FDA specifies what must be included on a dietary supplement label as well as how it must be displayed. The various requirements for information coupled with the typically smaller size of a dietary supplement label and packaging can make for, at times, a complicated puzzle of fitting the pieces together in a compliant manner. A lack of compliance can cause your product to be considered misbranded and subject to regulatory action and penalties.
Our team of labeling experts will also ensure that finished dietary supplement product labels meet the requirements dictated in 21 CFR 101, Food Labeling, while formulation experts provide guidance and recommendations on necessary intentional overages and manufacturing process strategies to ensure that all label claims are met upon release and throughout the product shelf life as demonstrated through a robust and scientifically sound dietary supplement Stability Program.
EAS Consulting Group can design or review your company’s label and package inserts to ensure compliance with FDA regulations for all manner of health claims, structure-function claims, nutrient content claims, appropriate formatting, allergens. Also, EAS is available to assist dietary supplement firms in the preparation of 30-day notification of claims for submission to the FDA.