Microformulation
Forum Replies Created
-
@Sibech First, kudos on this statement touting wisdom we should all follow “@Dr You are welcome to disagree, that is what debate is all about. ” We need to not lose sight of that fact.As far as “Natural” goes, the markets that we are dealing with are evolving. In 2008 I was doing a lot of Whole Foods work and I mean a LOT. At that point, their buyers were more concerned with meeting a market model that was based upon the naturalistic fallacy and chemophobia. I can recall relatively few instances where a prototype was rejected for performance (less than a handful) and we were subjected to somewhat less scrutiny in regards to raw material costs. It was “natural” above all.Since that time, the larger “natural” markets have evolved. “Natural” is still an issue although there has been a movement to qualify what this means and to address a natural standard. I am fortunate to have developed some friendships with people at Whole Foods at the corporate level in Personal Care and they relay the pressure that they have faced to “evolve” the “natural” market in their stores. No longer is “natural” the only aspect, but the gaps in price and performance are narrowing rapidly. Cost and performance are now issues.A Customer will now accept a slight difference in the performance with a “natural” product vice a traditional product, but not nearly what it was in years past. No longer will they pay 100% more just because it is “natural.”A good naturally compliant product is like a three-legged stool (natural marketing story, price, and performance). The amount of “wobble” (imbalance in the 3 factors) has steadily decreased and will continue to do so. This is the concept that we must keep in mind if working with these products, especially if you want to get into the US mainstream market and to breach out of the “Farmers Market/Craft Market.”Again, I will steal freely from Sibech, “You are welcome to disagree, that is what debate is all about.” My Statements are derived from being immersed in this market for numerous years and a track record of assisting clients in getting “naturally compliant” products into the Market. I am seeing that the clients that evolve (especially in taking on a LOHAS Marketing Model) are thriving. I have a client that grossed a million last year in just 3 years after evolving their line. She made honest and supportable claims, met them with the Formulation and promoted them in Social Media. In the end, there was no reason to rest on fear or poor science. -
Hot selling equals Marketing. Hence the existence of $400 creams with a dollar of raw materials in the Formulation.Well performing makes it a drug in the US. Hence the OTC Monograph. Otherwise, we are dealing in Snake oil.
-
Also is Phenoxyethanol a mineral? I wanted all mineral ingredients.Never allow Marketing (as in I want all minerals) to drive the Formulation as such a primary focus. There are ingredients that are required to make these type Formulations effective and well received by the Market. Science first. You can set a rough guideline for raw materials, especially in certain niche markets, BUT never make the Science bow to Marketing. A poor performing product that meets some rigid Marketing will fail.A customer will buy a good product that meets a natural standard. They will not buy a restrictively “natural” product that does not perform well.
-
I keep seeing these posts. Why do you feel this is an unorthodox product? This is a pretty common Formula that I have seen tens of times? Also, when developing naturally derived pomades and fixatives, keep in mind that you may have to accept a gap in performance between the naturally based Formulation and market leaders using newer, superior raw materials.
-
-
Minoxidil is allowed in 2% and 5% concentrations, in a hydroalcoholic solution or a solvent-free foam. The form is important as this is defined in the OTC monograph. I had a client want to do a different dosage form and the Regulatory person we retained stated his “new form” would require a New Drug Application (NDA).Ketoconazole is not properly a Hair Loss active as defined by the OTC monograph and in fact, is only approved for Tinea versicolor caused by Malassezia furfur. While many sources speak to the role of Malassezia furfur in hair loss, this active can’t be promoted for Hair loss.
-
Are you located in the US? If so, you are strictly limited in active materials which you can endorse for Haircare. This is considered a Medical Claim in the US and as such, not allowed.
-
Actually, if you look at the mortality rates of the bleeding crabs, it is very low, in fact below their natural mortality rate. Here in SC, the Pharmaceutical Industry lobbied to stop the use of Horseshoe crabs as bait. The Commercial Fishing Industry would kill far more crabs on a yearly basis by far than the Pharmaceutical Industry. In fact, the Horseshoe crab population is expanding here in the Carolina’s.I only know this because the facility is for ann intents and purposes in my neighborhood. It is less than 5 miles away and I have toured the Facility.
-
In Industrial Pharmacy they use the LAL system quite often. It is also a cool backstory with a link to me locally. The Limulus Amebocyte reagents are obtained through the bleeding of Horse Shoe Crabs and the isolation/standardization of the proteins. The reagents react in the presence of microbial contamination. The company has a handheld system using slides. It has even been used on the International Space Station. Recently I visited a College roommate at his work, a Pharmaceutical Manufacturer and the LAL systems were ubiquitous throughout his facility.
