I was speaking with a close friend the other day and she mentioned that the popular breath-freshener, Breath Asure, had been “crushed” out of the market by the big, bad, evil corporate pharma-mega-corps who had sued the brand into oblivion (this may be a slight embellishment, but fairly true to her intent, I believe. Update: make that two friends). Breath Asure, for those of you unfamiliar, was a gel-capsule that contained some herbs that functioned as “the internal breath freshener” to remove food odors from your stomach, and therefore (?) from your breath.
The KnowsJack perspective is always one of assuming that there is more to the story, that processes actually work better than we think, and that life, in fact, despite our complaints, is pretty damn good. So it seems appropriate to shine the KnowsJack “Spotlight” on plight of Breath Asure.
There are some other things going on in the non-prescription drug market as well. You may have noticed that Airborne, the vitamin-C based cold preventative for use at airports, disappeared for a little while, returning recently with new packaging. Since yours truly has been an Airborne user as well as a Breath Asure customer since the their respective beginnings (but have never been a power user of either), I would be the first to agree that many people think these are useful if not effective products.
The Feds and your medicine cabinet – the strange world of FDA regulation.
When you walk down the OTC (over the counter) medicine aisle in your local drug store, you’re seeing a big industry in action. It’s an industry whose marketing and competition is profoundly shaped by the FDA,…but probably not in the way that you think. Let’s take as examples, Kava-Kava, Airborne, Claritin and Paxil. The last of these is not in the OTC aisle but it is the most prescribed drug this year, and the Food and Drug Administration (FDA) regulates both prescription and non-prescription drugs. The contract between big pharma drugs (Claritin and Paxil) and the “lesser” OTC drugs is pretty interesting and plays to the heart of the matter.
Claritin has a similar pedigree to Paxil, in that it was a prescription drug and later allowed to be sold as an over-the-counter (OTC) drug in 2002. Both Claritin and Paxil have established “claims” that have been verified by the FDA – Claritin provides relief from symptoms of allergies (allergic rhinitis) and Paxil is effective in treating various psychological maladies. They can make these claims (health claims) because they have proven them. And that is the primary mechanism of the FDA: if you make a health claim, then it needs to be recognized by the FDA as being valid. To be more specific, if you claim that either an ingredient (called the active ingredient for that claim) or the whole formulation has a health benefit, then that claim has to be recognized by the FDA. It is interesting to note that the main function of the FDA is to regulate claims that are made, as opposed to regulating drugs, per se. This is largely historical and we’ll come back to it.
Getting approval for a new drug (a claim and the ingredient(s) that provides the claimed benefit) is expensive – most of the cost is the clinical trials – and runs several million dollars for even the simplest of ingredients. Good news for the smaller drug companies is that the FDA also has a list of chemicals and compounds, for which when used in the approved way (ex: saline rinse for clearing your eyes), you are allowed to make the claim. They’re called GRASE (Generally Recognized As Safe and Effective), and they include those things that are well understood, as well as “grandfathered” drugs that have been used historically, have not been tested, but are not contraindicated by data. So, although not likely, KnowsJack could offer a line of saline eye drops (named “KJ’s Hope-Will-Lead-Us-Out-of-the-Recession See Clear Saline Eye Drops”) for our readers, the bleary-eyed businesspeople. Making the claim that the KJ Hope Eye Drops soothe tired eyes is probably fine with the FDA, but I couldn’t make the claim that they would, for example, help you sleep since well since saline, when used in the eyes is not recognized as a sleep aid. And I can’t get tricky about it either and name my eye drops: “KJ’s Sleep-Well-During-This-Recession Saline Eye Drops”, as the FDA includes a sort of “totality of your marketing test” – if you say it, or if it would be reasonable to assume it based on the messaging, then you are making the claim.
And what of Kava-Kava? I remember drinking Kava-Kava “tea” when on a trip to Fiji, where it is drank socially and makes one quite mellow. I look at the label and it says “May Promote Relaxation”…I seem to remember a whole bunch of people that looked like they were a bit more than just “relaxed” back in Fiji! But it hasn’t been proven to the FDA, so they can’t claim it. There is probably research that suggests that relaxation may improve, but mere research doesn’t allow you to make a claim. So what’s a poor Kava-Kava marketer to do?
And now we enter the world of off-label drugs and “GRASE-labeling”.
Being clever, I could make “KJ’s Global Recession-Buster Easy-Sleep with Kava-Kava” and claim that it is a sleep aid, despite the fact that the FDA doesn’t recognize Kava Kava as having any health benefits. How do I do that? I’ll just add acetaminophen (aka Tylenol, recognized as an FDA OTC GRASE sleep aid) and will claim it as the active ingredient. So you’re buying Kava Kava with some Tylenol in it, and I get to claim that it will help you sleep. The sneaky little implication (perceptual at least) is that Kava Kava somehow contributes to this. And here is the interesting piece: in general, this implication is allowed as long as the claim is valid and only applies to the active ingredient. Here’s my label concept:
1) Images and background: Show sleepy-moon, downward stock chart, etc.
2) Claim 1: “Helps you sleep”
3) Claim 2: “Contains Small-batch Organic Kava-Kava Grown by Indigenous Famers using 3rd-World Micro-loans”
4) Back label: “Active ingredient: acetaminophen. Inactive ingredient: Kava Kava.”
