Tag: FDA

We’re closing in on comments-due on 8 August 2014. If you haven’t commented, I urge you to do so by then. I will be submitting my own comment as well.

The process from 9 August 2014 is for the FDA to read all the comments they have not yet read, process them, and then formulate their new view of the matters at stake. Then they will amend the proposed regulation and it goes through the OMB loop again, letting them push back a bit. And then it eventually gets finalized.

Once finalized, the fun really starts. Lawyers of various stakeholders will begin helping them formulate their compliance behaviors for the new rules (larger and more established companies probably already have regulatory compliance work ongoing, but it will have to be modified and extended to fit the new rules). Lawyers will also begin considering how challenges to various provisions of the rules on various grounds might play out.

The provisions will all have effective dates, compliance periods, and so on. The companies will have to decide whether they want to force the issue on certain provisions by failing to comply entirely or let the FDA come after them for partial compliance, etc. Posturing will go on. The media will do whatever it is that they do. Throw darts at the proposal and print the words they land on?

But right now we still have time to finish our comments. For a little under a week, anyway. And then we get to wait for the final rule. Or maybe another comment period. If the FDA believes enough has changed once they reformulate, they could offer us another chance to comment, on an updated proposal. I actually think this may be the case.

We asked the FDA to extend the comment period, which they did. But they didn’t extend it very much. A very strange move, that. My guess is that either they don’t think the comments matter very much, or they feel that enough will change that spending too much time on first-round comments will be somewhat wasted. Given the comments do tend to matter, I lean toward the latter.

Keeping it short today, as I want to spend more time on my comment. Good luck!

The FDA’s deeming regulations target electronic cigarettes. Much of the how of the regulations is by statute, originally meant to mainly cover tobacco cigarettes. The FDA gives an option in their proposal to largely exempt cigars that retail at over $10, on the premise that they are not likely to be smoked heavily by most of the population and especially by youth.

But why go after ecigs? That’s one choice the FDA does have, and is making, in their proposal. Aside from smokeless tobacco and cigarettes (and NRTs like the patch, which are exempt from the TCA as drug delivery devices), the FDA has discretion in which tobacco products to regulate. The question should be examined.

Foremost, vaping caught the FDA off guard back around 2007. At the time, some companies were making what the FDA (and likely the law) views as medical claims. The notion that you can quit smoking with some product makes it a medical matter, as smoking addiction is viewed as a medical problem (the disease model of addiction) that requires a medical solution. Never mind the fact you can write a book about ecigs, How to Quit Smoking with Electronic Cigarettes and the FDA can’t touch it. Or you can open the Church of the Electronic Cigarette and have people pray away their addiction while puffing on vaporizers and the FDA can’t do anything.

The FDA tried to take these companies to task, playing house detective for the pharmaceutical industry’s NRT and psychotropics meant to combat smoking addiction. The pharmaceutical industry does a lot of business with the FDA. The FDA believes all firms in similar businesses should therefore be subject to similar approval processes. This is both a feeling of fairness to the FDA and a way to guard their reputation; they need to believe their work matters: both that it both protects public health and that their labor is worthwhile.

Vaping won in court. The FDA could have shrugged it off, continued policing for medical claims, but leaving the vaping industry alone otherwise. Here’s where the inertia of bureaucracy kicks in. Having made overtures to regulate as NRTs, the FDA felt like they had to keep coming in whatever capacity remained. The perception of vaping as the latest stunt by the tobacco industry to skirt the 40-foot border fence put up to try to finally rid us of tobacco-related disease meant the FDA felt compelled to act. Out of internal pressures from the failed first attempt, out of media pressures, out of public health pressures, and out of political pressures, the FDA has to show they are up to the challenge.

It would be like if someone invented electronic food that gave the sensation of eating without gaining weight, and the health community came out, along with the legislators and executive agencies, demanding that we keep electronic food under a tight leash. They might do so on the premise that it would actually encourage more eating. They might say it will entice children to become over-eaters in the future. And, of course, they might say the risks of virtual food are unknown, unstudied. They would definitely say that we’ve been played by the food industry before (remember the TwinkieⓇ diet), and we can’t afford a repeat of that.

The problem is, even if there were problems with the current form of vaping (and there are no real indications of any major problems at present), the general goal and the technologies that exist can and should moot them. That is, the promise of vaping, even if it weren’t the reality, is entirely real. And even still there are members of Congress, employees of the FDA, and representatives of the public health community, that oppose vaping at its root on a variety of false premises (even Senator Tom Harkin of Iowa, political beneficiary and protector of the herbal supplements industry, showed confusion and lamentation that the FDA couldn’t regulate ecigs as drug delivery devices, something he would lose his seat for if he said it about herbal supplements).

Their main reason for opposition is the history of the tobacco industry. History they contributed to, mind you. The Tobacco Control Act largely protects the basic tobacco cigarette which is the main cause of tobacco-related disease and is the biggest seller of the tobacco industry. The TCA says that the tobacco cigarettes on sale as of 15 February 2007 may remain on the market despite any and all advances in technology (i.e., even if by some miracle biology invented a carcinogen-free combustion cigarette, the FDA would not be able to mandate the switch without a new law from Congress).

If anything, the TCA is built to impede progress. It requires an onerous process to garner approval for better, safer products. It requires an even harder road to make legitimate claims that a product is safer. Yet the world of perception that the media and the Congress live in says, ‘We have a law to protect us from tobacco, and e-cigarettes must be thereby regulated.’

The design isn’t necessarily meant to protect tobacco, but could just as easily have arisen from a desire to prevent what public health sees as tobacco’s ulterior motive of making deadlier, or at least more addictive, products. Yet it equally blocks safer, less addictive, or otherwise improved products all the same.