The U . S . FDA ’ s implementation of the Modernization of Cosmetics Regulation Act ( MoCRA ) passed by Congress on December 29 , 2022 , affects all businesses manufacturing and selling cosmetic products , including those in the spa and wellness industries . While MoCRA should not change the day-to-day activities of most spa and wellness providers , it is important that the products your company sells comply with MoCRA to avoid potential FDA interference and penalties . Since these compliance activities can be costly , MoCRA likely will affect your company ’ s bottom line .

Key MoCRA Requirements

Facility and Product Registration Spa and wellness businesses that sell cosmetic products manufactured by the business or privately labeled from a third-party contract manufacturer need to understand MoCRA . Unless subject to a special exception , MoCRA places special duties on those businesses to ensure the manufacturing facility is registered with FDA and a list of all applicable products were submitted , including a list of ingredients , by no later than July 1 , 2024 . These exceptions , thankfully , include many spas and wellness centers : l

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Small businesses ( average annual sales of less than $ 1 million over the past three years ) Businesses that compound and sell products directly to customers Retailers l Establishments that only label , relabel , package , repackage , hold or distribute cosmetics products likely revision , of the product labels requires the “ responsible person ” or and company policies . company to maintain records of all

Under MoCRA , a “ responsible such adverse event reports and person ” ( i . e ., responsible company ) provide reports of any serious adverse must include on its product labels events ( e . g ., death , permanent injury , information sufficient for a customer hospitalization and serious or persistent rashes ) to FDA within 15 days of to contact the “ responsible person ” should the customer experience an the company ’ s learning of the issue . adverse event they believe is due to These requirements need to be use of the product . MoCRA also addressed as soon as possible as they

“ Unless subject to a special exception , MoCRA places special duties on those businesses to ensure the manufacturing facility is registered with FDA and a list of all applicable products were submitted ... These exceptions , thankfully , include many spas and wellness centers .”

Labeling and Adverse Event Reports Regardless of whether the business must register its facility or products , any spa or wellness business selling products under its name qualifies as a “ responsible person ” under MoCRA and will be subject to MoCRA ’ s labeling and adverse event recordkeeping requirements , requiring a review , and

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