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Parabens – Part IV

Well kids, it is that time of year again.  The Scientific Commission on Consumer Safety (SCCS) has re-evaluated propylparaben and butylparaben for safety.

As you may remember, after multiple reviews of methylparaben and ethylparaben the SCCS found them to be completely safe for human use.  Even taking into account exposure through several products per day.

Not bad.

So let’s get to propylparaben and butylparaben.  This opinion was published on May 3, 2013.  You can find the actual report here: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_132.pdf  (Warning: legal language and science presented!)

The opinion was based on two key questions.

1. Taking into consideration recent data, does the SCCS consider that its opinions of 2010 (SCCS/1348) and 2011 (SCCS/1446) on propylparaben when it is used as preservative in cosmetics products, both intended for adults and young children, need to be updated? 

2. Taking into consideration recent data, does the SCCS consider that its opinions of 2010 (SCCS/1348) and 2011 (SCCS/1446) on butylparaben when it is used as preservative in cosmetics products, both intended for adults and young children, need to be updated?

Bottom Line: No.

However, there is significant concern about difference in the toxicokinetics of parabens in the rat model used vs. humans.  In fact, several member states of the EU have banned the use of propylparaben and butylparaben for use in products for children under the age of 3 years.  The main areas of concern are in the nappy (diaper) area and the use of sunscreens.  It is recommended that children under the age of three should be protected from the sun by physical means.  Use umbrellas, hats, long-sleeved shirts, etc.

Now you may think that you did not have to do that when you were young.  But way back then we had a protective ozone layer which sadly has been slowly destroyed, letting much more radiation through to us.  It is a different world my friend.

So, are parabens safe?  Looks that way.  Effective, over 100 years of safe usage and financially prudent. There are lots of newer preservatives out there, but we do not know the effects of long-term use yet.  Personally, I like parabens.  But everyone is willing to take different levels of risks and Dr. Tim  is doing many studies on new preservatives.  I’m looking for that perfect preservative that will save the world.

After all, Doc Johnson wants all of our friends to live long and buy our products often!

Love you guys and gals!

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Why Use Lube? (Or Caution, Slippery When Wet!)

Why on earth would anyone use a personal lubricant?  Don’t you know that “If it ain’t Spit, it ain’t Love?”

(Plug: Watch for Sasha’s Love Spit Lubricant from that amazing manufacturer Doc Johnson!)

So, other than paying Dr Tim’s salary, why would anyone use a personal lubricant?  And why are there different kinds?  What’s the dealio?

First off, paying my salary to keep me off the street is a fine and noble reason.  Imagine the trouble I would get into if I didn’t have a place to go during the day.  Now imagine the trouble I get into playing in my laboratory every day.  Now try not to imagine me “testing” all of my lubes and potions.  Yep.  Keep me off the street.  Society will thank you later.

But there are serious and fun reasons to use a personal lubricant as well.

To begin, some women have trouble lubricating naturally.  This could be from a physical or psychological problem.  If you are one of these women, there is no shame in visiting your physician to rectify the situation.  Life is rough with all that stress of daily living, the demands of children and significant others, working in this economy and the joys of menopause can really dry you up.  You are the main reason that personal lubricants were invented.  Everyone should have a fair chance to enjoy sex.  And without lubrication, sex is a rough road to travel.

Technically, personal lubricants were invented so that the doctor could use a speculum or other device in his office without requiring the ladies to become excited enough to self-lubricate.  Dang decent of them.  Now if only they wouldn’t keep those darn tools in the freezer before using them on us!  In fact, one of my favorite lubricant ingredients was designed for pre-lubricated enema tips.  The tips were lubed up and set in an oven, uncovered for over four months.  And they were usable afterwards!  Although I would hate to have been the one upon which they tested them.

And there are lots of fun reasons to use personal lubricants too!  They work great with dildos, vibrators, strap-ons and can be flavored so that your partner doesn’t only have good taste, they taste good too.  And since we are talking about fun uses, let’s talk briefly about the back door.

