Entries Tagged '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.

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?

In a recent interview with ECigaretteDirect.co.uk Carl Phillips, Associate Professor at the University of Alberta in Canada, told us that the electronic cigarette was an order of magnitude safer than regular cigarettes and that an FDA study into the electronic cigarette was “pure propoganda”.

The electronic cigarette carried, he estimated, around one percent of the risk of regular cigarettes.

While he acknowledged that the electronic cigarette carried traces of carcinogens, he pointed out that banning the electronic cigarette based on the very low levels of carcinogens contained within would also mean “banning half the foods available.”

Given that, he argued, the FDA’s stance on the electronic cigarette was motivated by propoganda and not by science.

You can read the full interview here: Electronic Cigarette Interview with Carl Phillips.

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

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.

American Blend cigarettes like Marlboro are now banned in Canada so the Philip Morris International subsidiary Rothmans, Benson & Hedges is now able to only exports its AB products.    Canada’s law banning the manufacture, importation and sale of flavored cigarettes and small cigars, except those with menthol, and prohibiting tobacco product advertising in newspapers and magazines, took effect on October 8th, despite criticism from the tobacco industry and lawmakers in US tobacco-growing States that the measure was too broad and would unfairly restrict the import of US-grown burley leaf since most of it is exported as licorice-cased blended strip ready for use along with other  cocoa and vanilla flavored leaf.  Anti-smoking groups said the criticism was unfounded since Canada did not import any US-grown burley leaf in 2007 and 2008, and “American-blend” cigarettes make up less than 1% of the Canadian cigarette market. The anti-smoking groups also said fruit-flavored cigarettes and small cigars were marketed like candy to lure young smokers. The law had support from both government and opposition lawmakers (Reuters 10/8).

What makes this particularly interesting is that it now appears that at the Framework Convention on Tobacco Control meeting taking place now in Jordan, the TobReg committee, which is tasked with making recommendations about flavors in cigarettes, is apparently seriously looking at the possibility of recommending the elimination of all flavors – not just the characterizing flavors such as cherry, lemon etc.

Prof. Michael Siegel of Boston University School of Public Health welcomed Action on Smoking and Health UK’s statement (http://www.ash.org.uk/files/documents/ASH_715.pdf) supporting the use of e-cigarettes by smokers who are otherwise unable to quit smoking, as it represents one of the first major anti-smoking groups that is in favor of allowing the product on the market.  ASH UK’s statement says it supports a “harm reduction approach to tobacco,” and for those who do not wish to stop smoking or find it difficult to quit, products that deliver nicotine in a safe way should be made available. Since most of the smoking-related diseases are caused by inhaling smoke, the e-cigarettes, which deliver nicotine without the harmful toxins in cigarette smoke, are “likely to be a safer alternative to smoking,” ASH UK said. ASH’s US counterpart has called for a ban on e-cigarettes. Siegel said anti-smoking groups in the US support a policy of banning e-cigarettes, though such an approach would result in ex-smokers returning to cigarette smoking (tobaccoanalysis.blogspot.com 10/15).