To market dietary supplements in US, manufacturers need to be FDA registered and ensure that their product ingredients are safe and approved by FDA.
In public interest, the FDA has unveiled an online tool, Dietary Supplement Ingredient Advisory List, that alerts the public when FDA identifies any ingredients that do not appear to be lawful ingredients in dietary supplements.
The new list can be used by consumers who do not wish to purchase any dietary supplements that contain questionable ingredients as well as manufacturers or distributors who wish to avoid selling supplements with such ingredients in their products.
Inclusion on the Dietary Supplement Ingredient Advisory List does not mean that FDA has determined the ingredient to be unsafe. Ingredients are added to this list on the basis of preliminary assessment enabling FDA to communicate to public while it completes a final determination regarding such ingredients. The reasons based on which an ingredient may be added to the list are:
- The ingredients appear to be excluded from use in a dietary supplement
- The ingredient does not appear to be a dietary ingredient, or does not appear to be an approved food additive or GRAS for use, or
- The ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been met
The list is not exhaustive, and ingredients may be added to or removed from the list as and when FDA deems fit.
This new list is a step in the FDA’s ongoing effort to strengthen and regulate the dietary supplement market and better protect consumers from unsafe products.
To ensure that the ingredients that the manufacturers are adding to their products or planning to add to their products are safe and not questionable, an ingredient and label review service of LMG can be availed.
Liberty Management Group Ltd has been serving clients across the world with FDA registrations, label and ingredient compliance and many more FDA regulations. Our technical experts have in-depth knowledge of FDA regulations and guide you every step of the way regarding all FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on: May 22, 2019
Does the dietary supplements has different labeling requirements or is it same as any other food product?
While most of the requirements are the same, Dietary supplement labeling is slight different from food labeling. To make sure your labels are FDA compliant, sign up for our label review service.
How long will it to complete the review, if I sign for Advanced label review?
Label Review takes 2 weeks for initial review and 3 days for each additional review. During the process, we advise you corrections which you implement and send us back the modified labels. The number of additional reviews depends on the number of corrections implemented.
How do i know if the ingredients in my product are allowed by FDA? Can you check that for me? What is the fee?
We do a detailed ingredient review as part of our label review. Our label review experts check FDA warning letters and databases thoroughly and make suggestions accordingly. Our fee for standard label review is USD 649.