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Prepare for MoCRA! The FDA has the Authority to Issue A Mandatory Recall Order

FDA Recall

At the Korea Food and Drug Administration (KFDA) briefing on January 31st, Dr. Linda Katz, Director at the U.S. FDA, emphasized the FDA's authority for mandatory recalls.


For products considered defective cosmetics or falsely labeled cosmetics, the FDA has regulatory powers. If usage and exposure to a product are deemed to pose a reasonable possibility of causing health issues or death due to serious adverse events, the FDA will first instruct the Responsible Person (RP) to voluntarily recall the product. However, if the RP refuses voluntary recall, the FDA has the authority to issue a mandatory recall order.


Additionally, through the judiciary, it can enforce disposal measures and prevent future shipments.


It also has the authority to issue sanctions against manufacturers and distributors

of cosmetics violating federal laws. This applies to any company's violation of MoCRA,

and all parties—brand owners, manufacturers, and distributors—can suffer consequences.


For example, if a brand owner outsources production to a contract manufacturer

and entrusts distribution to a 3PL logistics company, if the brand owner inserts exaggerated promotional statements on labels resulting in Misbranding and FDA sanctions,

both the contract manufacturer and the distributor involved in producing the product

may face FDA warning actions.


Therefore, to prevent unnecessary harm and ensure smooth distribution and sales within the U.S., even for a single product, it is imperative to meticulously adhere to FDA MoCRA regulations.


Cosmetic manufacturing and processing facilities must always consider FDA inspections

that can be conducted at any time. Under MoCRA regulations, FDA inspections of cosmetic facilities extend to specific records such as adverse incident reports.


Furthermore, under specific conditions, FDA can access and retain copies

of specific records related to cosmetics, including safety records.


Dr. Linda Katz also mentioned that FDA can receive reports regarding defective and falsely labeled cosmetics through credible information sources.


In an era of communication and information, inappropriate regulatory violations

and unreasonable behaviors cannot remain hidden. Smart consumers now prefer transparent and trustworthy products from companies that honestly and correctly adhere to MoCRA regulations. This adherence will truly be the competitive edge in the U.S. market.


Before facing serious disadvantages later on, we hope everyone complies with MoCRA regulations honestly and successfully enters the U.S. market!


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