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!

WTBPA? (or Bisphenol A, What’s that about?)

Bisphenol A. 

What is it?  Where is it?  Is the a risk?  Won’t somebody please think about the children?

This is a toughie.  You may have contact with Bisphenol A (BPA) every day and just not know it.

What is it?  It is a monomer used in many plastic items like; polycarbonates, epoxy, phenolic, ethoxylene, ion-exchange resins, corrosion-resistant unsaturated polyester-styrene resins, reinforced pipes, food packaging materials and vulcanizates intended for use in contact with food and drink.  It is also one of many stabilizer for polyvinyl chloride (PVC.)

That’s a whole lot of BPA going around.  Canada just banned its use in baby bottles back on October 20, 2008.  Which is strange because the FDA, the ECB, the EFSA and the ACC all claim it is harmless as used in humans.  (FDA – US Food and Drug Administration, ECB – European Chemicals Bureau, EFSA – European Food Safety Authority, ACC – American Chemical Council)

However, the NTP (US National Toxicology Program) thinks that there could be a risk.  And they have announced that they will review its decision and re-evaluate the evidence.  And while telling us not to worry, the FDA has formed a BPA Task Force for the review of current research and new information.

That kind of leaves us all in the air, huh?  Canada says it is bad for babies and some groups want to ban it completely.  Not as easy as it sounds.

Have you used anything from the grocery store that is in a can?  Vegetables, aerosol whipped cream, tuna, soda, beer?  Most metal food cans are lined with and epoxy resin.  Remember that long paragraph earlier in this column?  Yep.  They all have BPA in them.  Now can manufacturers are looking into replacements.  They have to, it is a matter of economic survival.  Whether or not BPA is harmless, if the consumers want it gone, it had better go away.  You would pay a nickel more for safe packaging, right?  So even if it is harmless, industry will make more money off your fear.  The practice is very common.  Ever watch the “news?”

So what does BPA allegedly do?  The usual litany of diseases: cancer, diabetes, obesity, lower sperm count, Downs Syndrome, alters development of babies.  Not one good thing in the bunch.

How can we avoid it?  I’m glad you asked.  Stay away from polycarbonate bottles.  BPA can leach out of the plastic if heated, exposed to acids or even just with age.  (By the way, plastic water and soda bottles in the store don’t have BPA in them.)  Don’t cook in plastics.  I use glass on the rare occasion that I use a microwave.  Watch your recycle codes.  The safer choices for use with food are 1 (PETE), 2 (HDPE), 4 (LDPE) and 5 (PP).  Try to avoid preparing, storing or eating/drinking from 3 (V), 6 (PS) and 7 (other, except new bio-based plastics that are labelled as such.)

Avoid using plastic containers in the microwave.  Beware of cling wraps for microwave use.  Use alternatives to plastic packaging whenever possible.  And always recycle everything you can!  If you want to know more, drop me a line and I will help as much as I can.

And to think people used to laugh at me when I drank out of a beaker…

1,4-Dioxane – Are we all going to die?

So there I was a few months back, blissfully washing my hair.  (Yes, I still have some.  There’s not much there, but it is all mine!)  When my attention was brought to an article proclaiming that many name brand organic shampoos contained 1,4-dioxane a listed carcinogenic material.

My first thought was, “Now I know why all my hair is falling out!”

My first thought was incorrect.

So, let’s talk about 1,4-dioxane and what it means to us.

What is 1,4-dioxane?  Looking to the US Department of Health and Human Services, we find that 1,4 dioxane is used as a solvent in processing other materials and is used as a reagent in laboratories.  One use common to our lives is when manufacturers treat vegetable oils with 1,4-dioxane to help them function as a surfactant.  So that’s where it might show up in organic or natural shampoo.

Where is it? You know, it can show up just about anywhere.  It has been found in tap water, in contaminated air, contaminated food, cosmetics and more!

Cosmetics?  Yep.  It can appear as a trace contaminant because of reasons we talked about earlier.

Wait!  You’re a chemist!  I sure am!  And I do believe in better living through modern science, but that doesn’t mean I support all things chemical.  There is an old saying that goes “The dose makes the poison.”  For example, belladonna – a little inflames, a lot kills.  1,4-dioxane – a lot can cause liver and kidney damage, a little, well we just don’t know what happens.

Can I avoid it?  Sure!  If you would like to avoid 1,4-dioxane, avoid all products that have some of the following words: PEG, Polyethylene, Polyethylene Glycol, Polyoxyethylene, -eth or -oxynol-.  Many chemical manufacturers have added a simple cost-effective process that removes any remaining contamination, but there is no way the consumer can know from whom the shampoo guys buy their chemicals.  Call the 800 number or send an email or letter to the maker of your products and ask.  I would answer it.  They should too.

Will it cause cancer?  Tough question.  It does pose a risk in animals but not aquatic ones apparently.   Fish and plants do not seem to accumulate it.  There are no studies or tests done in humans.  Just hasn’t happened.  The risk is rather unknown.

HUH?  What few studies have been done show that there is a generally accepted safe exposure limit of 10 ppm of 1,4-dioxane.  It is listed as reasonably anticipated to be a human carcinogen.  That means it hasn’t been proved conclusively, but the likelihood is high. 

Now what do we do?  Well, you can avoid cosmetics that have chemical names like those outlined above, if you live near a hazardous waste dump, don’t drink the water and don’t let your children play near the dump.  Especially after a good rain.  1,4-dioxane is stable in water.  Drink uncontaminated bottled water.

You can ask your doctor to test you for exposure, but he probably won’t have the equipment.  However he can collect the samples from you (urine or blood) and ship them to a lab.  But it has to be quick.  1,4-dioxane and its byproducts leave the human body fairly quickly.  So if you think you have been exposed to high amounts, test within a couple days.

Friend or Foe?  The jury is out on this one.  I will call it personal choice.  I know that my products use uncontaminated surfactants.  But if you aren’t sure, I would recommend that you avoid it.

Questions?  Send me a note!  I will answer, maybe privately but very likely in this column.  Let me know if you need your identity hidden for privacy.

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