Another way FDA is cutting ecig companies slack: shelf life

E-cigarettes have finite shelf lives because they become more toxic over time while they sit on the shelf.  E-cigarettes are often contaminated with bacteria and fungus that grow while the e-cigarettes sit on the shelf. In addition, the chemicals in the e-liquid continue reacting with each other after they are mixed, growing more toxic over time.

That is why FDA appropriately considers the microbial and chemical stability of e-cigarettes when deciding whether or not to authorize the sale of particular products.  FDA specifically notes this consideration in its Marketing Granted Order notifying RJR that it can sell its Vuse Vibe and Vuse Ciro e-cigarettes:

It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data.

In a footnote, however, FDA reports that, in fact, RJR did not submit actual data to support this conclusion:

For [the Vuse Vibe and Vuse Ciro], you stated that the shelf life of the subject products is [redacted] but did not provide data that would allow FDA to evaluate whether the products are microbially stable over [redacted]. The data provided support microbial stability of the products over [redacted, but from context less time]. The stability data for is acceptable and there are no other stability concerns, so the lack of stability data for does not preclude an APPH [appropriate for the protection of public health] finding for the subject products.

The Marketing Granted Orders for RJR’s Vuse Solo (TPL; commentary) and NJOY (TPL, commentary) were also granted despite incomplete stability data. In contrast, FDA reports that JTI submitted acceptable data supporting 12 and 15 month stability for its  Logic (TPL; commentary) e-cigarettes

FDA’s treatment of product stability for RJR and NJOY products raises several questions:

  • Why did the FDA withhold how long RJR and NJOY claimed for the shelf life?  This is important information for consumers.
  • Why did FDA approve RJR and NJOY products despite the fact that RJR did not provide proof of product stability through the claimed shelf life?  (Collecting this information is not hard; all RJR and NJOY would have to do is let the products sit on the shelf longer before measuring them, as JTI did.)
  • If the lack of stability data “does not preclude an APPH finding,” why did FDA bother to consider it and why was this important enough to assess in the TPL?
  • Why didn’t FDA require an expiration date on all the e-cigarettes it authorized to inform consumers?

It also looks like the redactions are designed to hide FDA’s failure to apply its own standards rather than to protect any legitimate trade secrets.

These are more examples of FDA prioritizing tobacco company interests over transparency and public health.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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