Nanoparticles cosmetic or a drug? — Cosmetic Science Talk

Nanoparticles cosmetic or a drug?

I've been a long-time observer and have wanted to bring this up for a long time but wasn't sure if this topic was allowed or not. Please let me know if this violates any rules and I will happily delete. This question is simply for the sake of discussion and is something that's been rolling around in my own head for a while now. I own a small skin care company and my family owns a biotech lab that specializes in the functionalization of nanodiamonds and so this conversation always comes up. 

The increase in nano materials in cosmetics seems to be creating a fine line between cosmetic products and transdermal drug delivery masked as cosmetics. Any substance that penetrates the dermis or affects skin metabolism is considered a drug (assuming no drug claims are made, etc). But where does the line exist with nano 'carriers' (liposomes, nanosomes, nanocapsules, nanodiamonds, etc) of cosmetic ingredients, which have the potential to amplify ingredient efficacy, deliver ingredients into deeper skin layers and target specific sites based on ph, temperature etc? For example, functionalizing the surface of a nanodiamond with HA could deliver the ingredient deeper into the skin's surface, making it more biologically active, or, due to the massive surface area of nanoparticles, they could also magnify the efficacy of salicylic acid or retinol while remaining within cosmetic limits. It has also been shown that certain ingredients can 'unwind' from nanocarreirs based on wound/acne based on ph, resulting in targeted, sustained delivery and the creation of ingredient 'reservoirs' at the site (again, potentially overcoming the limitations of allowable concentrations in cosmetics).

While it is debatable whether some nanoparticles actually penetrate the skin, it's been proven that specific nano carriers are effective transdermal delivery vehicles and lack of peer reviewed product-specific studies hasn't stopped some companies from making claims that resemble transdermal delivery. For example, Loreal uses nanosomes of pro-Retinol A and makes the claim "enriched with fortified Pro-Retinol A®, penetrates the skin’s surface to effectively fight wrinkles and reduce the appearance of neck creases." Does the 'penetration' of the skin's surface through the use of nanosomes (which is debatable in reality) classify it as a drug? Or is it considered a cosmetic if it hasn't been proven to enter the blood stream? Either way, it raises the question: Does delivery mechanism impact whether a cosmetic is no longer considered a cosmetic, but a drug?

Nanodiamond–insulin complexes as pH-dependent protein delivery vehicles: https://www.researchgate.net/profile/Xiaoyang_Xu4/publication/26698662_Nanodiamond-insulin_complexes_as_pH-dependent_protein_delivery_vehicles/links/5728b5a408aef7c7e2c0c158.pdf). 

Comprehensive evaluation of carboxylated nano diamond as topical drug delivery system:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4887070/

Comments

  • edited May 2017
    For example, functionalizing the surface of a nanodiamond with HA could deliver the ingredient deeper into the skin's surface
    I can't see the logic here. Hyaluronic acid is a large, high mol-wt molecule. It is used by the body specifically because it does not migrate or penetrate the dermis. It's used in joint capsules to cushion forces. Synovial fluid, for instance, is mainly HA, it's a transparent, Non-Newtonian fluid. (Recently I had a problem with my foot leaking this stuff, so I got a chance to examine it quite closely.)
    While it is debatable whether some nanoparticles actually penetrate the skin
    Exactly.
    For example, Loreal uses nanosomes of pro-Retinol A and makes the claim "enriched with fortified Pro-Retinol A®, penetrates the skin’s surface to effectively fight wrinkles and reduce the appearance of neck creases."
    If pro-Retinol A has been proved to be equivalent to Retinol, then it matters not how it's delivered. It's going to be absorbed by the skin's liposome just as long as it's available in some convenient carrier. And Retinol definitely has well known drug-effects on the skin; it's a standard tool for dermatologists.
    BUT, note the weasel wording of the claim:
    penetrates the skin’s surface
    -
    by how much? 
    to effectively fight wrinkles
    - I might "effectively" fight the world MMA champion but I don't think I would last very long.
    and reduce the appearance of neck creases.
    "reduce (by how much?) the APPEARANCE OF (try car body filler, should work too) neck creases.
    I imagine Loreal probably has spies in the FDA.

    Design of anti-aging creams, gels, and serums; shampoos; and therapeutic cosmetics. In-house label and box design capability.
  • By the way, isn't there a danger with these nanodiamond thingies, of creating a carbonic plague?
    Design of anti-aging creams, gels, and serums; shampoos; and therapeutic cosmetics. In-house label and box design capability.
  • @belassi:

    Super low molecular weight Hyaluronic Acid does indeed penetrate the dermis.  Higher molecular weight HA will not, so if the SLMW HA is complexed with nano diamonds, it could possibly enhance the delivery.  But, since SLMW HA penetrates on its own, there would seem to be little point in incurring the expense of complexing it with nanoparticles.

