The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j))

Transcription

1 The Tobacco Control Act s Premarket Review Authorities: Reports on Substantial Equivalence and Exemption Requests (905(j)) January 12, 2011 Cristi Stark, MS Senior Regulatory Health Project Manager Office of Science Center for Tobacco Products

2 Presentation Outline Premarket Authorities New Tobacco Products and Marketing Substantial Equivalence Substantial Equivalence Exemption Frequently Asked Questions

3 Tobacco Overview Current Tobacco Products Regulated by FDA Cigarettes Roll-your-own Smokeless Tobacco Control Act is a Public Health Law Science-based regulation CTP makes the decision as to the appropriateness for public health

4 Why Are Premarket Authorities Important? Beginning in March 2011, manufacturers must submit new tobacco products for FDA review Generally, the premarket provisions provide FDA with authority over a tobacco product before it enters the market. New products that do not meet the statutory premarket requirements cannot be legally marketed (misbranded and adulterated).

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6 What is a New Tobacco Product? Section 910(a) of the Tobacco Control Act defines new tobacco product as: - (A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or

7 New Tobacco Product (cont d): Section 910(a) defines new tobacco product as: - (B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

8 Options for Marketing New Tobacco Products: In general, three pathways to enter commercial distribution as a new tobacco product: (1) a report of substantial equivalence and compliance with the Act (905(j)(1)(A)(i)); (2) exemption from substantial equivalence (905(j)(3), must also report under 905(j)(1)(A)(ii)); or (3) new product application (910(b)). This presentation focuses on the 905(j) report and exemption from substantial equivalence pathways.

9 Substantial Equivalence (SE)

10 Substantial Equivalence Notes of Interest FDA s determination of substantially equivalent (or not) to a predicate tobacco product is a necessary foundation for protecting the public health. FDA reviews a substantial equivalence report (905(j) report) and issues an order that a tobacco product is substantially equivalent (or not) for marketing: Interim products: submit 905(j) report by March 22, 2011, and market unless FDA issues an order that the tobacco product is not substantially equivalent (see 910(a)(2)(B)). New tobacco products with 905(j) reports submitted March 23, 2011 and after: the manufacturer must wait for an FDA order of substantial equivalence prior to marketing

11 Substantial Equivalence Section 910(a)(3) defines substantial equivalence as: with respect to the new tobacco product being compared to the predicate tobacco product, that the FDA by order has found that the new product (1) has the same characteristics as the predicate tobacco product; or (2) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by FDA, that demonstrates that it is not appropriate to regulate the product under section 910 (premarket application) because the product does not raise different questions of public health.

12 Characteristics Section 910(a)(3)(B) defines characteristics as the materials, ingredients, design, composition, heating source, or other features of a tobacco product. CTP has interpreted other features as: Harmful and/or Potentially Harmful Constituents (HPHC) Any additional characteristics

13 Predicate Tobacco Product Section 905(j)(1)(A) states that the manufacturer must include information in the 905(j) report that explains why the new product is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that FDA has previously determined is substantially equivalent and in compliance with the requirements of the Act. In short, the predicate product.

14 Substantial Equivalence: Statutory Framework As an alternative to a premarket application under 910, a manufacturer--at least 90 days prior to introducing the product into interstate commerce for commercial distribution--may submit a report intended to demonstrate the tobacco product is: (1) Substantially equivalent to a predicate tobacco product; (2) In compliance with the requirements of the Act; and (3) In compliance with any applicable standards. (sections 905(j)(1) and 910(a))

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16 Substantial Equivalence Guidance Broad guidance explaining: recommendations for information that should be included with substantial equivalence reports, including information on substantial equivalence to a predicate and compliance with the requirements of the Act. Recommendations include information on the following: (1) Single predicate

17 Substantial Equivalence Guidance (cont d) Broad guidance explaining: recommendations for information that should be included with premarket reports, including information on substantial equivalence to a predicate and compliance with the requirements of the Act. Recommendations include information on the following: (2) When the predicate product is a product previously found substantially equivalent (SE) by FDA, the new product should also be compared to a grandfathered product;

18 Substantial Equivalence Guidance (cont d) Broad guidance explaining: recommendations for information that should be included with premarket reports, including information on substantial equivalence to a predicate and compliance with the requirements of the Act. Recommendations include information on the following: (3) Characteristics to be reported: -design features -ingredients -materials -composition -heating source -HPHC

19 Substantial Equivalence Guidance (cont d) Broad guidance explaining: recommendations for information that should be included with premarket reports, including information on substantial equivalence to a predicate and compliance with the requirements of the Act. Recommendations include information on the following: (4) Other information FDA needs to make a determination to demonstrate the new product does not raise different questions of public health. -clinical data -abuse liability data -consumer perception studies -toxicology data

20 Enforcement Discretion At this time, FDA does not intend to enforce the requirements of sections 910 and 905(j) for: Tobacco blending changes required to address the year-to-year variation of tobacco crops Components (e.g., filters, papers) of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products CTP intends to work on a case-by-case basis with manufacturers of tobacco products first marketed between February 15, 2007 and March 22, 2011 who submit reports as required.

