If you've been following us, you know that we announced the Modernization of Cosmetics Regulation Act (MoCRA) when it went into effect last year. Since then, we’ve been closely monitoring how the regulations would impact Amazon sellers. As expected, the compliance updates for Amazon have started rolling out this year, and if you're selling cosmetics on the platform, there are important steps you need to take to stay compliant.
MoCRA introduces a new era of accountability and safety for cosmetic products in the U.S., and Amazon sellers are not exempt from these regulations. Whether you’re a small brand or an established seller, here’s what you need to be aware of:
1. Facility Registration
If you manufacture or process cosmetics, you’re required to register your facility with the FDA. This applies to both domestic and international companies selling products in the U.S. through Amazon. You must also provide a list of all cosmetic products you sell, along with their ingredients, as part of your registration.
2. Good Manufacturing Practices (GMP)
MoCRA mandates that all cosmetics be produced according to Good Manufacturing Practices (GMP). If you’re selling products manufactured by third parties, it's critical that you confirm they follow GMP guidelines. Non-compliance could result in product removals, fines, or other penalties.
3. Adverse Event Reporting
Any serious adverse events linked to your product must be reported to the FDA within 15 days. This means that if a customer experiences a harmful reaction, you need to document it carefully and report it promptly to avoid non-compliance.
4. Updated Labeling Requirements
MoCRA has introduced more stringent labeling requirements, especially when it comes to allergens and product claims. For example, if your product contains certain fragrance allergens, those need to be clearly disclosed on the label. This transparency will help avoid consumer confusion and ensure compliance with FDA guidelines.
5. Product Recalls
MoCRA grants the FDA the authority to mandate recalls if a product is found to be unsafe. Sellers must have recall protocols in place and be prepared to act swiftly if required. Failure to manage a recall properly could lead to significant penalties or being delisted from Amazon.
6. Record Keeping
Another key update under MoCRA is the requirement for sellers to maintain comprehensive records for their products. This includes ingredient lists, safety data, and manufacturing information, which must be retained for at least six years. Keeping detailed records is essential to passing potential FDA audits.
moCRA Compliance Dates
To comply with the FDA's requirements and Amazon’s policy, all sellers need to ensure their product listings are up to date by September 24, 2024. Any and all listings that don't meet these guidelines may be at risk of being deactivated.
These latest guidelines help ensure that customers receive safe and trusted cosmetic products that meet all U.S. regulatory standards.
Belonging to a rather specific product category, cosmetics are sensitive products that are usually rubbed, poured, sprinkled, or sprayed onto the body to cleanse, beautify, or change the appearance of the body. This category also includes products such as lipsticks, perfumes, fingernail polishes, temporary tattoos, eye and facial makeup, shampoos, hair colors, toothpaste, and deodorants.
Amazon Seller Account Wrongly Deactivated
Some sellers will most likely believe that their listings have been incorrectly deactivated. To fix this, go to Account Health, select the appeal button next to the deactivated listing, and include the following information:
- "Cosmetics" in the subject line
- A list of all affected ASINS
- Confirmation that you have provided a complete list of product ingredients (and drug facts, if applicable)
To check more about the compliance requirements, Amazon Seller Central has provided a detailed moCRA checklist for sellers to ensure all guidelines are followed.
How to Stay Ahead
Navigating these new regulations can seem overwhelming, but the sooner you ensure your compliance, the better positioned you’ll be to continue selling on Amazon without disruptions. Here are a few steps you can take:
- Audit Your Products: Review your current product listings, ensuring labels meet the updated MoCRA requirements.
- Communicate with Manufacturers: If you use third-party manufacturers, confirm they are following GMP and other necessary safety protocols.
- Set Up an Adverse Event Reporting System: Make sure you have a process in place to track and report any customer complaints regarding serious reactions.
Compliance isn’t just about avoiding fines; it’s about building trust with your customers by ensuring that the products you offer are safe, well-labeled, and responsibly produced.
If you have any questions or need help navigating MoCRA compliance for your Amazon business, don’t hesitate to reach out. We're here to support you in this new regulatory landscape!
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