Inappropriate! (Or, Did I Just Mention Sex Out Loud?)

13 Jul 2012 Leave a comment

by Mystertim in ANME, Couples Sexuality, Doc Johnson, Female Sexuality, Fetish, Male Sexuality, Masturbation, Medical, Regulatory, sex toys Tags: , , , , , , , ,

So how is your summer going?

Did you take some time off, go to the Newberry Library Book Fair (July 26-29  just saying), or just sit around naked next to the air conditioner at home?

Well I have been quite busy.  Yes it is time for the Annual Summer ANME show!  http://www.anmefounders.com/  During the wicked heat of July, the Adult Novelty Manufacturer Expo will be taking place in beautiful downtown Burbank this weekend.  (Actually it is by the airport, but how often do I get the chance to say “Beautiful Downtown Burbank?”)

And boy oh boy are we going to be showing some wild stuff.  Of course I cannot tell you what it is because the show starts tonight.  And just like Christmas Eve, I must wait until it is approved for me to tell you about all of the wonders.  Maybe I will even get to post pictures!  (Like these: https://quantumcogitation.com/2012/01/16/trade-show-fever-or-part-one/)

Ron & Chad Braverman (Read about them in Los Angeles Magazine!)

But what an exciting weekend this will be!  I will be strolling around looking at all of the new and exciting products that will be unveiled.  Products designed to lift your sexual appetites and show you ways of pleasure that perhaps you have never imagined.  There will be something for everyone no matter your preference.

Fifty Shades of “Oh My!”

Life is pretty good.  But while we do our best to help you fulfill your fantasies, we often run into some risky situations.

You see, our job is to think about sex EVERY DAY.  We have to think about it, analyse it and look for ways to make it more enjoyable.  There are lots of different people out there in the world with a lot of different needs.  How can we help them?  And as such, sometimes we say inappropriate things at inappropriate times.  And it can cause a stir, an argument, a fight or even end relationships.

Mild Example: I was in class earlier this week.  Scientists need to stay up on new developments, so along with those classes I also study psychology, religion and particle physics.  Yes, I am an absolute gas at parties.  During this class, the professor asked us to brainstorm ways to relieve stress.  As he went around the room, he got the usual answers like exercise, meditation, read a book.  He got to me and I answered, “Masturbation.”  Valid, but it caused a minor ruckus because it is something that many of these older students were raised not to discuss.  They wondered aloud whether I was a sex addict or just a pervert.

You’d think I was the Devil himself when I explained that work in the sex industry and that sexual health and wellness was my particular field.  I do not argue or try to justify my job to people with closed minds any more.  And sadly, the woman with whom I had been doing quite well decided that we shouldn’t sit next to each other in class or hang out during break.

C’est la vie.

Sometimes you cannot separate your job life and your home life.  But you can try your best to keep it to yourself.  Yet a slip of the tongue is only a split second away.  (How many of you when I said “Slip of the tongue” started thinking about oral sex?  I thought so.  I’m a big fan myself.)  Life can be difficult when it revolves around sex during all of your waking hours.  Statements like “I’ve made a breakthrough in anal sex.” or “What do you think of this?  Would you use it on your pussy/cock/tits/ass?” or “How does this feel in your mouth?  Creamy?” taken out of context can be trouble.  And you just can’t use a slogan like, “Dr Tim, making butt-fucking easier for 30 years!”

I wouldn’t trade my life for anything. 

Check out this link: http://www.lamag.com/features/Story.aspx?ID=1715666  It is the story of Doc Johnson and how my boss and his family handle being in the industry.  It is a fascinating read.  I read it and I still like him!

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

10 Oct 2011 Leave a comment

by Mystertim in Anatomy, chemicals, Couples Sexuality, Dildos, Doc Johnson, Dr Susan Block, Female, Female Sexuality, Fetish, Male Sexuality, Masturbation, Oral Sex, Personal Lubricants, Physiology, Psychology, Regulatory, Science, sex toys, sexuality, Strap-ons, Transexual, Vibrators, Wendy Williams Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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!

Vacation! (or Did you miss me?)

16 Sep 2011 1 Comment

by Mystertim in Anatomy, chemicals, cosmetics, Couples Sexuality, Dildos, Doc Johnson, Fashion, Female, Female Sexuality, Fetish, Male Sexuality, Masturbation, Medical, Oral Sex, Personal Lubricants, Physiology, Psychology, Regulatory, Safe Sex, Science, sex toys, sexuality, Strap-ons, Transexual, Vibrators Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Believe it or not, I took a vacation last week.  No, really!  I was not in my laboratory for nine days.  Nine long, empty, meaningless days…

Actually I had a grand time.  It was my first vacation in four years and my third in the last twelve years.  It seems like I take a week off every four years or so.

