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In the case of a product for which the modified risk application is limited to an explicit or implicit reduced-exposure claim, authorizes FDA to approve such a product for a five-year period (renewable) if the manufacturer demonstrates that: (1) the reduction in exposure to a harmful substance or substances is substantial

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Nicotine Replacement Therapy (NRT) Nicotine gum, lozenges, patches, inhalers, and nasal sprays deliver a dose of nicotine without burning or heating, preventing many of the dangers caused by smoking or vaping

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