§375. Publicity — Inbound Citations

Citations to §375(b)

• 21 U.S.C. § 360h(e)(2)(B)

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  (B) An amended order under subparagraph (A)—

  (i) shall—

  (I) not include recall of a device from individuals, and

  (II) not include recall of a device from device user facilities if the Secretary determines that the risk of recalling such device from the facilities presents a greater health risk than the health risk of not recalling the device from use, and

  (ii) shall provide for notice to individuals subject to the risks associated with the use of such device.

  In providing the notice required by clause (ii), the Secretary may use the assistance of health professionals who prescribed or used such a device for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 375(b) of this title.
• 21 U.S.C. § 387h(c)(2)(B)

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  (B) An amended order under subparagraph (A)—

  (i) shall not include recall of a tobacco product from individuals; and

  (ii) shall provide for notice to persons subject to the risks associated with the use of such tobacco product.

  In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 375(b) of this title.