Friday, December 20, 2013

Trying To Make Simple The Utterly Confusing. Product Claims. What Is In, What Is Out?

Over the past few months I have had both individuals, as well as people asking for information in a Facebook Group that I started about what claims are ok, and not ok in regards to skin care products, essential oils, and skin care products WITH essential oils in them.

Ok, first the bad news:  There is no simple little chart that will clear up all confusion and guarantee your claims are always within legal bounds.

Now the good news!  There are a few things that can be explained to help you understand the process, and get more clear insight on how the law works.  I am an example person.  I need examples of what IS and IS NOT ok to do/ say.  General guidelines often leave me confused and depressed.  So I promise I will be as clear as I can, and use many examples to demonstrate compliance and non-compliance.

#1.  What Is The Difference Between "Cosmetic Claims" and "Medical Claims"

It often seems a fine line to dance, but once you see a few examples, I think you will get the gist.   I will give you examples of acceptable cosmetic claims, and then follow with un-acceptable claims that would be deemed as a "medical" claim according to the FDA.

Cosmetic Claim:  "This product may help hide, or reduce the appearance of fine lines and wrinkles."

Medical Claim: "Fades age spots, reduces wrinkles, eliminates, heals, or reverses aging."

Cosmetic Claim: "Cleanser for oily skin, reduces the appearance of oily skin." (notice it is not for acne (which is a medical condition, but simply for oily skin)

Medical Claim: "Prevents, heals, or stops acne."

Cosmetic Claim: "Helps the hair appear thicker, helps remove loose dandruff, revitalizes the appearance of damaged hair."

Medical Claim: "Controls or eliminates dandruff, prevents or cures hair loss, restores hair cells, promotes hair health."

Are you kind of catching the drift?  Claims about appearance, are cosmetic, but claims about healing, restoring, preventing, etc., are considered medical claims.  You could say "Causes the skin to appear more refreshed and youthful" but could not say, "helps refresh, and promotes youthful skin" because that is considered a medical, rather than a cosmetic (appearance) claim.  I could go on and on with these examples, and sometimes the rules change a little on what you can and cannot say for certain products.  For more information visit: http://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/CosmeticsQA/ucm136560.htm


#2.  FDA Guidelines For Specific Ingredients Or Ailments

Here is where things usually get de-railed in discussions as navigating the FDA regulations can be quite a daunting task.  First things first:  The FDA has a process by which various active ingredients in OTC (Over The Counter) drug products are reviewed to determine their safety and effectiveness for use in self treatment.  After a lengthy process, (which I will not go into here) ingredients are categorized in one of three ways:

Category I: generally recognized as safe and effective for the claimed therapeutic indication
Category II: NOT generally recognized as safe and effective or unacceptable indications.
Category III: Insufficient data available to permit classification

Once an active ingredient has been categorized, reviewed, evidence presented, public opinion obtained etc., and a certain amount of time has passed, what is called a "drug monograph" (Drug Monograph = a recipe / rules for labeling and marketing/advertising)  is then put together as a kind of guide for using these active ingredients, and establish what conditions each ingredient is considered "safe and effective" to treat.  For ingredients that do not have a monograph, a "new drug application" must be filed, and approved before any marketing claims are made.

So what does all this mean?  If you want to know what percentages of a specific ingredient can be legally used in a product to make certain claims, or what claims are allowed to be made with certain ingredients, you can access specific drug monographs that will tell you that.  If there is NOT a monograph that goes along with a specific ingredient, then LEGALLY the only claims that can be made are cosmetic (assuming of course it actually IS for topical use.)

Educational claims can be made, in books, via articles, blogs etc., without any fear of breaking the law because this is covered under the freedom of speech act.  However, if any of these types of "educational material" are used as an advertisement for your products, or for promotional material in any way, then you have crossed the line, and are back to making a drug claim.

