Microformulation
Forum Replies Created
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You make both Formulations and you do hair strand testing. It’s not something you grade on paper.
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I would suggest doing your research off blog. While it’s easier to get a simple question with little effort, you will never gain enough deep knowledge or overall familiarity of any topic by plugging your questions in to “chatbot 1000.”
This goes for Formulating in all areas. In this day these references are even easier to reference than it was for those of us starting in the 80’s and 90’s.
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“Shikakai, also known as Shika in Tamil, Seekaaya in Telugu, and Soap pod
in English, is a powerful ayurvedic plant that has been used for
generations as a cleanser for healthy, long hair, dandruff management
and relief of skin diseases.” https://pharmeasy.in/blog/ayurveda-uses-benefits-side-effects-precautions-of-shikakai/That said, we were once contracted to make a knock-off of this product years ago. We did do some marketing comparisons and in a US Market, it fell far short of the expectations of the US Consumer and would likely have some barriers to the market.
If your demographic is highly rooted in the ayurvedic claims it may appeal to a niche market. However, if selling in a US Market I would avoid ANY and ALL claims to any disease state whatsoever. This is not bias but is based on the regulatory experiences the line was subjected to.
pharmeasy.in
Shikakai - Uses, Benefits, Side Effects & Precautions - PharmEasy
The content has been written by a medical expert. Introduction: Shikakai, also known as Shika in Tamil, Seekaaya in Telugu, and Soap pod in English, is a powerful ayurvedic plant that has been used for generations as a cleanser for healthy, long hair, dandruff … Continue reading
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No offense but people “new to formulating should NOT, absolutely NOT attempt to make an SPF product. There are numerous posts from experienced Formulators echoing this sentiment.
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Unfortunately, you will have to discard the entire batch. There is no magic bullet.
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Is there existing product and/or sample clear OR are they insisting that the final product be clear?
If it’s the latter, you will simply have to manage expectations.
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Keep in mind that the term “antibacterial” must be supported with objective testing data. You can’t simply extrapolate the function based upon the Formulation. I have seen several cases where lines were cited for this reason.
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Magnesium has no credible Science behind it for Hair Loss and in fact, you would be producing an illegal OTC Product. “Every little bit helps” is more a Marketing Statement, It’s a great “marketing story” but an ineffective product.
fda.gov
Rulemaking History for OTC Hair Growth and Loss Drug Products
The Status of Over-the-Counter (OTC) Rulemakings contains the citation number of the Federal Register notices organized by therapeutic category subtopics.
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I have some real-world experience in this area.
My first piece of advice is that you will get limited value in reaching out to a Consultant outside your State. The majority of your Guidance will come from your State’s Environmental Agency. Each State has an internal agency oftentimes similar to the FDA in function. While this will likely not be their primary function (they generally also regulate other Healthcare Industries as well). If you reach out however you will find the person who regulates these programs and can provide guidance.
In my case, I was called in to consult for DHEC (the South Carolina Agency). To be honest I was retained less for any specific knowledge but rather because there were very few Industry Consultants in my State. The issue was with a Cosmetic Manufacturer who had gone bankrupt and left behind over 30 drums of unlabeled/poorly labeled materials on the loading dock. The owner of the property had contacted the State for assistance. Based on the few barrels that had the original labels, we felt the majority of the materials were Sunflower Oil. However, without proper labeling and documentation (MSDS’s/COA, etc) I could not certify that the materials were indeed Sunflower Oil. In addition, they had discarded product BUT it was intermingled. Proper procedures would have been to maintain each product in separate containers with proper internal documentation.
We were able to get a Hazardous Material Disposal company to take the product but due to the poor documentation, their fee was significantly more expensive than it could have been. Had the oil been properly labeled and documented we could have diverted it to a local biodiesel company.
The takeaways were to maintain proper labeling and documents for all stored products including waste. Consult your State Environmental Agency for guidance. Do not intermingle products EVER! A drum is not your only storage option. You may want to have a documented procedure for this process in your SOP Manual and a process to place these materials in “QC/QA hold.” If properly done, it is usually affordable to retain a disposal company for these materials. They do exist. If you don’t do it right, still contact the disposal company but expect to spend more time and money to complete the process. This is truly an area where proper SOPs and Procedures will save you time and money. There should be a written document and properly monitored processes if you want to do it right.