So what did I do?  Things that would make the Marquis de Sade jump up on a chair and go “Eeek!”

Well, I’m sure that someone would.  I spent two days travelling.  It was nice to see the green fields and blue skies of the Midwest again.  You know, they have air that can be seen through almost all of the time.  Then I came home to study.

Yes you read that correctly, I came home to study.  I was buried in quantum theory, chemistry, mathematics and porn.

A person needs to stay sharp and up-to-date with the latest and greatest theories and inventions.  Who wouldn’t want to unravel the theories of time and the universe while experiencing mind-blowing orgasms?  Somehow I find that climaxing while learning brings me to an amazing brain-gasm.  Nothing like a good cum to fix things in your brain.  The universe seems to open itself up to me during sex.  (Now you understand why I call my Lady Friends, “My World, My Universe.”)

Here you thought I ignored my studies to do a lot of screwing around!  Nonsense.  As serious students, we always recited our class notes during sex.  In fact, that is the main reason people like the dirty talk in the bedroom.  Have you ever said anything naughty that your partner forgot?  Nope, they remember every last thing you said in bed and try to hold you to it.  A lot of jewelry gets sold that way.

Did you know that two people can squeeze into an orgone box?  They can!  If you can have sex in an airplane bathroom, you can make it in an orgone box!  Although that isn’t the point.  One of these days I promise that I will write a blog about Wilhelm Reich.  His work is fascinating.

Back to my vacation!  Out of nine, I had seven days of Science, Sex and Ice Cream.  Hmm, Seven of Nine does make me think about Science, Sex and Ice Cream, although not in that exact order.

However, serious study needs a serious study group.  How fortunate that I know such a group who could really help me concentrate on my studies.  Anything that could happen, did happen!  There were tons of official Doc Johnson toys and lubes which everyone shared to their hearts’ content.  There were strap-ons, oral sex, anal, sex, vaginal sex, armpit sex, straight, gay, trans, couples, singles and more!  Best smorgasm-borg ever!  We really got into some interesting experiments of spacial geometry and I do believe we defied the laws of physics and anatomy more than once.  How many dimensions do we occupy during orgasm?

You would have to see the film to believe it!  But until I star on a reality show, you will probably never have a chance to see it, unless someone posts clips on the internet.  Don’t be a pirate!  Buy your porn!  Somehow the idea of sex tapes going viral seems wrong to me.

So what or who did you do on your summer vacation?  Feel free to send me cards, letters, pictures or video!  Even a postcard would be nice…

Cock Rings (or Heavy Metal for Your Junk)

29 Apr 2011 Leave a comment

by Mystertim in Anatomy, Couples Sexuality, Doc Johnson, Female, Female Sexuality, Fetish, Male Sexuality, Oral Sex, Personal Lubricants, Physiology, Psychology, Regulatory, Safe Sex, Safety, sex toys, sexuality, Strap-ons Tags: , , , , , , , , , , , , , , , , ,

Cock rings.  Not talking about a Prince Albert piercing.  (We can talk about erotic piercing later.)

What is it and why would anyone want to wear some sort of band around their penis or even their scrotum and penis?

A cock ring is a device that encircles the penis or the scrotum and penis to restrict the flow of blood through the region.  You put it on when you are soft so when you erect, blood gets in, but does not get out.  So what’s the point?

It makes you last longer, orgasm harder, your erection is harder, thicker and just a little bit longer.  Often these are prescribed by a urologist as a remedy for erectile dysfunction.  You put the cock ring on, add a vacuum pump and *claps* pump yourself up.  If your ED is not severe or you don’t even have ED (from the amount of commercials I see on the talking parlor box it seems to be an epidemic!) you may just enjoy wearing one.

Dr Tim’s favorite is a thick, heavy stainless steel band that wraps around his entire package.  It increases the sensation similar to someone’s hand wrapped tightly around my excitable bits, and the metal helps me channel my inner barbarian.  You should see the way the veins pop up.  Textured for her pleasure indeed.

But a cock ring does not have be made out of metal.  They can be made out of silicone, leather, nylon, rubber tubing and probably some I have forgotten.  But let’s talk about the safe use of cock rings.

1. Make sure you get a proper fit.  If you are using leather or silicone, there are a variety of snaps and stretchiness to give you a comfortable fit.  Heck, I have even seen some with velcro closures on them.  But metal cock rings are not for beginners.  Grab your junk and a tape measure.  Not the one from your toolbox!  The cloth one from her sewing kit.  (Or yours, I don’t judge.  Wish I had learned a bit more than basic sewing…)  If you are using a larger ring which fits over your cock and balls, wrap the measuring tape around the area behind your testicles and over your penis.  You know, where she grabs you to get your attention.  Make it snug, but not tight.  Take that measurement and divide by 3.14.  This will give you the diameter of the ring you need.