YES!  Dr Tim Talks Anal Sex Again!  (https://quantumcogitation.com/2010/05/ and https://quantumcogitation.com/2010/04/30/interesting-question-caution-naughtiness-ahead/)

The anus and anal canal is favorite place to play for many folks.  However, while the anal canal is technically a mucosal membrane it does not self-lubricate the way a healthy vagina does.  You need lube.  Especially for those strap-ons!  Word is, that if you use a warming lube, it will overload their senses hopefully sending them orgasmically out of control.  Be careful, you have been warned.

So why are there so many different types of personal lubricants?  Why are there so many types of shoes?  Different lubricants for different needs and tastes.  Let’s do a brief overview:

Oil-based Lubes:  Some people use baby oil, Crisco or massage oils for lubricant.  Nothing wrong with that.  But remember, oils will rapidly degrade latex, you know, condoms.  Weakened condoms equal broken condoms.  Broken condoms can equal pregnancy or disease.  Pregnancy or disease lead to more complicated lives.  Keep your head in the game people!  Oh yes, these can stain your linens and lingerie.

And Heaven Forbid if you ruin their latex clothing with oil.  That stuff is expensive!  Oil works, its inexpensive and probably everyone has one form or another in their home.  I do not want to know what happened to the olive oil in my kitchen when my son came to stay with me for a while.  (I know.)

Water-based Lubes: Everyone is probably familiar with KY Jelly, one of the best-know personal lubricants on the market.  Not everyone loves it, but hey, the trend had to start somewhere.  So, water-based lubes contain lots of water, a couple of slippery ingredients and preservatives.  Just about any product that is mostly water needs preservatives.  Now some people don’t like certain preservatives and some people don’t care.  You may notice that some of the global companies use preservatives that are out of vogue, but have worked safely for fifty years or more.  Really, this is up to you.  Read my posts about parabens if you like.  (https://quantumcogitation.com/2008/09/08/how-bout-them-parabens/, https://quantumcogitation.com/2009/11/19/parabens-part-ii/, https://quantumcogitation.com/2011/01/17/parabens-part-iii-more-info-still/)

There can also be nice things like flavor, aloe vera, chamomile extract and other fine skin care items.  Folks love these, but they can have a tendency to dry out (water, remember?) and have to be re-applied since your man is a marathon sled dog!  (Go get ’em stud!  You are a Stallion!)  Personal preference, you love them or hate them.  They tend to wash out easily.

Silicone Lubes: Now these bad boys are made from silicone and are different from the others.  Long-lasting, can work underwater and for my money, give the best ride.  Try Doc Johnson’s new iLube!    Drawbacks?  Well not all silicone is created equal and some are definitely better than others.  They could possibly stain your linens depending on the fabric and silicone is not inexpensive.  This is probably the most expensive type of lubricant.

Condom-Compatible?  Well, oil isn’t.  But water-based and silicone can be condom compatible.  But here is the catch: To claim that a lubricant is condom-compatible, it must be a registered medical device and have gone through rather extensive testing including the condom tests.  This takes time and a fair chunk of money.  If you aren’t sure if the company is telling you the truth, call their information number and ask for their 510 (k) number.  It is public information.  Or you can search for the company on the FDA website for medical devices.  But that can get complicated.  You techies out there shouldn’t have a problem though.

To make a long story short, (TOO LATE!) try out some different kinds of lubricants and see which one your prefer.  I prefer that you try all of Doc Johnson’s lubricants first!  Please!  Keep me off public access television!

As always: Write to me!  drtim@quantumcogitation.com

Parabens – Part III (More Info Still!)

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

 

 

Parabens – Part II

Sparing you any pithy comments, here is an article from Cosmeticsdesign.com which can be found here:

http://www.cosmeticsdesign.com/Formulation-Science/New-data-on-parabens-suggests-no-adverse-hormonal-effect-on-the-body/

New data on parabens suggests no adverse hormonal effect on the body
By Katie Bird, 18-Nov-2009
Related topics: Formulation & Science

The industry awaits the judgement on parabens following the release of further data on skin absorption and the distribution of the chemicals in the body.

Florian Schellauf from industry trade body Colipa presented the findings from a recent study on rats at a conference organised by the Scandinavian Society of Cosmetic Chemists (SCANCOS) in Sweden.

