If a company is planning to add a new dietary ingredient to their supplement, they must make sure that FDA regulations are being followed. This means notifying the FDA of the new ingredient and going through the registration process and showing that the intended use of the ingredient is safe. The submission process can be difficult to navigate, and companies must stay informed about all aspects of registration to gain FDA approval.
Notifying the FDA
Companies planning on adding new dietary ingredients must first submit notifications to the FDA regarding their ingredients. In this notification, they must show that the dietary ingredient is safe for its intended use and that the labeling of the product meets FDA standards. This responsibility falls to the manufacturer or distributor using the dietary ingredient (either on its own or as part of a supplement).
It is also important for companies to decide whether their new ingredients are dietary ingredients or if they are something else. Dietary ingredients include vitamins, minerals, herbs or other botanicals, amino acids, and metabolites. Companies should make sure that their ingredients fall under one of these categories to meet FDA regulations.
What to Submit to the FDA
The manufacturer or distributor must submit a submission report that includes evidence supporting the safety of the dietary supplement containing the new ingredient. They must give the report to the FDA at least 75 days before the dietary ingredient’s introduction into interstate commerce (before marketing begins). The report must include the company name and address with the name of the new dietary ingredient. The report also must contain a description of the dietary supplement, the level of the dietary ingredient being used in the supplement, conditions for use, history of use, the company responsible for determining the safety, and a signature of the person responsible for overseeing the submission process.
GRAS
The FDA has also designated certain substances as “Generally Recognized as Safe” (GRAS). These substances are or pharmacologically similar to FDA-approved ingredients that are already being used in foods. Companies can provide self affirmations that their ingredients are GRAS, and not require pre-market approval from the FDA.
FDA Compliance
Although registering new dietary ingredients may seem relatively simple, there are many important considerations that companies must keep in mind throughout the process. Consulting with a legal expert to help navigate the submission process is crucial for companies looking to bring their supplements to market.
If you have questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.
I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market — and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.
If you have questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.
I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market — and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Podcasts or on Apple Podcasts.
Originally published at https://www.darshankulkarni.com on September 26, 2019.
