Are Cosmetic or Skincare Products FDA Approved or Certified?

WOW... Now I Know These Products Are Safe

As I do my ongoing research and participate with scientists in discussions about the industry and all the facets within it, I find these claims all the time, "our products are FDA approved" or "our products are manufactured by an FDA certified lab."

So naturally, the consumer who may not realize the facts of the situation take it at face value.  I know this because I have had many customers contact me and pose these questions.  Or they will share their stories of past products, stating they knew they were safe because they were supposedly FDA approved.

I can't even count the websites within my industry that make this claim as well.

Let Me Make Things Perfectly Clear And Dispel This Myth

The FDA is solely responsible for protecting the public health by regulating human and animal drugs, biologics, medical devices, food and animal feed, cosmetics, and products that emit radiation.

The FDA does NOT approve or certify any cosmetic or skincare products on the market today.  The only ingredients in cosmetics that are FDA approved are the colorants that go into products.  And the FDA has a separate division for this.

They DO NOT approve or certify manufacturing facilities, and they DO NOT approve or certify labs.

But They Are FDA Registered

As an FDA registered facility ourselves, this does not mean the FDA endorses, approves or certifies our products are the best or safe or proved promise of efficacy.  We are not manufacturing drugs here.  This is of course a voluntary program and as a cosmetic formulator, I believe this is vital to credibility of the products we provide as complying with all FDA regulations....such as GMP (Good Manufacturing Practices).

The FDA DOES inspect facilities to make sure they (we) are complying with those GMP guidelines because if they do discover violations, it can be grounds for being shut down or penalized.

FDA registration however, is mandatory for owners and operators of domestic or foreign food, drug, and most device facilities are required to register with FDA. Blood and tissue facilities also must register with the agency.

What The FDA Does Approve Or Certify

Mammography facilities must be FDA certified.  Mammography facilities are required to display their FDA certificates where patients can see them.  The certificate indicates that the facilities have met stringent standards and can provide quality mammography.

New drugs and biologics must be proven safe and effective to FDA's satisfaction before companies can market them.  In fact this is where some of the confusion occurs and the truth gets stretched.  Since the FDA does not develop or test products, they rely only on FDA experts which review the results of the private laboratory, animal, and human clinical testing done by manufacturers, and if FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.

So even though a manufacturer gets a product approved under these stringent regs, it does not make their facility an FDA certified lab.  So I guess if one were looking for a lab to produce a product for them, then a track record of sorts on the labs products gaining approval from the FDA is beneficial as showing a standard of producing exceptional quality using GMP.... but that is as far as it goes.

Colorants for purposes of cosmetics........

As I stated earlier about colorants, the FDA does approve these and they are found in food, dietary supplements, drugs, cosmetics, and some medical devices.  These color additives (except coal-tar hair dyes) are subject by law to approval by the agency, and each must be used only in compliance with its approved uses, specifications, and restrictions. 

In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.  This is why some of our colorants used are clearly noted that they are not safe for lips, such as Ultra Marines, so these should never be found in a lip color.  If they are found in a lip color for sale then these would be determined as a violation and deemed unsafe for use.

As a whole FDA does not, nor ever has approved cosmetics such as perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations.

FDA field investigators inspect cosmetic companies, examine imports, and collect samples for analysis.  FDA may take action against non-compliant products, or against firms or individuals who violate the law.  This can also be said for making medical or anti-aging claims since then this would put the product into the DRUG category whereby requiring compliance with the approval process, anything short of this is a violation of FDA regulations.

Side Note: Some may think Sunscreens are approved by the FDA since they are considered OTC drugs.  However, the FDA does not approve the sunscreen per se, but only the ingredients used to create sun protection are approved.  It is still up to the company to validate their SPF levels as proof of efficacy, followed by submission of their testing to the FDA for approval, and then comply with all drug monograph labeling practices.

So always be suspicious of labels that try to claim FDA Approval.  False and misleading statements are a violation and should be reported to the FDA when located, whether at the point of sale, such as websites, or on the product packaging itself.

