FDA fines Johnson & Johnson subsidiary $1.6 Billion for marketing "misbranded" drug, same could occur for e-cigs if Deeming Reg is imposed

[Bill Godshall]

The FDA has fined Johnson & Johnson subsidiary Janssen Pharmaceuticals, Inc. more than $1.6 billion for marketing a "misbranded" drug
FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal

If the FDA imposes the deeming and other regs on e-cigs, >99% of e-cig products now on market will likely be labelled as "misbranded" tobacco products, with manufacturers facing somewhat similar prosecutorial actions by FDA and Justice Dept as J&J just received.

Please note that any tobacco product (including any e-cig product, if the deeming reg is imposed) FDA doesn't officially approve (by approving a Substantially Equivalent or New tobacco Product application) will be considered "misbranded" by the Tobacco Control Act, and FDA will issue a cease and desist letter to the manufacturer/importer.

 

[Petrodus]

I'm sure the FDA will target distributor's labeling of e-liquids.
Easy target for them and the FDA will feel they are bullet-proof
from lawsuits.

 

[Pickleskunk]

"The FDA maintains that physicians may, within the practice of medicine, use a drug to treat patients for symptoms or diseases even when the drug is not FDA-approved for such uses. However, if a pharmaceutical manufacturer intends its drug to be used for a new use, not approved by the FDA, and introduces the drug into interstate commerce for that use, the drug is misbranded, and introduction of that misbranded drug into interstate commerce is a violation of the law."
I'm starting to think this is going to turn into massive litigation. On the bright side, it may put regulations on court-ordered holds for a long time, until some things get sorted out.

 

[Myk]

If the FDA imposes the deeming and other regs on e-cigs, >99% of e-cig products now on market will likely be labelled as "misbranded" tobacco products, with manufacturers facing somewhat similar prosecutorial actions by FDA and Justice Dept as J&J just received.

Not the same thing as J&J misbranding. There are already rules in place against that.

Ex post facto - Definition and More from the Free Merriam-Webster Dictionary

Article I, Section 9 of the United States Constitution
"No Bill of Attainder or ex post facto Law shall be passed."

 

[Bill Godshall]

Myk wrote:

Not the same thing as J&J misbranding. There are already rules in place against that.

Just as the FDCA bans manufacturers from selling "misbranded" drugs, it also bans tobacco manufacturers from selling "misbranded" tobacco products. If FDA passes the deeming regulation to apply Chapter IX regulations to e-cigs, all e-cigs would become "misbranded" until/unless they are first approved by the FDA.