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Pharmaceuticals vs Cosmeceuticals
We all know that pharmaceutical drugs undergo rigorous processes and some can be as much as decades of drug approval testing, which may cost hundreds of millions of dollars. Then we know that cosmetics do not have to prove any such claims, but they can cite “scientific studies” of the ingredients used in their product formulations to validate the safety and efficacy of the ingredient formula.
Where is the boundary between these two? -
20 Replies
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It’s pretty clear. If a product actually has an impact on cell metabolism or cures a disease, then it is a drug. If it merely affects the appearance, it is a cosmetic.
“Cosmeceuticals” are technically drugs.Recently the FDA has been sending warning letters to companies making antiaging claims which are drug claims. See this letter they sent to Cell Vitals.<edited> -
@Perry, check the last statement of the first paragraph in your reply again, please.
Nice reference, Perry.I visited the said website and at the bottom right of page of the product referenced by the FDA, there is a picture of before and after of the results in topical usage of the website’s product. Now, is that product still cosmetics or it has actually transitioned into a pharmaceutical? Perhaps, the matter is still being investigated and the company is still riding their luck, but I doubt it. -
On the one hand, we have the admirable intent to protect consumers. On the other, we have a body that’s set in concrete and acts like a hand of death on innovative products. Acne treatments are a good example: the FDA appears to believe that only a very narrow range of products offer suitable treatment, and ignores evidence that other systems may perform better. In my opinion the US system is very, very over-regulated and is controlled by vested interests with deep pockets. The European system is far, far better.
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For this, I’m glad I live in Europe; although, the North American market is truly an enviable market. -
Funny, there are lots of people who say the US industry is unregulated and are pushing for more regulations.
I don’t really have a problem with the US regulatory system but you are right, it favors big, rich companies. If you could demonstrate a clinical effect for a new acne treatment then you can file an NDA and get it approved as a new drug.Basically, if you can prove something works you can get it approved for use (if you have enough money). -
I am of the faction that would prefer to state “It may help” instead of “It cures or will” and allow the buyer/user to make her choice. Then, after the buyer uses and finds it does help “cure” (or whatever), she now makes the claim that it did cured and recommends. For me, that is a subtle but better winner than go through all the hassles of the FDA without the money to spend. It may not make the world to queue in front of your outlet, but at least, you are likely to meet your sales target.
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That’s a pretty good philosophy for a smaller cosmetic brand.
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Isn’t so that there will always be a grey area somewhere, drugs do not always cure. Cosmetics do sometimes interfere with cell metabolism. intended or unintended.
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I am getting more and more confused about what can be said and what cannot.
There are some claims on well know companies’ websites that I would think are drug claims but apparently they are fine to be used in cosmetics. Here are some examples:“Vitamin C: Supports natural collagen production and contains antioxidant properties.”
“Stimulates collagen production without irritation“
“Strengthened by vitamin C, it calms, heals, brightens, and boosts collagen…“
“…this formula provides intense moisture and supports natural collagen production.“I’ll appreciate any comments.
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Welcome to the wonderful world of weasel words.
1. “Supports” - that can pretty much mean anything.2. “Stimulates” - that’s vague and can pretty much mean anything too3. “Strengthened” - how do you strengthen collagen? More vagueness.4. “clams, heals, brightens” - what does it mean to calm collagen? or heal collagen or brighten collagen?5. “provides intense moisture” - what would non-intense moisture be? more vagueness.This is all very clever copywriting. They write sentences that when picked apart don’t actually mean anything.Notice what they don’t say…“Increases the amount of collagen” That might be a measurable claim which could get them in trouble. -
Thank you Perry.
It is unfortunate that it would be hard to sell anything without using “weasel words.” Maybe you could offer an online workshop a some point about how to write clever claims without getting in trouble. -
Nice idea about clever claims without troubles.
A claim that a product has an ingredient which has therapeutic / anti irritant properties but not that the product itself has these properties, is problematic? What do you think? -
I like that idea. I’ll give it some thought and see if I can put together some for later this year.
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A word that helps is “known”. “The ingredient X is known for its anti-inflammatory action”. You aren’t saying the ingredient X will give an anti-inflammatory effect on your skin, you’re just saying the ingredient X is known for this… LOL
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My personal favourite is “up to”. “Up to 50% reduction in your apparent age!”
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Belassi: I love “up to” as well. “Up to 50%” could be 0%.
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I love that phrase, Belassi, beautiful concept!
I can imagine the twinkle in the eyes if the lady who picks up your antiwrinkle product in the shops and reads: “Up to 50% reduction in your apparent age!” - wallet gets opened - FAST! -
Here is a link to an archived document from the Australian TGA (Similar to the US FDA) that gives some good guidance on what cosmetic claims you can make for different product types. It gives examples of how to word your claims.
https://www.tga.gov.au/publication/cosmetic-claims-guidelines
NOTE: This document is no longer current but is a great starting point.
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Also, Health Canada has a very detailed list of cosmetic claims. I don’t know how well these would apply to the US though.
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To the FDA, there is no grey area. One of the reasons that they focus so much on “claims” is so that they don’t have to do any testing themselves.
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