21 U.S.C. § 331 : US Code - Section 331: Prohibited acts

      The following acts and the causing thereof are prohibited:
      (a) The introduction or delivery for introduction into interstate
    commerce of any food, drug, device, tobacco product, or cosmetic
    that is adulterated or misbranded.
      (b) The adulteration or misbranding of any food, drug, device,
    tobacco product, or cosmetic in interstate commerce.
      (c) The receipt in interstate commerce of any food, drug, device,
    tobacco product, or cosmetic that is adulterated or misbranded, and
    the delivery or proffered delivery thereof for pay or otherwise.
      (d) The introduction or delivery for introduction into interstate
    commerce of any article in violation of section 344, 350d, 355, or
    360bbb-3 of this title.
      (e) The refusal to permit access to or copying of any record as
    required by section 350a, 350c, 350f(j), 350e, 354, 360bbb-3, 373,
    374(a), 379aa, or 379aa-1 of this title; or the failure to
    establish or maintain any record, or make any report, required
    under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k),
    360b(a)(4)(C), 360b(j), (l) or (m), 360ccc-1(i), 360e(f), 360i,
    360bbb-3, 379aa, 379aa-1, 387i, or 387t of this title or the
    refusal to permit access to or verification or copying of any such
    required record; or the violation of any recordkeeping requirement
    under section 2223 (!1) of this title (except when such violation
    is committed by a farm).

      (f) The refusal to permit entry or inspection as authorized by
    section 374 of this title.
      (g) The manufacture within any Territory of any food, drug,
    device, tobacco product, or cosmetic that is adulterated or
    misbranded.
      (h) The giving of a guaranty or undertaking referred to in
    section 333(c)(2) of this title, which guaranty or undertaking is
    false, except by a person who relied upon a guaranty or undertaking
    to the same effect signed by, and containing the name and address
    of, the person residing in the United States from whom he received
    in good faith the food, drug, device, tobacco product, or cosmetic;
    or the giving of a guaranty or undertaking referred to in section
    333(c)(3) of this title, which guaranty or undertaking is false.
      (i)(1) Forging, counterfeiting, simulating, or falsely
    representing, or without proper authority using any mark, stamp,
    tag, label, or other identification device authorized or required
    by regulations promulgated under the provisions of section 344 or
    379e of this title.
      (2) Making, selling, disposing of, or keeping in possession,
    control, or custody, or concealing any punch, die, plate, stone, or
    other thing designed to print, imprint, or reproduce the trademark,
    trade name, or other identifying mark, imprint, or device of
    another or any likeness of any of the foregoing upon any drug or
    container or labeling thereof so as to render such drug a
    counterfeit drug.
      (3) The doing of any act which causes a drug to be a counterfeit
    drug, or the sale or dispensing, or the holding for sale or
    dispensing, of a counterfeit drug.
      (j) The using by any person to his own advantage, or revealing,
    other than to the Secretary or officers or employees of the
    Department, or to the courts when relevant in any judicial
    proceeding under this chapter, any information acquired under
    authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,
    360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc-1, 360ccc-2,
    374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of
    this title concerning any method or process which as a trade secret
    is entitled to protection; or the violating of section 346a(i)(2)
    of this title or any regulation issued under that section..(!2)
    This paragraph does not authorize the withholding of information
    from either House of Congress or from, to the extent of matter
    within its jurisdiction, any committee or subcommittee of such
    committee or any joint committee of Congress or any subcommittee of
    such joint committee.

      (k) The alteration, mutilation, destruction, obliteration, or
    removal of the whole or any part of the labeling of, or the doing
    of any other act with respect to, a food, drug, device, tobacco
    product, or cosmetic, if such act is done while such article is
    held for sale (whether or not the first sale) after shipment in
    interstate commerce and results in such article being adulterated
    or misbranded.
      (l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997,
    111 Stat. 2380.
      (m) The sale or offering for sale of colored oleomargarine or
    colored margarine, or the possession or serving of colored
    oleomargarine or colored margarine in violation of subsections (b)
    or (c) of section 347 of this title.
      (n) The using, in labeling, advertising or other sales promotion
    of any reference to any report or analysis furnished in compliance
    with section 374 of this title.
      (o) In the case of a prescription drug distributed or offered for
    sale in interstate commerce, the failure of the manufacturer,
    packer, or distributor thereof to maintain for transmittal, or to
    transmit, to any practitioner licensed by applicable State law to
    administer such drug who makes written request for information as
    to such drug, true and correct copies of all printed matter which
    is required to be included in any package in which that drug is
    distributed or sold, or such other printed matter as is approved by
    the Secretary. Nothing in this paragraph shall be construed to
    exempt any person from any labeling requirement imposed by or under
    other provisions of this chapter.
      (p) The failure to register in accordance with section 360 or
    387e of this title, the failure to provide any information required
    by section 360(j), 360(k), 387e(i), or 387e(j) of this title, or
    the failure to provide a notice required by section 360(j)(2) or
    387e(i)(3) of this title.
      (q)(1) The failure or refusal - 
        (A) to comply with any requirement prescribed under section
      360h, 360j(g), 387c(b), 387g, 387h, or 387o of this title;
        (B) to furnish any notification or other material or
      information required by or under section 360i, 360j(g), 387d,
      387i, or 387t of this title; or
        (C) to comply with a requirement under section 360l or 387m of
      this title.

