FDA's May 22, 2009 update to its Warning Letter webpage lists 9 such letters sent to internet distributors of unapproved new drugs masquerading as dietary supplements.  All of these products have one thing in common:  they claim to be able to cure or prevent the H1N1 virus ("swine flu").  FDA has correctly targeted these products and the companies that market them for serious enforcement action, as they represent the worst kind of fraud targeted at a frightened public. Significantly, FDA has given each of the recipients 48 hours to contact it and advise what corrective actions have been taken.  Normally companies are given 15 working days to respond to Warning Letters like these.

The one troubling aspect of the letters is that many are simply addressed to whatever contact information is provided on the relevant website.  One is simply addressed to www.healthychoicenaturals.com.  Another is addressed to email@perelandra-ltd.com. A third is addressed to viana800@aol.com. Addressing significant regulatory communications in this manner makes me wonder whether FDA is seriously trying to deliver these Warning Letters.  After all one of the companies in question lists a street address on its website, but FDA apparently chose to send an email to an address that may or may not work.  To the extent that no brick and mortar address is listed on any of these sites, it appears that FDA did not even attempt a “who is” search which would have revealed a street address for the one company that I did such a search for. 

All of this makes me wonder whether we will see some pronouncement from someone at FDA bemoaning the fact that the Agency is trying very hard to communicate with “dietary supplement” companies selling H1N1 cures, but the “irresponsible industry” just refuses to respond.