Dear Mr. pdib:
We have received reliable information that you intend to sell this and similar products to consumers in the United States. This is to notify you that under current statutes and FDA regulations, it will soon be unlawful to sell any tobacco products in this country which have not been approved by this agency. Until and unless you have submitted a Pre-Market tobacco Application ("PMTA") and such application has been approved, this or similar devices are prohibited, effective August 8, 2018.
Furthermore, if you have any intention of marketing or selling these products after August 9, 2016, you must register with this agency as a tobacco product manufacturing establishment and submit a detailed list of your products. In addition, you must take measures to assure that you do not sell any of these products to persons under the age of 18. This may include requiring presentation of a government issued photo ID, such as a U.S. Passport or state issued driver's license. We will notify you as and when we impose additional onerous restrictions.
We are compelled by law to also inform you that all unauthorized sales and shipments of this or similar products will subject you to stringent fines and penalties, as well as possible seizure of the offending product(s) as contraband, and an injunction against any future manufacture, sale and/or shipment of such devices.
Although we understand and can sympathize with your stated position that the sale of these devices is an important source of personal income and support for your family, a source of personal satisfaction, and represents a significant investment in fabrication equipment, it is our legal responsibility, as a regulatory agency charged and empowered by Congress, to protect the cheeldrun from the dangers of addiction to tobacco products. We believe that the cheeldrun will be particularly attracted to devices such as those made by you, given their interesting wood patterns, shiny surfaces, and extremely low cost.
Accordingly, we would urge you to submit a PMTA for each product and variation thereof as soon as possible so that these devices may be legally marketed and sold (this will require a separate submission for each variety of wood and/or other variations in the materials used in the manufacture of these products). Alternatively, we suggest that you find a different line of work.
Should you elect the former path and wish to continue marketing and selling these products, we suggest you contact Dr. Stanton Glantz at UCSF, who can supply you with names of and contact information for attorneys specializing in regulatory compliance, chemists, biochemists, epidemiologists, pollsters, and a variety of other stunningly expensive specialists who can assist you with preparation of your PMTA.
Alternatively, we will be happy to put you in touch with a representative of the Small Business Information who can provide guidance and advice on training and educational opportunities leading to new career paths.
Thank you in advance for your immediate attention to this matter. Should you have any questions about the dire situation you are in, please do not hesitate to contact me personally or any member of my vast staff.
Sincerely yours,
Mitch Zeller
FDA Anti-tobacco Czar
