Microformulation
Forum Replies Created
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Good Lord. SMH
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$2400 in fees. This is not a source if the most basic information, for free.
Your question is so broad as to be unanswerable.
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We will have to agree to disagree. Looking at my to-do list, you have already exceeded the time which promotes this dialogue. Learn, experience and deal with the FDA. They are not the enemy.
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My background is in Pharmaceutical, Personal Care, and Cosmetic Manufacturing. As such, my practical experience is being the appointed liaison to an FDA Inspector in excess of ten times, maybe even closer to 15.
The FDA Inspector will present his/her ID and they will tell you the primary reason they are there. Be polite and respectful. You are a Business and this is what Professional means. Answer their questions succinctly and ask follow-up questions. The Inspector will suggest corrective action. In fact, in many cases, you and the Inspector can turn it into a teachable moment. You will get a list of corrective actions. Complete them and move on.
As far as Guidance goes, yes I am not a neophyte Chemist and I submit that if you got some of the more experienced Chemists in a room and formulated a plan to comply in almost any situation, I would wager that we would all likely be almost 100% in agreement. The regs are not so murky that you can’t navigate them. And if you have any doubt or disagree, consult a Regulatory Professional. Get their input on letterhead and POLITELY disagree via writing. They have a review process.
In the end, no offense but I believe that you damn the torpedoes, full speed ahead, us versus them attitude will become an obstruction to your Regulatory compliance.
Most cases where I see someone rail against the FDA they are so far out of spec that they are fearing correction. Small start-ups that foolishly choose to manufacture themselves without formally trained staff will get dinged, as they should.
So, what is my experience? Likely as much as any Chemist can get outside of someone working in Regulatory can get.
My attitude on compliance? 100% compliance. Do it right.
My attitude towards the FDA? They are not the enemy.
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I have NEVER had an issue with the FDA and I have gone through quite a few audits.
1. The rules are widely set. Just be conservative. Honestly, I see more problems arise from lines looking to skirt the regulations using the “what if I do this” mentality.
2. The FDA is not one faceless entity and when you do an audit, don’t make it adversarial. They will tell you in advance why they are there. Cooperate. Ask questions. In the end, each of the 10 plus audits I have been through ended well. We assuaged the FDA’s concerns and by following their guidance, our processes were improved.
In summary, believing the FDA is an evil force or part of a bigger conspiracy is a waste of time. If anything, they are a much larger presence in the Prescription Drug Industry where I first started.
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I doubt that many Consultants will share their hourly rate here. As one myself, my fees are structured to be competitive and as such are confidential.
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I would seek out the proper forums. There are candle forums and groups that will be much more helpful than this forum. They are targeted towards this product and have numerous experienced people participating.
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I have used DMAE as part of an anti-aging cream. It was easily incorporated. The only real downside is the odor.
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Still a losing proposition. Dimethicone is nowhere near lanolin.
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I didn’t weigh-in since in my experience these exercises where a Formula is substituted en masse are always a losing proposition. The changes tend to be sweeping and as such can greatly change the stability and properties of the product. It is usually best to start the Formulation from scratch with regionally available raw materials. This (and the differing regulatory status’s) is why I restrict my work to North America.
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Regulatory and Documentation. Several times a quarter I get a frantic call from a Cosmetic line that is trying to place their product with a specific company or buyer. They also “over estimated” the marketing advantage of “using our own harvested” raw material. As soon as they deal with the buyer, they get a document like this;
This documentation comes routinely with a credible wholesale source. If you are using your own undocumented product, you will either have to obtain this testing ($$$ and slow) or switch to a reputable source that does supply these documents. Note, that some of this documentation ($$$) is done each and everytime you harvest and create the raw material not just one time. In the end, the fallacy that “we use our own harvested material” is a false economy. There are so many other more important marketing benchmarks, and this is a distraction. I know this is not an objective and eminently proveable statement, but it is based upon numerous (>25) cases where this mistake was made.
Also, one of the goals of good manufacturing is a consistent product. In these cases the feedstock (the initial plant material) varies based upon many conditions. One advantage of processed materials is that the presence of the preferred active material is quantified and the final raw material is standardized within a narrow window.
Can use use it? I suppose. However, it will eventually be a barrier to growth of your line.
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The best guess I can make is that they dispersed the SAP into the oil base. I don’t see significant aquesous phase for any other option.
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I doubt that the CBD is “75% potent” as this is really not how they report the testing. Somewhere I have a testing report from a lab in Oregon. If I can find it I will redact it and post later. Essentially it delineates the CBD per a volume of extract and the THC in a volume of extract. You then have to use this known extract breakdown to get the final concentration in the finished product. Without this testing result, the calculations are inaccurate and difficult.
