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FDA is establishing staggered initial compliance periods based on the expected complexity of the applications to be submitted, followed by continued 12-month compliance periods of FDA review. Substantial
Equivalence exemptions have a total compliance period of 24 months and an enforcement deadline of
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A new tobacco product is either a product commercially marketed in the United States after
February 15, 2007, or any modification to a tobacco product commercially marketed after February 15, 2007. If a predicate product existed prior to February 15, 2007, applicants can apply via the Substantial
265:"Guidance Document - Deeming Tobacco Products To Be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products"
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August 8, 2017. Substantial
Equivalence applications have a total compliance period of 30 months and an enforcement deadline of February 8, 2018. Premarket tobacco applications have a total compliance period of 36 months and an enforcement deadline of August 8, 2018.
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can be legally marketed in the United States. The first PMTA, and only to date, was approved by US FDA on
November 10, 2015, when the FDA authorized the marketing of eight
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84:. The rule also authorizes FDA to take enforcement action against manufacturers who sell and distribute products with unsubstantiated
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On May 10, 2016, the US FDA finalized its "deeming" rule, subjecting additional products to scrutiny under the
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FDA issues first product marketing orders through premarket tobacco application pathway
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27:) is an application that must be reviewed and approved by the
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smokeless tobacco products (to be marketed under the
72:. The rule gives the US FDA authority to regulate
70:Family Smoking Prevention and Tobacco Control Act
16:FDA application for marketing tobacco products
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120:Substantial Equivalence Exemption Request
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224:"Premarket Tobacco Application (PMTA)"
56:Equivalence (SE) regulatory pathway.
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137:Substantial Equivalence Application
66:Federal Food, Drug and Cosmetic Act
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199:"Premarket Tobacco Applications"
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154:Premarket Tobacco Application
86:modified risk tobacco product
21:premarket tobacco application
309:Tobacco in the United States
299:Food and Drug Administration
272:Food and Drug Administration
252:Food and Drug Administration
203:Food and Drug Administration
29:Food and Drug Administration
109:Continued Compliance Period
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115:FDA Enforcement Deadline
106:Initial Compliance Period
112:Total Compliance Period
60:FDA deeming regulation
254:(November 10, 2015).
51:New tobacco product
39:North America Inc.
92:Compliance periods
68:as amended by the
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103:Product Pathway
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88:(MRTP) claims.
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37:Swedish Match
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31:before a new
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275:. Retrieved
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206:. Retrieved
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74:e-cigarettes
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47:"General").
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293:Categories
185:References
45:brand name
163:36 months
160:12 months
157:24 months
146:30 months
143:12 months
140:18 months
129:24 months
126:12 months
123:12 months
82:vape pens
173:See also
277:1 June
233:1 June
208:1 June
80:, and
78:cigars
268:(PDF)
279:2016
235:2016
210:2016
41:snus
25:PMTA
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250:,
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19:A
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23:(
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