Black Sea Rod Oil and Eyelash Growth Prostaglandins

Does anyone have experience with this coral eyelash growth ingredient?

Comments

  • Another marketing gimmick
  • PerryPerry Administrator, Professional Chemist
    Eyelash growth products are a drug. The only approved ingredient shown to actually work is produced by Latisse.
  • LeoLeo Member
    I understand that prostaglandins are able to grow eyelashes and are considered to be drugs due to the growth claim(s) but many companies use PG analogs in their eyelash products. It is also my understanding that this natural product has prostaglandins that can cause eyelash growth? Just wondering if anyone had experience with the use of this ingredient...without mentioning the growth claim, so that it is not a drug.
  • I don't have experience, but there are a lot of derms/plastic surgeons recommending against using this class of products given potential negative side effects. 
  • MicroformulationMicroformulation Member, Professional Chemist
    I have experience in producing the projects. I have also seen the FDA discipline letters. You may not make any eyelash growth claims whatsoever. Hair growth of any kind is a drug claim.

    There were several "Cosmetic" actives touted for this claim, but they have become much less common. Also, if you read their copy they usually say something like "volumizes" or "increases the appearance of."
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • PhilGeisPhilGeis Member, Professional formulator
    FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" (emphasis added) .


    Not claiming eyelash growth does not change the fact of intent.  FDA will not let you play stupid but will assume intent unless you convince otherwise.  You'd have to justify why  this expensive ingredient is in your product, and they'd likely insist you demonstrate it is not having a drug effect.
  • MicroformulationMicroformulation Member, Professional Chemist
    I agree with @PhilGeis entirely. You need to remember that the FDA Auditors likely have more experience in the Market, specialized training in Regulatory, and will quickly recognize the claim. They are not ignorant.

    As a rule of Thumb, if you believe your customers will make the leap on their own to "eyelash growth", of course so will the FDA.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • PerryPerry Administrator, Professional Chemist
    @Leo - "It is also my understanding that this natural product has prostaglandins that can cause eyelash growth?"

    Lots of people claim they have "natural versions" of synthetic things proven work (prostaglandins, retinol, botox, etc.). That doesn't mean these "natural versions" actually work. In fact, usually it means it doesn't work but the marketer of the ingredient wants to convince you it does without having to conduct a proper study.

    Stay skeptical. Require proof before you accept the claims of marketers.
  • LeoLeo Member
    Perry and others--I fully understand what everyone is saying with regards to the FDA and the claims and the lack of robust clinical evidence of benefit with the PG ingredients used.

    My question: how do the 20 or more companies in the market place that use PGs in their product such as Revitalash and others handle these issues seemingly without concern? Is it because the PGs they use do not lead to the intended effect and have no side effects at the concentrations used? Is it all marketing hogwash or do they really grow the eyelashes in some people?
  • PhilGeisPhilGeis Member, Professional formulator
    Good point - guess they're trying to fly under the radar with "conditioning" claim.  They do mention hair growth with ingredient 

    Trifluoromethyl Dechloro Ethylprostenolamide

    Trifluoromethyl dechloro ethylprostenolamide is a prostaglandin, or lipid compound, that is associated with increased hair growth.

  • PhilGeisPhilGeis Member, Professional formulator
    My bet - if FDA asked for safety data, they'd have nothing much to share.
  • PerryPerry Administrator, Professional Chemist
    @Leo - I don't know the answer but here is my guess.

    All this PG / eyelash growth stuff started with Jan Marini back around 2006/7. That brand was using the PG active ingredient that is being used in Latisse now. Jan Marini was doing it off-label and illegally and ultimately their products got confiscated by the FDA. But the Prostaglandin story was now out there.

    Revitalash started after they saw the success the Jan Marini was having. Originally they talked about PG analogs and built a recognizable brand. When Jan Marini got into legal trouble Revitalash was quick to rework their claims & dumb down their product. I'm not sure if it ever worked as they implied but enough people were convinced that it worked so they kept selling it. 

    The success of these early brands spawned the dozens of other copycats and that's where we are now. 

    All of them claiming the PG analogs grow eyelashes without any proof that it works.

    I personally believe it is all just unproven hogwash. Others might disagree. But I will add that no one wants to think that they have been duped.  Consumers who just spent a lot of money on a product are much more inclined to say that it works than to say it doesn't. I wouldn't take the reports of consumers on whether a product helps hair growth or not as anything other than anecdotal evidence. 
  • LeoLeo Member
    @Perry I have visibly seen the eyelashes extend in size with the use of certain PGs when I do a paired comparison study. The PGs work if used at the correct dose within a stable formulation. The downside is the side effect of coloration.
  • LeoLeo Member
    @ Perry I have no experience with this Black Sea Rod Oil that is claimed to contain lots of PGs but it should be analyzed with a legitimate study. I have no idea what dose to try and was hoping someone had some experience with the ingredient.
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