waste, re-usability of the products and the intent the product has for disposal. Through the discussion of these five topics, the FDA hopes to encourage a community of information that can continue to exist and thrive as new information on electronic cigarettes becomes more available. While many organizations and manufacturers are still waiting on the FDA for some direction in the world of e-cigarettes, the FDA is quick to point out this workshop is not intended to be a factor in the agency’s rule-making procedures.
The question for the FDA on whether they choose to regulate or not does not lie in the actual information being presented at the workshop. The FDA already has a proposed rule, as of April 25th, 2014, to add e-cigarettes to the list of products covered in the Federal Food, Drug & Cosmetic Act (FD&C Act). All comments regarding the proposed rule were to be submitted to the agency by August 8, 2014, therefore studies and information presented at the workshop will not affect that proposed rule. If the rule is finalized as reviewed, e-cigarettes that are tobacco products would be subject to FDA regulation under the FD&C Act.
The FDA’s decision to host this workshop is in response to the increased prevalence of e–cigarettes use. They have stated that there is much to be learned about these relatively new products on the market. These workshops are intended to better inform the FDA about these products, should the agency move forward with regulation of e-cigarettes. The FDA says additional information about the products would assist the agency in carrying out its responsibilities under the law to regulate products for consumer consumption.
The focus of this first workshop is primarily based on the science of the product, but the FDA states that future workshops will focus on individual health and overall population health. While regulation seems imminent, it is encouraging to know that the FDA is taking the proper steps to become informed on the truth of e-cigarettes, rather than just buying into the propaganda that is presented by either side of the e-cigarette debate. The best thing for the e-cigarette community, for both proponents and opponents of the devices, is to keep knowledgeable and truthful information out there and hopefully workshops like this one will do just that.