      (2) With respect to any device or tobacco product, the submission
    of any report that is required by or under this chapter that is
    false or misleading in any material respect.
      (r) The movement of a device or tobacco product in violation of
    an order under section 334(g) of this title or the removal or
    alteration of any mark or label required by the order to identify
    the device or tobacco product as detained.
      (s) The failure to provide the notice required by section 350a(c)
    or 350a(e) of this title, the failure to make the reports required
    by section 350a(f)(1)(B) of this title, the failure to retain the
    records required by section 350a(b)(4) of this title, or the
    failure to meet the requirements prescribed under section
    350a(f)(3) of this title.
      (t) The importation of a drug in violation of section 381(d)(1)
    of this title, the sale, purchase, or trade of a drug or drug
    sample or the offer to sell, purchase, or trade a drug or drug
    sample in violation of section 353(c) of this title, the sale,
    purchase, or trade of a coupon, the offer to sell, purchase, or
    trade such a coupon, or the counterfeiting of such a coupon in
    violation of section 353(c)(2) of this title, the distribution of a
    drug sample in violation of section 353(d) of this title or the
    failure to otherwise comply with the requirements of section 353(d)
    of this title, or the distribution of drugs in violation of section
    353(e) of this title or the failure to otherwise comply with the
    requirements of section 353(e) of this title.
      (u) The failure to comply with any requirements of the provisions
    of, or any regulations or orders of the Secretary, under section
    360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.
      (v) The introduction or delivery for introduction into interstate
    commerce of a dietary supplement that is unsafe under section 350b
    of this title.
      (w) The making of a knowingly false statement in any statement,
    certificate of analysis, record, or report required or requested
    under section 381(d)(3) of this title; the failure to submit a
    certificate of analysis as required under such section; the failure
    to maintain records or to submit records or reports as required by
    such section; the release into interstate commerce of any article
    or portion thereof imported into the United States under such
    section or any finished product made from such article or portion,
    except for export in accordance with section 381(e) or 382 of this
    title, or with section 262(h) of title 42; or the failure to so
    export or to destroy such an article or portions thereof, or such a
    finished product.
      (x) The falsification of a declaration of conformity submitted
    under section 360d(c) of this title or the failure or refusal to
    provide data or information requested by the Secretary under
    paragraph (3) of such section.
      (y) In the case of a drug, device, or food - 
        (1) the submission of a report or recommendation by a person
      accredited under section 360m of this title that is false or
      misleading in any material respect;
        (2) the disclosure by a person accredited under section 360m of
      this title of confidential commercial information or any trade
      secret without the express written consent of the person who
      submitted such information or secret to such person; or
        (3) the receipt by a person accredited under section 360m of
      this title of a bribe in any form or the doing of any corrupt act
      by such person associated with a responsibility delegated to such
      person under this chapter.

