- Is a notification even necessary?
- If so, what information must they submit to the FDA
- What process is in place to facilitate registration?
When registering with the FDA is necessary
Registering with the FDA becomes necessary when companies introduce new dietary ingredients. If a company has a new dietary ingredient, they must submit a notification to the FDA informing them of the ingredient’s presence. The distributor or manufacturer using the new ingredient in their dietary supplement remains responsible for testing the safety of the dietary ingredient for potential users.
What to submit
When submitting a report about a new dietary ingredient, the manufacturer or distributor must include information supporting the safety of the ingredient for users. This report needs to be provided at least 75 days before the dietary ingredient is introduced or delivered in interstate commerce before the marketing process begins.
In the report, there must be mention of the company’s name and address and the name of the new dietary ingredient. It must also describe the dietary supplement containing the new ingredient. Additional details like conditions for use, history of use, and the company held responsible for determining its safety must be given. The FDA also requires a signature of the person overseeing the submission process.
Generally Recognized As Safe (GRAS)
Companies may come across what is known by the FDA as “GRAS,” or Generally Recognized As Safe. This is a substance that is regarded as being safe by qualified experts based on its similarities to pre-existing, FDA approved ingredients. The FDA has created a list including the consideration of chemically similar ingredients that are approved and already being used in foods. Companies can provide voluntary self-affirmations showing that the use of their substance is GRAS by meeting specific conditions. Under the law, this process of self-affirmed GRAS is considered being at the same level as a GRAS notification to the FDA.
Even if companies do not end up submitting reports to the FDA, there is still a need for them to understand the FDA regulatory process. This means notifying the FDA after introducing a new product to market and reviewing manufacturing requirements to ensure compliance. This may also require reaching out to compliance experts to develop a quality or hazard plan. Consult with an attorney to ensure that regulations are being properly followed.
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.