Joining Attorney General Miller in signing the letter were Professor David Abrams (New York University), Scott Ballin (Health Policy Consultant), Clive Bates (Counterfactual), Professor Michael Cummings (Medical University of South Carolina), Dr Konstantinos Farsalinos, Dr Thomas Glynn (Stanford University), Ethan Nadelmann (Drug Policy Alliance), Dr Raymond Niaura (New York University), Steven Schroeder (University of California San Francisco), David Sweanor (University of Ottawa), Dr Kenneth Warner (University of Michigan), Dr Daniel Wikler and Mary Saltonstall (Harvard T.H. Chan School of Public Health).

The signatories were shocked by coverage on Bloomberg’s news service that claimed vaping could compound health problems relating to the COVID-19 outbreak. Moreover, they were disheartened that the FDA’s contribution to the coverage was limited solely to an email reply. It left a headline that “continues to portray vaping as an additional risk factor for COVID-19 health impacts.”

Addressing Zeller, Stephen Hahn (FDA), Anna Abram (FDA), Matthew Holman (FDA), David Murray (National Institutes of Health), Helen Meissner (National Institutes of Health), and Nora Volkow (National Institute on Drug Abuse), the letter raised three points:

Process

“There are around 12 million vapers and 34 million smokers in the United States. If they are to receive information with life or death consequences, especially at this time of greatly enhanced personal pressures, they deserve better than an ad hoc email from an FDA spokesman sent to a single online news service. If the federal government is going to provide advice, it should be available via FDA and CDC websites, validated for its veracity and clarity, tested for unintended consequences, and made widely available through recognized and trusted health professionals.”

Evidence

“It is likely that many older adult vapers will have underlying conditions that increase their vulnerability and likelihood of severe or fatal COVID-19 symptoms. This is because many are former or current smokers and will have accumulated damage to their cardiovascular and respiratory systems through many years of smoking. Many will be vaping with the express purpose of reducing their smoking-related risks and/or relieving their symptoms. It is therefore particularly important that great care is taken with advice to this group. On what basis is FDA confident that it is right to discourage people with underlying smoking-related conditions from vaping at this time, given the likely alternative for many is a return to smoking? Where is the evidence-based reasoning that advising adult smokers against vaping is appropriate for the protection of public health at any time, but especially during this COVID-19 crisis? We know of no relevant and informative evidence on vaping and COVD-19 and the evidence on smoking and COVID-19 is inconclusive and contradictory.”

Advice

“If FDA is going to provide advice on smoking and vaping at this time, it must do this based on recognition of the pronounced difference in risk between smoking and vaping, the difficulty that many face in quitting nicotine use completely, the risks of harmful unintended consequences, and the strong association of smoking with poverty and various forms of disadvantage. Harm reduction is a valid concept and its potential is well-established. We do not believe the FDA has any basis for making recommendations about smoking and vaping that are specific to COVID-19 at this time. At this point, therefore, we believe that advice to smokers should be consistent with the longstanding public health imperative to quit smoking using whatever methods work, and that includes by switching to vaping or other low-risk non-combustible nicotine products.”

The authors conclude: “It is important that the FDA does not assert or imply, in any circumstances, an equivalence in risk between smoking and vaping.”

“We are also concerned that FDA statements have effects outside the United States and around the world, which is another reason for taking great care. If the FDA is able to provide candid and clear advice that puts the health of millions of Americans first, and this is based on sound behavioural and biomedical insights, then it should do so, and we would welcome the agency’s contribution.”

“If, however, its communications are arbitrary and ill-conceived, spreading fear and confusion with little scientific basis and with unpredictable consequences, then it would be better if FDA and its media spokespeople did not comment further at this time.”