      (z) Omitted.
      (aa) The importation of a prescription drug in violation of
    section 384 of this title, the falsification of any record required
    to be maintained or provided to the Secretary under such section,
    or any other violation of regulations under such section.
      (bb) The transfer of an article of food in violation of an order
    under section 334(h) of this title, or the removal or alteration of
    any mark or label required by the order to identify the article as
    detained.
      (cc) The importing or offering for import into the United States
    of an article of food by, with the assistance of, or at the
    direction of, a person debarred under section 335a(b)(3) of this
    title.
      (dd) The failure to register in accordance with section 350d of
    this title.
      (ee) The importing or offering for import into the United States
    of an article of food in violation of the requirements under
    section 381(m) of this title.
      (ff) The importing or offering for import into the United States
    of a drug or device with respect to which there is a failure to
    comply with a request of the Secretary to submit to the Secretary a
    statement under section 381(o) of this title.
      (gg) The knowing failure to comply with paragraph (7)(E) of
    section 374(g) of this title; the knowing inclusion by a person
    accredited under paragraph (2) of such section of false information
    in an inspection report under paragraph (7)(A) of such section; or
    the knowing failure of such a person to include material facts in
    such a report.
      (hh) The failure by a shipper, carrier by motor vehicle or rail
    vehicle, receiver, or any other person engaged in the
    transportation of food to comply with the sanitary transportation
    practices prescribed by the Secretary under section 350e of this
    title.
      (ii) The falsification of a report of a serious adverse event
    submitted to a responsible person (as defined under section 379aa
    or 379aa-1 of this title) or the falsification of a serious adverse
    event report (as defined under section 379aa or 379aa-1 of this
    title) submitted to the Secretary.
      (jj)(1) The failure to submit the certification required by
    section 282(j)(5)(B) of title 42, or knowingly submitting a false
    certification under such section.
      (2) The failure to submit clinical trial information required
    under subsection (j) of section 282 of title 42.
      (3) The submission of clinical trial information under subsection
    (j) of section 282 of title 42 that is false or misleading in any
    particular under paragraph (5)(D) of such subsection (j).
      (kk) The dissemination of a television advertisement without
    complying with section 353b of this title.
      (ll) The introduction or delivery for introduction into
    interstate commerce of any food to which has been added a drug
    approved under section 355 of this title, a biological product
    licensed under section 262 of title 42, or a drug or a biological
    product for which substantial clinical investigations have been
    instituted and for which the existence of such investigations has
    been made public, unless - 
        (1) such drug or such biological product was marketed in food
      before any approval of the drug under section 355 of this title,
      before licensure of the biological product under such section 262
      of title 42, and before any substantial clinical investigations
      involving the drug or the biological product have been
      instituted;
        (2) the Secretary, in the Secretary's discretion, has issued a
      regulation, after notice and comment, approving the use of such
      drug or such biological product in the food;
        (3) the use of the drug or the biological product in the food
      is to enhance the safety of the food to which the drug or the
      biological product is added or applied and not to have
      independent biological or therapeutic effects on humans, and the
      use is in conformity with - 
          (A) a regulation issued under section 348 of this title
        prescribing conditions of safe use in food;
          (B) a regulation listing or affirming conditions under which
        the use of the drug or the biological product in food is
        generally recognized as safe;
          (C) the conditions of use identified in a notification to the
        Secretary of a claim of exemption from the premarket approval
        requirements for food additives based on the notifier's
        determination that the use of the drug or the biological
        product in food is generally recognized as safe, provided that
        the Secretary has not questioned the general recognition of
        safety determination in a letter to the notifier;
          (D) a food contact substance notification that is effective
        under section 348(h) of this title; or
          (E) such drug or biological product had been marketed for
        smoking cessation prior to September 27, 2007; or

        (4) the drug is a new animal drug whose use is not unsafe under
      section 360b of this title.

      (mm) The failure to submit a report or provide a notification
    required under section 350f(d) of this title.
      (nn) The falsification of a report or notification required under
    section 350f(d) of this title.
      (oo) The sale of tobacco products in violation of a no-tobacco-
    sale order issued under section 333(f) of this title.
      (pp) The introduction or delivery for introduction into
    interstate commerce of a tobacco product in violation of section
    387k of this title.
      (qq)(1) Forging, counterfeiting, simulating, or falsely
    representing, or without proper authority using any mark, stamp
    (including tax stamp), tag, label, or other identification device
    upon any tobacco product or container or labeling thereof so as to
    render such tobacco product a counterfeit tobacco product.
      (2) Making, selling, disposing of, or keeping in possession,
    control, or custody, or concealing any punch, die, plate, stone, or
    other item that is designed to print, imprint, or reproduce the
    trademark, trade name, or other identifying mark, imprint, or
    device of another or any likeness of any of the foregoing upon any
    tobacco product or container or labeling thereof so as to render
    such tobacco product a counterfeit tobacco product.
      (3) The doing of any act that causes a tobacco product to be a
    counterfeit tobacco product, or the sale or dispensing, or the
    holding for sale or dispensing, of a counterfeit tobacco product.
      (rr) The charitable distribution of tobacco products.
      (ss) The failure of a manufacturer or distributor to notify the
    Attorney General and the Secretary of the Treasury of their
    knowledge of tobacco products used in illicit trade.
      (tt) Making any express or implied statement or representation
    directed to consumers with respect to a tobacco product, in a label
    or labeling or through the media or advertising, that either
    conveys, or misleads or would mislead consumers into believing,
    that - 
        (1) the product is approved by the Food and Drug
      Administration;
        (2) the Food and Drug Administration deems the product to be
      safe for use by consumers;
        (3) the product is endorsed by the Food and Drug Administration
      for use by consumers; or
        (4) the product is safe or less harmful by virtue of - 
          (A) its regulation or inspection by the Food and Drug
        Administration; or
          (B) its compliance with regulatory requirements set by the
        Food and Drug Administration;

    including any such statement or representation rendering the
    product misbranded under section 387c of this title.
      (uu) The operation of a facility that manufactures, processes,
    packs, or holds food for sale in the United States if the owner,
    operator, or agent in charge of such facility is not in compliance
    with section 350g of this title.
      (vv) The failure to comply with the requirements under section
    350h of this title.
      (ww) The failure to comply with section 350i of this title.
      (xx) The refusal or failure to follow an order under section 350l
    of this title.
      (yy) The knowing and willful failure to comply with the
    notification requirement under section 350f(h) of this title.
      (zz) The importation or offering for importation of a food if the
    importer (as defined in section 384a of this title) does not have
    in place a foreign supplier verification program in compliance with
    such section 384a of this title.