SUBCHAPTER II—DEFINITIONS
§321. Definitions; generally
For the purposes of this chapter—
(a)(1) The term "State", except as used in the last sentence of
(2) The term "Territory" means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
(b) The term "interstate commerce" means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
(c) The term "Department" means Department of Health and Human Services.
(d) The term "Secretary" means the Secretary of Health and Human Services.
(e) The term "person" includes individual, partnership, corporation, and association.
(f) The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to
(2) The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.
(h)(1) The term "device" (except when used in paragraph (n) of this section and in
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to
(2) The term "counterfeit device" means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.
(i) The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
(j) The term "official compendium" means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.
(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
(l) The term "immediate container" does not include package liners.
(m) The term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.
(o) The representation of a drug, in its labeling, as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.
(p) The term "new drug" means—
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
(q)(1)(A) Except as provided in clause (B), the term "pesticide chemical" means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act [
(B) In the case of the use, with respect to food, of a substance described in clause (A) to prevent, destroy, repel, or mitigate microorganisms (including bacteria, viruses, fungi, protozoa, algae, and slime), the following applies for purposes of clause (A):
(i) The definition in such clause for the term "pesticide chemical" does not include the substance if the substance is applied for such use on food, or the substance is included for such use in water that comes into contact with the food, in the preparing, packing, or holding of the food for commercial purposes. The substance is not excluded under this subclause from such definition if the substance is ethylene oxide or propylene oxide, and is applied for such use on food. The substance is not so excluded if the substance is applied for such use on a raw agricultural commodity, or the substance is included for such use in water that comes into contact with the commodity, as follows:
(I) The substance is applied in the field.
(II) The substance is applied at a treatment facility where raw agricultural commodities are the only food treated, and the treatment is in a manner that does not change the status of the food as a raw agricultural commodity (including treatment through washing, waxing, fumigating, and packing such commodities in such manner).
(III) The substance is applied during the transportation of such commodity between the field and such a treatment facility.
(ii) The definition in such clause for the term "pesticide chemical" does not include the substance if the substance is a food contact substance as defined in
With respect to the definition of the term "pesticide" that is applicable to the Federal Insecticide, Fungicide, and Rodenticide Act [
(2) The term "pesticide chemical residue" means a residue in or on raw agricultural commodity or processed food of—
(A) a pesticide chemical; or
(B) any other added substance that is present on or in the commodity or food primarily as a result of the metabolism or other degradation of a pesticide chemical.
(3) Notwithstanding subparagraphs (1) and (2), the Administrator may by regulation except a substance from the definition of "pesticide chemical" or "pesticide chemical residue" if—
(A) its occurrence as a residue on or in a raw agricultural commodity or processed food is attributable primarily to natural causes or to human activities not involving the use of any substances for a pesticidal purpose in the production, storage, processing, or transportation of any raw agricultural commodity or processed food; and
(B) the Administrator, after consultation with the Secretary, determines that the substance more appropriately should be regulated under one or more provisions of this chapter other than
(r) The term "raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.
(s) The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—
(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.
(t)(1) The term "color additive" means a material which—
(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and
(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto;
except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.
(2) The term "color" includes black, white, and intermediate grays.
(3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest.
(u) The term "safe" as used in paragraph (s) of this section and in
(v) The term "new animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed,—
(1) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a "new animal drug" if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
(2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Provided that any drug intended for minor use or use in a minor species that is not the subject of a final regulation published by the Secretary through notice and comment rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the exception to the criterion in paragraph (1) has been met) is a new animal drug.
(w) The term "animal feed", as used in paragraph (w) 2 of this section, in
(x) The term "informal hearing" means a hearing which is not subject to
(1) The presiding officer in the hearing shall be designated by the Secretary from officers and employees of the Department who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action.
(2) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and a general summary of the information which will be presented by the Secretary at the hearing in support of such action.
(4) At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action of the Secretary which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral or written information relevant to such action.
(5) The presiding officer in such hearing shall prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer's report of the hearing.
(6) The Secretary may require the hearing to be transcribed. A party to the hearing shall have the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer's report of the hearing.
(y) The term "saccharin" includes calcium saccharin, sodium saccharin, and ammonium saccharin.
