Tag Archives: FDA

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

CDC press release about e-cigarettes: blatant lying by government officials

by Carl V Phillips

Yesterday I peer reviewed the latest journal article about by CDC and FDA about kids’ use of e-cigarettes, pointing out the massive methodological flaws, inaccurate conclusions, Orwellian language, and overt political advocacy that it contained. I mentioned CDC’s associated press release, but did not go into details. But the press release is arguably a far greater crime (and that is not hyperbole — it is criminal for the US government to lie to the people), and calls for a post of its own. Continue reading

CDC refines their lies about kids and e-cigarettes

by Carl V Phillips

I will interrupt my series on the failures of peer review to look at a great example of the failures of peer review, a new broadside (I hesitate to call it a study) from the CDC that appears in Nicotine and Tobacco Research, an alarmist piece about kids’ reported use of e-cigarettes.  Here is the official abstract at the paywalled journal page.  And here is a bootleg copy of the full manuscript (the US government does not let you hide your work behind paywalls if it comes from taxpayer-funded grants, and so I am not going to let them do it when we are paying for it directly). Continue reading

CASAA comments on FDA deeming of ecigs

by Carl V Phillips

Hello.  Sorry for the blog silence.  I was busy.

Half of it was writing our comment to the FDA about the e-cigarette deeming regulation.  You can download a copy of it here.   For the other half, see the next post I put up on EP-ology.

The CASAA comment is a few(!) blog posts worth of material for you to read, so I will end at that.  Oh, and this represents the end of this series, which was the basis for some of the comment.  I was going to do two more posts in it, but I ran out of time to do the intermediate step and that material just went straight into the comment.

 

Predicting the black market in e-cigarettes

by Carl V Phillips

The anti-tobacco movement is fundamentally dishonest and unethical, and it is also led by minimally-skilled people who isolate themselves in an echo chamber that avoids scientific review.  As a result, it is frequently difficult to determine whether one of their false scientific claims is an intentional lie or blatant ignorance.  Most of their epidemiologic claims seem to fall into the former category.  But most of their economics-related lies seem to stem from an utter failure to understand even first-semester level economics.  Snowdon and I (mostly at EP-ology including a few days ago, but also on the present blog) have documented this extensively.

One of their fundamental failures in this area is the apparent belief that — contrary to all we know from the results of the Drug War, to say nothing of all other observations of supply and demand — that bans will eliminate supply even when there is huge demand.  One critical appearance of this ignorance relates to the current U.S. FDA draft regulation of e-cigarettes.  FDA has clearly made no attempt to consider what the real — as opposed to fantasy idealized — results of their proposed e-cigarette ban would be.  It is not difficult to understand that there will be a continuing market in e-cigarettes — mostly not actually “black” despite the shorthand in the title. Continue reading