USA MoCRA requirements – what it means for your cosmetic brand

I’m a small Indie brand – do I need to comply?

YES! Cosmetic business of all sizes need to comply with the following US cosmetic rules:

• cosmetic claims and labelling requirements;
• listing cosmetic fragrance and essential oil allergens on product labels;
• the overarching requirement that products must be safe and suitable to use;
• contact information to report adverse events; and
• ensure ingredients are used within current regulatory limits.

Learn essential claims and labelling requirements – essential for cosmetic brands of ANY size – as well as what is considered a cosmetic vs drug in the USA (and other regions) with our Certificate in Cosmetic Labels and Claims.

when do exemptions apply?

Small cosmetic brands with less than US$1M average annual turnover for the previous 3 years are exempt from the activities listed below:

• Good Manufacturing Practice compliance;
• Product listing with the FDA; and
• Facility registrations.

However, even if you are a small cosmetic manufacturer, you are not exempt from these 3 items if:

• your cosmetic brand exceeds US$1M annual sales; and/or
• you are a cosmetic manufacturer of any size that manufactures cosmetic products that come into contact with the mucuous mebranes of the eye; and/or 
• you are a cosmetic manufacturer of any size manufacturing or marketing products for injection, ingestion or internal use; and/or
• you are a cosmetic manufacturer of any size manufacturing or marketing products that are intended to alter the appearance for greater than 24 hours or remain on the skin indefinitely.

Please note: The items listed in the first section above (labelling, safety, quality, ingredients and adverse event reporting) apply to all cosmetic brands, even small cosmetic brands. 

Remember too that what is regulated in the US as a cosmetic, compared to a drug, varies from other regions of the world.

Safety substantiation is essential for cosmetic brands of all sizes

Cosmetic brands of all sizes need to hold safety substantiation to support the safe and suitable use of their cosmetic products. This safety substantiation needs to be:

• in the form of studies, test results, research or other suitable evidence that provides certainty about the safety of the cosmetic formula and its ingredients;
• apply to the shelf life of the cosmetic product; and
• able to show that the cosmetic product, when used as directed, will be safe and without harm to the user.

You can conduct your own safety and shelf life testing in house and save on outsourcing these essential MoCRA requirements. Study with Institute of Personal Care Science will enable you to compile the necessary safety data, as well as conduct your own in-house testing programs to ensure quality, safety and stability of your cosmetic formulas are maintained. When you study with IPCS, you will also be able to attain professional Industry membership so you can act as the Responsible Person for reporting requirements. Any of these courses will provide you with the Internationally Recognised qualifications to fulfill this requirement:

• Diploma of Personal Care Formulation – become a qualified Cosmetic Chemist; or
• Certificate in Cosmetic Regulatory Essentials – all the MoCRA regulatory training needed in one convenient program.

QUALITY AND STABILITY is ESSENTIAL for cosmetic brands of all sizes

Inherent in the new MoCRA requirements is the need for safety, quality and ensuring prevention of adverse events. There is no way to ensure all of these things if you haven’t conducted the appropriate quality and stability tests on your cosmetic products.

If you do not already have the appropriate quality and stability data for your product formulations, study our Certificate in Cosmetic Quality and Stability to get your protocols and tests underway. The great thing about this program is it teaches you to conduct most of the testing within house, saving you thousands on outsourcing these test methods and procedures with other labs.

Quality and stability testing is included in the Certificate in Cosmetic Regulatory Essentials – all the MoCRA regulatory training needed in one convenient program.

All adverse events must be reported & Recall procedures documented

One of the best things to come out of MOCRA is the need to report any adverse events from use of a cosmetic product – this helps ensure brands are taking greater responsibility for the safety substantiation of a product and will also wipe out all of the ‘free-from’ fear campaigns.

Adverse events must be reported by cosmetic business of all sizes, using certain forms and procedures. Reporting includes:

• any hospitalisation, life-threatening experience, significant or ongoing disability or incapacity, birth defects, death and disfigurement (including serious or persistent rashes); and
• the need to report any infections.

Cosmetic business of all size must keep records of any adverse events and allow the FDA to inspect their records. Good safety substantiation before releasing a product on to the market is key to avoiding the need to report on adverse events!

Cosmetic brands of all sizes will need to have a specified product recall procedure in place, and must comply with recalling any products that are found to be in breach of the regulations or pose a safety issue. Learn how to prepare your company for this step with our Certificate in Cosmetic Product Recalls.

Learn how to report adverse events and initiate mandatory cosmetic product recalls with our:

• Certificate in Cosmetic Recalls as a stand alone Certificate program; or,
• study our full Certificate in Cosmetic Regulatory Essentials which has all your MoCRA training in one comprehensive online course, including adverse event reporting and product recall procedures. 

Good Manufacturing Practice compliance required

Cosmetic products must be manufactured in a facility that can show its compliance with Good Manufacturing Practice. While a licence is not essential, proving that your facility has the required layout, procedures, quality standards and record keeping to comply with Good Manufacturing Practice will be mandated.

The great news is we teach that too! Learn how to comply with Good Manufacturing Practice with our How to manufacture cosmetics workshops – this workshop series is ideal for indie brands manufacturing cosmetics from 5 – 100kg. If you are manufacturing greater quantities than this, we recommend you should be a qualified Cosmetic Chemist by studying our Diploma of Personal Care Formulation – this contains GMP training relevant to large organisations.

Cosmetic companies will need to be registered – and product details listed - with the FDA

Previously, registering your cosmetic brand with the FDA was voluntary, and up to the discretion of the company. Under these new rules, all cosmetics brands (except those meeting the criteria of small businesses) will need to register their brand with the FDA.

Under these new rules, cosmetic companies will need to provide full ingredient information to the FDA in the form of a product listing, and updates made annually.

Learn how to ensure your ingredients comply with all regulations, and your cosmetic product labels and claims also comply with registration requirements, by studying our Certificate in Cosmetic Regulatory Essentials which has all your MoCRA training in one comprehensive online course, including adverse event reporting and product recall procedures. 

Be mocra compliant - study with ipcs today - 100% online!

These rules across all US states. Previously, different states could mandate different rules, but with the signing of MOCRA, it has now been established that states cannot contradict these rules or provide rules that may otherwise be in conflict with these rules. This will help make it easier to regulate and ensure compliance with this new set of rules.

These changes have been implemented for the long term benefits of consumers and industry. Click on the relevant hyperlinks above to be redirected to the right courses to fulfill your learning gaps and get MoCRA compliant now! 

Remember, our Certificate in Cosmetic Regulatory Essentials has all your MoCRA training in one comprehensive online course. Click here to get started today! 

If you are not sure, contact [email protected] with your learning needs and we can help you find the right study program to suit your career goals.

Happy formulating!