(z) The term "infant formula" means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.
(aa) The term "abbreviated drug application" means an application submitted under
(1) in the case of
(2) in the case of
(bb) The term "knowingly" or "knew" means that a person, with respect to information—
(1) has actual knowledge of the information, or
(2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information.
(cc) For purposes of
(1) means—
(A) an officer or director of a corporation or an association,
(B) a partner of a partnership, or
(C) any employee or other agent of a corporation, association, or partnership,
having duties such that the conduct of such officer, director, partner, employee, or agent may fairly be assumed to represent the policy of the corporation, association, or partnership, and
(2) includes persons having management responsibility for—
(A) submissions to the Food and Drug Administration regarding the development or approval of any drug product,
(B) production, quality assurance, or quality control of any drug product, or
(C) research and development of any drug product.
(dd) For purposes of
(ee) The term "Commissioner" means the Commissioner of Food and Drugs.
(ff) The term "dietary supplement"—
(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
(2) means a product that—
(A)(i) is intended for ingestion in a form described in
(ii) complies with
(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does—
(A) include an article that is approved as a new drug under
(B) not include—
(i) an article that is approved as a new drug under
(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,
which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.3
Except for purposes of paragraph (g) and
(gg) The term "processed food" means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.
(hh) The term "Administrator" means the Administrator of the United States Environmental Protection Agency.
(ii) The term "compounded positron emission tomography drug"—
(1) means a drug that—
(A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for the purpose of providing dual photon positron emission tomographic diagnostic images; and
(B) has been compounded by or on the order of a practitioner who is licensed by a State to compound or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that State's law, for a patient or for research, teaching, or quality control; and
(2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic synthesizer, or other apparatus or computer program to be used in the preparation of such a drug.
(jj) The term "antibiotic drug" means any drug (except drugs for use in animals other than humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative thereof.
(kk)
(ll)(1) The term "single-use device" means a device that is intended for one use, or on a single patient during a single procedure.
(2)(A) The term "reprocessed", with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.
(B) A single-use device that meets the definition under clause (A) shall be considered a reprocessed device without regard to any description of the device used by the manufacturer of the device or other persons, including a description that uses the term "recycled" rather than the term "reprocessed".
(3) The term "original device" means a new, unused single-use device.
(mm)(1) The term "critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.
(2) The term "semi-critical reprocessed single-use device" means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
(nn) The term "major species" means cattle, horses, swine, chickens, turkeys, dogs, and cats, except that the Secretary may add species to this definition by regulation.
(oo) The term "minor species" means animals other than humans that are not major species.
(pp) The term "minor use" means the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually.
(qq) The term "major food allergen" means any of the following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.
(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following:
(A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil.
(B) A food ingredient that is exempt under paragraph (6) or (7) of
(rr)(1) The term "tobacco product" means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
(2) The term "tobacco product" does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in
(3) The products described in paragraph (2) shall be subject to subchapter V of this chapter.
(4) A tobacco product shall not be marketed in combination with any other article or product regulated under this chapter (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).
(5) The term "tobacco product" does not mean an article that is a food under paragraph (f), if such article contains no nicotine, or no more than trace amounts of naturally occurring nicotine.
(ss) The term "critical food" means a food that is—
(1) an infant formula; or
(2) a medical food, as defined in
(June 25, 1938, ch. 675, §201,
Editorial Notes
References in Text
The Food and Drugs Act of June 30, 1906, as amended, referred to in par. (p)(1), and the Food and Drug Act of June 30, 1906, as amended, referred to in par. (v)(1), is act June 30, 1906, ch. 3915,
The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (q)(1), is act June 25, 1947, ch. 125, as amended generally by
The Poultry Products Inspection Act, referred to in par. (s)(4), is
The Meat Inspection Act of March 4, 1907, as amended and extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967,
Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in par. (kk), is section 101(4) of
Amendments
2022—Par. (rr)(1).
Par. (rr)(5).
Par. (ss).
2021—Par. (h).
Par. (qq)(1).
2016—Par. (h).
2009—Par. (rr).
2007—Par. (ff).
2004–Par. (u).
Par. (v).
Pars. (nn) to (pp).
Par. (qq).
