How Do You Register Your New Dietary Ingredient?

If a company is planning to add a new dietary ingredient to their supplement, they must ensure that all FDA regulations are being properly 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 remain 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 about their ingredients. In this notification, they must show that the dietary ingredient is reasonably 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 determine whether their new ingredients are dietary ingredients or if they are something else entirely. Dietary ingredients include vitamins, minerals, herbs or other botanicals, amino acids, and metabolites. Companies should ensure that their ingredients fall under one of these categories to meet FDA regulations.

What to Submit

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 provide the report to the FDA at least 75 days before the dietary ingredient’s introduction into interstate commerce (typically 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 finally 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 chemically 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.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.