    @greensara:  You're probably delving into the territory where cosmetic actives complexed with nano diamond could be classified by the FDA as a cosmetic and a drug.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

  • @greensara - The L'Oreal copywriters and lawyers are clever when it comes to advertising claims.  

    "enriched with fortified Pro-Retinol A®, penetrates the skin’s surface to effectively fight wrinkles and reduce the appearance of neck creases."

    - enriched with - That just means they added some amount of the ingredient to the formula. It could be 1% or it could be 0.0001%. 

    - penetrates the skin's surface - So does every other skin lotion that you can 'rub in' to your skin. This doesn't mean it penetrates down to the dermis or into the body.

    - effectively fights wrinkles - Standard skin moisturizers do this.

    - reduce the appearance of - Yes, just like every other moisturizer.

    There is nothing particularly 'druggie' about the claims they are making.

    If there is a notable effect that is the result of an ingredient interacting with the skin metabolism, then the products would technically be drugs. If you make any claims to that effect then they are drugs. If you stick to the claims that L'Oreal makes above, then they are still cosmetics.
  • I totally agree---these are well worded cosmetic claims with out drug implications.
  • @Belassi, nanodiamonds have attracted so much attention for the very reason that they are so biologically compatible. The government is funding research with nanodiamonds as safe alternatives to quantum dots for bioimaging and as low-toxicity vehicles for targeted drug delivery. Believe it or not, nanodiamonds are literally all around us (some the result of cosmic collisions millions of years ago, and are even created when you burn a candle-albeit they are burned up in the process).

    @MarkBroussard just using HA as an example. Due to the potential for creating 'reservoirs' and slow release of active ingredients, is it not feasible that functionalizing the surface of the diamond could magnify/extend the benefits of HA over a period of time? Yes, the cost would be significant but I find it absolutely fascinating and still wonder if it is not the next generation of cosmeceuticals...assuming companies can carefully formulate and craft claims so as not to be considered a drug. In fact, the number of companies now offering cosmetics containing 'diamond dust', 'diamond hydrosol' or nanodiamonds is rapidly expanding. Diamond-based ingredients are now even carried by suppliers that cater to home crafters (Formulator Sample Shop, I think?). None of the claims are substantiated, and some just don't make sense, but its use is nonetheless on the rise.

    @Perry I think you answered my question to large degree: If there is a notable effect that is the result of an ingredient interacting with the skin metabolism, then the products would technically be drugs. What a fine line. I was under the impression that making claims of skin penetration was asking for trouble, but perhaps it's dermal penetration that would pique the interest of the FDA? I would argue that plenty of products offer 'notable effects', although I wouldn't know if it was a direct result of interaction with skin metabolism. Interesting.
  • edited May 2017
    The official FDA definition of what makes a drug is something that affects the structure and/or function of the body. Anything that only affects appearance is a cosmetic.

    The question that introduces some gray areas is "how does the FDA know which ingredients do that?" There is, after all, zero budget for testing cosmetics to see if they are drugs or not.

    So, the FDA relies on two (relatively) simple tests to determine this. The first test is "Does the product in question include any ingredient at any level that the general population would recognize as a drug?"

    The second test is where the lawyers earn their money. "Does the product make any claims in any way that it affects the structure and/or function of the body?" This is the source of all the convoluted language used by cosmetic marketers.
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • "Notable effects" is the gray area. Technically, water has a notable effect on skin. Overhydrate and you get skin pruning. Moisturizers certainly have a notable effect. But these things have been considered cosmetic effects.

    Companies get in trouble when they go beyond simple moisturizing / appearance change claims. If they say that their formula stimulates collagen or lightens skin or removes wrinkles (instead of just improving the appearance) then they'll get in trouble from the FDA.

    The reality is that the vast majority of products have not been tested to determine the mechanism by which they work. Most effects are not different than simple moisturizing.  And cosmetic companies are not inclined to do this kind of research. They don't want to know if their products work like a drug.

    Sure, there are tests done in the lab to give marketers some grist for their advertising stories.  Raw material suppliers are happy to declare how ingredients work and explain biochemical mechanisms based on theory but the science of anti-aging products is soft and underfunded.

    Aging is a complicated subject & I'm skeptical of most any research I see.
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