Best Safety Practices for Micro Businesses
MoCRA: This information is applicable to: All Cosmetic Manufacturers
If your business is exempt as a small business, you won’t have to follow the Good Manufacturing Practice regulations that will be issued by the FDA. However, no matter how big or small your business is, selling an adulterated cosmetic product is prohibited (illegal).
Why do you need best safety practices?
Just because the GMP regulations won't apply, you still need to have safety practices in place to ensure that your product is safe, that your ingredients don’t get contaminated, and the final product doesn’t get adulterated while you are making or storing it. That’s the most important thing – being sure that your product is safe and clean.
There is also the fact that the FDA (and likely a department or division of your state government) has the right to inspect cosmetic manufacturing facilities. When they inspect, they are looking to see if your cosmetic products are or are likely to become adulterated. That means the inspector can come into wherever you make your cosmetic products and poke around, check out what you are doing, how you make things, where you store your ingredients and finished products, etc. Under MoCRA, you must give them access to your records, including the safety substantiation for your product(s).
What practices should you have in place?
You should be doing whatever you need to ensure your product is well-made and doesn’t get adulterated.
Traditionally, the GMP guidelines have been the standard to make sure a product isn’t likely to become adulterated because of an issue with the facility, personnel, processing, product, or ingredients. While the guidelines often have to be adapted for very small businesses (especially home-based businesses), the principles still hold true.
What should you do now?
The current Draft Guidance for Industry: Cosmetic Good Manufacturing Practices issued by the FDA in 2013 , and the International Standard ISO 22716, Cosmetics – Guidelines on Good Manufacturing Practices both provide a good overview of what you should think about when looking at your own best practices.
You can use the FDA guidance as a sort of checklist to do an inspection of your own operations and see where improvement may be needed. Good Manufacturing Practices for Soap and Cosmetic Handcrafters by Marie Gale (available in the HSCG store) also gives good suggestions for implementing aspects of GMP and keeping appropriate records.
If you are making cosmetics that are clean, safe, and don’t get contaminated during the manufacturing process, you probably already have some sort of processes and procedures (manufacturing practices) in place. Anything you do now to improve your manufacturing practices and record-keeping will help down the road as your business expands and grows.
1 21 USC 364b and 21 USC 364h(a)
2 31 USC 331(a)
3 A full copy of the draft guidance is included in Navigating the Rules and Regs by Marie Gale and available in the HSCG store.
4 ISO 22716 is published by the International Standards Organization and is available to purchase.