FDA’s Gift to Big Business Finally Ships

It’s been years in the making.  I’ve been screaming on this site that the sky is falling for ages now. The time has finally come when the FDA has taken the wraps off its deeming regulations for the vapor industry.

Despite some heroic efforts on the part of consumers and industry groups, efforts to take the edge off of the regulations seem to have been for naught.  A push to move the grandfather date of the regulations from 2007 to the modern era would have helped preserve the industry and many small businesses.

Alas, the regulations remain as they were, complete with the positively stone age date of 2007.  I started vaping in 2011, and even that recently the technology was abysmal.  I’m not even sure anything actually exists in the same form it was back in 2007.

Of course the FDA said that they understood that, so they gave the industry a break by allowing a 1 year grace period.  After that products will have to be submitted for either substantial equivalence (fat chance) or pre-market authorization.

By their own admission the FDA says it will force “some” closings of small businesses, but says that others will stay around.  So long as they can pony up millions of dollars per yer to meet the regulatory burden imposed on them.

The Agency’s own numbers show just how much we’re talking about in terms of cost.

E-cigarette manufacturers or importers are expected to spend $827,000 to $1.21 million in the first year, $832,000 to $1.21 million in the second year, and $22,000 to $64,000 in subsequent years.

Based on some of the cost estimates put forward prior to this hot mess of a regulation being finalized, it looks like the FDA is counting on companies having maybe 4 products.

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The FDA Thinks this is accurate
What the FDA sees as a 2007 equivalent product

Now, let’s think about who counts as manufacturers and importers.  That would be your e-liquid companies on the manufacturer side and maybe a small selection of overseas factories.  The importers end up being your local and online vape shops.

How many of those do you know that sell only 4 products?  Remember, each flavor and strength of e-liquid counts as a product.

But, hell let’s assume the cost is around a million a year regardless of the number of products.  How many vape shops and e-liquid manufacturers can you think of that make enough of a profit that they can afford to drop a couple mil over two years?

The number I come up with is somewhere between not many and none.  What’s left over is going to be your brands owned by big companies… tobacco companies for the most part.  If big tobacco wants to fund their vapor products, they’re not going to have much of an issue.

Most independents, however, not so much.

From an economic standpoint this will be a disaster thinking about the destroyed businesses and lost jobs.  But, there’s also the consumer side of this.  When’s the last time less choice has been good for the consumer?

These consumers aren’t ordinary consumers either, these are by and large smokers and former smokers who found an alternative to smoking.  Not only is choice being taken away, so is in many cases the opportunity for a healthier lifestyle.

All this comes on the heels of the UK’s Royal College of Physicians announcing that they support vaping as a viable harm reduction method.

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Meanwhile on this side of the pond it seems our government is doing everything it can to drive smokers back into the arms of Big Tobacco.  Or, probably more realistically, they want those consumers in bed with Big Pharma.  Since you can’t vape, might as well go back to the death pills.

The good news is that there’s a little bit of time left.  The regulations have 90 days before they kick in.  Then there’s the 1 year grace period.  That may be enough time for some activism to make some changes.

There’s been some great efforts so far.  But we’ve fallen short.  Perhaps this move might light a fire under the asses of those business owners and consumers who didn’t give enough of a shit to think they needed to fight for their ability to vape.

What do you think the landscape will look like in an FDA regulated world?

Steve K

Hello and welcome to Steve K

1 Comment

  • In FDA world, it will be just BT and BP. BT is the probably the only ones able to fund the testing required for FDA approval.
    Results. Thousands of small vape shops will go out of business. Hundreds of thousands of people will be out of work. Hundreds of thousands of people will go back to smoking.

    BP will win, because people will keep buying there wholly ineffective tobacco reduction products. BP will also win in the long term from selling all the drugs, when people get the cancers related to smoking.

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