[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23968-23969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2834]


Extension of Certain Tobacco Product Compliance Deadlines Related 
to the Final Deeming Rule; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the withdrawal of a guidance for industry entitled ``Extension of 
Certain Tobacco Product Compliance Deadlines Related to the Final 
Deeming Rule,'' which was issued in 2017. The guidance was intended to 
assist persons who manufacture, package, sell, offer to sell, 
distribute, or import for sale and distribution within the United 
States newly regulated tobacco products, roll-your-own (RYO) tobacco, 
and cigarette tobacco in complying with the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention 
and Tobacco Control Act (Tobacco Control Act), and FDA regulations. FDA 
is withdrawing the guidance because the compliance deadlines contained 
therein have passed, have been vacated or stayed, or are otherwise 
described in other guidance.

DATES: The withdrawal is applicable April 30, 2020.

FOR FURTHER INFORMATION CONTACT: Eric C. Mandle, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-
0002; 1-877-287-1373, CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is withdrawing the guidance for industry 
entitled ``Extension of Certain Tobacco Product Compliance Deadlines 
Related to the Final Deeming Rule,'' which was issued in 2017 (see 82 
FR 37459 (August 10, 2017)) and which has been revised several times 
since then. The guidance was intended to assist persons who 
manufacture, package, sell, offer to sell, distribute, or import for 
sale and distribution within the United States newly regulated tobacco 
products, RYO tobacco, and cigarette tobacco in complying with the FD&C 
Act, as amended by the Tobacco Control Act, and FDA regulations.
    The Tobacco Control Act (Pub. L. 111-31) granted FDA the authority 
to immediately regulate the manufacture, marketing, and distribution of 
cigarettes, cigarette tobacco, RYO, and smokeless tobacco products to 
protect the public health and to reduce tobacco use by minors.
    The Tobacco Control Act also gave FDA the authority to issue a 
regulation deeming all other products that meet the statutory 
definition of a tobacco product to be subject to chapter IX of the FD&C 
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 
2016, FDA issued that rule, extending FDA's tobacco product authority 
to all products that meet the definition of tobacco product in the law 
(except for accessories of newly regulated tobacco products), including 
electronic nicotine delivery systems, cigars, hookah, pipe tobacco, 
nicotine gels, dissolvables that were not already subject to the FD&C 
Act, and other tobacco products that may be developed in the future (81 
FR 28974 at 28976) (``the final deeming rule'').
    In May 2017, FDA published the first edition of this guidance, 
under which it provided a 3-month extension of all future compliance 
deadlines under the final deeming rule. The second edition of the 
guidance, published in August 2017, revised and updated the first 
edition by further extending certain of the future compliance dates.
    On May 15, 2019, the U.S. District Court for the District of 
Maryland issued an order vacating the extended compliance dates for 
premarket review in the guidance.\1\ On July 12, 2019, the court issued 
an order directing FDA to require that premarket authorization 
applications for all new--i.e., not ``grandfathered'' \2\--deemed 
tobacco products to be submitted to the Agency within 10 months, by May 
12, 2020, and providing for a 1-year period during which products with 
timely filed applications might remain on the market pending FDA 
review.\3\ As

[[Page 23969]]

required by the court's order, deemed new tobacco products on the 
market as of August 8, 2016, for which premarket authorization 
applications are not filed by May 12, 2020, are subject to FDA 
enforcement actions, in the Agency's discretion. The court subsequently 
clarified that its order did not restrict FDA's authority to enforce 
the premarket review provisions against deemed products, prior to May 
12, 2020, or during the 1-year review period.\4\ On April 22, 2020, the 
court, upon FDA's motion, extended the premarket application deadline 
set out in its order by 120 days (until September 9, 2020) in light of 
the global outbreak of respiratory illness caused by a new 
coronavirus.\5\
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    \1\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., 379 F.Supp.3d 461 (D. Md. 2019).
    \2\ A ``grandfathered'' product is one that was on the market as 
of February 15, 2007. ``Guidance for Industry, Establishing That a 
Tobacco Product Was Commercially Marketed in the United States as of 
February 15, 2007,'' dated September 2014, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007.
    \3\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., 399 F.Supp.3d 479 (D. Md. 2019). The court 
has granted intervention to vapor industry trade associations for 
purposes of appealing the court's decision and remedies order. See 
American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., No. 8:18-cv-883 (PWG), Dkt. No. 154 (October 
2, 2019). An appeal is pending. See American Academy of Pediatrics 
v. Cigar Ass'n of America, Nos. 19-2130, -2132, -2198 (4th Cir.).
    \4\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., Case No. 8:18-cv-883 (PWG), (D. Md. August 
12, 2019), Dkt. No. 132.
    \5\ American Academy of Pediatrics, et al. v. Food and Drug 
Administration, et al., Case No. 8:18-cv-883 (PWG), (D. Md. April 
22, 2020), Dkt. No. 182.
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    FDA is withdrawing the guidance because the compliance deadlines 
contained therein have passed, have been vacated, or are stayed, with 
the exception of those for reporting requirements for harmful or 
potentially harmful constituents (HPHC). FDA has published and 
described these deadlines in the Small Entity Compliance Guide for the 
final deeming rule; \6\ they are also listed on the Center for Tobacco 
Products' HPHC website.\7\
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    \6\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-deems-certain-tobacco-products-subject-fda-authority-sales-and-distribution-restrictions-and.
    \7\ For more information, please see https://www.fda.gov/tobacco-products/products-ingredients-components/harmful-and-potentially-harmful-constituents-hphcs.

    Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09163 Filed 4-29-20; 8:45 am]
 BILLING CODE 4164-01-P


