How to Make Sure Your Products Pass FDA‘s Label Exam! 

It is critical that you make sure your products comply with FDA’s labeling regulations because the labels are usually the first things that an FDA inspector sees when they examine your products!

 At a quick glance, your labels may appear to be just fine because they look like other products that are already on the market. But there are many small details on the label that may seem unimportant at first, but which could be significant violations for which FDA may take regulatory actions such as: 

• Issuing a Warning Letter to your company. 
• Initiating a product recall.
• Having the product seized. 
• Refusing imported products. 
• And other regulatory actions.  

Examples of small but significant labeling errors include: using an inappropriate ingredient name in the ingredients list, rounding nutrient values incorrectly, and placing required statements on the wrong part of the label. It’s easy to miss small but important details on a label!  

Also, it’s a mistake to assume that a product’s label is compliant just because it’s on the market. FDA does not have the resources to immediately review all products in commerce. But FDA does perform routine surveillance exams, and it’s a matter of time before FDA may find violations in your product that you may not be aware of! 

Let’s see how many errors you can spot on the following label:

1. The information panel with the Nutrition Facts Chart, Ingredients List, and the Business Name and Address should appear to the right of the Principal Display Panel.

2. The product’s statement of identity is not appropriate for this product. A mixed nut product is a standardized food that must contain at least 4 types of tree nuts.

   According to this product’s ingredient list, there are only 3 nut ingredients in this product.

   An example of an appropriate name for this product would be Nut & Seed Snack Mix.

3. The Net Quantity of Contents statement must appear on the bottom 30% of the principal display panel and must be formatted properly.

Now let’s see if you can spot the errors on the information panel:

• The serving size for this product should be declared in cups and grams and needs to be right justified.
• Calorie content should not be declared in kilojoules.
• Total Fat should be rounded to the nearest whole number.
• The Daily Value for Calcium should be rounded to the nearest 2 percent.  
• There must not be any intervening material between the Nutrition Facts chart, the Ingredients List, and the Business Name and Address.  
• All ingredients must be declared by their common or usual name. 
• The Business Name and Address declaration must include a physical address and may not be a P.O. box.  

FDA Specialist takes pride in thoroughly examining our clients’ labels to make sure they do not contain any violations, even those that may seem small or minor, because any violation can cause FDA to take regulatory action!  

FDA Specialist’s label review reports are complete and thorough but are not any longer than they need to be. Also, our instructions are easy to follow and don’t require you to be an expert in FDA regulations to be able to understand them!  

So contact FDA Specialist right away to review your labels to prevent costly regulatory actions and delays resulting from any labeling errors!