2002—Par. (kk).
Pars. (ll), (mm).
1998—Par. (q)(1).
Par. (q)(3).
1997—Par. (aa).
Par. (dd).
Par. (ff)(3)(A).
Par. (ii).
Par. (jj).
1996—Par. (q).
Par. (s)(1), (2).
"(1) a pesticide chemical in or on a raw agricultural commodity; or
"(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or".
Pars. (gg), (hh).
1994—Par. (g)(1).
Par. (s)(6).
Par. (ff).
1993—Pars. (c), (d).
Par. (h).
Pars. (v) to (ff).
1992—Pars. (c), (d).
Par. (h).
Par. (u).
Par. (y)(1).
Pars. (bb) to (ee).
Par. (ff).
1990—Par. (g)(1).
Par. (h)(3).
1988—Par. (w)(3).
1980—Par. (aa).
1977—Par. (z).
1976—Par. (h).
Par. (n).
Par. (y).
1972—Par. (q).
1970—Par. (a)(2).
Par. (v).
1968—Par. (a)(2).
Par. (p).
Par. (s)(5).
Par. (u).
Par. (v)(3).
Pars. (w), (x).
1965—Par. (g).
Par. (v).
1962—Par. (a).
Par. (p)(1).
Par. (p)(2).
1960—Par. (s).
Par. (t).
Par. (u).
1958—Pars. (s), (t).
1954—Pars. (q), (r). Act July 22, 1954, added pars. (q) and (r).
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Effective Date of 2021 Amendment
Effective Date of 2004 Amendment
Effective Date of 1997 Amendment
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1976 Amendment
Amendment by
Effective Date of 1972 Amendment
Amendment by
Effective Date of 1970 Amendment
Amendment by
Effective Date of 1968 Amendments; Transitional Provisions
Amendment by
Effective Date of 1965 Amendment
Effective Date of 1962 Amendment
"(a) Except as otherwise provided in this section, the amendments made by the foregoing sections of this part A [amending this section and
"(b) The amendments made by sections 101, 103, 105, and 106 of this part A [amending
"(c)(1) As used in this subsection, the term 'enactment date' means the date of enactment of this Act; and the term 'basic Act' means the Federal Food, Drug, and Cosmetic Act [this chapter].
"(2) An application filed pursuant to section 505(b) of the basic Act [
"(3) In the case of any drug with respect to which an application filed under section 505(b) of the basic Act is deemed to be an approved application on the enactment date by virtue of paragraph (2) of this subsection—
"(A) the amendments made by this Act to section 201(p), and to subsections (b) and (d) of section 505, of the basic Act [par. (p) of this section, and subsecs. (b) and (d) of
"(B) clause (3) of the first sentence of section 505(e) of the basic Act, as amended by this Act [
"(4) In the case of any drug which, on the day immediately preceding the enactment date, (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force [par. (p) of this section], and (C) was not covered by an effective application under section 505 of that Act [
Effective Date of 1960 Amendment
Amendment by
Effective Date of 1958 Amendment
Amendment by
Effective Date of 1954 Amendment
For effective date of amendment by act July 22, 1954, see section 5 of that act, set out as a note under
Construction of Amendments by Pub. L. 102–282
Amendment by
Construction of Amendments by Pub. L. 101–535
Amendments by
Savings Provision
"(a) Prosecutions for any violation of law occurring prior to the effective date [see Effective Date of 1970 Amendment note above] of section 701 [repealing
"(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of section 701 shall not be affected by the repeals or amendments made by such section, or abated by reason thereof.
"(c) All administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on the date of enactment of this Act [Oct. 27, 1970] shall be continued and brought to final determination in accord with laws and regulations in effect prior to such date of enactment. Where a drug is finally determined under such proceedings to be a depressant or stimulant drug, as defined in section 201(v) of the Federal Food, Drug, and Cosmetic Act [par. (v) of this section], such drug shall automatically be controlled under this title [subchapter I of
"(d) Notwithstanding subsection (a) of this section or section 1103 [of
Transfer of Functions
Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by
Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Federal Food, Drug, and Cosmetic Act, to the extent such functions related to administration and enforcement of the Poison Prevention Packaging Act of 1970 (
Regulation of Tobacco
Congressional Findings Relating to Pub. L. 103–417
"(1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;
"(2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;
"(3)(A) there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and
"(B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;
"(4) healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty;
"(5) preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures;
"(6)(A) promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and
"(B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country;
"(7) there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;
"(8) consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;
"(9) national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition;
"(10) studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs;
"(11) the United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are undertaken to reverse the increase;
"(12)(A) the nutritional supplement industry is an integral part of the economy of the United States;
"(B) the industry consistently projects a positive trade balance; and
"(C) the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000;
"(13) although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
"(14) dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and
"(15)(A) legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and
"(B) a rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements."
