Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
  • Print
  • Share
  • E-mail
-

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR1114.35]
 See Related Information on Withdrawal of a marketing granted order. in CDRH databases



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

Sec. 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.

-
-