What Happened to Breath Asure? The Big Bad Business of Off-Label OTC Products.

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).   BreathAsure Package lo resBreath 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!

Airborne-Label

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.

ORA_Blast-small

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.

Picture 51

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.

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