Difference between revisions of "Federal Food, Drug, and Cosmetic Act"

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'''Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301, et. seq.'''
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{{Law
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|Short title=Federal Food, Drug, and Cosmetic Act
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|Official text=https://govtrackus.s3.amazonaws.com/legislink/pdf/stat/52/STATUTE-52-Pg1040a.pdf
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|Country/Jurisdiction=United States
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|Regulatory bodies=FDA
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|Date enacted=1938/06/25
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|Scope of the law=Individuals, Applicants
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|Short summary introduction=The Federal Food, Drug, and Cosmetic Act establishes the safety of food, drugs, medical devices, and cosmetics. It prohibits distribution of human growth hormones. Moreover, the Act protects consumers from directing them with advertisements, which indicates false or misleading information.
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|Text of the law=21 U.S. Code § 333.Penalties
  
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'''Text of Law'''
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{{SectionHarm|Section=(c)Exceptions in certain cases of good faith, etc.|Harms=Disclosure, Decisional Interference}}
  
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21 U.S. Code § 331.Prohibited acts-The following acts and the causing thereof are prohibited:
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No person shall be subject to the penalties of subsection (a)(1) of this section,  
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(a)The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
 
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(b)The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
 
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(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.
 
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(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.
 
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(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).
 
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(f)The refusal to permit entry or inspection as authorized by section 374 of this title.
 
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(g)The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
 
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(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.
 
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(i)
 
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(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.
 
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(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.
 
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(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.
 
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(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.
 
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(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.
 
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(l)Repealed. Pub. L. 105–115, title IV, § 421, Nov. 21, 1997, 111 Stat. 2380.
 
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(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.
 
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(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.
 
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(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.
 
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(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.
 
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(q)
 
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(1)The failure or refusal—
 
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(A)to comply with any requirement prescribed under section 360h, 360j(g), 387c(b), 387g, 387h, or 387o of this title;
 
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(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
 
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(C)to comply with a requirement under section 360l or 387m of this title.
 
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(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.
 
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(r)The movement of a device, drug, 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, drug, or tobacco product as detained.
 
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(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.
 
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(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, the distribution of drugs in violation of section 353(e) of this title, failure to comply with the requirements under section 360eee–1 of this title, the failure to comply with the requirements under section 360eee–3 of this title, as applicable, or the failure to otherwise comply with the requirements of section 353(e) of this title.
 
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(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.
 
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(v)The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 350b of this title.
 
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(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.
 
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(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.
 
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(y)In the case of a drug, device, or food—
 
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(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;
 
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(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
 
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(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.
 
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(z)Omitted.
 
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(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.
 
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(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.
 
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(cc)The importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred from such activity under section 335a(b)(3) of this title.
 
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(dd)The failure to register in accordance with section 350d of this title.
 
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(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.
 
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(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.
 
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(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.
 
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(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.
 
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(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.
 
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(jj)
 
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(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.
 
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(2)The failure to submit clinical trial information required under subsection (j) of section 282 of title 42.
 
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(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).
 
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(kk)The dissemination of a television advertisement without complying with section 353c 1 of this title.
 
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(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—
 
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(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;
 
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(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;
 
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(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—
 
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(A)a regulation issued under section 348 of this title prescribing conditions of safe use in food;
 
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(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;
 
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(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;
 
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(D)a food contact substance notification that is effective under section 348(h) of this title; or
 
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(E)such drug or biological product had been marketed for smoking cessation prior to September 27, 2007; or
 
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(4)the drug is a new animal drug whose use is not unsafe under section 360b of this title.
 
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(mm)The failure to submit a report or provide a notification required under section 350f(d) of this title.
 
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(nn)The falsification of a report or notification required under section 350f(d) of this title.
 
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(oo)The sale of tobacco products in violation of a no-tobacco-sale order issued under section 333(f) of this title.
 
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(pp)The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 387k of this title.
 
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(qq)
 
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(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.
 
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(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.
 
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(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.
 
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(rr)The charitable distribution of tobacco products.
 
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(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.
 
