The regulation of the labeling of pharmaceutical, medical, nutraceutical, and dietary products is one of the most important responsibilities the FDA has. This is meant to keep the consumer safe and knowledgable about what they are putting in their bodies and how it can affect them. The FDA wants to ensure that all products are labeled correctly by their companies, so there is minimal risk when consuming or using the products.


Labeling Responsibilities

The healthcare industry is responsible for making their labels durable in different environments from when it is distributed, stores, and used. The labels must be able to remain in place and be legible throughout their lifespan. The product manufacturers must comply with the content and format requirements.


Displaying Product Information

Certain information and claims can be made on each label, but there is also information that must be included. The label should include:

  • Product Name
  • Drug Facts table
  • Ingredients (active and inactive)
  • Purpose and Use
  • Warnings
  • Directions of Use
  • Allergic reactions/side effects

The FDA requires each drug and medical device classification to put the information on the label that will be shown on the product.


Formatting Labels for Approval

The FDA requires a certain format depending on what classification your product is. Classifications can include over the counter (OTC) medications, oral contraceptives, combination products, and more. When you design your label, you must keep the FDA require formatting in mind. FDA approval requires:

  • Legible font size and type
  • Proper language
  • Organization of format
  • Materials


Choosing Approved Materials

Not all products need materials, but for the ones that do the regulations aren’t as strict. Your materials label can be made on white paper, holographic films, or shrink sleeve labels. It depends on the purpose of the label. Booklet labels are often used with pharmaceutical and healthcare products due to the amount of information that is needed.


Controlling Label Quality

Label inspections are thoroughly done to ensure the information on the labels are accurate and consist of the same information. It is important to discuss with the label manufacturer their quality control processes. When they print multiple pharmaceutical labels, the products should be separated, so nothing gets mix-up, and information doesn’t get switched. Make sure the manufacturer clears the presses from the previous jobs before they start working on your labels to avoid printing errors. It is also important to verify that they properly store the products.


Companies should be carefully examining their products and labels to ensure they are in compliance with the FDA standards. As a consumer, you want also want to make sure that your pharmaceutical products are being labeled correctly and giving you all the information you need to use their products.