By Tony Ruiz and Claire Bing
Just when you think you have everything under control it’s time to learn the latest on how to manage a recall with your third-party logistics (3PL) provider.
The challenge with MoCRA is that it requires cosmetics companies to coordinate compliance among external parties, not just within their own organization. This includes 3PL providers, which have a very specific role in a beauty company’s MoCRA compliance journey.
All 3PLs have their own MoCRA rules to comply with. For example, they should keep detailed records relating to product shipments and handling. They must also track the origin of each shipment, expiration dates, and lot codes, as well as a product’s complete chain of custody, including storage time, conditions of when a product has been picked and packed, when a shipment was authorized, the route it traveled, and its arrival at destination.
However, the ultimate burden of compliance falls directly on a brand. Here, some examples:
Adverse Event Reporting
If a serious adverse event occurs with a consumer, a cosmetics company needs to report it to the FDA within 15 days. As part of that reporting process, the cosmetics company’s 3PL’s “chain of custody” records may need to be accessed.
Recalls
As the scouts say, “Be Prepared.”
Recalls may occur for something as simple as mislabeled ingredients, or for something more challenging, such as contamination during production.
Before any adverse events or recalls occur, a brand and its 3PL must create a recall action plan. While a cosmetics company will depend on a 3PL’s experience in recall planning, the recall plan itself needs to be customized to comply with a brand’s own policies, procedures, and challenges.
The recall plan must then be “practiced” so each side is ready. That way, if a recall is required, any challenges discovered during the run-through can be addressed before a crisis occurs.
A brand is ultimately responsible for initiating a recall, otherwise the FDA can force it upon them. Thanks to the 3PL’s receiving data – the lot numbers, etc. – a beauty brand may be able to minimize the volume of products needed to be recalled.
While a 3PL is actively managing the “boots on the ground” and relevant paperwork for the recall, it’s up to a cosmetics company to work closely with the FDA to determine the exact scope of the recall.
B2B Recalls
While consumers often approach retailers regarding a product complaint, it’s the burden of the product company to rectify the issue. The seller is simply a passthrough.
For B2B recalls, a 3PL will coordinate the logistics with the retailer – based on the existing recall plan, but the cosmetics company or the FDA must initiate it.
Product Reporting
Cosmetic products must be registered with the FDA, with some exemptions provided to small businesses. Annually, a beauty brand must update each item’s ingredients list. The 3PL itself must comply with hazardous shipping regulations, so a cosmetics company needs to ensure that the 3PL is informed when an ingredient change occurs.
While the 3PL has no direct responsibility for product reporting compliance, they typically assist the cosmetics company by providing cross-referenced data about products arriving at a warehouse so that a brand can ensure that each product has been reported.
Allergens
As of this writing (October 2024), the comment period for allergen labeling is still open. Should this become law, the cosmetics company will need to work with the 3PL to ensure that all new products arriving at a warehouse have been properly labeled.
Supporting the MoCRA Journey
Many 3PLs have been supporting the cosmetics industry for decades, and they have worked through challenges with a variety of clients. In addition, once a 3PL registers with the FDA, they receive regular updates, which can be reviewed with the cosmetics companies.
Of course, the 3PL is a great starting point for MoCRA questions, helping smaller companies understand what is required of them and getting them to the point where they can ask the right questions.
Third-party logistics providers often have extensive networks that allow them to direct newer cosmetics companies to consultants who will be able to provide specific recommendations.
While a 3PL and consultants can smooth the path, it’s up to the brand itself to ensure they are in full compliance.
About the Authors
Tony Ruiz is Vice President of Logistics at Capacity LLC, a third-party logistics provider specializing in beauty brands, health and wellness, and apparel, among other industries.
Claire Bing is Chief Executive Officer and Owner at Confiance Cosmetic Group. a boutique consultancy firm providing strategic guidance and expert solutions tailored to meet the unique regulatory challenges of the cosmetic industry.