21 SE Guidance Summary Includes recommendations related to describing a new tobacco product s characteristics (materials, ingredients, design, composition heating source, other features) and how the new product compares to the predicate tobacco product. Includes a recommendation that information on HPHC be included as part of addressing other features of the new tobacco product. Recommends that the manufacturer report levels of HPHC with a side-by-side comparison to the predicate tobacco product and, where applicable, to a grandfathered tobacco product. When a predicate is a product previously found SE by FDA, the new product should also be compared to a grandfathered tobacco product. In the case of products with characteristics different from the predicate, to help ensure that the product does not raise different questions of health, the guidance explains that FDA may request: Additional data on clinical endpoints, abuse liability [addiction potential], toxicology, and consumer health risk perception. Enforcement discretion is currently being utilized for: certain tobacco blending changes components of regulated tobacco products that are sold/distributed solely for further manufacturing

22 Substantial Equivalence Exemption

23 Substantial Equivalence Exemption: Statutory Framework FDA may exempt from substantial equivalence requirements tobacco products that are modified by adding or deleting an additive or increasing or decreasing the quantity of an existing additive, if FDA determines that-- (1) the modification is a minor modification to a tobacco product that can be sold under the Act, (2) A 905(j) (substantial equivalence) report is not necessary to ensure the marketing of the product is appropriate for the protection of public health, and (3) The exemption is otherwise appropriate.

24 Exemption from Substantial Equivalence (cont d) After obtaining an exemption determination under 905(j)(3) need to report to FDA at least 90 days before introducing a tobacco product into interstate commerce for commercial distribution the basis for determining: (1) the product is modified as described in 905(j)(3); (2) the modifications are to a product that is commercially marketed and in compliance with the Act; (3) all modifications are covered by exemptions granted pursuant to 905(j)(3); and (4) action taken to comply with applicable requirements under 907 (standards). (905(j)(1)(A)(ii) and (B))

25 Draft Proposed Rule on Exemptions The proposed rule would implement section 905(j)(3) (establishing a process for making an exemption request). Under the proposed rule, the exemption request: (1) may be made only by the manufacturer of a legally marketed tobacco product for a minor modification to that manufacturer s product; (2) must include detailed information describing the modification and how the statutory criteria are met; (3) must be submitted electronically; (4) must include a certification by a responsible official that the change does not increase the tobacco product s appeal to/use by minors, toxicity, or addictiveness/abuse liability. Proposal does not include categories of modifications.

26 Some Points to Remember-- Submitting a 905(j) report by March 22, 2011, enables a tobacco product that was introduced into commercial distribution after February 15, 2007, and before March 22, 2011, to continue legal marketing (unless FDA determines the product is not SE). CTP intends to work on a case-by-case basis with manufacturers of tobacco products first marketed between February 15, 2007 and March 22, 2011 who submit reports as required. On or after March 22, 2011, new products must obtain FDA review and an order prior to marketing. Enforcement discretion for certain tobacco blending changes and components of regulated tobacco products sold/distributed solely for further manufacturing. Exemption proposal does not include categories of exemptions.

27 Frequently Asked Questions Are cigarette rolling papers subject to the Substantial Equivalence requirements? If we introduce a new cigarette rolling paper, does that need FDA approval even though there is no tobacco in the paper? If approval is needed, how is that done?

28 Frequently Asked Questions (cont d) We are an importer of fine papers for the cigarette industry. We import tipping base, plugwrap and cigarette paper used to manufacture Tipping Paper, Filters and Cigarettes. We understand that FDA intends to limit its enforcement of the requirements of Section 910 and 905(j) to finished, regulated tobacco products. Are we in compliance under the Tobacco Control Act if we do not file any reports under section 905(j) and 910 at this time? Is there a date when we are required to file these reports? We also import generic (no-name) cigarette paper booklets and tubes that are used by tobacco product manufacturers as part of kits and are not sold separately to consumers or are being used for internal laboratory testing. Please provide guidance and advice regarding our responsibility to file reports under Section 910 and 905(j) for these products.

29 Frequently Asked Questions (cont d) In the guidance document, what does FDA mean by the phrase "tabular format"? Do companies have flexibility in creating tables or spreadsheets to present their information, or are there specific rows/columns the Agency expects to see?

30 Frequently Asked Questions (cont d) Whose responsibility is it to know when a product was first commercially marketed?

31 Frequently Asked Questions (cont d) Would a cigarette be a "new tobacco product," and subject to a Substantial Equivalence filing, if the cigarette was marketed before February 15, 2007 but the packaging has been changed for compliance with the new tobacco law (e.g., removal of descriptors of light, low, mild, addition of graphic warnings, etc.) or due to other factors (e.g., a change from hard pack to soft pack, a de minimis change such as font size, ink color, background color, etc)?

32 Frequently Asked Questions (cont d) Do I need to file? I am with a small business that was established before February I have the same product...just switched the supplier of the dressing/conditioner. This was listed in my ingredients when I submitted it.

33 Frequently Asked Questions (cont d) I have a question for you concerning the proposed rule in the Federal Register on Thursday, Jan 6, 2011: Tobacco Products, Exemptions From Substantial Equivalence Requirements Can you tell me if this is expected to affect foreign manufacturers of tobacco products?

34 Frequently Asked Questions (cont d) When can I submit a request for an exemption from the substantial equivalence requirements?

35 Frequently Asked Questions (cont d) Has FDA considered allowing the current proposed rule to act as a safe harbor for manufacturers who are acting in good faith? FDA has already stated it will do so with respect to the guidance. I think having no route for the exemptions actually puts a greater burden on both the industry and FDA. It allows for or will create, more (tasks) then we're already going to see. FDA has already noted that it is going to use enforcement discretion with regard to the applications themselves. And again, I wonder whether you have considered or will consider using the current proposed rule as a safe harbor. Thank you.

36 Questions? CTP Call Center: (9:00am 4:00pm ET) esforyou/forindustry/ucm htm