Dissemination of Information Regarding the Dangers of Drug Abuse
Congressional Findings and Declaration of Policy
Effect of Drug Abuse Control Amendments of 1965 on State Laws
"(a) Nothing in this Act [enacting
"(b) No provision of this Act nor any amendment made by it shall be construed as indicating an intent on the part of the Congress to occupy the field in which such provision or amendment operates to the exclusion of any State law on the same subject matter, unless there is a direct and positive conflict between such provision or amendment and such State law so that the two cannot be reconciled or consistently stand together.
"(c) No amendment made by this Act shall be construed to prevent the enforcement in the courts of any State of any statute of such State prescribing any criminal penalty for any act made criminal by any such amendment."
Effect of Drug Amendments of 1962 on State Laws
Definitions
Executive Documents
Transfer of Functions
Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Drug Abuse Control Amendments of 1965 [see Short Title of 1965 Amendment note set out under
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out in the Appendix to Title 5, Government Organization and Employees. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953.
Food and Drug Administration in Department of Agriculture and its functions, except those functions relating to administration of Insecticide Act of 1910 and Naval Stores Act, transferred to Federal Security Agency, to be administered under direction and supervision of Federal Security Administrator, by Reorg. Plan No. IV of 1940, set out in the Appendix to Title 5.
1 So in original. Probably should be "Pharmacopeia,".
2 So in original. Probably should be paragraph "(v)".
3 So in original. Provision probably should be set flush with subpar. (B).
§321a. "Butter" defined
For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768) "butter" shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.
(Mar. 4, 1923, ch. 268,
Editorial Notes
References in Text
The Food and Drug Act of June 30, 1906, referred to in text, is act June 30, 1906, ch. 3915,
Codification
Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to
§321b. "Package" defined
The word "package" where it occurs the second and last time in the act entitled "An act to amend section 8 of an act entitled, 'An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes,' " approved March 3, 1913, shall include and shall be construed to include wrapped meats inclosed in papers or other materials as prepared by the manufacturers thereof for sale.
(July 24, 1919, ch. 26,
Editorial Notes
References in Text
An act approved March 3, 1913, referred to in text, is act Mar. 3, 1913, ch. 117,
"An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes", referred to in text, is act June 30, 1906, ch. 3915,
Codification
Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to the last sentence of paragraph third of
§321c. Nonfat dry milk; "milk" defined
For the purposes of the Federal Food, Drug, and Cosmetic Act of June 26, 1938, (ch. 675, sec. 1,
The term "milk", when used herein, means sweet milk of cows.
(Mar. 2, 1944, ch. 77,
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch. 675, sec. 1,
Codification
Section was not enacted as a part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, but was made applicable thereto.
Amendments
1956—Act July 2, 1956, substituted "nonfat dry milk" for "nonfat dry milk solids or defatted milk solids".
§321d. Market names for catfish and ginseng
(a) Catfish labeling
(1) In general
Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (
(A) the term "catfish" may only be considered to be a common or usual name (or part thereof) for fish classified within the family Ictaluridae; and
(B) only labeling or advertising for fish classified within that family may include the term "catfish".
(2) Omitted
(b) Ginseng labeling
(1) In general
Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (
(A) the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax; and
(B) only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term "ginseng".
(2) Omitted
(
Editorial Notes
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(1), (b)(1), is act June 25, 1938, ch. 675,
Codification
Section is comprised of section 10806 of
Section was enacted as part of the Farm Security and Rural Investment Act of 2002, and not as part of Federal Food, Drug, and Cosmetic Act which comprises this chapter.