Tag Archives: FDA

Burstyn comments at FDA workshop on ecig science

by Igor Burstyn

[Editor’s Note: As I mentioned previously, FDA refused CASAA’s application to have Igor appear on the agenda of the FDA workshop on e-cigarette chemistry and related science. After seeing who they did put on stage, it became doubly clear that they were intentionally avoiding Igor because he had the expertise and credibility to point out fundamental flaws in a solid majority of what was presented. Fortunately Greg Conley had three minutes on the agenda and gave it to Igor, so that he could present the following talk. It was not a lot of time, but it was enough for Igor to point out how absurd is most of what passes for science in this realm. His slides are here. I have inserted the slide advance marks in the text. –CVP]

[Slide 1] Good morning, folks. First, a small correction. Actually, my affiliations are on the slide now, not from the previous introduction.

[Slide 2] So what I’d like to talk to you about today very briefly is that there’s really not that much new under the Sun about e-cigarettes. I don’t come from the tobacco control world. I come from a very different area of academia and research. And I was surprised that so many things about electronic cigarettes were surprising to people. So that’s my story.

So we’re really not all that ignorant about toxicology of what comes out of electronic cigarettes. And I talk about it as somebody who’s trained in industrial hygiene, environmental health, who was taught to anticipate what would happen if my workplace had a source of environmental emission introduced to it that was very much like electronic cigarettes, and it was there, and it was exposing me. And I was trained through my undergraduate and my graduate training to recognize and deal with those situations and be able to make rational decisions about mitigating risks for myself, and my co-workers and my colleagues.

We have rich experimental experience from other areas of environmental and workplace emission controls and hazard assessments that are incredibly helpful and can be easily applied, and are portable to the world of electronic cigarettes and tobacco products. And there’s really no reason to assume this precautionary posture that really amounts to willful ignorance. We really know a lot more than we sometimes give ourselves credit for. And my claim to credibility, such as it is, is summarized in this paper, and if you’re really interested in what I have to say on this topic, it’s all published out there. You’re most welcome to contact me. I’m easily found.

[Slide 3] But this is my main point, which was made yesterday as well: The dose makes the poison. We have known that for a very, very long time, and it’s really not helpful for us to think otherwise because nothing really has changed in the truth of that statement since Paracelsus put it forward. And this is part of the story. [Slide 4] If we apply the standards that are admissible in workplaces to emissions from electronic cigarettes and look at about nine thousand chemical measurements that were available to me back last summer, we can see that across chemicals, we see individual exposures that are way below a threshold where we’d actually begin to worry about them. There’s really no reason to be concerned here. Most of them are in trace quantities. They’re present, but they’re not going to hurt you.

[Slide 5] And if you look at similar calculations based on emissions from vapers, you can reach the same conclusion. You can sit or stand near a vaper and experience emissions they generate, and you should not be worried or afraid for your life or health.

[Slide 6] So we do know a good deal about electronic cigarettes. If the word “cigarettes” was not in that title, we wouldn’t really be that worried about them because it’s just a name. And it’s not really appropriate to deal with these things as if we learned nothing since the 16th century. Scientists don’t try to avoid vials of chemicals; likewise, public should understand and treat chemicals with respect, but we should not be afraid of them.

Thank you very much for your attention.

[Slide 7 contains further observations that could not be fit in the limited time.]

 

Don’t annoy us with the facts, we got us some regulatin’ to do

by Carl V Phillips

Sometimes parody is hard. For example, in their page requesting public comments associated with their upcoming workshops on the science of e-cigarettes, FDA states (repeating what they said in their Federal Register notice on the matter):

[T]he workshops are not intended to inform the Agency’s deeming rulemaking. The workshops are intended to better inform FDA about these products. Should the Agency move forward as proposed to regulate e-cigarettes, additional information about the products would assist the Agency in carrying out its responsibilities under the law.

Continue reading

More on the FDA and MRTP

by Carl V Phillips

In the previous post, I linked to CASAA’s comment to the FDA re Swedish Match’s MRTP application, wherein they ask to be able to change the “warning” labels on their smokeless tobacco products to not “warn” about risks that do not exist and to move a bit(!) closer to communicating the low risk of these products as compared to smoking. Clive Bates also weighed in on this, via this post and his own comment to FDA on the application. It is worth following up on some of his points and some others. Continue reading

CASAA comment on Swedish Match’s MRTP application

by Carl V Phillips

As most readers probably know, the FDA tobacco regulation include the “modified risk tobacco product” (MRTP) process, through which a manufacturer can apply to be able to make risk claims about their products (which basically boils down to: can communicate that they are lower risk than standard cigarettes). It has always been clear this process is (a) misnamed (nothing has to be modified to make this true) and (b) silly (when it is obviously true, why is this even necessary?). What has not been clear is whether FDA intends for it to work at all, or whether it just lets them pretend to offer an option and a formal process while just imposing whatever rules they want, as seems to be the case with the “substantial equivalence” process. Swedish Match has decided to invest an enormous effort in finding out, filing the only MRTP application that FDA has considered. (There have been a few other applications in the past but FDA refused to consider them, including at least one case where they basically changed their own rules to avoid doing so and then changed them back again later.)

