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Preparing for Future Products of Biotechnology (2017)

Chapter: Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates

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Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
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Appendix D

Congressionally Defined Product Categories
That the U.S. Food and Drug
Administration Regulates

Cosmetic 21 U.S.C. § 321(i)—The term “cosmetic” means:
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 articles intended for use as a component of any such articles; except that such term shall not include soap.
Food 21 U.S.C. § 321(f)—The term “food” means:
Articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.
Food Additive 21 U.S.C. §321(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), 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 . . . to be safe under the conditions of its intended use; except that such term does not include [pesticide chemicals and residues, color additives, new animal drugs, or dietary supplements].
Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×
Major Food Allergen 21 U.S.C. § 321(qq)—The term “major food allergen” means any of the following:
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, and soybeans. A food ingredient that contains protein derived from a food specified in paragraph 1, except for [specified exceptions].
Dietary Supplement 21 U.S.C. 321(ff)—The term “dietary supplement” means:
  1. A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
    1. a vitamin
    2. a mineral
    3. an herb or other botanical
    4. an amino acid
    5. a dietary substance for use by man to supplement the diet by increasing the total dietary intake or
    6. a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause a, b, c, d, or e
  2. A product that:
    1. is intended for ingestion
    2. is not represented for use as a conventional food or as a sole item of a meal or the diet; and
    3. is labeled as a dietary supplement; and
  3. Does not include:
    1. an article that is approved as a new drug, [or] certified as an antibiotic [or] licensed as a biologic
Except for purposes of paragraph g [defining drugs] and section 350f [defining reportable foods for which there is a reasonable probability that use or exposure will cause serious adverse health consequences or death to humans or animals], a dietary supplement shall be deemed to be a food.
Medical Foods 21 U.S.C. § 360ee(b)(3)
The U.S. Food and Drug Administration (FDA) originally created this category administratively by interpreting powers elsewhere provided in its statutes (Hutt et al., 2014), but the Orphan Drug Act Amendments of 1988 later defined it as “a food that is formulated to be consumed or administered enterically under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on scientific principles, are established by medical evaluation.”
Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×
Color Additive 21 U.S.C. § 321(t)(1)—The term “color additive” means a material which:
  1. 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
  2. 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.
Infant Formula 21 U.S.C. § 321(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.
New Animal Drug 21 U.S.C. § 321(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
  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.
Animal Food 21 U.S.C. § 321(f)—See term “food” on p. 209.
Tobacco Product 21 U.S.C. § 321(rr)—The term “tobacco product” means:
Any product made or derived from tobacco 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).
Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×
Drug (relevant insofar as it sets boundaries on other product definitions) 21 U.S.C. § 321(g)(1)—The term “drug” means:
  1. Articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
  2. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
  3. Articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
  4. Articles intended for use as a component of any article specified in clause 1, 2, or 3
A food or dietary supplement [that makes nutritional or health related claims that comply with FDA’s regulations at 21 U.S.C. § 353(r)] is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with [21 U.S.C. § 353(r)(6), which requires manufacturers of dietary supplements to substantiate claims and provide certain disclosures to customers] is not a drug.
Device (relevant insofar as it sets boundaries on other product categories) 21 U.S.C. § 321(h)—The term “device” means:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is
  1. Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
  2. 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
  3. 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.

REFERENCE

Hutt, P.B., R.A. Merrill, and L.A. Grossman. 2014. Food and Drug Law: Cases and Materials, 4th Ed. St. Paul, MN: Foundation Press.

Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×
Page 209
Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×
Page 210
Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×
Page 211
Suggested Citation:"Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates." National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press. doi: 10.17226/24605.
×
Page 212
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Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5–10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?

Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

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