21 U.S.C. § 387j — Application for review of certain tobacco products

(a) In general: (1) New tobacco product^* defined — A "new tobacco product" is (A) any tobacco product, including one only in test markets, that wasn't commercially marketed in the United States^* as of February 15, 2007, or (B) any modified version — a changed design, component, part, ingredient, or nicotine^* content, delivery, or form — of a product that was commercially marketed in the United States after that date. (2) Premarket review required — (A) An approval order is required for a new tobacco product unless the manufacturer has filed a substantial-equivalence report under section 387e(j) and the Secretary^* has ordered that the product is both substantially equivalent to a pre-February 2007 product and compliant with this chapter, or unless the product is exempt from that reporting requirement under a regulation issued under section 387e(j)(3). (B) That exception doesn't apply to a product first sold in the United States after February 15, 2007 and before roughly 21 months after June 22, 2009, if its equivalence report was filed within that 21-month window — except that full approval is required after all if the Secretary rules the product is not substantially equivalent. (3) Substantially equivalent defined — (A) A product is "substantially equivalent" to a predicate product if the Secretary finds, by order, that it has the same characteristics, or has different characteristics but the submitted information (possibly including clinical data) shows regulating it under this section isn't appropriate because it doesn't raise different public health questions. (B) "Characteristics" means the materials, ingredients, design, composition, heating source, or other features of the product. (C) A product can't be found substantially equivalent to a predicate product that the Secretary has already removed from the market, or that a court has ruled misbranded or adulterated. (4) Health information — (A) When filing a substantial-equivalence report, the applicant must give an adequate summary of the product's health information, or state that it will provide that information on request. (B) That summary must include detailed data on adverse health effects, and the Secretary must make it public within 30 days of ruling the product substantially equivalent.

(b) Application: (1) Contents — A full application under this section must include full reports on health-risk investigations (including whether the product is less risky than others); a full statement of the product's components, ingredients, additives, properties, and how it operates; a full description of its manufacturing, processing, packing, and installation methods and facilities; a reference to any applicable product standard under section 387g and proof of meeting it (or justification for any deviation); product samples the Secretary reasonably requires; proposed labeling^* specimens; and any other relevant information the Secretary requires. (2) Referral to Tobacco Products Scientific Advisory Committee — Once a qualifying application is received, the Secretary — on their own initiative or at the applicant's request — may refer it to the Advisory Committee for a report and recommendation, with underlying data and reasoning, within a period the Secretary sets.

(c) Action on application: (1) Deadline — Within 180 days of receiving the application, and after considering the Advisory Committee's report and recommendation, the Secretary must (A) approve the product for interstate introduction if none of the denial grounds in paragraph (2) apply, or (B) deny it and explain the basis for that finding; an approval order may restrict the product's sale and distribution, but only as far as section 387f(d) already allows. (2) Denial of application — The Secretary must deny the application if the evidence shows (A) there's no adequate showing that marketing the product would protect public health; (B) the manufacturing, processing, or packing methods and facilities don't meet the standards in section 387f(e); (C) fairly evaluated, the proposed labeling is false or misleading in any respect; or (D) the product doesn't conform to an applicable product standard under section 387g, with no adequate justification for the deviation. (3) Denial information — Where practicable, a denial must be accompanied by a statement telling the applicant what's needed to fix the application, which could include further research under a protocol the Secretary prescribes. (4) Basis for finding — Whether marketing the product is "appropriate for protection of public health" is judged against risks and benefits to the whole population, including whether existing users would be more or less likely to quit, and whether non-users would be more or less likely to start. (5) Basis for action — (A) This finding is normally based on well-controlled investigations, which may include clinical investigations by qualified experts. (B) But if the Secretary determines other valid scientific evidence is sufficient, the finding may rest on that evidence instead.

(d) Withdrawal and temporary suspension: (1) In general — After obtaining Advisory Committee advice where appropriate, and after notice and an informal hearing^*, the Secretary must withdraw a previously issued approval order if the Secretary finds (A) continued marketing is no longer appropriate for public health protection; (B) the application contained or was accompanied by an untrue material statement; (C) the applicant failed to set up a proper recordkeeping system, repeatedly or deliberately failed to keep records or make reports required under section 387i, refused to allow record inspection or verification required under section 374, or didn't comply with section 387e's registration rules; (D) new evidence, combined with the evidence reviewed originally, shows the manufacturing methods, facilities, or controls don't conform to section 387f(e) and weren't fixed within a reasonable time after written notice; (E) new evidence, similarly combined, shows the labeling is false or misleading and wasn't corrected within a reasonable time after written notice; or (F) new evidence, similarly combined, shows the product doesn't conform to an applicable product standard under section 387g, with no adequate justification for the deviation. (2) Appeal — The holder of a withdrawn approval may petition for judicial review under section 387l within 30 days of receiving notice of the withdrawal. (3) Temporary suspension — If, after an informal hearing, the Secretary finds a reasonable probability that continued marketing would cause serious adverse health consequences or death greater than ordinarily caused by tobacco products on the market, the Secretary must temporarily suspend the manufacturer's authority to market the product, and must then move quickly to withdraw the approval under paragraph (1).

(e) Service of order: An order under this section must be served either in person^* by a designated department^* officer or employee, or by registered or certified mail to the applicant's last known address on file with the Secretary.

(f) Records: (1) Additional information — While an approval order is in effect, the applicant must keep records and make reports the Secretary prescribes, by regulation or order, as necessary to determine whether grounds exist to withdraw or temporarily suspend the order. (2) Access to records — Anyone required to keep these records, and anyone in charge of them, must let a designated Secretary official access, copy, and verify them at reasonable times.

(g) Investigational tobacco product exemption for investigational use: The Secretary may exempt tobacco products intended for investigational use from this subchapter's requirements, under conditions set by regulation.