Pub. L. 94-278, tit. IV, sec. 502

Sec. 502. (a) (1) Section 403(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(a)) is amended (A) by inserting “(1)” after “If”, and (B) by inserting before the period at the end a comma and the following: “or (2) in the case of a food to which section 411 applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2)”. (2) (A) Section 201 (n) of such Act is amended by inserting “or advertising” after “labeling” each time it occurs. (B) Section 303 of such Act is amended by adding at the end the following new subsection: “(d) No person shall be subject to the penalties of subsection (a) of this section for a violation of section 301 involving misbranded food if the violation exists solely because the food is misbranded under section 403(a)(2) because of its advertising, and no person shall be subject to the penalties of subsection (b) of this section for such a violation unless the violation is committed with the intent to defraud or mislead.”. (C) Section 304(a) of such Act (21 U.S.C. 334(a)) is amended by adding after paragraph (2) the following new paragraph: “(3) (A) Except as provided in subparagraph (B), no libel for condemnation may be instituted under paragraph (1) or (2) against any food which— “(i) is misbranded under section 403(a)(2) because of its advertising, and “(ii) is being held for sale to the ultimate consumer in an establishment other than an establishment owned or operated by a manufacturer, packer, or distributor of the food. 90 STAT. 412 “(B) A libel for condemnation may be instituted under paragraph (1) or (2) against a food described in subparagraph (A) if— “(i) (I) the food’s advertising which resulted in the food being misbranded under section 403(a)(2) was disseminated in the establishment in which the food is being held for sale to the ultimate consumer, “(II) such advertising was disseminated by, or under the direction of, the owner or operator of such establishment, or “(III) all or part of the cost of such advertising was paid by such owner or operator; and “(ii) the owner or operator of such establishment used such advertising in the establishment to promote the sale of the food.”. (b) Chapter VII of such Act is amended by adding after section 706 (21 U.S.C. 376) the following new section: “advertising of certain foods “Sec. 707. (a) (1) Except as provided in subsection (c), before the Secretary may initiate any action under chapter III— “(A) with respect to any food which the Secretary determines is misbranded under section 403(a)(2) because of its advertising, or “(B) with respect to a food’s advertising which the Secretary determines causes the food to lie so misbranded, the Secretary shall, in accordance with paragraph (2), notify in writing the Federal Trade Commission of the action the Secretary proposes to take respecting such food or advertising. “(2) The notice required by paragraph (1) shall— “(A) contain (i) a description of the action the Secretary proposes to take and of the advertising which the Secretary has determined causes a food to be misbranded, (ii) a statement of the reasons for the Secretary’s determination that such advertising has caused such food to be misbranded, and “(B) be accompanied by the records, documents, and other written materials which the Secretary determines supports his determination that such food is misbranded because of such advertising. “(b) (1) If the Secretary notifies the Federal Trade Commission under subsection (a) of action proposed to be taken under chapter III with respect to a food or food advertising and the Commission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that— “(A) it has initiated under the Federal Trade Commission Act an investigation of such advertising to determine if it is prohibited by such Act or any order or rule under such Act, “(B) it has commenced (or intends to commence) a civil action under section 5, 13, or 19 with respect to such advertising or the Attorney General has commenced (or intends to commence.) a civil action under section 5 with respect to such advertising, “(C) it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act respecting such advertising, or “(D) pursuant to section 16(b) of such Act it has made a certification to the Attorney General respecting such advertising, the Secretary may not, except as provided by paragraph (2), initiate the action described in the Secretary’s notice to the Federal Trade Commission. 90 STAT. 413 “(2) If, before the expiration of the 60-day period beginning on the date the Secretary receives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)— “(A) the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this subsection respecting the advertising described in the Secretary’s notice, “(B) the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or “(C) the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respecting such advertising, or, if the Commission does make such a certification to the Attorney General respecting such advertising, the Attorney General, before the expiration of such period, docs not cause appropriate criminal proceedings to be brought against such advertising, the Secretary may, after the expiration of such period, initiate the action described in the notice to the Commission pursuant, to subsection (a). The Commission shall promptly notify the Secretary of the commencement by the Commission of such a civil action, the issuance and service by it of such a complaint, or the causing by the Attorney General of criminal proceedings to lie brought against such advertising. “(c) The requirements of subsections (a) and (b) do not apply with respect to action under chapter III with respect to any food or food advertising if the Secretary determines that such action is required to eliminate an imminent hazard to health. “(d) For the purpose of avoiding unnecessary duplication, the Secretary shall coordinate any action taken under chapter III because of advertising which the Secretary determines causes a food to be misbranded with any action of the Federal Trade Commission under the Federal Trade Commission Act with respect to such advertising.” (c) The amendments made by subsection (a) shall take effect 180 days after the date of the enactment of this Act.