## Facts

- Nonprofit public-interest organizations challenged the FDA’s 2016 final rule governing substances “generally recognized as safe” (GRAS) for use in food.
- The Food Additives Amendment to the FDCA requires premarket approval for “food additives” but excludes from that definition substances that are generally recognized by qualified experts as safe under intended conditions of use.
- The GRAS Rule preserves a voluntary notification process: manufacturers may (a) submit a GRAS notice to FDA for review and a response letter or (b) make a GRAS determination without notifying FDA.
- If a manufacturer does not notify FDA and the GRAS conclusion is incorrect, FDA may treat the substance as an unapproved food additive and pursue enforcement (including adulteration-based actions).
- Plaintiffs alleged the Rule permits opaque, conflict-prone self-determinations that allow unsafe substances into the food supply without adequate government oversight.
- The parties filed cross-motions for summary judgment on statutory, APA, and constitutional theories.

## Issues

1. Whether the GRAS Rule unlawfully subdelegates FDA’s statutory responsibility for food safety to private manufacturers in violation of the FDCA, the APA, or constitutional separation-of-powers principles.
2. Whether the Rule exceeds FDA’s statutory authority or is arbitrary and capricious under the APA by allowing non-notified GRAS determinations and allegedly insufficient controls on conflicts of interest, scientific rigor, and transparency.
3. Whether the Rule conflicts with the FDCA by enabling substances that are actually “food additives” to avoid premarket approval.

## Decision

- Defendants’ motion for summary judgment was granted; plaintiffs’ motion was denied.
- The GRAS Rule was upheld in full.
- The court held the Rule does not unlawfully subdelegate governmental power because GRAS status is a statutory exclusion and FDA retains enforcement authority to challenge incorrect determinations.
- The court held the FDCA does not require mandatory GRAS notification and FDA reasonably chose a voluntary notification framework.
- The court held plaintiffs did not show the Rule was contrary to statute or arbitrary and capricious, including as to scientific standards, conflicts of interest, and disclosure expectations.

## Legal Principles

- A substance meeting the statutory GRAS standard is excluded from the FDCA’s “food additive” definition and therefore is not subject to the food additive premarket approval regime.
- A regulatory scheme does not effect an unlawful private subdelegation where private parties cannot conclusively determine legal status and the agency retains power to enforce statutory limits against incorrect private assertions.
- Under APA arbitrary-and-capricious review, an agency may select among reasonable policy options within statutory bounds, including resource-allocation choices, if it provides a rational explanation supported by the administrative record.
- The FDCA does not, by itself, impose a mandatory GRAS-notification requirement; FDA may structure how it receives information about GRAS conclusions and how it responds, so long as the approach remains consistent with the statute.

## Conclusion

The court sustained FDA’s 2016 GRAS Rule, concluding that Congress made GRAS a self-executing statutory exclusion from food additive premarket approval, that FDA permissibly retained a voluntary notification process, and that the Rule remained within FDA’s statutory authority and satisfied APA review.


Ctr. for Food Safety v. Becerra, 565 F. Supp. 3d 519 (S.D.N.Y. 2021)