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(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—
 
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(1)the product is approved by the Food and Drug Administration;
 
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(2)the Food and Drug Administration deems the product to be safe for use by consumers;
 
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(3)the product is endorsed by the Food and Drug Administration for use by consumers; or
 
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(4)the product is safe or less harmful by virtue of—
 
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(A)its regulation or inspection by the Food and Drug Administration; or
 
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(B)its compliance with regulatory requirements set by the Food and Drug Administration;
 
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including any such statement or representation rendering the product misbranded under section 387c of this title.
 
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(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.
 
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(vv)The failure to comply with the requirements under section 350h of this title.
 
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(ww)The failure to comply with section 350i of this title.
 
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(xx)The refusal or failure to follow an order under section 350l of this title.
 
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(yy)The knowing and willful failure to comply with the notification requirement under section 350f(h) of this title.
 
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(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.
 
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(aaa)The failure to register in accordance with section 381(s) of this title.
 
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(bbb)The failure to notify the Secretary in violation of section 360bbb–7 of this title.
 
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(ccc)
 
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(1)The resale of a compounded drug that is labeled “not for resale” in accordance with section 353b of this title.
 
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(2)With respect to a drug to be compounded pursuant to section 353a or 353b of this title, the intentional falsification of a prescription, as applicable.
 
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(3)The failure to report drugs or adverse events by an entity that is registered in accordance with subsection (b) of section 353b of this title.
 
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(ddd)
 
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(1)The manufacture or the introduction or delivery for introduction into interstate commerce of a rinse-off cosmetic that contains intentionally-added plastic microbeads.
 
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(2)In this paragraph—
 
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(A)the term “plastic microbead” means any solid plastic particle that is less than five millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof; and
 
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(B)the term “rinse-off cosmetic” includes toothpaste.21 U.S. Code § 343–3.Disclosure-(a)No provision of section 321(n), 343(a), or 348 of this title shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that is more prominent than the declaration of ingredients required by section 343(i)(2) of this title.
 
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(b)In this section, the term “radiation disclosure statement” means a written statement that discloses that a food has been intentionally subject to radiation.21 U.S. Code § 350c.Maintenance and inspection of records-(c)Protection of sensitive information
 
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The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section.,21 U.S. Code § 387i.Records and reports on tobacco products-(a)In generalEvery person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence—
 
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(1)may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience;
 
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(2)shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported;
 
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(3)shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this subchapter;
 
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(4)when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information;
 
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(5)when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; and
 
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(6)may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, report, or information submitted under this subchapter.
 
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In prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (6) continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.
 
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(b)Reports of removals and corrections
 
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(1)In generalExcept as provided in paragraph (2), the Secretary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the removal or correction was undertaken—
 
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(A)to reduce a risk to health posed by the tobacco product; or
 
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(B)to remedy a violation of this subchapter caused by the tobacco product which may present a risk to health.
 
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A tobacco product manufacturer or importer of a tobacco product who undertakes a corrective action or removal from the market of a tobacco product which is not required to be reported under this subsection shall keep a record of such correction or removal.
 
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(2)Exception
 
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No report of the corrective action or removal of a tobacco product may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).21 CFR § 50.20 - General requirements for informed consent.-§ 50.20 General requirements for informed consent.
 
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Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
 
  
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'''Related harms under the Solove Taxonomy:'''
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(1) for having received in interstate commerce any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith, unless he refuses to furnish on request of an officer or employee duly designated by the Secretary the name and address of the person from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; or
  