So, for example, Camphor is approved by the FDA for the treatment of acne.  So you would need to then go and read the actual drug monograph for camphor and find the information on what claims can be made, what percentages can be used etc.  Your product could contain other ingredients such as lavender, tea tree, etc., that have been shown to reduce acne, but have not been approved by the FDA for such, but these ingredients would need to be listed as "inactive" ingredients to be correctly labeled.  Whether or not the ingredients are in fact inactive in your product is not the point.  The point is Camphor has been approved, so if you wish to market your product for acne, you camphor (or another approved ingredient) used in the approved percentages, would be the "active" ingredient in your solution, and other ingredients you add based on your knowledge or research that are not approved by the FDA would need to be listed under "inactive" ingredients.

For another example, Vicks, follows all the specifications in the drug monographs of all of it's ingredients, so they are LEGALLY allowed to market their product for colds, and chest congestion etc.  BUT, you could make a product with the EXACT same ingredients and it would NOT be legal for you to market for chest congestion if your percentages, etc. were not in line with the Drug Monograph.
So that is why it is VERY important if you are going to make a claim, that you find the drug monograph that goes with your active ingredients and follow any specifications given.  And like I said above, this does NOT mean that the only ingredients you are allowed to use in your product have to be FDA approved for the condition you are wishing to market your product for.  But ONLY the FDA approved ingredient, used in the correct percentages can be listed as the "active" ingredient, and thus is the basis for your legal "claim" of what your product can help, or heal.

So specific drug monographs allow you to understand why it can seem SO CONFUSING, when one company makes a claim and it is ok, and it seems looking in from the outside that another company makes the EXACT SAME claim and it is deemed illegal.  To be able to make non-cosmetic claims, you must not only use approved ingredients, but use them in the correct percentages, and ONLY make the claims that are specifically spelled out and allowed in the monograph.

So, for example, if you asked a question like "I would like to make a wrinkle cream, what claims can I make or not make on it" no one would be able to give you a good direct answer, other than pointing you towards making ONLY cosmetic or appearance claims.  The only way anyone could help you know what claims you would be legally allowed to put on a certain product would be if they knew every ingredient, and the percentages etc, and could help you find the appropriate drug monographs that will give you the information you need.  If for example Vitamin E is approved for wrinkles, then you could follow that specific monograph and legally claim that your product helps wrinkles.

Is it a pain in the butt to wade through drug monographs?  YEP!  But you CAN find the information you need, and that is what I find exciting.  Many people choose to take the easier route and simply not make any claims, or only cosmetic claims on their products, which is of course just fine as well.  But if you DO want to make a claim, be sure to follow all specifications in the appropriate drug monographs.  To find specific drug monographs, you can go to the FDA website and search from there, or you can just type into google your ingredient and that you wish to find the drug monograph. (ie. Boric Acid Drug Monograph, or Camphor Drug Monograph)  You will also need to label your product with the appropriate warnings, cautions, and possible interactions according to the monograph.  This allows the customer to be fully informed, and be able to use your product in a safe and responsible way, rather than guessing and possibly causing themselves, or their families harm.

Now it is also important to remember that this only applies to those selling products.  You can make whatever product you wish in your kitchen, and tell your friends it healed your acne, and removed all your wrinkles.  The FDA does not care about that.  They care about claims being made for marketed products.  So when you look online, and see a product making a claim, and wonder to yourself "well how come they can do it but I was told it would be illegal if I said that!", it is probably because they have followed a specific drug monograph which allows them to make said claim.  However, it is important to note here too that MANY companies simply break the law, or at the very least try to scoot around it and find loop holes to market topical applications as nutritional supplements (which has completely different laws).  And this is neither honest, nor in the best interest of the customers, as safety issues with incorrectly labeled products causes huge potentials for reactions, drug interactions, and other unwanted side effects.


Ok, that is all for today, I hope this helps some of you desperately trying to understand this confusing system!  Hopefully this will clear up a little of the confusion surrounding the questions that have been popping up off and on for the last few months!

Until next time have a blessed week!


Ashley Glassman
Real Essential Oil Education
Real Essential Oil Education Facebook Page

References:  FDA Approval Process
OTC Ingredients
Example Of A Drug Monograph
Cosmetic Q&A

3 comments:

  1. That was very helpful. THANK U!!! :)

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