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Mineral Makeup and Skincare SPF and FDA Compliance

Dear Friends,

As our industry thrives and is ever changing, much of the information can become antiquated.  Our content is continuously updated as we are made aware of the latest information and scientific research presented to us.

In dealing with the FDA, I have found it to be a quagmire of sorts of varying interpretations of the regulations.  I have spent countless hours in phone conversations with the FDA: Cosmetics and Color division, only to have further confusion instilled when asking for clarification.  In most cases you can get a completely different answer on a different day.

It is clear that cosmetics cannot cross the line of OTC (over the counter) drugs, such as making claims that using a certain skincare or makeup product will heal or cure a skin condition without the proper clinical trials.  But as to how far a company can go in conveying an intended purpose is the fine line that many cross, perhaps unintentionally.

The Federal Trade Commission is less confusing and their language is far from ambiguous.  The FTC states that no products offered as a cosmetic can be represented as curing, clearing up or healing, including providing ingredient lists with the inference of doing same for it's intended purpose. 

An independent lab from the manufacturer must perform double blind clinical trials on the combined formulation of ingredients since potency and efficacy may not be retained, or may be altered from the individual ingredients purported benefit, depending on composition of the completed formula.

SPF Claims Or Natural Sunscreen Protection

The same goes for SPF claims in mineral makeup or other skincare products without the FDA approved testing required to prove benefit.  This testing is not only expensive, but it is also subjective to how much of a product is applied, rarely achieving the actual SPF Rating due to application technique.  Mineral Powders for instance, rarely will reach the levels claimed by manufacturers due to how little is used, and is a key factor in not pursuing our SPF Rating at all.

We all know that Titanium Dioxide and Zinc Oxide are used for sun protection, and the FDA endorses these as broad spectrum sunscreens.  However, without a company presenting the results of their clinical tests, followed by receiving approval on their drug monograph application by the FDA, they cannot even make a claim to offering natural sun protection or anything else that equates to protection from the sun, based on what I stated above.

Herbal Extracts And Essential Oils

Individual Herbal Extracts and Essential Oils cannot be described as anti-inflammatory, antibacterial, antiseptic, or anti-fungal unless noted in a preservative context.  Otherwise it gives the inference that it will do something similar for problem skin.

Are we all aware of what most organic and natural products will do for us emotionally and physically?….YES!  Do we recognize their Holistic benefits as provided by other resourced data?….YES!  Can I claim it on my site and shout it from the rooftops?….NO!

So, in accordance with FTC mandates, this is where I will comply since nothing is open to interpretation.

Let me clearly state this is being done voluntarily and I have not received any “warning” letters from FDA or FTC.  I simply wish as always, to conduct business in a transparent and ethical manner.  Truth in Labeling and Marketing continues to be a part of my business ethic for Sterling Minerals.

For the full story, including litigation against the FDA for Ambiguous Language and Censorship, letters from the FDA, Federal Court Rulings and a bit of humor, visit an archived article in my Skin Care Guide, FDA & FTC Compliance: Wading Through The Muck!  

Some of the links to the FDA have been archived. For those letters in regard to "May Contain" and "Certified Colorants and INCI Names" you can locate them within FDA Response on Industry Requests.

Customer Testimonials

I love receiving all of your letters telling your stories of how our products worked for your skin and seeing reviews posted on our products.  Regardless of how wonderful you feel our products are, raves claiming that they cured, cleared up or healed the affliction, according to the FTC they'll need to be edited for content if we opt to publish them.  We make every effort to make sure product reviews are in compliance so it does not give the connotation it is an OTC drug!

So, if you should enclose a testimonial which contains language that will be construed as implying our products are OTC drugs, then this part will be edited out and you will see at the bottom of the testimonial, “Edited For Content Due To FDA and FTC Regulations.”

In order to remain in compliance, I will always continue with updating the site anytime there is an important change within the industry.

So I wish everyone continued enjoyment of our products and any benefit you feel they do for your skin and complexions.  It will just be between us and the many friends you share your story with, as to any improvements you may reap when using them.


Katherine Corkill
Owner/CEO Sterling Minerals