This Is My Favorite Most Of All

"Our products are certified organic by the FDA and ECOCERT."

FDA does not define or regulate terms such as “organic” and “natural.”  However, the U.S. Department of Agriculture (USDA) does regulate the use of the term “organic” when used in terms of agricultural ingredient marketing.  There are also private organizations that certify “natural” and other claims; however, these organizations are in no way affiliated with FDA.  ECOCERT and NOP (National Organic Program) would be an example of these organizations, however separate and apart from the FDA.

Also, remember that all cosmetics are required to be safe, regardless of the sources of their ingredients.  An ingredient’s source does not determine its safety.  Even natural ingredients can cause potential harm to a person if they should be allergic to it... in science and chemistry, nothing is perfect absolutely.

However, even products that are created under these organic certifications are still regulated by FDA, and are subject to their jurisdiction under the law.  The USDA requirements for the use of the term “organic” are separate from the laws and regulations that FDA enforces for cosmetics.  Cosmetic products labeled with organic claims must comply with both USDA regulations for the organic claim and FDA regulations for labeling and safety requirements for cosmetics. 

In A Nutshell

So there you have it, the facts surrounding the bogus claims of "FDA Approved" or "FDA Certified" made by many cosmetic and skincare companies....and I have seen them on doctors websites turned skincare entrepreneur, making the offense worse since one would think they should know better.  Unfortunately, this just doesn't exist in reality.....and of course one more thing that those within our industry stoop to just to try and compete in the beauty products market.

Hopefully, a time will come when this practice of deceiving customers will stop and all of us will be on a level playing field helping customers make educated decisions based on the true science and benefits that any one product may provide.

UPDATE: Green Tea Extract in Mineral Makeup: Was I Wrong?

Professionalism Is Key

Well....  it seems I have been nicely called out on the carpet again by someone claiming to be an ingredient supplier that provides Green Tea Extract to many cosmetic manufacturers, including well known mineral makeup brands.  This was discussed in my last article Mineral Makeup with Green Tea Extract, Just More Hype?

And as is fitting, I will always attempt to share both sides of the equation on an ingredient as I did with my Bismuth Oxychloride article with comments by the ingredient supplier.  I then was faced with making corrections to the Diamond Powder article with an updated Response article to address our many email exchanges we had many moons ago.  These two ingredients, I felt were not beneficial in the manner they were used through my own research.  I also had further consultations with the actual chemists that have gone through extensive R and D to create and provide many improved alternative, innovative ingredients to cosmetic manufacturers.

As luck would have it, I am no stranger to controversy since I am currently the liaison for my state in regard to ongoing cosmetic legislation and I will challenge and debunk marketing hype, along with addressing completely inaccurate pseudo science that is presented as I continue to do through my blog and over at Personal Care Truth.  I will only acquire and provide scientific facts within my research data and not support snake oil salesmanship that goes on within my own industry.  In case you missed it: Beauty Industry Professionals May Be Their Own Worst Enemy!

The supplier who contacted me in regard to my latest article on Green Tea Extract and other antioxidants was nothing short of professional and courteous, however they replied under the veil of anonymity through my blog, as was the similar case with the Bismuth Oxychloride and Diamond Powder article (using a Pseudonym).  This started a firestorm of comments on the BO article from many users of this potential skin irritant, and the Lumiere Diamond Powder caused me to prepare an updated response and correct the original article.

The supplier of this particular antioxidant conveyed to me that my description was not completely accurate.  It seems it did not correctly depict other available delivery systems which help to stabilize and prevent degradation, while preserving the phytochemical efficacy necessary that the antioxidant properties of herbal extracts, vitamins and minerals provide.  

So, I stand corrected in this regard, yet I chose to not publish their comments left anonymously since this leaves me at a disadvantage and lacks professionalism.  I decided after the comments on my Bismuth Oxychloride and Diamond Powder articles, those conveying their message under the shroud of the internet curtain will not get my full attention.  If someone wishes to engage me in a discussion and declare a statement as fact and present the science, then they should also stand behind it and the name the supplier or affiliation they represent.  However, out of respect for my customers and as a professional courtesy, I will acknowledge their comments were still worth noting and forced me to research the facts further, so let's just say for a moment, "not so fast!"

