Summary of FDA's Proposed GRAS Rule

Here is one of the best summaries of the FDA's Proposed GRAS Rule that I have seen.

FDA Proposes Mandatory GRAS Notification Requirement | Advisories | Arnold & Porter

There are many summaries out there, but this one really captures the key points well and provides good advice about what companies should be doing NOW to prepare. They recommend that companies may wish to consider the following key steps at this point:

- Inventory and classify GRAS uses.
- Strengthen GRAS dossiers.
- Plan for legacy substances.
- Assess market-timing risk.
- Address disclosure and supply-chain issues.

You can read the summary article for more details on each of these recommendations. Obviously, there will be some changes before this proposal from FDA will become a Final Rule based on the comments that are submitted by December 9th, but you should begin preparing now since many of the requirements are likely to be there in the Final Rule.

If you need any assistance in preparing and would like consulting advice, let me know and we can see if Black Diamond Regulatory Consulting LLC may be able to help you. Check out our qualifications and services which can be provided at: Black Diamond Regulatory Consulting, LLC