Good Manufacturing Practices
MoCRA: This information is applicable to: All Cosmetic Manufacturers
Under the new MoCRA requirements, if your business is not exempt as a small business, you will be required to follow the Good Manufacturing Practice regulations that will be issued by the FDA.1
Once the regulations are issued, if you manufacture a product in a facility that does not follow the GMP regulation requirements, that product is considered adulterated.2 Selling an adulterated cosmetic product is prohibited (illegal).3
What is the timeline for compliance?
First, the FDA issues proposed rules. They are open for comment.
Next, the FDA reviews the comments from the proposed rules, makes any changes, and issues a final rule (the official regulations).
The final rule will say when you have to be in compliance (the effective date). Usually, the effective date is a year (or more) after the date the final rule is published.
|By December 29, 2024:4||Proposed regulations published.|
(They will be open for comment.)
|By December 29, 2025:5||Final regulations published.|
|By December 29, 2026:|
(The date by which you must be in compliance).
What will the GMP regulations require you to do?
We don’t know yet. MoCRA does say that the GMP standards should go along with national and international standards as much as possible and appropriate. It also says that the point of the GMP regulations will be to protect public health and ensure that cosmetic products are not adulterated.
What we have right now are the Draft Guidance for Industry: Cosmetic Good Manufacturing Practices issued by the FDA in 20136, and the International Standard ISO 22716, Cosmetics – Guidelines on Good Manufacturing Practices7. They both provide a good guide for what is expected under good manufacturing practices.
Will everyone have to follow the same standards?
Probably not. MoCRA specifies that the FDA should consider the size and scope of the businesses manufacturing cosmetics and the potential risks associated with them. Obviously, simple soap and bath fizzies out of food-grade ingredients have a much lower risk factor than complex facial care products with active ingredients made in 1,000-gallon batches.
The FDA has also been directed to provide sufficient flexibility so that smaller businesses do not have undue hardship. We don’t know exactly what that will look like yet.
What should you do now?
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. Now – before the regulations are issued – is the time to review your facility, personnel, records, and procedures to make sure you have everything covered and documented.
Once the proposed regulations are issued, we’ll have a much clearer idea of what will be specifically required.
In the meantime, the guidance from the FDA gives a sort of checklist that you can use to do an inspection of your own facility 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.
Anything you do now to improve your manufacturing practices and record-keeping will help down the road when compliance becomes mandatory.
1 21 USC 364b and 21 USC 364h(a)
2 21 CFR 361(f)
3 31 USC 331(a)
4 21 USC 364b(c)
5 21 USC 364b(c)
6 A full copy of the draft guidance is included in Navigating the Rules and Regs by Marie Gale and available in the HSCG store.
7 ISO 22716 is published by the International Standards Organization and is available to purchase.