Researched and Documented

There is unequivocally no dispute as to the skin health benefits of Green Tea Extract.  It is proven to be quite effective as are vitamins A, C and E along with many other extracts.  It is the method of delivery that is called into question.

The supplier explained to me, and I am paraphrasing, through a liposome preparation, the freeze dried antioxidant can be delivered and preserved for extended periods so skin can benefit based on a liposome utilizing mild penetration enhancers.  Once it is encapsulated, sustainability and delivery of phytochemicals is improved and increased.....the length of sustainability was not determined or clarified except to be noted as many months.  Unfortunately, further research did not yield me an exact shelf life so I cannot comment further in this regard.

Now of course, I have discussed in past articles about delivery systems, including the use of penetration enhancers which have been proven beneficial based on substantiated research.

I located two PubMed articles.... the 1st PubMed  is as it relates liposome use in treatment of skin cancer, and the  2nd PubMed also reporting similar research in support of the claims this ingredient supplier made to me about antioxidant delivery and sustainability.  My long time readers know I am always about presenting true and accurate science on any ingredient, not marketing claims made by suppliers, company chemists or cosmetic formulators willing to stretch the truth so it sounds much better than it is just to sell a product.

In this case, however, I am impressed with the research and pleased to share it with you.  But as the article concurs with my past articles, these types of antioxidants are destroyed by light and oxygen, so sustainability is vital whether the ingredient is stabilized and delivered with liposomes or with the use of a preservative system and additional penetration enhancers.  Furthermore, based on scientific accuracy, these liposomes are delivered through the mean size of nano scale.  Although liposomes have been used for many years in delivery of vaccinations, medical creams and other beauty treatments, I'll limit my comments to cosmetic uses only, except for purposes of comparison.

Does This Information Negate My Last Article

Well let's see if what I presented is still accurate.  In followup, I did further research and contacted suppliers of this liposome ingredient, including acquiring a direct informational page about Liposome delivery of green tea extract.

Unfortunately, some cosmetic ingredient suppliers are not timely in their response or they ignore the email altogether.  And a phone call.... well I may be able to discuss it with them, but sometimes the hard questions about an ingredient can get muddied up or avoided if the question might challenge the "love" for their ingredient as exampled in my other two articles above.

Quite frankly, there are enough of the blind leading the blind in our industry, from product labeling to medical claims and SPF claims, or all natural cosmetic creators slamming synthetic cosmetic creators based on a belief of harm and not actual science.  And for me ethically, it is and always will be about the chemistry and the science of any ingredient I may choose or not choose to use in my cosmetics and skincare products.

One Company known as Cosmetochem International offers a technology known as Liposome Herbasec.

• This is a novel range of concentrated / standardized, liposomal-based botanical extracts in a lyophilized powder form.
• Phospholipids and lecithin are the safest, mildest, natural substances which allow the penetration of actives into deeper layers of the epidermis.
• Unsaturated phospholipids (used in Liposome Herbasec) have been shown to be excellent penetration enhancers.
• INCI Name: Maltodextrin, Plant Extract, Lecithin

Cosmetic and Toiletries also gave this company props for their innovation on providing a wonderful delivery system of antioxidants for many skincare or personal care products.

However, I was made aware that depending on the composition of the overall formula, an adverse effect can occur causing a loss of  liposome stability, making it ineffective, (example: use of emulsifiers) so cosmetic science must be sound in regard to the delivery system for best purported benefit.

Liposomes themselves are penetration enhancers, whether purchased in aqueous solution or freeze dried requiring some form of liquid be added. It is vital to be cognizant of what they are being combined with since other less desirable ingredients entering into the deeper layers of skin may cause concern and further argument from NGO's.  With them it is always about blood brain barrier interaction of what chemicals, synthetic or natural, can cause...proven or unproven...it doesn't seem to matter.  Hence why different types of penetration enhancers are used extensively in the delivery of topical drugs, such as cortisone creams and HRT for their ability to cross the blood brain barrier.