Swedish Match filed over 100K pages (!) to basically request permission to stop printing false and misleading warning labels on their snus in the USA. They wish to remove the two currently mandated warning labels that are clearly unsubstantiated (that the products cause oral cancer and dental diseases) and change the grossly misleading “not a safe alternative to cigarettes” warning to say, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” FDA asked for comments on the application, and CASAA submitted our assessment of the implications of the label change, which you can read at our main blog at this link.

 

FDA proudly harasses retailers for selling lowest-risk products

by Carl V Phillips

This is basically an update of this post, in which I analyzed FDA’s banning of new flavors of Ariva/Stonewall products by declaring them “not substantially equivalent” to the previous flavors. But I thought it deserved a post of its own.

You will recall that I noted (a) that the banned products were from a family of products that might well be the lowest-risk products on the market, (b) the stated reason for the ban was that they contained more (presumably an inconsequential amount) of one chemical, and (c) if a bit more of one chemical constitutes “not substantially equivalent” then basically nothing is ever substantially equivalent.

Today FDA proudly announced that they are also harassing retailers who still have some of the banned products still on their shelves (and posting their names and addresses, no less). The manufacturer has presumably stopped shipping these products, but they are slow-moving (they never really caught on, despite having some dedicated adherents and probably being ultra-low risk) so it is not surprising that retailers still have some on the shelf.

You might think that an agency whose job it is to protect the public’s health would not spend government money (and waste perfectly good product) by hassling retailers who are innocently selling off their remaining stock of a very-low-risk product, probably completely unaware of the ban. Moreover, you might think that a regulatory agency in charge of this would know who actually manufactures the products (they list Star Scientific Inc. on the webpage, but Star go out of this business a while ago and sold the brand to a new company started by their former employees).

You would be wrong.

Random observations about e-cigarette policy, terminology, and relationships

by Carl V Phillips

Four items, related primarily because they resulted from my observations over the last few days, though there is an underlying theme to be found.

Item 1: Many of you have no doubt seen this story that appeared in Business Week and various other publications via the Bloomberg feed. At the Global Tobacco Networking Forum, Reynolds CEO Susan Cameron made clear that a much-criticized line in the Reynolds comment on the FDA proposed regulation of e-cigarettes had not been misinterpreted.  The line, which basically called for the banning of open-system e-cigarettes, might have been a trial balloon, but it was certainly not a gaffe. Cameron made clear Reynolds’s support for that position. Continue reading

FDA signals that nothing is ever “substantially equivalent”

by Carl V Phillips

The FDA Center for Tobacco Products (CTP) recently ruled on “Substantial Equivalence” (SE) applications about a group of smokeless tobacco products in the Ariva/Stonewall family. They ruled that these are not substantially equivalent to predicate products, which is an Orwellian way of saying they are banning them. In a week filled with bad news about supposedly health-oriented organizations threatening people’s health and welfare with anti-THR lies, this perhaps passed unnoticed by many. It should not have. It is by far the worst news of the week for Americans. We are still trying to make sense of the details as they relate to the particular products (note all the complexities below), but one implication is clear: FDA plans to use the SE process to block the introduction of THR products. Continue reading

FDA is complicit in CDC’s lies; grossly inappropriate behavior for a regulator

by Carl V Phillips

The neglected half of the story about CDC’s latest lies about e-cigarettes — and it is fully half of what is important, at least — is FDA’s complicity in it. As I recounted in the last two posts, and Brad Rodu expanded upon, the latest CDC claims about kids’ use of e-cigarettes are based on a shoddy and misleading study (presumably intentionally so). It is full of lies in itself, and those were then further exaggerated and made more inaccurate in CDC’s press release. It is certainly not acceptable that our government officials at CDC are acting as blatant propagandists for a special-interest position. It is probably illegal and is certainly unethical. But we have come to expect this from CDC — they have been one of the leading anti-THR liars for 15 years. It is far more troubling that the agency that is supposed to be the impartial regulator of such products, FDA, is complicit in the lies. Continue reading