My question does not just refer to their commercial use but also the R&D one… Let’s say I want to submit a Horizon 2020 project for a nano-functionalized cosmetic crème (not a medical grade one), would I still have to foresee clinical trials?
Does anyone have any experience on the EU’s ethics guidelines on this point?
Hi Alexander
I suspect it depends upon what you expect to be able to claim for the product. There are no clear guidelines in relation to "user" trials of cosmetics, although of course you need to have your biological safety assessments and other toxicology data completed before you should consider going ahead.
From a commercial point of view there may be advantages to conducting a properly constructed randomised trial. Many Advertising Standards authorities now wish to see clear data in support of any claims made, especially if you are planning for marketing in countries like USA where the Federal Trade Commission will follow up on any claims - for example Lornamead were recently fined $500K for not being able to justify claims for a product (http://www.ftc.gov/news-events/press-releases/2014/05/company-settles-ftc-charges-head-lice-prevention-claims-were).
Also if the product is to be advertised through media like QVC they have a really quite strict code for what they want to see in terms of data (see attached).
So my advice is if you are confident of the effectiveness of the product, conducting a properly constructed randomised, controlled trial is not only the best way forward to give the product the best commercial start in life versus the opposition it could also save a lot of grief and money in the long term.
Good luck, Ian
Thanks a lot to both of you for the answers and the extremely helpful guidelines/links!
Having serve for many years on the national Editorial Board for the Journal of Pharmacy and Therapeutics and Chairman of one of our local hospital P and T committee . the issues of OTC products, dietary, nutraceuticals have also been of interest. The initial laws permitted many approvals without much testing as long as specific (unsubstantiated claims) were not made. Of course both TV media and print media tending toward exaggerating the claims and the FDA clamped down.
I think taking the legal, moral and ethical high road is in everyone's best interest and agree completely with colleagues Ian and Ali.
Hello to you all and thank you for your insight, it was indeed very helpful.
I did my “homework” based on your feedback and the documents you send me and this is a summary of what I came up with (applies only to Europe):
According to EU regulation 1223/2009 for Cosmetic Products, the SCCS is the responsible body for deciding on safety regultions for the use of nanomaterials in cosmetic products.The SCCS has published two related opinions, one on the Health Risks associated to the use of Nanomaterials in cosmetics (SCENIHR) and a second one for Zinc Oxide to be used as an UV Filter substitute in cosmetics (SCCNFP/0649/03). Sunscreen products are however considered a specific category of cosmetics and are thus also governed by Directive 2006/64/EEC.
Even though there exists a general Directive for Cosmetics (76/768/EEC), their safety assessment is highlighted by SCCS/1501/12. Based on that and even though it is not specifically written down anywhere, there should be some type of clinical trials involved for sure (as all of you already mentioned!).
Thanks again…
Yes- all chemicals have the risk of toxicity and therefore require some level of benefit to risk evaluation. This is good scientific and ethical practice regardless of what the regulations require. The best method to do that is a randomized clinical trial and in this area placebo or vehicle trials are easier to enable.
I agree with Frank. Preferably the vehicle (with any preservatives, stabilizers,etc) should also be evaluated in case there are patients who get sensitivity reactions to those rather than the active component. The types of reactions can range for T cell Delayed Hypersensitivity Type 4 contact reactions to Ig E mediate type 1 reactions or MOA still unknown and yet to be elucidated.
please also read COLIPA guidelines. GUIDELINES FOR THE EVALUATION OF THE
EFFICACY OF COSMETIC PRODUCTS
http://www.ncv-cosmetica.nl/upload/File/Richtlijnen/20080704Colipa_Guidelines_Efficacy.PDF
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