Dr. Gabriele Blume wrote an abstract and extensive article on Liposomes

So can green tea extract in mineral makeup offer similar benefits in the same fashion as it does in liquid preparations?   Scientific research and ingredient descriptions along with the recommendations of usage dictates the answer.

Back to the subject at hand....

With the links I provided above, along with my many science based articles published at PCT, and through countless discussions I have shared with cosmetic scientists whom I have a long standing relationship with, including those that are located in the EU which have been guest writers for my skin care guide as well.....the actual chemistry and science cannot be manipulated or refuted for the purposes of pseudo scientific bogus claims.

It is this same fight we currently are dealing with yet again, as in the case of the most recent draft of the Safe Cosmetics and Personal Care Products Act 2013.... onerous regulations being proposed based on non peer reviewed science, cosmetic medical claims by our industry, and the precautionary principle.

Furthermore, this is prompting some physicians to also share their views about cosmetic companies pushing the envelope on over promising and under delivering in order to sell skincare and cosmetics.  Dr. Ourian expressed in an interview we need better regulation to control these misleading claims, which falls back on my article about our beauty industry leaders being their own worst enemy.  Large to small companies do it because they can and they are only damaging the rest of us in the beauty industry that won't fabricate science.  However the larger firms like Loreal, the parent company of Lancome are beginning to get slapped for some of their anti-aging claims because they are highly visible, while smaller companies violating FDA and FTC regulations fly under the radar....

I believe it is only a matter of time before more whistle blowers, especially with new regulation, come forward to report those in violation....large or small.

Final Answers To This Debatable Question

Is Green Tea Extract wonderful as an antioxidant?.... absolutely.... as I conveyed in my last article by applying directly to the skin after brewing tea or delivered within a skincare product containing the hydrated form.  But, I also now have been further educated on how liposomes have improved on the delivery system of antioxidants based on the science of skincare and cosmetic products. 

Is it absolutely possible for freeze dried liposomes to be blended into mineral makeup.....of course....yet without compromise due to shearing.... well that is another story, but that point is moot.  Plus, based on the suppliers recommended dosing which is as high as 5%, nice efficacy can be achieved.

However, the key factor in all research articles and ingredient information as it relates to skin health benefit when used dry is irrefutable; an aqueous solution or similar is used and recommended in order for this ingredient to become viable as demonstrated. 

When used in mineral makeup, the benign liposome encapsulated Green Tea Extract will happily sit atop the skin without harm or penetration .... not a bad thing and definitely safer since no blood brain barrier confusion would occur with NGO's like the EWG or Campaign for Safe Cosemetics....well maybe.  So used in this application, science shows, that enjoying any skin health benefits is highly improbable.

Bottom line and with all due respect to the cosmetic supplier's valid point on sustainability, as science is shared with me through direct contact with actual innovators of these types of delivery systems and ingredient preparations... no matter how hard one tries to meet a marketing agenda, you can't change the science as to how and what any ingredient is capable and incapable of achieving. 

I am always grateful to those in the science community for providing pertinent information in regard to this valuable research as it pertains to improving sustainability to a beneficial antioxidant for skin health.  You may also enjoy this very informative editorial by BioEncapsulation Research Group addressing encapsulated ingredients used in personal care products today and in the future, presenting excellent innovation on bio-encapsulated research for many other consumer products we use for delivery of healthy nutrition in our foods as well.

I continue to learn something everyday.  Though it happens rarely, for those challenges that come my way from cosmetic ingredient suppliers, manufacturers and formulators, I will always meet them head on respectively where respect is given.  I am beholding to them as well since they encourage me to continue my research which keeps me on my toes, which in turn helps me to maintain the integrity I strive for in truth in marketing and labeling, and to make corrections when necessary.

Education is never-ending as Science is ever evolving!