Microformulation
Forum Replies Created
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Wouldn’t a comparison of Zemea vs. Propylene Glycol be more valid? I would contact DuPont, Tate, and Lyle (http://duponttateandlyle.com/) for this data. I have not seen any INDEPENDENT data, but in my experience, we have switched it out for PG with no changes in performance.
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Sorry, but that reckless attitude makes it harder for the rest of us to maintain any credibility in this Industry.
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I have to weigh-in 100% plus behind what @Perry has said.
First, many people believe that they can use clever verbiage to imply to their clientele that a benefit can be achieved. It is a mistake to believe that the FDA will not make that inference as well.
Secondly, I have seen lines try and let the clients make the inference and then post “testimonials” touting these benefits. They will blithefully disavow themselves from the claim with a justification of “I can’t control what others say.” The FDA has confronted this loophole. If it is on your social media or any other mode by which you control, publishing these statements falls squarely upon you.
Thirdly, many of the products are based upon botanicals and google citations of anecdotal data. This does not satisfy the research standard and in fact, it is naive. Many of the studies that are cited are informal and nonvalidated. In many cases, the raw materials are difficult to obtain. For example, I had a client who wanted to use Silkworm excrement (yes, look it up). The material had a 12 week lead time which in reality proved to be closer to 16 weeks.
Finally, there is no need to take such reckless and foolhardy risks such as promoting a noncompliant product with an end game of being “regulated” out of Business at some point. There are plenty of opportunities to make bonafide, useful and ethical products in this industry. As you will learn, the product is just one facet of a successful line. To a large extent, your marketing and market presence are the real values that you build. In your Business model, you have an end game that invalidates one of your most valuable assets; market presence and reputation.
There is plenty of room in this Market to do things right and still be successful.
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I have read several articles about these specialized polymers. Essentially they “depolymerize” under certain conditions, releasing the active materials. As far as I know, they are still in the early stages in Biopharm and I have not heard of any entry into the Cosmetic Industry. If you want more information, you may want to explore a site more properly dedicated to Polymer Science.
http://onlinelibrary.wiley.com/doi/10.1002/0471440264.pst610/abstract
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I actually think by pivoting away from the Growth claims, you are far better positioned.
Making quasi-drug claims in the US is risky, but as Perry pointed out rightfully COSMETIC claims (keep circling back to the FDA definition) are much easier. to make and I see them made all the time, often circling back to the Distributor’s literature or other such references.
I think if ou read the FDA Warnings I posted above you will see that it is when the lines “fly too close to the sun” and encroach upon a drug claim, this is where the FDA steps in. Not with claims that are truly Cosmetic, again as listed in that FDA definition.
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I believe we spoke briefly. The issue at heart was your strong desire to either claim beard GROWTH outright or to infer through crafted marketing copy that the product could deliver beard growth. As I have heard said on numerous occasions, “If you expect your customers to make the jump to the tacitly endorsed claim, it is naive to expect the FDA to miss this inference.”
In this case, the sole issue is the encroachment onto the FDA OTC Monograph for Hair Growth products; https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm071330.htm
For a more encompassing article on OTC monographs, I would suggest reading this.
When trying to decide if your product is a drug or a Cosmetic, I always refer people back to the FDA Definition;
The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”Jun 7, 2016As many will tell you, the risk of being cited by the FDA is small at first but is still quite real. If you look at the recent FDA Warning letters, you will see that there are many small to medium size companies cited as demonstrated here. Also, just because you can find a noncompliant company, this can not be taken as “permission” per se to make the same claims. This is a facetious assumption.
After we spoke briefly, I believe that I referred you to a well known Cosmetic Regulatory Expert.
It is indeed possible to start your own Cosmetic Line and in fact, it is done quite often. It is quite possible to make a product that stays well within the limits of the definition of a Cosmetic and to build a product that delivers realistic Cosmetic benefits to your clients. There are far too many examples to cite where companies have adhered to the limits and still built successful lines, without exposing them to possible censure.
