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Dr Tim is On-the-Air (or Turn your radio on!)

A post on Monday morning?

Inconceivable!

However, it has been brought to my attention that one or two of you were pulled away from your computer against your will Saturday night.

Well, you missed it.  Dr Tim was on the air.  A nice 30 minute interview with DerekD and Peter Dickem on “The DerekD SHow.”  They are on this nifty website www.pleasureradio.fm.

So go ahead, visit the site, check out the program archives and hear what I had to say.  I didn’t do much for world peace, but maybe you can get a piece from our conversation.

Big shout-out to: @pleasurefm @peterdickem @dirtyderekd @drsuzy @TsWendyWilliams

Follow them on Twitter, or if boredom is more your style, follow me on Twitter!  The link is over there to the right somewhere.

Happy Monday Everyone!

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Lubricant Study

Anyone else read this today?

http://www.biologynews.net/archives/2010/05/25/use_of_lubricants_with_anal_sex_could_increase_risk_of_hiv.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+biologynews%2Fheadlines+(Biology+News+Net)

http://www.xbiz.com/news/121017

As you might have guessed, I have a few comments.

1) Lubricants cannot prevent the transmission of HIV or STDs. Not yet. And when they do, they will be presciption-available only. I know that there are a few existing studies that show that carrageenan MAY inhibit the HIV virus, but anybody marketing on that claim faces substantial wrath from the FDA when caught.

2) Yes, if people are going to engage in unprotected anal sex, it would be nice if lubricants do not facilitate the virus. This is another reason the FDA wants all personal lubricants to become registered medical devices. So that they can have more control. Should they have it?

3) Medical device registration and testing is very thorough. It is safety based and until now, no one had considered whether lubes could be preventative.* The FDA requires so much testing of toxicity that this study surprises me. I mean the FDA even requires that lubricants are injected into the bloodstream of mice as a safety test related to rectal claims.

4) Lubes don’t cause infection. Unprotected sex with unsafe partners causes infection.

* Actually, I have been reading about companies working on lubricants that would actually prevent the transmission of HIV for years. How I wish I had that R&D budget!

So how much protection do we as a society owe people who are hard of thinking? Do we pass more and more laws until every chemical, food or activity is illegal?

Where does personal responsibility come in to the picture? If someone engages in unprotected anal sex with multiple partners, do they deserve to die? I don’t think so.

Should you have to get a prescription from your doctor for personal lubricants and tell that person it is for anal sex? Doctors can tell if you have even been anally receptive, so would that be a big deal for you?

Should all products of every kind be pulled off the market until such a time that they are deemed safe by scientific study? And will people believe it? The fact that every scientific organization around the world has cleared phthalates for use in toys has not stopped the emotional banning of the substances. People want science to help them, but then refuse to believe its findings because some reporter or blogger thinks they know more than hundreds of scientists.

Personal lubricants are a necessity of life. We need them. But trusting your lubricant to protect you from your poor choice is like trusting your car to protect you while driving drunk.

Please think and act responsibly. I do not want to lose any more of you.

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?

FDA Approved????

I hear things.

And some of them can really be exasperating.  How many times has someone told you that they are an FDA approved lab or that all of their products are FDA approved?  Probably quite a few.  And probably a lie.  Maybe not intentional, sometimes non-technical people misinterpret the meaning of certain things.

Let’s set this issue to rest.  Brought to you directly from the FDA website (www.fda.gov) is the following list:

The FDA does NOT approve: Companies, compound drugs from pharmacies, cosmetics, medical foods, infant formula, dietary supplements, food labels including Nutrition Facts, structure-function claims on dietary supplements and other foods.

The FDA does approve: New drugs and biologics, medical devices (risk-based tier system we’ll discuss further down), additives in food for people, drugs and additives in food for animals, color additives used in FDA-regulated products.

That’s it!  There is no FDA-approved cosmetic.  We are not an FDA-approved laboratory or manufacturer.  We are an FDA registered facility.  That means that the FDA knows where we are, knows what we are manufacturing and can drop in to inspect us at any time.  (We are also registered with the State of California Department of Public Health, Food and Drug Branch.  They inspect us too!)

Time to take a look at a couple of the items mentioned above:

1) Medical devices – OK, you may wonder how this category affects you.  But it is very relevant.  Condoms, personal lubricants, cock rings, clitoral engorgement items are all medical devices!  Cock rings are in the lowest risk category and the FDA allows their sale without pre-market approval providing that they have the same use and are of the same technology of what is already on the market.  They also need the appropriate instructions and warnings in the language provided by the FDA.

Personal lubricants and condoms are Class II medical devices.  They can be cleared for marketing based on an FDA determination that they are substantially equivalent to an already marketed device of the same type.  This requires a lot of testing and expense by the manufacturing company.  And upon that determination, the product is granted a 510(k) number.   In case you were going to ask, if your new product does not strongly resemble one already on the market, you have to complete a NDA (New Drug Application.)

High risk medical devices like a mechanical heart valve require FDA approval after what can be years of testing and review.

2) Color additives for FDA regulated products.  Those would be all Foods, drugs and cosmetics.  The US works on a positive list.  If the colorant is listed for your particular application, you can use it.  If it is not on the list, no way.

3) Dietary supplements.  If someone offers you a vitamin pill, energy shot, “enhancement” pill and claims they are FDA approved, run away!  The FDA requires the following statement: “This product has not been reviewed by the FDA and is not intended to diagnose, treat, cure or prevent any disease.”  And if it did, that dietary supplement would be a prescription drug.

So what have we learned today?  The FDA does not approve companies or bunches of products.  Since they don’t approve them, do we have to follow their rules?  You betcha!  Our products are regulated, but not necessarily approved.  There are many things that I haven’t touched on here.  Ask me!

Ask questions!  Question authority!