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Who Says Topicals Don’t Affect…..
I don’t think this debate is going to die off in the next 100years! Just as I was about settling my mind that “you heal from within”, then you get a REAL LIFE case that says you can also do the same from “without”. See this article. Of course, we know it is likely the beta-glucan in the oats that is likely to be the moisturizer, but is this not proving that you can heal (or affect the skin) from topicals?
You be the judge. -
10 Replies
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Strictly speaking, a cosmetic product is not allowed to heal or to show any pharmacological effect (with the exceptions of moisturising and barrier function etc.). If it does so, then it becomes a pharmaceutical, or, where accepted, a cosmeceutical product.
It goes without saying that the right pharmaceuticals do act topically and it’s likely that some cosmetic (or food) ingredients will work systemically on injured skin because it lacks it’s natural barrier. Sure enough, there’s not only things we can’t explain (yet) but there’s also a grey zone. -
Yes, I agree with you, @Pharma, but what do you say to this very article that ordinary Quaker oats is providing some topical solution to a debilitating problem?
What would you call this simple solution? Cosmetics or pharmaceuticals?Now, it is most likely that the actual solution to her eczema is the 1-3,1-6-beta-glucan polysaccharides, which can be extracted and made into a serum on its own.If a manufacturer makes a serum as such and labels it as a moisturizer and someone like this lady experiences the same, what would the product be called? Would the manufacturer be called into question as making a drug, too?I think anything that touches the skin is actually pharmaceutical - just my opinion. -
@braveheart: totally agree. I suspect the FDA has this regulation solely to protect “big money” drug industry players.
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There are actually multiple active ingredients in (colloidal) oatmeal. A link here:
I know from what my parents and grandparents have told me, oatmeal was a fairly popular folk remedy. They didn’t consider it a folk remedy, though-going to the doctor was expensive for them.
@braveheart: It’s a good question. I’ve seen the FDA go after companies who use testimonials as evidence, such as “I didn’t need to go to the hospital for my burns after using this lotion!” when the product didn’t have any active/drug ingredients. But on the other hand, companies are apparently safe if they have testimonials. I suppose it depends how the testimonials are worded.
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@Bellasi: Yes, it’s such a shame that with all the billions the big corporations make, they still have to be protected that much.
@MichelleReece: Informative article, “Today, colloidal oatmeal is available in the form of moisturizing creams. The high concentration of starches and beta-glucans in oat are responsible for its protective and water-holding functions. The hydration of the skin is one of the most important agents involved in preserving the integrity of the stratum corneum barrier. Oatmeal is a good option for moisturizing of dry or sensitive skin.”All these are opening my marketing eyes to wording my lines should any of my formulations come back with a similar testimony. -
Having some experience with the FDA I think you are all wrong about it being protectionism. Firstly, there are legions of smaller companies that fly under the radar and are wildly noncompliant so if it was intended to protect Big Business it is an abject failure.
Secondly most of the FDA Inspectors I have met had no ulterior motives. They were focused on ensuring compliance and in fact were great resources if you treated it as a learning experience rather than being adversarial.
Lastly, the whole “Big bad FDA is killing people and protecting Big Pharma” is generally what I hear almost daily when a clients project is noncompliant. I have seen ingested Essential oils (without trained advice) and other pseudoscience defended solely on the big bad FDA argument. I have seen smaller lines misuse testimonials and take the “I can’t control what people say about my product” to excess. I for one was happy to see the FDA adress this issue.
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The FDA’s attitude is extreme, compared to other countries. I can’t think of anywhere else that regulates claims like that. And I don’t understand how they justify it. Just one example, I was studying urea and there is no doubt, you can use it to make structural changes to the dermis. There are plenty of studies. But according to the FDA if you claim that your cosmetic containing urea does that, you are now marketing an OTC drug and breaking the law? That is a complete oxymoron.
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I agree that there needs to be a more streamlined OTC approval process, similar to what we are seeing with Sunscreen Innovation Act. HOWEVER, with some of the accounts I see it is the only censure they believe in and hence the only reason to comply. Without the FDA we would see egregious and disingenuous marketing. What I see is bad enough.
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I think part of the issue is that the skin is a very complicated organ. (Yes, medically speaking, it is considered an organ of the body, like the liver and heart.) It happens to be the only organ visible to the eye and we tend to view it as an static layer of impermeable matter that holds our innards inside and keeps the outside world outside. This leads to a very common worldview that anything you slop onto your skin is like a wood finish, or paint — purely cosmetic improvements that don’t affect the “real” structure of the body.
And I think that originally, the FDA regulations were created when this was the prevailing medical view as well. However, the past 20-30 years brought a lot of medical research that has revealed how phsyiological complex the skin actually is, as well as a lot of information about how to use the skin as an means of delivering pharmaceuticals to our innards. We’ve realized the skin isn’t some inert layer of tissue, but a dynamic organ with its own ecology so to speak. Dry skin isn’t like old, flaking wood in need of some varnish. Rather, it’s the symptom of a breakdown in the skin’s physiology, and to “moisturize” is to aid the healing of these systemic breakdowns.
So seen in this light, FDA concern may be considered justified, because they are trying to protect the consumer from unscrupulous or uninformed manufacturers who market products with ingredients that could harm their bodies -or- do not meet the claims that were made. On the other hand, one could question whether the FDA’s classification of a “drug” (i.e. a product that affects any structure of the human body) should be extended to the physiological functioning of our only external organ, the skin. It’s kind of a grey area. Is old, dry skin a sign of poor health? Or is it more of a cosmetic inconvenience? How about persistent excema? Dark circles under the eyes? Where do you draw the line?
So, I don’t see this so much as an issue of FDA protecting pharmaceutical companies so much as a clash of old and new worldviews.
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Whenever I see an article claiming some simple ingredient is getting amazing results I always keep in mind the three things that can happen whenever you apply an ingredient to a skin condition.
1. It gets better2. It gets worse3. There is no changeThis is exactly what can happen if you do nothing to a skin condition.Proof of effectiveness requires more than just random people, unblindedly trying things and unskeptically reporting results.There is a reason the FDA requires double-blind, placebo controlled evidence before approving something to treat a disease.Maybe the oat meal helped this person. Or maybe her skin would have cleared up on its own whether she applied to oatmeal treatment or not. Only a controlled study can answer that question.
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