Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 1114.35: Withdrawal of a marketing granted order.

(a) Grounds for withdrawal. FDA will withdraw a marketing granted order for a new tobacco product issued under this part if FDA determines that:
(1) Any of the grounds for withdrawal under section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act apply; or
(2) Any postmarket requirement imposed by the marketing granted order or by this part has not been met, which results in FDA finding that one or more of the grounds for withdrawal specified in section 910(d)(1) of the Federal Food, Drug and Cosmetic Act apply.
(b) Advice and other information. (1) FDA may seek advice on scientific matters from any appropriate FDA advisory committee in deciding whether to withdraw a marketing granted order.
(2) FDA may use information other than that submitted by the applicant in deciding whether to withdraw a marketing granted order.
(c) Informal hearing. Prior to withdrawing a marketing granted order, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under part 16 of this chapter.
(d) Order issuance. If the applicant does not request a hearing or, if after the part 16 hearing is held, the Agency decides to proceed with the withdrawal, FDA will issue to the holder of the marketing granted order an order withdrawing the marketing granted order for the new tobacco product.
(e) Public notice. FDA will give the public notice of an order withdrawing a marketing granted order for a tobacco product and will announce the basis of the withdrawal.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER K—TOBACCO PRODUCTS
PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS
Subpart C—FDA Review

(a) Grounds for withdrawal. FDA will withdraw a marketing granted order for a new tobacco product issued under this part if FDA determines that:

(1) Any of the grounds for withdrawal under section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act apply; or

(2) Any postmarket requirement imposed by the marketing granted order or by this part has not been met, which results in FDA finding that one or more of the grounds for withdrawal specified in section 910(d)(1) of the Federal Food, Drug and Cosmetic Act apply.

(b) Advice and other information. (1) FDA may seek advice on scientific matters from any appropriate FDA advisory committee in deciding whether to withdraw a marketing granted order.

(2) FDA may use information other than that submitted by the applicant in deciding whether to withdraw a marketing granted order.

(c) Informal hearing. Prior to withdrawing a marketing granted order, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under part 16 of this chapter.

(d) Order issuance. If the applicant does not request a hearing or, if after the part 16 hearing is held, the Agency decides to proceed with the withdrawal, FDA will issue to the holder of the marketing granted order an order withdrawing the marketing granted order for the new tobacco product.

(e) Public notice. FDA will give the public notice of an order withdrawing a marketing granted order for a tobacco product and will announce the basis of the withdrawal.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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