HA!  Made you do geometry!  You just figured out the diameter of a circle by using the circumference.  And all you thought about in geometry class was figuring out you fantasy girl’s cup size.  Heck, I even tried to figure out the water displacement if she lowered those magnificent globes into water.  STAY IN SCHOOL KIDS!

So you take your new metal cock ring, pull your scrotum (or ball bag) through first and then squeeze your penis through.  Told you to do it soft, didn’t I?  Get ready to Unchain Your Beast!  (Or as I like to say when being unzipped, “Release the Kraken!”)

2. OK, we have the right size and we got it on, now what?  Time to get hard.  It will feel rather strange at first.  Like someone has a tight grip on you.  Relax, it’s all good.  Look at how big it is, how thick, how hard, so amazingly masculine.  You are a stallion, baby!  Don’t ever forget it!

However, do not wear it for more than thirty minutes.  It will be easier to remove after orgasm, but long-term wearing could cause some damage.  And damage, especially if you didn’t listen to Dr Tim and bought one that was too tight, can lead to permanent nerve damage, priapism (https://quantumcogitation.com/2011/04/01/priapism-or-how-long-is-too-long/), gangrene which can lead to penile destruction and/or amputation!  Now that would suck.  So pay attention.

3. If your penis becomes cold, turns white or you experience loss of sensation.  Go to the doctor!  And take the ring with you.

Many cock rings have emergency release handles, silicone can be easily stretched or cut off and leather can be unfastened easily.  Several have a textured surface to allow minimal blood return from your erection.  These are not for those of you with ED, see your urologist.  Metal cock rings are not for beginners.

4. Unless prescribed by your physician, cock rings are not for folks taking blood thinners or have diabetes.  Don’t risk your life for a fuck.  Take care of yourself and follow your doctor’s orders!

5. Be careful with your partner.  Sure the cock ring can stimulate her clitoris, but if they can deep throat, watch the teeth.  Your playmate would not really like to explain to the dentist that they chipped their teeth on your metal cock ring.  They may get a discount for having skills, but this is an area that most folks feel uncomfortable discussing.  Oh yes, you may want to trim the pubes.  Trust me.

What else can a cock ring do for you?  Some have vibrators attached for clitoral stimulation or if you reverse it some great under-ball buzzing.  Some have an arm that will reach down and tickle your taint.  You know, it might be easier to go to your local adult emporium and view all of the wonderful cock rings from Doc Johnson.  We have something for everybody!

Guys and Ladies, you really should check out cock rings.  They really bring an extra dimension into your love life.  Why I have even seen women that put a cock ring on their strap-ons!  (Not in real life of course, but on the computer, yeah the computer!)  Functional in the barbarian kind of way, very psychological.

As always, play carefully, take good care of yourself and your partners and maybe next time Dr Tim will tell you what it is like when your Prince Albert gets caught on the shower door handle…

Parabens – Part III (More Info Still!)

17 Jan 2011 Leave a comment

by Mystertim in chemicals, cosmetics, Medical, Personal Lubricants, Physiology, Preservatives, Regulatory, Safety, Science Tags: , , , , , , , , ,

Here we are, back again to the parabens.  It may seem like this is a never-ending debate.  But that is fine with me.  Further debate leads to further investigation.  And further investigation may eventually lead us to some solid answers.  I’m a scientist.  I like solid answers, but truth is ever evasive.  As long as everyone is different, there may never be a final answer.

So let’s take a look at the latest information.  It comes to use from the Scientific Committee on Consumer Safety (SCCS) through the European Commission.  It is an independent non-food scientific committee with no financial gain from industry for their work.

The “Opinion on Parabens” paper can be found here: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf

It is some 35 pages long and gets deep into scientific lingo.  So I will try to sort it out for you.

Most parabens are OK.  Methylparaben and Ethylparaben are restricted to 0.40% by weight while Propylparaben and Butylparaben are restricted to 0.19% by weight.  Oh, if more than one paraben is used, they are restricted to .80% by weight in a formula.  Sound good?  Most cosmetic/personal care/personal lubricant formulations do not ever use them at that high of a level.  The most I have ever seen is around 0.40% by weight when using three of the four.

So looks like we are home and dry?  No.  We haven’t really even reached for a warm fluffy towel yet.

The Commission wants more data.  The rat and mouse models (yes, animal testing) do not have enough correlation to a human model.  They are asking for more in vivo human tests.  (In vivo means testing on a live creature, in vitro is testing in a petri dish.)  There are a few other parabens which have not been tested, but no one uses those in and personal care application.

It appears that parabens whether applied subcutaneously or orally rapidly metabolize into PHBA which is found in all plants and is expected to naturally occur in humans.  It is quickly passed through the system through our urine and faeces.  However, intact parabens have been found in the urine and/or serum and seminal plasma.