I would suggest taking one of the many courses available such as Perry’s course; https://chemistscorner.com/start-your-own-line-of-cosmetic-products/. This will give you information on how to start a compliant line.
https://chemistscorner.com/what-are-the-startup-costs-for-a-cosmetic-business/
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Very much on topic and recently posted on Prospector.
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As someone better stated, “The client is not always right, but the client is always the client.”
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Why do you want the pH so high?
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They are getting popular in the US and I will see if I can find one. The Recreational Marijuana Industry uses CO2 Extraction to create many of the oils.
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It is usually listed as Methyl salicylate or Wintergreen oil.
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@BelassiI can see your point. Many of the studies are small or single subject studies. I am also waiting for more in-depth validated studies.
I have helped design several muscle pain relief products but they used typical counter-irritants (Menthol, Eucalyptus) in addition to the CBD Oil.
As I say always, the jury is still out. I believe as these products are legalized on a wider scale in the US, larger more validated studies will e conducted.
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@BelassiI can see your point. Many of the studies are small or single subject studies. I am also waiting for more in-depth validated studies.
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CBD is derived from Medical marijuana. Certain strains have a higher CBD to THC ratio (4:1 I believe). CBD has many purported effects, many of which are just now being examined in human trials. Many of the skin care claims are still poorly studied (single small study NIH studies) but I imagine as time goes on they will have larger samplings.
I have consulted via distance since it is illegal for me to possess the actual raw materials. Most CBD sources are CO2 extracts diluted into an oil base so pretty easy to formulate. The real issues are shifting regulations (in some States they are practically writing them as they go), issues with encroaching on OTC monographs (the FDA will not overstep the state laws for medical/recreational use but will enforce OTC regs) and the still developing studies of efficacy.
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I am not based in California. On the lines I consulted on it was by long distance. I can not Formulate as the materials are not legal in my State,
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Be sure to use Leucidal with SECURE packaging as well. It really needs good hurdle technique.
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@johnb It was a joke that fell quite flat. I am a Formulator in the US. When you mentioned the caution to avoid asking for free work, I jokingly offered to put all my pending paid Formulation work onto the site for others and take a nap.
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The concentrations of 1,4 dioxane in ethoxylated products have been greatly reduced through new processing methods and are in the ppm range.
Phenoxyethanol issues have also been mitigated as well through the combination of the preservative with other products and better guidance. An experienced Formulator can practically eliminate this as an issue through proper use.
Much like most of the “maligned” raw materials, the Science behind the “bans” is spotty and weak.
Now, does that eliminate the issue as a factor we can ignore? Certainly not! Marketers will still put great emphasis in some cases on avoiding these materials. Fortunately, we have many alternatives.
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@johnb Quiet. I am about to start a post for every Formulation I have in my In Box and then take a nap!
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Formulator Sample Shop sells it retail. http://www.formulatorsampleshop.com/
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Good quality pH meters will adjust and account for the lower water content and conductivity (as well as temperature). Of course, if you don’t have one to this standard, it is much less accurate.
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I have recently used the Leucidal Complete Liquid (the product which essentially combines the two) in an entire product line with success as measured by PET (Challenge Testing). Keep in mind that I used a “holistic” approach of a secure packaging choice, pH control and good cGMP (sanitary practices).
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On point, one of my clients wanted to use a Food grade product recently. Yesterday the micro results on their product came back. 460 cfu/ml. Probably not a good idea.
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Calling PEG-100 Stearate and Glyceryl Stearate an emulsifying wax is improper terminology. It can be used as a stand alone. Rather than belabor it, here is a link to a helpful data sheet that explains it’s usage completely. https://drive.google.com/file/d/0BwuqL_fQzYhiZjlkSzREdm9xOE0/view?usp=sharing
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Peg-100 Stearate and Glyceryl Stearate is not another Emulsifying wax. It is a common product (Arlacel 165, Simusol 165, etc.) that has an HLB of 11.