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upon such other conditions as the Secretary may prescribe in such regulation, if, because of its potentiality for harmful effect or the collateral measures necessary for its use , the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness." 12 In the final tobacco rule, the FDA relied on the FFDCA's restricted device provision when it concluded that, because of the harmful effects of cigarette and smokeless tobacco and in the absence of a reasonable assurance of the safety and effectiveness of such products, it needed to implement additional restrictions on tobacco access and advertising in order to prevent new users from becoming addicted

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