January 30th, 2010 — Regulations: FDA etc.
I had the privilege of starting the FDA registration process recently for a tobacco client and thought it worth sharing my experiences.
All the information on what needs to be done including a check list is available on the FDA website. This is helpful; at least there’s a template to work from.
What’s missing is exactly how to do it. There’s a lot of detail and you must pay particular attention to the sequence.
The tricky part is obtaining the personal digital certificate. If you don’t have (much / any) experience with digital certificates and signatures this part will turn you for a loop. Nothing (with FDA) can be done without it!
On the FDA website there is a list of digital signature providers and links to their websites. One is free – all the others want money and in some cases quite a bit.
Assuming the correspondence for letters of non-repudiation has also been sent – and is correct, you wil receive a reply from FDA. You can then start setting up your (WebTrader) test account. Essentially you are verifying the communication link – to FDA – and exchanging parts of the digital certificates with FDA which allows your data to be identified as uniquely yours and FDA to receive encrypted secure data.
So far so good.
After this you receive further notifications from FDA and then make a second test submission. If this all goes well…………….you can set up a Production Account.
Remember up until now no data has been exchanged. More on this later.
If you haven’t started the process I encourage you to get going – the registration deadline is February 28 and there are other deadlines looming in April and June.
Enjoy.
January 4th, 2010 — Current Issues, Regulations: FDA etc.
Liggett group’s general counsel sent a letter to FDA protesting the nomination process representing small tobacco businesses.
FDA has previously made clear that only small manufacturers could vote / nominate a representative to their category. Liggett contends this was not intended in the legislation and they should have some say under a broader definition of a small manufacturer.
Any view and opinions?
December 21st, 2009 — Current Issues, Regulations: FDA etc.
Well if your year was anything like mine – 2009 raced by and it’s now Christmas again and the East coast is blanketed in snow!
We hope you had a good 2009 but wish you a better 2010. Have a great Christmas too and thanks for all your contributions, comments and visits. These are all appreciated.
For the Tobacco Industry a lot happened in 2009. We are still living with the changed lanscape but be sure it’s different now.
In the US tax increases (Federal and many States) were instrumental in making our business smaller / faster. Ironically the State tax increases were mostly driven by a desperate need to plug budget short falls. High taxes in Canada continued to encourage the development of a thriving contraband business from native reservations adjacent to the Provinces of Ontario and Quebec.
Much the same applies to the cigarette business in Paraguay into Brazil.
After years of speculation this administration passed FDA regulation of Tobacco. This fundamentally changes the US tobacco landscape permanently and irrevocably.
Our industy is smaller but continues to adjust to meet business challenges.
Finally we should not forget our customers. Thank-you.
Consider this: As smokers – there are around 60 million of you in the US – enough to make a loud noise if you choose to about smoking restrictions and many other issues affecting the daily lives of smokers.
We offer this forum to voice your concerns.
Merry Christmas
December 15th, 2009 — Current Issues, Fire Safe Compliant cigarettes / Low Ignition Propensity, Regulations: FDA etc.
In an attempt to prevent fires from unattended lit cigarettes various governments are requiring FSC cigarettes. 49 of the 50 US States require it or have already passed legislation that will. Lone stand-out is Wyoming (population 10) but this is only a matter of time. Canada required it several years go, Australia and South Africa will soon and the EU.
Look through this blog and you will see many complaints about the taste of FSC cigarettes. It would be interesting to know what Brands?
Many consumers dislike the taste and believe something noxious has been added to deter smokers- not true.
What has changed is the burn characteristics of the cigarette and when you do this the taste changes.
As FSC regulations come on board many Manufacturers are 100% migrating to FSC product to avoid shipping the wrong product into a FSC State and avoid the heavy fines associated with this error.
So what’s your experience? Tell us what Brands you’re smoking and if they taste good or bad??
Feedback welcome.
December 10th, 2009 — Conferences, Exhibitions, Key International Business & Market Developments
Even before it opened TabInfo Asia 2009, held in Bangkok Thailand November 11-13, had problems which only became worse.
Originally arranged as a private Tobacco Industry event, the Thai government declared it public shortly before opening. This meant all Thai tobacco restrictions on advertising and tobacco product display (which are stringent) were effective – something the organizers (Tobacco Reporter and Think Event Marketing) thought had been covered.
Caught wrong-footed the organizers rushed to issue statements to exhibitors advising the new restrictions and the penalties for violators. With this back-drop it became unviable to show any tobacco products or advertising without risking fines and / or imprisonment - something not too many exhibitors were willing to risk.
Under goverment pressure the Thai Tobacco Monopoly converted their mega show-case anchor stand into a Welcome to Thailand Center.
Demonstrators gathered outside the site to protest on the first day – kept at bay by last-minute security personnel.
Total attendance was less than 1,000 visitors over three days leaving plenty of time to renew acquaintances with tobacco colleagues and fellow exhibitors from around the world. Opportunities to develop contacts and conduct business evaporated -leaving dismay and cost.
Post exhibition; the original decision to hold a show in Thailand looked flawed. The exhibition hall at the Impact Centre (sic) was a considerable distance from the centre of Bangkok requiring a commute of 40 minutes each way – assuming traffic cooperated (which it didn’t.) Predictably exhibitors were upset – raising the broader issue of the number of Tobacco exhibitions in close proximity between Tobacco Reporter (TR), World Tobacco (WT) and Tobacco Intenational (TI.)
To illustrate; in 2010 Tobacco International (TI) holds its annual show in Krakow Poland April 15-17. WT plans its show in Hyderabad India April 21/21, TR a networking forum (gtnf) in Bangalore in October – followed by WT Asia in Jakarta October 27-29. 2011 sees a WT show in Munich November 8-10 then TR Prague November 15-18. WT plans another show in Jakarta in November 2012.
The industry can’t keep up. The Tobacco Industry cost structure has changed and the show organizers show no sign of acknowledging this fundamental shift. The signs are all around. Big tobacco withdrew its participation about 10 years ago, followed by the larger machinery suppliers. Shows have shrunk and so has attendance.
The show organizers need to reconsider their events as there is mounting evidence it is unsustainable.
Feel free to add your comments and suggestions…………………………
October 16th, 2009 — Current Issues, Regulations: FDA etc.
In a new twist the FDA appears to have included vendors / materials of any component / raw materials to the cigarette or its packaging.
Previously it was thought only cigarette producers / importers had to provide an ingredients list to FDA by December 22.
Suppliers of papers, filters, packaging, aluminum foil, poly-wraps and tear tapes will all have to comply.
FDA is curently pilot testing an electronic web-site version to facilitate this registration.
More to follow………………
October 16th, 2009 — Conferences, General
Will be held this November 11 – 13 at the Centara convention centre in Bangkok Thailand, hosted by Tobacco Reporter and organised by Think Event Marketing. Besides the exhibition there will be a concurrent congress on topical issues affecting the industry presented by Global leaders from the Tobacco Industry.
I plan on attending and will be pleased to see you there.
Let me know
October 16th, 2009 — Current Issues, General, Retail Cigarette Brand Prices Around the World
Mississippi announced this week it will hold a public auction on October 27th to sell about 1 million cartons of confiscated cigarettes and small cigars seized at a Tupelo warehouse facility earlier this year.
Presumably this is to recover / compensate the State for potential lost tax revenues?
What price will they sell for and how does this sit with other manufacturers and distributors in the state of Mississippi who have fully complied with the law and regulations? This sale undermines their efforts and fails to reward their honesty and integrity.
What do you think?