A start (may not be the proper Agency but they can advise); https://dec.ny.gov/about
dec.ny.gov
The New York State Department of Environmental Conservation (DEC) was created on July 1, 1970 to combine all state programs designed to protect and enhance the environment into a single agency.
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@mikethair It is certainly a positive to utilize your efforts to bring about positive change in one’s Community. In fact, in our initial brief to potential clients, we would identify a key part of Sustainability as being a positive corporate citizen, We have worked with lines who have facilitated the production of Argan Oil in Morrocan cooperatives populated by Widows and orphans, worked with a line that sent 5% of their annual net profits to Peruvian Orphanages, and a past line recently sent it’s entire inventory to people affected by Hurricane Helene here in the US. However, respectfully there is always a danger of setting a marketing metric (soaps good, syndets bad) as an immoveable goalpost as you will eventually find you will marginalize your efforts to engage in innovation. This is a recurring topic at numerous marketing symposiums I have attended.
We worked with several lines that utilized saponified soaps here in the US. While well received in niche markets, if you can look at objective sales data, these lines are generally self-limiting and generate a fraction of those using syndets. These products as well as “Natural” Insect Repellants are ubiquitous in most Farmer’s Markets and “Health Food” outlets here in the US. In my experience, syndets do possess some distinct advantages, are safe when appropriately formulated, and even offer some opportunities to meet sustainability standards. My root point is never to allow marketing to trump innovation.
@PhilGeis I agree with all your technical points. I have always respected and followed you as a credible industry asset. I simply believe he is so fixated on his root marketing and promotion of his line that you will fall on deaf ears. We saw this far too often in our initial client interactions and in fact, would generally use this as a reason to pass on certain projects. It may have been foolish from a marketing perspective, but we never lacked other opportunities and in general, my usual week was 60-plus hours.
I have recently retired but I do follow the Industry and products closely. I am simply weighing in as this discussion is starting to meander and lose sight of the true Technical value of this fantastic resource. As Scientists I believe we have an obligation to set the bar in discussions and as representatives in our Technical Fields.
Enough lecturing from me I suppose. As I followed the thread, I simply felt it was getting out of hand. Have a Great Day everyone.
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As mentioned, get rid of the Sodium Chloride. You may have seen it addressed for thickening, but that is with select surfactants for the most part. That is a topic far too broad to cover here.
You may not need the carbomer and the Xanthan gum. They are used in some cases together to potentiate each other but I don’t believe that this is the case here. I would strongly suggest that you do some independent study on carbomers and natural gums. I am not disparaging, but they are large areas of study and are far beyond the scope of blog learning.
I am not sure how you feel Disodium EDTA is thickening. It “could” be an issue with some carbomers.
Good luck formulating. There are lots of great posts in the group if you use the search function and keywords.
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You could get this information by speaking with Technical Services at Colonial Chemicals. Dennis there is pretty sharp.
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I have to disagree. I have 2 texts that cover these issues and I would wager I have read maybe 10 or so journal articles in the past year. The International Fragrance Association (IFRA) has lots of guidelines.
Research is key and what will in the end what will make you an effective Formulator, There are no short cuts.
The research would lead you to related issues such as MOCRA compliance, labeling, safety as well as others. For example, while these are likely part of the mandatory fragrance declaration (yet another area research would lead you to), are there cases where something like “Limonene” would be added? Those who do their due diligence already know the answer.
I’ve trained numerous techs who went on to become Chemists. One key trait was they read everything they could and I encouraged them to “stump” me. In these settings, the ones adverse to reading generally filed MSDS’s and did re-ordering until they tired of the job and moved on to other endeavors.
THERE ARE NO SHORT CUTS!
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This truly would quickly become work product. I agree wholeheartedly.
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I understand. I have worked with some lines where making money and capturing market share were never their focus. We learned to carefully vet these lines and one in particular (based on soaps and anhydrous products) is available in gift shops and small markets in Long Island. NY. My reason for vetting them was that early on we took on lines that had unrealistic expectations and lacked the requisite skills. In the case of their failures, they would deflect the blame on us, often in a public and petulant manner. As we learned, we were able to foster some great small lines. Often I would use this as learning exercises for our newer staff.
