Friday, December 12, 2014

Are E-cigarettes safe? Notes from the FDA December Workshop

I love technology. I was able to attend a two day conference held by the FDA in Washington DC without leaving home. The entire event was available live-stream. The only downside was it started at 8am east coast time and I live on the west coast, so I was getting up early.

This conference was a public workshop about E-cigarettes. Presenters included researchers from around the country, including a few delivered by representatives from the tobacco companies. There was a lot of science discussed and while I'm not a scientist, I could follow most of the discussion.

I'm not going to go into all the details and information that was presented but here are the highlights that I gleamed from this workshop:

  • Everything presented at this workshop is already out dated. E-cigarette technology is expanding so fast that it is almost impossible to keep up with the advancements. 

  • The evolution of e-cigarettes may hold great promise to curb the tide of death and disease from traditional smoking. However, because of the lack of product standardization, manufacturing  and product standards, there is the potential for a great deal of harm.

  • Studies regarding impurities, contaminants and toxicants vary greatly in outcomes because there are over 450 manufacturers of e-cigarettes and many different variations in product type. Levels of most toxicants are significantly lower that those in traditional cigarettes but the range is very wide depending on the manufacturer. There is a concern that high amounts of harmful chemicals are created with higher voltage batteries.

  • Every study is limited to what product is used. For the e-liquid there are over 7000 flavors with approximately 200 new flavors being introduced each month. 

  • Manufacturing standards are needed. Products in the marketplace currently vary greatly in chemical composition and quality of product. Counterfeit and sub-par products are widely available. Some manufacturers have established some good manufacturing and product standards.
  • Some of the concerns are: leaching of metals from the atomizer/cartomizer because of poor quality materials. Some chemicals in the flavors which are considered to be safe for ingestion, are hazardous when inhaled. GRAS (generally recognized as safe) is a designation issued for food products only and any claim that flavors are FDA approved as GRAS is false and misleading. The FDA does not issue approval for food flavors but letters of "no objections". Poor quality batteries can over heat and/or explode. E-liquids made by unscrupulous manufacturers substitute preservatives which are poisonous. Some flavors are toxic. 
As far as how e-cigarettes will be regulated in the future is anyones guess but it is clear that to protect the public that manufacturing and product standards need to be established. Products need proper labeling as to exact contents. E-liquids need to be in child resistance containers, with a limited amount of nicotine available (less than a lethal dose) and a flow restrictor in the lid. Had these last regulations been in place, the death of a young child in New York a few days ago, may have been avoided. 

No comments: