---
kind: "section"
citation: "21 C.F.R. § 1114.37"
title: "21"
number: "1114.37"
heading: "Temporary suspension of a marketing granted order."
url: "https://uscodex.org/cfr/21/1114.37"
---

# §1114.37. Temporary suspension of a marketing granted order.

- (a) FDA will temporarily suspend a marketing granted order if FDA determines that there is a reasonable probability that the continued distribution of such tobacco product would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market.
- (b) Before temporarily suspending a marketing granted order of a tobacco product, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under [part 16](/cfr/21/part16.md) of this chapter.
- (c) If, after offering the holder of the marketing granted order an opportunity for a [part 16](/cfr/21/part16.md) hearing, the Agency decides to proceed with the temporary suspension, FDA will issue an order temporarily suspending the marketing granted order for a tobacco product.
- (d) After issuing an order temporarily suspending the marketing granted order, FDA will proceed expeditiously to withdraw the marketing granted order for the tobacco product.

## Notes

### Authority

Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49.

### Source

Source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.