FDA Label Reviews
The FDA has very specific requirements for the labels of the products it regulates. In particular, the FDA requires certain statements to be made on the Principal Display Panel (PDP) of many FDA-regulated products, such as the Net Quantity of Contents, Statement of Identity, etc. However, it is important to note that the label requirements differ based on product classification. For example, while food labels must bear Nutrition Facts Panels, dietary supplements (although a subset of the food classification) are required to display Supplement Facts Panels. The regulations applicable to foods may be accessed here.
As you can see, because the labeling regulations are quite complicated and highly-technical, we frequently help our clients by providing label reviews. Label reviews are a key way of how we help our clients ensure that their product labels are fully compliant with FDA regulations.
FDA Label Reviews and FDA Regulatory Guidance
- At Mejia Shehadeh Giannamore, PLLC, a FDA regulatory attorney can help you ensure FDA compliance by:
- Conducting FDA label reviews of your draft and/or current product labels to determine whether they presently comply with FDA regulations;
- Providing an overview of the changes to your current labeling that must be made in order to bring your product into compliance with FDA regulations;
- Suggesting alternative wording to ensure that the claims made on your product labels do not pose an unduly high risk of FDA enforcement action, and
- Conducting label reviews of your revised labels after the initial review to ensure that all suggested and necessary changes are made and that your product labels are compliant with FDA regulations.