The Family Smoking Prevention and Tobacco Control Act: An overview

Food and Drug Law Journal

Volumn 64, Issue 4, 2009, Pages 717-732

  Carvajal, Ricardo ^a   Clissold, David ^a   Shapiro, Jeffrey ^a  

^a Hyman Phelps & McNamara PC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; CONTROLLED STUDY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT; HEALTH CARE POLICY; LAW; LAW SUIT; MARKETING; MEDICAL INFORMATION; REVIEW; SMOKING; TOBACCO;

NICOTIANA TABACUM;

EID: 73849097550     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (62)

1. Pub. L. No. 111-131, §§ 2(3), 2(5), 2(31) and 2(49), 123 Stat. 1776, 1777-1781 (2009).
2. See, e.g., O'Reilly, James T., FDA Regulation of Tobacco: Blessing or Curse for FDA Professionals?, FOOD & DRUG LAW J, Vol. 64, No. 3 (2009); Barker, Kevin G., Thank You for Regulating: Why Philip Morris's Embrace of FDA Regulation Helps the Company but Harms the Agency, ADMINISTRATIVE LAW REVIEW, Vol. 61, No. 1 (2009).
3. The establishment of a CTP Products is required under FSPTCA section 901(e).
4. Commonwealth Brands, Inc., et al. v. FDA, C.A. No.: 1:09-CV-0117-JHM-ERG (W.D. KY filed (Aug. 31, 2009)).
5. FDA is granted authority under section 906(e) to establish by regulation GMP requirements that address methods, facilities and controls.
6. Section 919 authorizes FDA to assess and collect quarterly fees from each manufacturer and importer of tobacco products to which Chapter IX applies FDA is authorized to collect $85 million in the first fiscal year and more thereafter, increasing to $712 million by fiscal year 2019. All fees are required to be used for the regulation of tobacco products.
7. FDCA § 908(a)(1).
8. Id. § 908(c).
9. Food legislation under consideration would impose a similar frequency-of-inspection requirement for food facilities.
10. Under section 904(d), FDA is required to publish a list of harmful and potentially harmful constituents in a tobacco product and its smoke, by brand.
11. FDCA § 909(a).
12. Id. § 909(a)(1).
13. Id. § 915(b)(1).
14. Id. § 907(e).
15. See Clove Cigars Avoid Ban on Flavored Cigarettes, WALL STREET JOURNAL (Sept. 7, 2009). The prohibition went into effect three months after the date of enactment. In addition, beginning two years after enactment, cigarette manufacturers may not use tobacco that contains a pesticide chemical residue in excess of any tolerance applicable under federal law.
16. FDCA § 907(a)(3)(A). FDA, however, cannot ban cigarettes, nor can it require nicotine levels to be zero. See id. § 900.
17. Id. § 907(a)(3)(B)(i).
18. Id. § 907(a)(3)(B)(ii).
19. Id. § 907(a)(4)(A).
20. Id. § 907(b)(2).
21. Id.
22. FDCA § 907(e).
23. Id. § 907(f).
24. If a new product is marketed between Feb. 15, 2007 and Mar. 22, 2011, a PMN need not be submitted until the latter date. In addition, FDA may by regulation exempt tobacco products for investigational use from premarket approval requirements. Id. § 910(g).
25. See id. §§ 515, 510(k).
26. Id. § 905(f). Under section 905(j)(3), a permissible modification consists of adding or deleting an additive (or increasing or decreasing its quantity) if FDA determines that such a modification is minor and that a premarket notification is not necessary to ensure that marketing of the product "would be appropriate for protection of the public health." FDA is required to issue a regulation that implements section 905(j)(3).
27. Id. § 910(a)(3).
28. Id. § 910(a)(4)(A).
29. Id. § 910(b)(1).
30. Id. § 910(c)(2)(A).
31. Id. § 910(c)(4).
32. Id. § 910(d)(1)(A).
33. See id. § 515(e).
34. Id. § 910(d)(3).
35. See Brandt, Allan M., The Cigarette Century, BASIC BOOKS, New York, N.Y. (2007).
36. As of the date of enactment, a distributor may not take any action reasonably expected to result in consumers believing that a tobacco product or its smoke may present a lower disease risk or is less harmful than other products, or that it presents a reduced exposure to a substance. FDCA § 911(m).
37. FDA, however, cannot subject modified risk tobacco products to regulation as drugs. See id. FDCA § 900.
38. Under FDCA § 911(b)(1), a tobacco dependence product is not subject to regulation as a modified risk tobacco product if it is approved as a drug or device.
39. Id. § 911(b)(2)(A)(iii).
40. Id. § 911(d).
41. Id. § 911(g)(l).
42. FDA is required to issue a regulation or guidance within two years of enactment that establishes standards for studies needed to support issuance of an approval order, and for postmarket studies (discussed further below). The regulation or guidance must also establish a "reasonable" timetable for the review of applications.
43. Id. § 911(h)(l).
44. Id. § 911(i).
45. Id. § 911(g)(2)(C).
46. 61 Fed. Reg. 44, 396 (Aug. 28, 1996).
47. See FSPTCA § 102(a)(2).
48. Proposed 21 C.F.R. § 897.30.
49. Id. § 897.32.
50. Id. § 897.34.
51. Lorillard Tobacco Co., 533 U.S. at 565.
52. FDCA § 906(d)(4)(A).
53. FSPTCA § 105(a).
54. Id. § 105(b). Under FDCA section 916, states and federal agencies retain authority to impose requirements in addition to or more stringent than those in Chapter IX, except insofar as they relate to standards, premarket review, adulteration, misbranding, labeling, registration, GMPs or modified risk tobacco products. With respect to advertising and promotion, FSPTCA § 203 amends the FCLAA to allow states or localities to impose bans or restrictions on the time, place, and manner of such activity, but not on content. In making statutory amendments that address state authority, Congress made clear that there is no intent to preempt state product liability laws.
55. FDCA § 906(d).
56. Id. § 906(d)(i).
57. Under the FSPTCA, the Federal Trade Commission (FTC) retains jurisdiction over the advertising, sale, and distribution of tobacco products unless otherwise provided under the FSPTCA. An advertising violation of Chapter IX or FDA's reissued regulation is an unfair or deceptive act or practice that violates section 5(a) of the FTC Act. FDA is directed to coordinate with the FTC with respect to relevant provisions of the FCLAA and CSTHEA.
58. There are some significant limitations on FDA's authority to restrict the distribution of tobacco products. For example, FDA cannot prohibit face-to-face sales by specific categories of retail outlets, nor can FDA raise the minimum age for purchase above eighteen. Under FSPTCA § 104, FDA is directed to conduct a study on the public health implications of raising the minimum age and report back to Congress within five years.
59. Section 900(8) defines "illicit trade" as "any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, distribution, sale or purchase of tobacco products including any practice or conduct intended to facilitate such activity."
60. Section 900(6) defines "counterfeit tobacco product" as "a tobacco product (or the container or labeling of such a product) that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a tobacco product listed in a registration under section 905(i)(l)."
61. C.A. No.: 1:09-CV-0117-JHM-ERG (W.D. KY filed (Aug. 31, 2009)).
62. The filing of this suit was predicted during Congressional deliberations on H.R. 1256 (which subsequently became the FSPTCA).