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'''Scope of the Law''' ''Pharmaceutical''
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{{SectionPersonalInformation|Section=(2) for having violated section 331(a) or (d) of this title, if he establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the article, to the effect, in case of an alleged violation of section 331(a) of this title, that such article is not adulterated or misbranded, within the meaning of this chapter designating this chapter or to the effect, in case of an alleged violation of section 331(d) of this title, that such article is not an article which may not, under the provisions of section 344 or 355 of this title, be introduced into interstate commerce; or |Personal=Identifying, Location}}
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(3) for having violated section 331(a) of this title, where the violation exists because the article is adulterated by reason of containing a color additive not from a batch certified in accordance with regulations promulgated by the Secretary under this chapter, if such person establishes a guaranty or undertaking signed by, and containing the name and address of, the manufacturer of the color additive, to the effect that such color additive was from a batch certified in accordance with the applicable regulations promulgated by the Secretary under this chapter; or
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(4) for having violated section 331(b), (c) or (k) of this title by failure to comply with section 352(f) of this title in respect to an article received in interstate commerce to which neither section 353(a) nor 353(b)(1) of this title is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time thereof contained the same directions for use and warning statements as were contained in the labeling at the time of such receipt of such article; or
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{{SectionPersonalInformation|Section=(5) for having violated section 331(i)(2) of this title if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a drug being a counterfeit drug, or for having violated section 331(i)(3) of this title if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the drug was a counterfeit drug.|Personal=Medical and Health}}
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(e)Prohibited distribution of human growth hormone
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(1)Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 355 of this title and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.
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(2)Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.
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(3)Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].
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(4)As used in this subsection the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them.
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(5)The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.
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{{SectionHarm|Section=(g)Violations regarding direct-to-consumer advertising|Harms= Intrusion, Distortion}}
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(1)With respect to a person who is a holder of an approved application under section 355 of this title for a drug subject to section 353(b) of this title or under section 262 of title 42, any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this chapter (including the civil penalty in subsection (f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation. With respect to advertisements that appear in magazines or other publications that are published less frequently than daily, each issue date (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations under this paragraph.
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|Categories of personal information covered=Medical and Health, Authenticating
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}}

Latest revision as of 02:00, 26 October 2020

Federal Food, Drug, and Cosmetic Act
Short Title Federal Food, Drug, and Cosmetic Act
Official Text Federal Food, Drug, and Cosmetic Act
Country/Jurisdiction United States
State or Province
Regulatory Bodies FDA
Date Enacted 1938/06/25
Scope of the Law Individuals, Applicants
Information
Taxonomy Decisional Interference, Disclosure, Distortion, Intrusion
Strategies
Template:Ad
Template:United StatesAd

The Federal Food, Drug, and Cosmetic Act establishes the safety of food, drugs, medical devices, and cosmetics. It prohibits distribution of human growth hormones. Moreover, the Act protects consumers from directing them with advertisements, which indicates false or misleading information.

Text of the law

21 U.S. Code § 333.Penalties

(c)Exceptions in certain cases of good faith, etc. Disclosure, Decisional Interference


No person shall be subject to the penalties of subsection (a)(1) of this section,

(1) for having received in interstate commerce any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith, unless he refuses to furnish on request of an officer or employee duly designated by the Secretary the name and address of the person from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; or

(2) for having violated section 331(a) or (d) of this title, if he establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the article, to the effect, in case of an alleged violation of section 331(a) of this title, that such article is not adulterated or misbranded, within the meaning of this chapter designating this chapter or to the effect, in case of an alleged violation of section 331(d) of this title, that such article is not an article which may not, under the provisions of section 344 or 355 of this title, be introduced into interstate commerce; or Identifying, Location "Personal#list" contains a listed "#" character as part of the property label and has therefore been classified as invalid.

(3) for having violated section 331(a) of this title, where the violation exists because the article is adulterated by reason of containing a color additive not from a batch certified in accordance with regulations promulgated by the Secretary under this chapter, if such person establishes a guaranty or undertaking signed by, and containing the name and address of, the manufacturer of the color additive, to the effect that such color additive was from a batch certified in accordance with the applicable regulations promulgated by the Secretary under this chapter; or

(4) for having violated section 331(b), (c) or (k) of this title by failure to comply with section 352(f) of this title in respect to an article received in interstate commerce to which neither section 353(a) nor 353(b)(1) of this title is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time thereof contained the same directions for use and warning statements as were contained in the labeling at the time of such receipt of such article; or

(5) for having violated section 331(i)(2) of this title if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a drug being a counterfeit drug, or for having violated section 331(i)(3) of this title if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the drug was a counterfeit drug. Medical and Health "Personal#list" contains a listed "#" character as part of the property label and has therefore been classified as invalid.

(e)Prohibited distribution of human growth hormone

(1)Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 355 of this title and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.

(2)Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.

(3)Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].

(4)As used in this subsection the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them.

(5)The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.

(g)Violations regarding direct-to-consumer advertising Intrusion, Distortion


(1)With respect to a person who is a holder of an approved application under section 355 of this title for a drug subject to section 353(b) of this title or under section 262 of title 42, any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this chapter (including the civil penalty in subsection (f)(4)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation. With respect to advertisements that appear in magazines or other publications that are published less frequently than daily, each issue date (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations under this paragraph.



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