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Proposed Rule2017-010302017-01-23

Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) is proposing a tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products. FDA is taking this action because NNN is a potent carcinogenic agent found in smokeless tobacco products and is a major contributor to the elevated cancer risks associated with smokeless tobacco use. Because products with higher NNN levels pose higher risks of cancer, FDA finds that establishing a NNN limit in finished smokeless tobacco products is appropriate for the protection of the public health.

Action & Dates

Action
Proposed rule.
Dates
Submit either electronic or written comments on the proposed rule by April 10, 2017. In accordance with 21 CFR 10.40(c), in finalizing this rulemaking FDA will review and consider all comments submitted before the time for comment on this proposed regulation has expired. If your comment is submitted after the expiration of the comment period, it will not be reviewed and considered by FDA unless you apply for, and receive, an extension of the comment period pursuant to 21 CFR 10.40(b)(3). Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by February 22, 2017, (see the "Paperwork Reduction Act of 1995" section). See section VII of this document for the proposed effective date of a final ruled based on this document.

CFR References

Topics

Administrative practice and procedureIncorporation by referenceLabeling

Public Comment

Comments Close
2017-04-10

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 1132 [Docket No. FDA-2016-N-2527] AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing a tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products. FDA is taking this action because NNN is a potent carcinogenic agent found in smokeless tobacco products and is a major contributor to the elevated cancer risks associated with smokeless tobacco use. Because products with higher NNN levels pose higher risks of cancer, FDA finds that establishing a NNN limit in finished smokeless tobacco products is appropriate for the protection of the public health. DATES: Submit either electronic or written comments on the proposed rule by April 10, 2017. In accordance with 21 CFR 10.40(c) , in finalizing this rulemaking FDA will review and consider all comments submitted before the time for comment on this proposed regulation has expired. If your comment is submitted after the expiration of the comment period, it will not be reviewed and considered by FDA unless you apply for, and receive, an extension of the comment period pursuant to 21 CFR 10.40(b)(3) . Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by February 22, 2017, (see the “Paperwork Reduction Act of 1995” section). See section VII of this document for t

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Full Document

Citation: 82 FR 8004