Follow Us:

FDA

Home FDA Label Review

Quick Contact

Need Help?

Please feel free to contact us.
enquiry@i3cglobal.com

Download

Company White Paper
1.30 MB

Company Media Kit
1.22 MB

FDA Label Review

FDA Label review is the verification of existing or new labels by our technical experts against FDA’s labeling regulation. Our experts will identify gaps and recommend corrections so that the corrected label follows the FDA regulations. Our label review includes the verification of label content, claims, ingredients, format, font size and the order of declarations of information as per the FDA.

 

As per FDA, the labels of drugs, food, cosmetics, and medical devices should comply with the labeling regulations enforced by the FDA and any non-compliance of the same will result in misbranding of the product and detention by the FDA.

FDA Label Review 1

Advantages of label review by a third party expert

FDA will not verify or approve the labels prior to marketing the product. However, once the product is available in the US market, FDA checks the products on a random basis.

 

FDA detains the product and issues warning letters for the non-compliance’s on labels which will be displayed on FDA websites. This will lead to huge financial loss as well as spoils the company’s reputation. Doing the label review by a third party expert prior to marketing is highly recommended due to the reason above.

US FDA Label Review process and timeline

US FDA Label review involves the verification of labels with respect to the product-specific regulations established by the USFDA.

 

Our time frame for the review is 2 weeks for the initial review, followed by a minimum of 3 days for additional reviews. However, the time required for the completion of the entire label review process depends upon how fast the label corrections are implemented and how far our comments are followed in the process of amending the labels!

How is the DRUG Label review conducted?

We follow the below steps in drug label review

  • Verification of active ingredients and their concentration as per the applicable monograph. If this is not complying, the customer will be informed, and label review will be continued only after reformulating the product as per FDA requirements.
  • A detailed review of the label with the help of checklist which is exclusively applicable for drugs and covers all the mandatory requirements, font sizes, format and order of declarations of information, etc.
  • A document named “Action Points”, with FDA requirements will be prepared for non-complying points marked in the checklist and the corresponding corrections required on those points will be detailed in the “Action points”. The action point document will be shared with the customer.
  • Based on the action points, comments will be marked on the existing label regarding the corrections to be done in the existing label
  • We also provide a Suggested Draft label (a draft copy of the corrected label) so that the customer can make the corrections easily on their label.

How is the COSMETIC Label review conducted?

We follow the below steps in cosmetic label review

  • FDA usually issues warning letters for cosmetics due to the drug claims present on labels. FDA does not accept any wordings which claim to treat or prevent disease or affects the structure or function of the body—including the skin, on a cosmetic label. Hence, the first step of the label review will be analyzing the claims. Wherever applicable, we share the FDA warning letters issued in the past for similar claims.
  • The second step will be ingredient checking. FDA had prohibited certain ingredients in cosmetics. Also, the cosmetic ingredients should be named on label as per the cosmetic ingredient dictionary and other documents referred by the FDA.
  • A detailed review of the label with respect to the mandatory requirements, font sizes, format and order of declarations of information as per FDA will be carried out with the help of a checklist which covers all the cosmetic labeling regulations established by FDA
  • A document named “Action Points”, with FDA requirements will be prepared for non-complying points marked in the checklist and the corresponding corrections required on those points will be detailed in the “Action points”. The action point document will be shared with the customer.
  • Based on the action points, comments will be marked on the existing label.
  • We also provide a Suggested Draft label (a draft copy of the corrected label) so that the customer can make the corrections easily on their label.

European Free Sale Certificate

Pricing

We provide multiple options to our customers

  • Basic Review – 350 USD
  • Standard Review – 650 USD
  • Premium Review – 950 USD

We are available 24x7 for you

Call Us Now +91 9945912081

Do you provide any guarantee that FDA would accept your label? If NO, let me know why?

We cannot assure 100 percent guarantee as it is the process of compliance with a regulation. However, we have been working in this field for the past 12 years and so far, we have not faced any rejection for the labels reviewed by us.

I have multiple labels, is it necessary I that should check all the labels? What should I do in this case?

We recommend conducting label review for all the labels. Even if the product is the same and varies only in pack size, it requires a separate review as the declaration of net content varies based on the quantity.

Also, the servings per container vary based on net content in case of food.

Which regulation of FDA ask for label compliance?

FDA’s labeling regulations are different for different types of products. Also, there is a lot of guidance established by the FDA for different requirements.

Will your company design the label for us? What would be the cost of developing FDA complied label?

We will not be able to create a graphic design of the label. However, if you provide an editable version, we can make corrections in the existing label and can provide a complying label for printing.

For complete designing, you need to utilize your graphic designer.

Is it necessary to do a label review ? Can I copy a similar label from the market?

It is mandatory to do a label review as all the labels available in the market are not verified by the FDA.

FDA selects the labels on a random basis for verification and hence, it is not guaranteed that the labels of all the products marketed in the USA are complying with the FDA regulations.

How to start the process? Is there anything that I should provide you with?

The customer needs to provide the existing label. If you don’t have a graphic or design of the label, you may provide the text in a word file as well.

In such cases, we will provide a draft label image file indicating the mandatory information required.