November 18, 2017 305-507-9843contact@sglawfl.com

Outer Packaging Requirements

Outer Packaging Requirements

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 must be noted 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. In addition, when products are packaged in both outer and inner containers, the general labeling requirements may differ. More information about inner and outer packaging requirements under FDA regulations may be accessed here.

As you can see, because the labeling regulations are quite complicated and highly-technical, we help our clients by providing label reviews. Label reviews and are a key way of how we help our clients ensure that their product labels are fully compliant with the FDA’s outer packaging requirements.

Outer Packaging Requirements and FDA Regulatory Assistance

At Shehadeh Giannamore, PLLC, we can help you with outer packaging requirements by:

  • Reviewing your draft and/or current product labels to determine whether they presently comply with FDA regulations;
  • Providing guidance with respect to the FDA’s outer packaging requirements;
  • Providing an overview of the changes to your current labeling that must be made in order to bring your product into compliance;
  • Suggesting alternative wording to ensure that the claims made on your product labels do not pose an unduly high risk of agency action, and
  • Reviewing your revised labels after the initial review to ensure that all suggested changes are made.

 

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