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Who’s Got Them? (Besides me…)

“If all of your friends jump off a bridge would you jump too?”

Sound familiar?  And not just from your Mother either.  I bet you hear that from your Regulatory Departments at least once a week.  And just like Mom, you sometimes ignore the advice and end up paying for it later.  And those particular lessons can be very costly indeed.

Ethics.  Some folks, particularly those in government, think our industry does not have them.  Well, we do, but like another thing Mom told us, “One rotten apple can spoil the barrel.” 

And so it goes for all of us.  All it takes is for one dishonest manufacturer to bring the FDA, FCC, and many other organizations down upon us.  And what could trigger such devestation?  Unsubstantiated claims for one.

Have you ever read the copy on a jar, a pamphlet or package and think, “Wow!  This is amazing!  Not only will it give me earth-shattering orgasms, but it will cure my STD’s too!”  If you did, there is a problem.  Anything that cures a condition is a drug.  Drugs require lots of safety testing, proof of efficacy, a special license and a boat-load of money.

I can pretty much guarantee that no adult novelty company is filing any New Drug Applications.

“But wait Dr. Tim!” you may say, “You make OTC Drugs!”  Yes we do, but there is a monograph that must be followed, specific language that must be used and other certain limitations which must be followed.

There is a big difference between “Delays the onset of premature ejaculation” and “Last ten times longer!”  Guess which one is correct.

Basically, if you claim it, you have to be able to prove it.  Phthalate-free is popular these days, but you need proof from your manufacturer that the product is indeed Phthalate-free.  It does no good to say it just because you believe it and then Greenpeace or someone tests it and calls you a liar in the media.  Unless you are a movie star or rock star, bad press is not good press.  And if you make drug claims, you better be able to back them up and have yourself and your product registered at the FDA. 

Yes, it does take time and it does cost money to do everything correctly.  But if you do, when the sweep comes, you may just be the last man standing.  Right next to me.

Ethics.  Got ’em?

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1 Comment (+add yours?)

  1. Desiree
    Aug 26, 2009 @ 08:52:29

    We got ’em! As the director of marketing for Topco Sales I can’t tell you all how incredibly fortunate this company is for having Tim as the director of drugs and cosmetics. He and his team work so diligently to make sure our claims are accurate and compliant.

    Reply

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