Article by: Perry Romanowski
Many of you are formulators who have notions of starting your own cosmetic line. In fact, some of you may have even made formulations in your kitchen and are wondering how to start selling. Before you do that, it is a good idea to see what the FDA has to say about manufacturing procedures. Here is a full report they recently updated on the subject of cosmetic good manufacturing practices.
While we encourage you to study the entire document, here are some tips to ensure that you are following appropriate cosmetic manufacturing procedures.
The first thing to know is that it is illegal in the US to sell misbranded or adulterated cosmetics. This essentially means you have to be able to prove that the cosmetics you sell are safe and labeled properly. To do this you will have to properly test it doing stability testings, safety testing, and microbial challenge testing. See this post we did on the tests needed to sell a cosmetic product.
To prove that you are following GMP when producing your cosmetics you should capture the proper documentation. You should write down in procedure form everything about how you are making your products. Set up a coding system for all your batches and have a way to back track to see when something was made, what specific raw materials were used, how it was filled, initial batch specifications, etc. Not only will this help you prove the safety of your product, it could also help troubleshoot problems if any occur.
The FDA recommends keeping electronic versions of all your documentation. This is easy enough with computers and handheld smart phones. In fact, if you still want to work with paper just take a photo of the paper after you’ve finished filling it out. No need to keep paper copies when an electronic one will work just as well.
While some people might be making products in their kitchen, it is a much better idea to have a space separated from your living area to create your formulations. Many cosmetic chemist consultants have labs built in their basements or garages. Ultimately, if you are serious about making your own formulas, you will need to have a dedicated facility.
The FDA simply talks about how you should keep equipment clean and calibrated. They don’t say what type of equipment you need to have. If you are interested in this, see our post on essential equipment for a cosmetic lab.
The FDA recommends having a method for identifying raw materials and a place to appropriately store them. Most raw materials come with a name and a lot number written on them. When I was at Alberto Culver we had a 4-digit code for every raw material. It makes a lot of sense for you to develop your own internal code by which you label all your incoming raw materials. That way if you get an ingredient from multiple suppliers you will know what the ingredient is.
Also in these guidelines you will find a list of ingredients that are prohibited from being included in your cosmetic formula. These include things like Bithional, Vinyl chloride, Certain halogenated salicylanilides, Chloroform, Methylene chloride, and more. Of course, no one uses these in cosmetics any more so the list is a bit outdated. It’s good to know though and also proof that the FDA does regulate cosmetics.
Production, lab testing and more
The final sections of the FDA recommendations are that you have written Standard Operating Procedures (SOP) and that you follow them. You should include things like double-checking weights, calculating actual yield versus theoretical yield, and proof that you are preventing any micro contamination. You should also have lab testing and keep samples of all your production lots (we called them retains). And you should have a system set up by which you can audit your procedures to ensure you are still following you SOPs properly.
Finally, every cosmetic maker should have some system set up to receive consumer complaints and also have a way of recalling your product if it is necessary.
While some claim the cosmetic industry in the US is unregulated, this is demonstrably wrong. Cosmetic companies do have to follow standards set out by the FDA and for the most part, they do. You should too if you are a small company trying to make it big in the cosmetic market.