Registering with the FDA is necessary for facilities distributing or manufacturing dietary supplements, but often the process surrounding registration can seem unclear. What are some key factors that companies should keep in mind? When it comes to registering your dietary supplement with the FDA, companies must know the following:
- Is a notification is even necessary?
- If so, what information must be submitted 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 evaluating 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–long before the marketing process begins.
In the report, there must be mention of the company’s name and address, as well as the name of the new dietary ingredient. A description of the dietary supplement containing the new ingredient must also be provided. Additional details like conditions for use, history of use, and the company held responsible for determining its safety must be given. A signature of the person overseeing the submission process is also typically required.
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 generally 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 which 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 to be 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.