FDA introduced new regulations for dietary supplement labeling in May 2016. The new rules remove “Calories from Fat”, add Vitamin D as a required nutrient, and introduce a new diet disclaimer for supplements intended for children. These are only a few examples of the changes. Labelling mistakes are one of the leading causes of FDA detentions. Additionally, improper use of claims can cause a product to be regulated as a drug, subjecting it to much stricter regulation. It’s prudent to have a specialist review your product labeling for compliance.
MASTER MANUFACTURING RECORDS (MMRs)
Firms manufacturing dietary supplements must write and implement Master Manufacturing Records (MMRs) for each unique formulation and batch size of dietary supplements they manufacture. MMRs identify steps and stages in the manufacturing process for each supplement to ensure consistency in the components, quality, labeling, and packaging of the supplement from batch to batch. Registrar Corp’s Specialists can develop or review your MMRs for FDA compliance.
EXPORT ACCESS is the Authorized Agent for UK & Ireland for REGISTRAR CORP, USA – the leading global provider of compliance services for goods entering the USA which are subject to regulation by the US Food & Drug Administration (FDA)
Image courtesy of FDA web site