
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC378]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                    SUBCHAPTER VII--GENERAL AUTHORITY
 
                Part A--General Administrative Provisions
 
Sec. 378. Advertising of foods


(a) Determination of misbranding; notification of Federal Trade 
        Commission by Secretary; contents

    (1) Except as provided in subsection (c) of this section, before the 
Secretary may initiate any action under subchapter III of this chapter--
        (A) with respect to any food which the Secretary determines is 
    misbranded under section 343(a)(2) of this title because of its 
    advertising, or
        (B) with respect to a food's advertising which the Secretary 
    determines causes the food to be 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) Action by Federal Trade Commission precluding action by Secretary; 
        exception

    (1) If the Secretary notifies the Federal Trade Commission under 
subsection (a) of this section of action proposed to be taken under 
subchapter III of this chapter 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 [15 
    U.S.C. 41 et seq.] 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 [15 U.S.C. 45, 53, or 57b] with respect 
    to such advertising or the Attorney General has commenced (or 
    intends to commence) a civil action under section 5 [15 U.S.C. 45] 
    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 [15 U.S.C. 45(b)] 
    respecting such advertising, or
        (D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] 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.
    (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) of this section--
        (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, does 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) of this section. 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 be brought against such 
advertising.

(c) Secretary's determination of imminent hazard to health as suspending 
        applicability of provisions

    The requirements of subsections (a) and (b) of this section do not 
apply with respect to action under subchapter III of this chapter 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) Coordination of action by Secretary with Federal Trade Commission

    For the purpose of avoiding unnecessary duplication, the Secretary 
shall coordinate any action taken under subchapter III of this chapter 
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 [15 U.S.C. 41 et seq.] with respect to such 
advertising.

(June 25, 1938, ch. 675, Sec. 707, as added Pub. L. 94-278, title V, 
Sec. 502(b), Apr. 22, 1976, 90 Stat. 412.)

                       References in Text

    The Federal Trade Commission Act, referred to in subsecs. (b) and 
(d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, as amended, which is 
classified generally to subchapter I (Sec. 41 et seq.) of chapter 2 of 
Title 15, Commerce and Trade. For complete classification of this Act to 
the Code, see section 58 of Title 15 and Tables.