That is why the SCCS set the above stated limits, because they need more data.  They set the threshold much higher than the Industry’s recommendation.  Enough animal tests, we need to test on humans.  Pretty scary, huh?  Want to be a human test subject?  I would!

Bottom Line Straight from the Report: 

With respect to the safe use of parabens as cosmetic ingredients, concern was expressed as to the potential endocrine modifying effects of parabens of higher chain length including Propylparaben, Butylparaben and related iso compounds. Benzylparaben was also of concern. Based upon the currently available in vitro data and in vivo rodent test results, the SCCS agrees that the estrogenic properties displayed by parabens appear to increase with increasing chain length. Nevertheless, the SCCS stresses that the displayed potency levels remain about 3 to 6 orders of magnitude lower than the potency of the positive controls.

So the jury is still out, but the deliberation is drawing near a close.  We should have more definitive answers in 4-5 more years.  Stay tuned…

Questions?  Love Letters?  Topics?  Nude Pictures?  Send them to me at: drtim@quantumcogitation.com

 

 

Wrap That Wrascal!

05 Aug 2010 1 Comment

by Mystertim in Anatomy, Couples Sexuality, Female, Female Sexuality, Male Sexuality, Physiology, Psychology, Regulatory, Safe Sex, Safety, Science, sexuality, STD Tags: , , , , , , , , , , , , ,

How’s your summer going?  Haul any boxes of books lately?  Make the evening news?

Mine has been pretty interesting.  Bar-Be-Que, Barq’s and Babes!  True summer living.

But even though these are those crazy, hazy, lazy days of summer, you had better watch out.

There was a report released by Harvard University claiming that men over 40 who use erectile dysfunction medications have triple the rate of sexually transmitted diseases as compared to men who did not use the drugs.

May I see a show of hands for those that are surprized by this result?  Not too many of you, huh?

In fact, according to the CDC, the 40-49 year age range accounted for the largest proportion of newly diagnosed HIV/AIDS cases in 2007.  Don’t believe me, go check it out.  I’ll wait.

Welcome back.  Sobering, isn’t it?  Let’s pull up our psychiatric armchairs and see if we can’t figure out why this is so.

Older folks are from a different time, a different age, a different mindset.  Last century, back when I was in college, the worst thing we could catch could be cured with a shot of penicillin.  There were fewer taboos.  And a LOT more risky sex than happens today.  After all, tis better to fail a Wasserman test than never to have loved at all!  The younger set may have more recent partners, but they actually tend to be safer than us old fogeys.

Even old Dr Tim isn’t sure if he has any condoms at home.  I’ll admit it, I hate condoms.  I hate wearing them, I hate the feel or lack thereof of them, I hate the taste they leave behind.  There isn’t much I like about them at all!  Except maybe the saving my life part.  I grew up with skin on skin and that my friend is a hard habit to break.  Even though I get a full STD workup every other month, I should still wear them.  And I do, if she insists.  But it shouldn’t have to be that way.  Even though women do ask to  see my test results before we proceed to Happy Land, using condoms should be an SOP.  (Standard Operating Procedure)

What about choice?  You may ask.  What about condoms in adult entertainment films?

So choose, Death or Cake. (Pie really.)  And as for adult entertainers, they are making a risky choice, but I defend their right to make it.  I consider adult film performers as stunt people.  They make risky decisions on how to use their bodies for the gratification of others.  I respect that.  Quite a few of those performers are my close personal friends and I would hate to see them be debilitated by some gruesome disease.  But I am not about to tell them how to do their job.  And I don’t think anyone else should either.  Those that try should probably try to get their own houses in order first.  However that is just my opinion.

And now that men suffering from ED can get help, they are picking up where they left off thirty years ago.  The game has changed since then and they havn’t read the new playbook.  Everyone needs to be reminded about the joys of safe sex.  No matter how old they are.  Anyone watch Penn & Teller’s show Bullsh*t about old people?  They still have sex.  The back alley slut is now the nursing home slut who thanks to modern medicine can get her favorite treat! 

Teach your parents well.  And your grandparents.  Anyone can die from HIV/AIDS and I’d rather it wasn’t you.

Lubricant Study

27 May 2010 Leave a comment

by Mystertim in Anatomy, chemicals, Couples Sexuality, Female Sexuality, Male Sexuality, Personal Lubricants, Regulatory, Safety, Science, sexuality, Uncategorized Tags: , , , , , , , , ,

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…)

31 Jul 2009 1 Comment

by Mystertim in chemicals, cosmetics, Personal Lubricants, Physiology, Preservatives, Psychology, Regulatory, Safety, Science Tags: , , , , ,

“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????

22 May 2009 2 Comments

by Mystertim in chemicals, cosmetics, Personal Lubricants, Regulatory, Safety, Science, sex toys Tags: , , ,

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!