-
Was it the Charles River Endosafe handheld Limulus Amebocyte Lysate based detection system?
-
That is why we use GRAS ingredients at proper levels and recommend testing. As for the question, that is simply the interpretation under US Civil Law. Somewhere on my server, I have the letter from the FDA stating as much. The Regulatory Person is well known and he mirrored the same answer at a seminar I attended.
-
I will weigh-in as well. In my experience, your liability and exposure are directly related to your visibility in the Market. At first, you will be small enough to avoid any real enforcement actions (unless you are reported or make Drug claims) but at some point, you will hopefully grow large enough to command some attention. This is where product liability becomes more important. As such, I always tell my clients to do it right from the start.As the Formulator, you have limited liability as this rests upon the distributor (this is backed up by the FDA and a Regulatory person I spoke with). There could be a case where they could attempt to breach this exemption but again it is unlikely. As such I would be more cavalier in such a scenario.
-
Perry makes some great points above.On point 3 Perry touches on the issue of ownership of the Formulas. We work with clients to do their Formulation Development and then source out manufacturing. It is very important to be clear with the Contract Manufacturer about this issue. Also, to expedite this process, have a Formulator do your project or at MINIMUM have one experienced in Contract Manufacturing review the Formulas. I have had numerous Contract Manufacturers send us clients because the Formula “wasn’t ready.”On Point 5 Perry touches on Private Label. For many lines, this is the best way to start and allows one to minimize the costs as well as any liability. The Private Label Formulations are for the most part quality products which will have your branding.Lastly, my best advice when sourcing out Manufacturers is to start first with the HAPPI Contract Manufacturer Directory (https://www.happi.com/directory/). This is somewhat searchable for product type and location. While it is nice to have someone immediately local, I will say that for a novice a Site visit is of minimal value. After ensuring the manufacturer can produce the number of pieces needed, can produce the type of product and has any needed certifications, I would urge you to look at their programs (cGMP, ISO, OTC, NSF). This will indicate that they have in place at least some QA/QC programs and are credible.
-
For all, I want to point out that SteveW is a Technical Representative for Kinetik. I emailed him and as a member of the board he reached out and answered directly. He is a great source of info in this matter.
-
If you are using a reputable manufacturer, the plastic type is reflected on the bottom of the component.If there is a repeatable soft spot that is flimsy, @Belassi is spot on. You need to send them back.
-
I have seen the same issue in PET. In many cases, we fixed it by changing the material of the components.
-
What is the material the bottle is made of? Is it PET?
-
I use it as it is better tolerated in today’s”natural” markets. EDTA’s are generally frowned upon. It is a product that Kinetik (Dr. Straetman’s US Rep) pushes hard. I guess otherwise my other option is Dissolvine GL-47-S which I also have in stock.I will email Kinetik right now and share their thoughts.
-
@Doreen Interesting! I will have to read-up on it and ask my Kinetik rep regarding the issue.
-
Sunscreens are difficult Formulations and it is counter-intuitive to try to use “fewer ingredients” unless you know the function of each. Even with a bare-bones Formulation, it will have a long Ingredient Declarations. Between you and me, I hate these silly, gimmicky lines that try to aggressively reduce ingredients. It is laborious.My questions are, some recipes that claim to work using zinc oxide don’t have dispersing ingredients added so even if it does clump might it still provide better protection than nothing at all?1. It will not pass mandatory testing.2. It is inexpensive enough that your cost savings of making your own are a false economy.I can’t use preservatives or many other ingredients without a reaction.
I can’t even begin to tackle this one accurately. For example, since there are so many different classes of preservatives, I would be HIGHLY skeptical that every preservative makes you develop a reaction.
-
In the US?
-
Many are. If you look at the FDA Warning Letters, most of the warning letters start with drug claims made either in their packaging or advertising.This article goes into the drug claims and how the FDA identified the claims; https://www.mariegale.com/look-for-product-drug-claims/Here is a link to the warning letter. Once the company got onto the FDA’s radar, they were cited with numerous cGMP violations. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm609437.htm
-
Florida has an absolute prohibition and the State is aggressive. As far as the FDA, in my experience, the people who produce at home often tend to cut some corners and are exposed to cGMP compliance actions. Read about the recent Silver Armor recall by the FDA. While they were not making it at home, they were cited for Drug claims and when the FDA inspected they had HUGE cGMP compliance issues.
-
You may want to check with your State if you are in the US. Some States such as Florida have an absolute prohibition against making Cosmetics at home for resale. In addition, should you face scrutiny from the FDA, I am almost certain that you will not achieve the cGMP standards out of your home.