But what if Kava-Kava actually works? What if it is a sleep aid? How does it get on that GRASE list? Can I ever claim “sleep like a care-free South Pacific Islander”? The answer is that I would need to spend millions of dollars to take the new drug “Kava Kava taken orally as a sleep aid” through FDA clinical trials. And even if Kava Kava was a fantastic sleep aid, nobody would ever pay the millions needed to get it approved. Because once those millions have been spent and it is on the GRASE list, anyone can sell it and make that claim. The businessman in me was hoping for some, how-you-say, ex-clus-ivity. The only way to get that would be to protect it with a patent, just like the big pharmas do with drugs like Claritin and Paxil. But patents must be unique and novel, as in non-obvious, as in nobody has thought of it before.… Given the legions of Kava-Kava-induced comatose South Pacific islanders and the centuries-long heritage of its use, there is nothing to patent…they got there first. And this is why the big pharmas like “new molecules” – they can discover them, patent them, push them through the FDA and then through your wallet on the way down your throat.
So What Do We Know, Jack?
And you would think…and here is the point…that the most novel drug, most researched, the one that is pushed through the FDA at the price of million$ and time, would be the best. And likewise, the one that is least known, least certified and least understood is the worst. And that’s not true.
There are products on the OTC shelf at your local drug store that are good for you, and yet nobody can make those specific claims, because they are not proven. And there can be products that have no health claims that do nothing or that may be bad for you, and the FDA does nothing. And…there are drugs that make FDA-approved claims that don’t really work. Pretty crazy. Check it out.
Let’s take Claritin, the former prescription drug that became a “blockbuster OTC” in 2005, selling $300Mn+ in the US alone. The claims are that it alleviates symptoms of allergic rhinitis without drowsiness, is that true? No. In fact, Claritin doesn’t work for a lot of people (less than 50%) at the specified dosage…and if you increase the dosage, then it makes most people drowsy. Yet it is approved. So not all claims are what they appear to be – YMMV.
So let’s fly back over to Airborne – what is going on there? Flu season and you can’t buy it? My vintage 2005 tube of Airborne says: “Take at the FIRST sign of cold symptom or before entering crowded environments.” Great instructions! I KNOW exactly what this product does!
The new package (saw it while buying my 22.5lb turkey at Costco) says: “Take Airborne whenever you feel your immune system needs support.” (!) What the hell happened? The old one OBVIOUSLY fights cold, right, and the new one…well, how the hell do I know when my immune system needs support? It always needs support, right? And does the new one fight colds like the old one?
Well, as it turns out, it doesn’t. And the folks who make Airborne had to pay 23.3Mn to those of us who bought their claims: “In the class action, the Plaintiff alleges that the Defendants made untrue and misleading statements about the Airborne Products by claiming, among other things, that the Airborne Products cure or prevent colds.” Or so states the settlement agreement.
And what does the FDA have to say about Kava Kava? In fact, KJ’s Recession-Buster formulation may cause liver damage (from the Kava-Kava and from the acetaminophen) or even heighten anxiety in the presence of other drugs. And yet I COULD sell it, such is the enforcement gap between drug that make claims and those that don’t. Oh well, another KJ Blockbuster Product down the tubes.
KJ says “Caveat Emptor” to all his free-marketer friends.
I actually like this system, even though it sounds a little wacky. At the end of the day it means that we must all understand what we are putting in our bodies, which is a good thing. And the FDA pretty much makes sure that nobody makes outlandish claims like those that existed in the early 1900’s when tonics and elixirs were hawked with life-saving properties, when many of them just turned out to be, um, brown sugar-water. If the FDA says that a drug works, then that is your starting point, not the ending point – you still need to find out if it works for you. And if they say nothing about it, then you need to start doing your work.
At least we have Breath Asure…so simple, so effective! Or we did. Or was it? I bought (Chewy) Ora-Blast (from Breath Asure, “A blast of minty freshness”) in 2008. You can’t find either product now. And the real story behind Breath Asure’s demise now comes into focus….
Did “Big Pharma” crush Breath Asure? Yes, they did. But not by relentlessly suing them into oblivion. Rather, Warner-Lambert (Certs, Clorets, Listerine, and Dentyne) did this by subjecting Breath Asure’s claims to legal scrutiny. They asked the Better Business Bureau to investigate and the BBB (actually its National Advertising Division) found them guilty of making false and misleading claims. And at the subsequent trial, prior to declaring bankruptcy, the makers of Breath Asure admitted that: “…that BreathAsure and BreathAsure-D are not effective in reducing bad breath.”
Wow! They lied? They got sued by a competitor for lying.? And they went bankrupt? I’m not feeling sad about this.
So, no more Breath Asure? Of course not! They just had to abandon their brand name as part of the judgment. All those snaky (as in sneaky and slimy) off-label marketers never really die, they just come up with a new version of their product. It doesn’t take muchg looking to find something that looks a heck of a lot like our old non-effective friend Breath Asure: Health Asure Mint Assure.
Wow, that’s working pretty hard to leverage the bygone brand and use the GRASE properties of mint (menthol) — notice that they say “fresh breath” (describes a scent) rather than “bad breath” (describes a (potential) health condition). Snaky, like I said.
And it’s a KnowsJack kind of ending. They made a product that people liked — good for them. They lied about the product to consumers — not so good. They got spanked for doing so — justice is served. They are still free to market the product and you can still buy it — the system works.