The study was performed at the request of the Scientific Committee on Consumer Safety (SCCS) (formerly the SCCP) for more data on the longer parabens, propyl- and butylparaben, following research that claimed the commonly used preservatives may affect the reproductive and hormonal systems of the body.

According to the study data presented at the SCANCOS conference, in rats, parabens are well absorbed after oral administration but only partially absorbed after dermal exposure.

In addition, the data suggests that the compounds are fully metabolised before they enter the blood stream.

Blood plasma tests highlighted only the presence of a paraben metabolite PHBA (p-hydroxybenzoic acid) and no concentrations of the parabens themselves, regardless of which paraben was used and how it was applied (oral, dermal or subcutaneous).

According to Schellauf, PHBA is not known to have any estrogenic effects and is found widely in plants and human food, so trace exposure in the human organism poses no health risk.

“The study confirms the results of a number of research studies, which concluded from their work that parabens are metabolised rapidly and to a large extent in living organisms and therefore cannot exhibit any adverse effects,” said industry trade body Colipa.

The study will be submitted shortly to the SCCS, which will have to come to a decision on whether this new data means the acceptance of methyl-, ethyl, propyl- and butyl-parabens as preservatives in cosmetics products, should remain unaltered.

According to Maria Lodén founder of Sweden-based consulting firm Eviderm and a member of SCANCOS, a decision from the SCCS can’t come soon enough.

Anti-paraben stance

A number of consumer groups, environmental organisations and some industry members have taken an anti-paraben stance which may not be based on respectable scientific evidence, she said.

For example, the Nordic Swan, an environmental label well known in Denmark and Sweden has said products aiming to gain its label cannot contain parabens. Following the release of this new data and the SCCS’s forthcoming opinion, Lodén believes the Swan label should change their criteria and allow the compounds.

“My interpretation of the current data is that, in addition to methyl- and ethylparaben, also propyl- and butylparaben will represent the safest option for preserving cosmetics in the future,” she said.

“The society anxiously await the final SCCS report on the issue to reduce dissemination of misleading information on parabens,” Lodén added.

Me again –

WOW! It looks like scientists may not have been lying to you!  Of course I blame the Media…

Eat it? I just want to lick it!

Here is a question I hear fairly often, “Hey Dr Tim!  Is that edible?”

Quick answer, “Does it have Nutrition or Supplement Facts?  If not, no!”

So what about flavored lubricants, gels or lotions?  If they have flavors, they must be edible!

Yes, we make these!

Yes, we make these!

No, not really.  But here is the thing.  Have you ever heard of incidental ingestion?  Let me explain, if you have ever used for example, lipstick or lip balm, you have accidentally eaten some of it.  If you have ever kissed someone wearing lipstick, lip balm or lip gloss, you have consumed some.  Who hasn’t kissed someone and licked their lips afterwards, especially if they are using that yummy new acai berry/pomegranate lip gloss (now with kiwi!)?

Kiss me now!

Kiss me now!

That is incidental ingestion.  With flavored lubes, haven’t you ever pounded it hard and long, then given it a quick kiss of gratitude afterwards?  Well, would you rather take away the slight taste of strawberry or the industrial taste of a high-functioning, chemical tasting lube?  Thought so.  me too.  Strawberries are just so much tastier than motor oil.

So why don’t flavored lubes have nutritional facts?  You are not supposed to eat them!  If we wanted you to put the anal jelly on your toast, we would have that cool box with the information about calories, trans fat, etc, etc on a label sans naked people with a grocery store friendly name.  The same goes for lotions, creams and such.  Remember Jessica Simpson?  Her line of “edible” cosmetic products were actually called “kissable” after the Regulatory Department got through with it.

Desert Beauty

And what about those throat numbing mints?  Well, those don’t have nutritional facts because they are drugs!  They need the drug facts box on the label.  Yeah, it gets complicated.  But if you want to play with the Government, you really do have to play by their rules.  (Unless you are a real gambler.  But when you get caught, you will wish you hadn’t!)

We make these too!

We make these too!

Supplements meant to be consumed have different rules too!  They need supplement facts about daily values and junk.  Confused yet?