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Mark Broussard has always stood out in the Forum as one of the best Formulators, He has the skills needed and his MOCRA compliance services are worth every penny. As I wind down my practice, I will send clients his way, knowing he will also treat them.
Lots of success to Mark.
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This is far too wide of a topic for a blog and should entail some study on your own. I would suggest reading some Lubrizol documents on neutralizing carbomer and other sources. 3V makes some superior products as well. I believe in the value of self-guided research as it makes you a better chemist. It’s the standard I hold on any techs I train as well.
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This reply was modified 3 months, 3 weeks ago by Microformulation.
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This reply was modified 3 months, 3 weeks ago by
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Yes, absolutely. It would be best to track the neutralization with a calibrated pH meter, not strips. Your “assumption” that the other items will neutralize the product is 100% incorrect.
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Are you neutralizing the C10-30 Alkyl Acrylates?
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I can only speak to US regulatory restrictions and have some extensive personal experience with these materials and formulations from many years ago.
Most simply it comes down to the definition of a Drug versus a Cosmetic and the FDA’s Definition. Any product that would have a physiological effect or response is a drug. Over-The-Counter drugs (OTCs) have approved actives and have identified claims you can promote such as acne, hair growth, or numerous other claims. Legend Drugs (aka prescription drugs) are yet a third category. Latisse is (at least to my knowledge still) a product that requires a prescription.
In my experience, when Latisse was being promoted aggressively to physicians and in advertising, distributors promoted these raw materials heavily. Many “entrepreneurs” tried to capitalize on Latisse’s popularity. These peptide-based products became popular. The Formulations were fairly straightforward with a dash of greenwashing. The unit fill sizes were small and there was a potential for good profits if you could sell enough units. HOWEVER, unless you wrote a very well-crafted market copy that flirted with the claims but never crossed the line, the FDA would cite you. I can recall one person who lost over 45,000 units due to an FDA Enforcement action.
In summary, they are cosmetic raw materials with no real documented effect outside of small studies generally performed by raw material suppliers. You must rigidly adhere to the FDA limitations. The project costs must consider packaging and fill costs as they will likely contribute more to your material costs per unit than the actual product contained within.
Again, this would vary from region to region, but I imagine the EU and online sellers would have similar requirements and limitations.
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Your ingredients aren’t “organic or natural,” and simply adding “natural” ingredients won’t make your product “natural or organic” overall. This can lead to greenwashing. Be cautious if you’re making claims about eyelash growth, especially in the US. In 2009 these ingredients were popular, and marketers used them to compete with Latisse. The growth from these actives was insignificant. The FDA did cite some lines; https://www.cosmeticsandtoiletries.com/regulations/claims-labeling/news/21841967/fda-issues-warning-letter-for-eyebrow-eyelash-growth-product-claims
cosmeticsandtoiletries.com
FDA Issues Warning Letter for Eyebrow/Eyelash Growth Product Claims
Cosmetic manufacturer Lifetech Resources LLC has been issued a warning letter by the US Food and Drug Administration (FDA) regarding claims touted on three of its eye care products.
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Fortunately, I rarely have to deal with these retailers as we have great relationships with most US Wholesale Distributors, get sampled materials in most cases, and have access to their Technical Service Department.
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Agreed. I had a line that strongly insisted on using Leucidal. We provided lots of feedback from credible sources. They were “sold on” that fact from the retailer that it was an “effective natural preservative” and even told them a chelant was unnecessary and there was no need to boost the preservative. (This was several years ago). As always we documented the fact that marketing overrode our “strong” concerns.
Less than a year later we got a frantic call, “One of our retailers is pulling product off the shelf due to a black growth. What is it???” We pointed out it was likely a contamination issue. They tried to assign blame on us to their higher-ups saying we created an underpreserved product. Fortunately, we retained the email where they said, “Use what we want.”
“Natural” should never be your primary reason to select a preservative.
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Agreed. If they are in the US and follow some of these recommendations, they are impinging upon the US OTC Acne Monograph. Hopefully, they can follow the Regulatory Guidance.