If you are going to do a product with any credibility, you must have a consistent product. My issue here is that on the surface we want to treat it as a credible medical product. If you want to do so you must treat the entire process as a quasi-pharmaceutical across the board. If you are not 100% behind this, just put in a small amount for label copy and move on.
If you treat it as a credible product, you will need to use standard Pharmaceutical calculations. There are numerous resources to learn these online. I could weigh-in to help initially, but this is a skill you MUST learn as well. The difficulty in solving this immediately is that you don’t have all the factors. Essentially you have “solve for Y using X.” We know what Y should be, but you have no definition of X (the composition of the extract).
Lastly, “This does not stop people for wanting to jump on the band wagon of a public trend right now,” is not the greatest argument to put forth. In my opinion, the people who will persevere in this Industry are the ones which do it right at the level of a credible product. Remember, lemmings running off a cliff into the ocean are also “following a popular public trend.”
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Might be too late, but I did know of an intern who brought representative samples of their work and handed it out as a “goodie bag” with their resume to Contract Manufacturers. They got some great feedback and an offer. They did have to pay to relocate.
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@Perry While I agree with the Organic Chemistry analogy, I am quite sure that the USDA has a differing opinion.
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French Calcium is their bastardization of Calcium Ketogluconate. Is this the Holi(oil) Refining Youth Serum Agent Nateur? https://www.agentnateur.com/collections/products
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I am wondering how they obtained “Organic Sodium Ascorbyl Phosphate.”
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You need the analysis of the CBD tincture giving you the yield of CBD.
@BProvisons did an excellent breakdown of the process several weeks ago. https://chemistscorner.com/cosmeticsciencetalk/discussion/4067/cannabis-in-shampoo-and-conditioner#latest
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Simply, you will not likely be able to sell a home manufactured product on Amazon.
Google the FDA definition of Cosmetic. Your product is a Cosmetic. “Topical” is not a category in this case.
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@Melanie27 I think you will find that most trained Chemists will advise to avoid the lemon slices. It brings little to the table and it could stress your preservative system. The remainder of your products have good technical documentation and this does not. Keep in mind that LUSH has more assets available to limit the issues with the preservation which you do not.
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But why the Lemon slices? That is not great practice in Cosmetic Chemistry.
Also, there are many different emulsifiers any of which I would highly encourage you to try as your experience level increases. EWax, as I was saying, has many issues. It’s one advantage perhaps is that it is easy to use. As a Batchmaster, I dealt with when I started 30 years ago told me, “use 25% of the oils and that is your EWax percentage, If it isn’t Polawax, add another percentage point of Ewax.” Ewax, however, does soap. This soaping can be overcome to some extent with silicones and esters but it is limited when compared to some of the newer emulsification systems. Also, if you are trying to meet a credible “natural standard”, most Ewax’s would need to be avoided. Check the INCI names, but the majority are ” Cetearyl Alcohol, Polysorbate 60.” Polysorbate 60 as an ethoxylated compound is not allowed under most of the “natural standards.”
If you are looking to start with some newer emulsification systems which can be purchased in smaller retail quantities, check out some of the available products at the Formulator Sample Shop for instance.
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@Perry I am also heavily skeptical regarding any Cosmetic claims as well. Honestly, I would see it as a much more expensive alternative to Hemp Seed oil, likely bringing the same benefits. Any “upsell” in this area will likely be marketing driven and not Scientifically supported evidence.
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@BProvisions Great summary! I was happy to see someone weigh-in who is applying the proper level of technical documentation and knowledge in the Industry.
As far as the studies go, I agree with one caveat. I have honestly read almost every study that existed up to 2 months ago and the most credible research was in the UK, Israel, and Canada. In the US most research money is either from Federal grants (not an option here) or from Industry R&D which is expected to pay off in the long run. As of yet, very few US Studies meet the standard which would be required by the FDA to substantiate its use as a prescription or therapeutic agent. I came over from Pharmaceutical manufacturing and I simply say that it has not been evaluated to the standard of a traditional drug trail.
My frustration with the lack of drug trials is most likely a result of the endless unsubstantiated memes which purport it to treat everything, that “Big Pharma” is holding it back out of greed and lack any credible citations. I believe that it will treat many conditions, but far less than the scope that these “memes” propose. Many of these memes are posted by people who I infer are not really suffering from a credible condition, but rather are more likely fans of the recreational use. I just wish they would cut to the chase and just admit that they are more motivated by recreational use and leave the medicinal aspects to “Scientists” who will use the proper methodology. As a Libertarian, I really couldn’t care less about anyone’s recreational usage.
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Do people use Ewax outside of DIY markets? Seriously though, there are far superior emulsifiers.
I would leave the lemon slices out also.