<<Generally, the
tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. The Substantial Equivalence provision of the Tobacco Control Act requires nothing of manufacturers of unaltered tobacco products which were
commercially available on February 15, 2007.
Under section 910(c) of the Tobacco Control Act, to introduce a new or modified tobacco product an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health. Section 905(j) of the Tobacco Control Act, however, provides an alternative pathway to the 910(c) pathway. Under section 905(j), a manufacturer may submit a substantial equivalence report demonstrating that its new tobacco product is substantially equivalent to a predicate tobacco product, as defined in the Tobacco Control Act. FDA reviews this report to determine whether a market authorization order finding the new tobacco product substantially equivalent to the predicate product and in compliance with other requirements of the law is appropriate.
It is important to note that the Tobacco Control Act contains a special provision for new tobacco products that were introduced into the market between February 15, 2007 and March 22, 2011, and for existing tobacco products for which changes were made in this time period. Manufacturers who submit substantial equivalence reports for these products by March 22, 2011 may continue to market their products unless FDA issues an order finding the product to be not substantially equivalent to the predicate product. Manufacturers of these tobacco products must remove their products from the market if they do not submit a report to FDA before March 23, 2011.
Information contained in substantial equivalence report submissions by tobacco companies will provide FDA with important information about the characteristics of the products, including what is actually in the products. Importantly, the substantial equivalence report submissions will also inform FDA about how these products change over time. This information is fundamental for FDA’s evaluation of the potential impact of changes made in the ingredients and constituents of tobacco products on public health, which is a requirement of the Tobacco Control Act.
It is the responsibility of each manufacturer to know when its new or changed products were first introduced into the marketplace. While manufacturers can choose, where applicable, whether to submit a New Product Application or a Substantial Equivalence Report for a new or changed product, FDA’s guidance provides important information for manufacturers to better determine if they should submit a Substantial Equivalence Report and FDA’s current thinking on the type of scientific data that will support a determination of substantial equivalence.
FDA also intends to issue guidance on materials that manufacturers may rely on to document that their tobacco products were on the market on February 15, 2007, as well as hold a Webinar Series in order to provide even more assistance to companies.
Final Guidance for Industry and FDA Staff – Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
* This guidance provides recommendations and information related to the submission and review of reports under section 905(j) of the Federal Food, Drug. And Cosmetic Act (Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31).
Proposed Rule – Exemptions from Substantial Equivalence Requirements for Tobacco Products (PDF-92KB)
FDA is issuing this proposed rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
* The proposed rule would describe the process and criteria for requesting an exemption and explain how FDA would review requests for exemptions.
* Once finalized, this regulation will satisfy the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.
Webinar Series
FDA Center for Tobacco Products (CTP) will hold Webinars with stakeholders to inform them of the substantial equivalence regulation and requirements. The webinars will feature a presentation about the new requirements and a question and answer session.
Participants are encouraged to submit questions in advance to
AskCTP@fda.hhs.gov.
We will do our best to answer all questions submitted during the Webinar; however, we may not be able to address all questions in the timeframe and/or may need more time to answer some questions. We will continue to update our Frequently Asked Questions: Substantial Equivalence. Please register for our weekly email updates for the latest information from CTP.
Webinar Schedule
Call in information will be posted here when available.
* Tobacco Industry: Small and Large Business - January 12, 2011, 11:30 a.m. – 2 p.m. ET
* Public Health and Tobacco Control Organizations - January 14, 2011, 10:30 a.m. – 12 pm ET
* Small Business Follow-up - January 25, 2011, 11:30 a.m. – 2 p.m. ET
CTP welcomes inquiries and feedback on all tobacco-related activities. Below is a list of additional ways to contact and communicate with CTP.
* Via Email:
AskCTP@fda.hhs.gov
* Via our Call center: 1-877-287-1373 (9:00 am to 4:00 pm Eastern)
* Submitting comments on proposed rules, dockets, and guidance documents to CTP through the public comment process at
Regulations.gov
* Registering for weekly updates “This Week in CTP”
Regulatory submissions can be mailed to:
Center for Tobacco Products
Food and Drug Administration
Attn: Document Control Center
9200 Corporate Boulevard
Rockville, MD 20850
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Additional Resources
* Guidance for Industry and Food and Drug Administration Staff; Reports: Demonstrating Substantial Equivalence for Tobacco Products (PDF - 109KB)
* Proposed Rule – Exemptions from Substantial Equivalence Requirements for Tobacco Products (PDF - 92KB)
* FDA to require substantial equivalence reviews for new tobacco products
* Public Dockets for Comment
* NCTR - Office of Scientific Coordination - Organization - 012510 (PDF - 27KB)
* CTP Ombudsman
* This Week in CTP -- Updates from the FDA Center for Tobacco Products (CTP)>>
Interesting twist in events "commercially", e cigs are bootleg not a commercial product, well at least that is my interpretation. Now we finally know the bullet they will use.
lmao
