Late December 2022, The Modernization of Cosmetic Regulation Act of 2022 (MOCRA) was passed in the USA – and while the actual regulations are yet to be finalized, the clever cosmetic businesses will be looking at what changes they may need to make sooner rather than later, as they’ll only have one year to update and comply when they are put into place. Here are some of the regulations you’ll need to be aware of, and how you can get up to speed with what your cosmetic brand will need to do to comply.
Who do the new USA cosmetic regulations apply to?
Small businesses with less than US$1M average annual turnover for the previous 3 years will be exempt from some of these requirements – BUT – many of the new rules will apply to cosmetic businesses of all sizes, and will in any case apply if your business grows. In other words, while you may escape some items from being ‘mandatory’ right now, best practice would be to adopt all the rules as a long-term growth strategy.
Even if you do fit the ‘small business’ exemption on some items, you will not be considered exempt if you sell any of these types of products:
- Those that come into contact with the mucous membrane of the eye; and/or
- Any products which are injected or intended for internal use (including ingestion); and/or
- Intended to alter the appearance for greater than 24 hours or remain on the skin indefinitely.
Cosmetic businesses of all sizes need to ensure their products:
- Comply with all cosmetic claims and labeling requirements; and
- Ensure their products are safe and suitable to use throughout the entire shelf life; and
- Make sure all ingredients used are within current regulatory limits.
In addition to brands of all sizes needing to comply with all claims and labeling requirements, cosmetic brands will also need to include the following on their product labels:
- Contact information to report adverse events; and
- Fragrance allergens – these are likely to follow the EU list of allergens
Prove your products are safe for use = safety substantiation
To help stamp out fear campaigns, all cosmetic companies will now be required to prove their products are safe to use. This evidence will need to use studies, research, test results, or other data that prove safety of the cosmetic formula and its ingredients and will need to show that the directions for use help ensure safe and suitable use by the consumer.
For cosmetic brands, this means compiling safety data for all cosmetic ingredients and the formula as a whole. The USA regulators will be drawing a lot of their rules from existing models and the EU model is by far the most stringent and well-prepared for safety compliance and reporting.
Cosmetic registration and reporting will be mandatory
Under the previous regulations, registering your cosmetic brand with FDA was voluntary. Under MOCRA, however, all cosmetic brands (except small businesses) must register their brand with FDA. When registering with FDA, you will need to provide:
- Full ingredient information as a product listing and
- Annual updates to the formula/information.
Brands of all sizes must soon report any adverse events from the use of their cosmetic products. An adverse event is considered to include, but not limited to: hospitalization, life-threatening experiences, significant or ongoing disability or incapacity, birth defects, death and disfigurement (including serious or persistent rashes), and any infections.
If your brand has to report any of these (or other significant) adverse events, you’ll need to keep records and allow the FDA to inspect your records. This is why good safety evaluations BEFORE you release a product onto the market are essential – so you can prevent having to report!
On the up-side, having the need to report adverse events will start to rule out untruthful fear campaigns associated with so many safe and unnecessarily avoided cosmetic ingredients. If you’ve been using ‘free from’ or ‘clean beauty’ campaigns in your marketing, it is time to rethink your strategies, as these new regulations will make it clear that all products sold on the USA market are safe and suitable for use.
Good manufacturing practices required
Cosmetic brands of all sizes will need to show their products have been manufactured in a facility with Good Manufacturing Practice standards. The good news is this doesn’t mean your manufacturer or facility needs to be GMP licensed, but instead, compliance with GMP requirements must be proven. This includes documents showing your facility or manufacturer has the required layout, procedures, quality standards, and records in accordance with GMP standards, which by default means your end product would be of suitable quality.
Quality tests, stability results, and product recalls are mandatory
The MOCRA rules are all about ensuring – and proving – your cosmetic products will be safe, suitable, of the required quality, and deliver on their performance claims. Your brand can’t provide the required evidence of quality and shelf life without the required quality tests or stability results.
Finally, a documented product recall procedure must be held by cosmetic brands of all sizes in the case of a safety issue or regulatory breach.
Start preparing for MOCRA now!
The new MOCRA regulations will apply to cosmetic brands across all US states. This is great news for the industry – it will raise the standard for all cosmetic brands, create a more level playing field, and remove fear campaigns from the marketplace. Consumers should be confident in the safety and quality of their cosmetic products, and MOCRA regulations aim to achieve exactly that.
Use this knowledge to future-proof your cosmetic brand and start on strategies now to comply with these procedures well before they become mandated. That way you can focus on innovation and compliant growth for better market success.
Happy formulating!
Resources offered by the author, Belinda Carli, and the Institute of Personal Care Science:
- Certificate in Cosmetic Labels and Claims – to learn essential claims and labeling requirements
- EU Cosmetic Compliance Requirements – to learn how to compile safety data for all cosmetic ingredients and the formulas
- Certificate in Cosmetic Regulatory Essentials –to learn how to check ingredients, evidence and claims, and all your compliance needs
- How to manufacture cosmetics for small brands (workshop series) – to learn how to comply with Good Manufacturing Practices, for small businesses
- Certificate in Personal Care Formulation – to become a qualified Cosmetic Chemist which contains GMP training relevant for large organizations.
- Certificate in Cosmetic Quality and Stability – if you do not already have the appropriate quality and stability data for your product formulations, you can learn to conduct most of the testing within house
- Certificate in Cosmetic Product Recalls – to learn how to prepare your company for a documented product recall procedure in the case of a safety issue or regulatory breach
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