FDA Regulatory Update
01 — Context
What’s Actually Changing
Until now, a company could decide on its own — internally, without ever telling the FDA — that an ingredient was “Generally Recognized As Safe.” This self-affirmation remains, today, entirely legal. The proposed rule seeks to end the ability to rely on such GRAS conclusions without notifying FDA.
Today — voluntary system
- A company can self-affirm an ingredient’s GRAS status without ever notifying the FDA.
- Filing a GRAS Notice remains optional — many self-affirmed ingredients are never reviewed by the FDA at all.
- No reliable public list tracks the real status of every ingredient on the market.
If the rule is finalized
- Any substance claimed to be GRAS that falls within scope will require an FDA notification, unless an exemption applies.
- The rule would apply to new substances as well as substances already on the market that rely on self-affirmed GRAS conclusions.
- It covers substances used in human and animal food, including ingredients and certain substances migrating from food-contact materials.
- Failing to notify becomes a factor the FDA uses to prioritize substances for post-market review.
What exemptions are proposed?
- The FDA has already issued a “No Questions” letter covering the substance and its intended use.
- The substance is already listed or affirmed as GRAS in FDA regulations (21 CFR Parts 182, 184 or 186).
- The substance qualifies as GRAS under certain provisions of 21 CFR § 170.30.
- The intended use has already been reviewed through an established FDA process, with no GRAS Notice required.
- A Threshold of Regulation (TOR) exemption or a Food Contact Notification (FCN) already applies.
- The substance qualifies for the proposed streamlined pathway for certain substances already in interstate commerce.
02 — Diagnostic
Where Do You Actually Stand?
Pick the profile that matches your business, then flag every situation that applies to you. You’ll get an exposure read and a recommended next step.
03 — Your options
How FoodChain ID Can Help
Affected companies generally take two paths, often combined: first, verify what they know about their ingredients and their regulatory status; then, take the appropriate steps to document or support their GRAS status and, where required, notify FDA.
Regulatory Solution
Supplements R&D Insight
Check your ingredients’ real US regulatory status in minutes: already listed as authorized food additive or GRAS in the Code of Federal Regulations (CFR), notified (GRAS notices, NDI notifications), public self-affirmed GRAS, or absent from any known filing.
Regulatory statuses tracked and updated daily across North America, Europe, and ASEAN.
Finished-product references to benchmark your own formulations.
Ingredient-by-ingredient status mapping, claims, and studies in one search.
Expert support
Regulatory Consulting
Our experts work with you to build your compliance strategy, from status assessment through to a filed notification.
Status assessment already authorized according to the US law, already notified or tailored GRAS strategy.
Preparation and filing of the FDA notification (GRAS Notice).
Response to FDA questions during the review period.
Most companies combine both: Supplements R&D Insight to diagnose, Consulting to act.
Questions about your regulatory exposure?
Our team can review your ingredient portfolio and tell you what to do next before the comment period closes.