So lubes aren’t food.  Drugs aren’t food.  Supplements aren’t food.  Only food is food!  Follow the directions!  If it does not have nutritional/supplement facts available, it is not supposed to be eaten, chugged, or swallowed in big mouthfuls. 

And if someone wants you to eat it, ask them to take the first swallow.  That’ll separate the wheat from the chaff.

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?

How ‘Bout Them Parabens?

Time to talk about preservatives.  This is a pretty touchy subject with a lot of big guns on both sides of the debate.  Let’s see where we go…

The first thing to mention is that preservatives can be toxic.  Of course they can.  Their sole job is to kill things so that our products stay fresh and usable.  Preservatives kill off nasty microbiological organisms like viruses, bacteria, yeast and mold.  That’s a good thing right?  Otherwise we would only have local cosmetics that have to be kept in the refrigerator and replaced every few days.  No more national brands and a big upswing in the sale of portable coolers.

I mean, how clean are your hands?  Pretty darn clean you think.  You think incorrectly.  One of my favorite show and tell demos when training new chemists is to ask them just like I asked you how clean their hands are.  Then I have them put their thumb on the agar in a micro plate.  (Agar is what we use as food to test for microbial growth.  Give ’em food, a moist warm place to thrive and see if it can survive.)

Two days later, I show them the plates.  And the amount of growth is always amazing.  All kinds of bumps and fuzz of many different colors.  Now we know with great certainty who washes their hands after using the restroom and who doesn’t.  It is truly an eye-opener.

Wash your hands!

Wash your hands!

So if a scientist’s hands which are washed religiously and covered with gloves aren’t clean, how do you think the average person’s hands compare.  Chemistry 101: A real chemist washes their hands before they use the restroom as well as after.

And you think nothing about sticking your finger into your jar of cream after a long day?  Ugh!

OK, so now we know that things are dirty and that preservatives are used to combat all the nasties that can grow on our skin.  So let’s cut to the chase and get to parabens.

parabens

Parabens: A group of preservatives (esters of p-hydroxybenzoic acid) used very commonly in cosmetics, food, pharmaceutical and industrial products.  You can find them on labels listed as: methylparaben, propylparaben, ethylparaben, butylparaben, isopropylparaben or isobutylparaben.  They were first introduced in the 1920’s, hit commercial cosmetic use in the 1930’s, were first listed as GRAS (generally recognized as safe) in 1995 by the US EPA at a combined percentage of 0.8% in cosmetic products.  The average cosmetic concentration of parabens usually runs between 0.20-0.40%.  And as with any material, it is possible to be allergic to parabens.

But in 2004, there was a study by Dr Philippa Darbre at the University of Reading that showed out of twenty breast tumors studied, all of them had parabens in them.  Wow. That set the press in motion and before long many thought that parabens cause breast cancer.  Why would they think that?  Well, it seems that parabens (butylparaben is the most potent of the family) have some oestrogenic activity.  Estrogen is an endocrine distrupor.  Disrupt the endocrine system enough, cancer can grow.  The test was published in the Journal of Applied Toxicology.

So on the one hand, there are a few studies that show a causal link between parabens and breast cancer.  However, those studies bring more questions than answers.  On the other hand the US, EU, Japan, the National Cancer Institute and several respected naturalists do not see any cause for alarm.  The oestrogenic activity of parabens is approximately 100,000 times weaker than a woman’s natural estrogen.

Give the public what it wants.  Several groups have reopened studies on parabens and more work is being. done.  We should probably ban everything that causes cancer, huh?

Did you know that all plants naturally produce p-hydroxybenzoic acid?  They produce parabens to protect themselves against attack by micro-organisms.  Gee, just like we use them in cosmetics and personal lubricants!  And guess what?  Almonds, apples, broccoli, cherry, mango and many, many more have potent oestrogenic activity.  We consume more parabens through organic foods than we get from cosmetics.

Fruit Basket!

How does it end?  Parabens have been used safely for over 50 years.  They are stable, recommended for use with sensitive skin and no link has been conclusively shown between parabens and any cancer or illness.  If the thought of using them makes you uncomfortable, read the labels and buy products with alternative preservative systems.  It does however remind me of an old saying,

“A rumour can run around the world before the truth gets its shoes on.”

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