DrMA inquired
Interesting... How did FDA determine the company sold products to underage persons? If this was a purchase orchestrated by FDA, wouldn't it constitute entrapment? Also, does a foreign entity (physical person or company) even possess 1st Amendment rights?
Back in the late 1980's and early 1990's, a group of concerned citizens (including me) began conducting what we called "compliance tests" to see how many retailers would sell cigarettes to minors (that we sent in to buy cigarettes, including some as young as 12 years old). We were shocked to find that 60%-80% of retailers tested in dozens of different cities and states sold cigarettes to the minors (without even asking for ID).
In 1991 we successfully urged US Congress to enact what became known as the "Synar Law", named after now deceased sponsor US Rep. Mike Synar, which required all states to conduct annual compliance checks on tobacco retailers, and required all states to sharply reduce the percentage of retailers who sell cigarettes to minors, or face loss of federal SAMHSA block grant funds.
We also urged many state and local health depts to conduct sting operations on tobacco retailers (which are the same as compliance tests except violators would get fines as well as their names published in newspapers). And the 1996 FDA tobacco regulations (that I assisted then FDA Deputy Commissioner Mitch Zeller develop) were subsequently struck down in 2000 by the SCOTUS) included sting operations on several thousand retailers (before 2000 when the SCOTUS shut them down).
Despite the 2000 SCOTUS ruling (which didn't even cite the FDA's sting operations), the courts have consistently upheld the legality of sting operations on tobacco retailers using undercover youth.
I don't know the answer to DrMA's last question (do companies abroad enjoy 1st Amendment rights of the US Constitution when marketing to customers in the US?). But I do know that all US based companies enjoy protections by the US Constitution. Perhaps that was why the FDA decided to send the letter to a foreign based company.
It would be interesting to see what would happen if the FDA sent a letter to Reynolds similarly claiming that all of Reynolds cigarettes and smokeless tobacco products are "misbranded" because Reynolds website similarly cites scientific evidence about THR at
Reynolds American Inc.
Reynolds American Inc.
Reynolds American Inc.
I suspect Reynolds' lawyers would respond to the FDA with the same or similar legal arguments that I posted on this thread.
The only difference between Reynolds' website and the snuff website FDA sent a letter to is that Reynolds' website doesn't sell tobacco products to customers.