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Need pointers for info
Hi,
I am a synthetic chemist with 16 years of process
chemistry experience (API synthetic route, scale-up and tech transfer to CRO).I have interest in developing (independently) a
new oral gel product for XYZ indication and have been laying out the groundwork
for some time. I am planning to develop a finish formulation by myself,
although I find the learning curve much steeper than I thought. I work with
complex scientific issues all the time, and was not anticipating that this
aspect of my project would actually be a major component of the work. Granted, I actually understand that formulating a shelf stable neutral-gel that is safe is more than googling a recipe. Eventually, I want to have most of the wrinkles ironed out before I talk to a CRO.I have a rough working knowledge by now of
formulating basics, reading through countless papers, although I am clearly out of my comfort zone for a synthetic chemist. What I just can’t seem to
find are answers to some very basic questions related to regulation “and stuff”.I thought I would try asking on this
forum, since this is the only open discussion on the topic I can find and even
if my product is not a cosmetic, it relates to many of the subjects discussed
here. If anyone can answer any of the Q below, or point out to a good resource available online, I would greatly appreciate it.1) Is the FDA involved in the approval of “natural” (Vs prescription drugs) non-sterile oral product (like gels) or non-fluorinated toothpaste? Can anyone
start selling legally such product over the web without filing anything?2) Why are there so many so-called “natural toothpaste” that claim to be preservative free? Wouldn’t they fail a microbial challenge test? If so, is it strictly up to the consumers to judge what can harm them?
3) Whats the mood out there in the formulation community regarding paraben? Are there any new products being developed with them, or are they considered an automatic marketing suicide?
4) Any web based resources that could be a good starting point to learn about how to use formulation in your patent filings?
Thanks in advance for any pointers. (sorry for the long post).
Regards,
DL
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4 Replies
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2. not necessarily - if there’s not enough water in the formula to sustain microbial growth, the product can easily pass a challenge test without an active preservative (at my last place, this was our preferred method for preserving toothpastes)
personally I’d describe that as “self-preserving” rather than “preservative free”, as it’s less ambiguous and less open to legal challenges
3. that depends on your target market, and their attitude towards parabens - there is nothing intrinsically wrong with them, and plenty of evidence to show that they’re safe in finished products, they’ve just been maligned due to bad/misunderstood science
plenty of major branders on this side of the Atlantic still use them, and it doesn’t harm their sales or their reputation
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Thanks for your comments.
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” 2. not necessarily - if there’s not enough water in the formula to sustain microbial growth, the product can easily pass a challenge test without an active preservative (at my last place, this was our preferred method for preserving toothpastes)
personally I’d describe that as “self-preserving” rather than “preservative free”, as it’s less ambiguous and less open to legal challenges”
@ Bill_Toge
I have been trying to determine a water activity for a series of toothpaste I am working on that would keep their microbial activity down and effectively make them “self-preserving” as you described. What water activity would you recommend to be below in order to achieve this?
The literature I have found has implied that a water activity of less than ~ 0.9Aw.
Thanks for your time
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1. No. The FDA does not define or regulate “natural” - https://www.fda.gov/cosmetics/resourcesforyou/industry/ucm388736.htm#7 Whether you can sell them or not depends on the claims you’re making. If the product is a cosmetic then you probably don’t need any special approval. You should follow the suggestions by the FDA though. If you make any drug claims then you’d have to follow FDA guidelines for producing an OTC drug.
2. No, it’s not up to the consumer to determine what can harm them. It is up to the manufacturer to be able to prove that their product is safe. It is illegal to sell unsafe cosmetic (or drug) products.
3. I believe Parabens are still the most frequently used preservative in cosmetic products. I think you’d be surprised how small a percentage of the consumer population actually has even heard of the word paraben.
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