Guideline for Assigning Titles to USP Dietary Supplement Monographs
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Guideline for Assigning Titles to USP Dietary Supplement Monographs Approved by the Nomenclature & Labeling Expert Committee on August 19, 2019 INTRODUCTION The purpose of this Guideline is to provide a systematic approach to the development of monograph titles for dietary ingredients and dietary supplement (DS) dosage forms admitted to the United States Pharmacopeia–National Formulary (USP–NF) and Dietary Supplements Compendium (DSC) published by the United States Pharmacopeial Convention (USP). There are many considerations when naming monographs for dietary ingredients and DSs. These considerations include, but are not limited to, available scientific conventions, existing products in commerce and the practices of the DS industry, USP’s historical and scientific practices, international aspects of products, their common names originating from traditional medicine, environmental and agricultural practices, regulatory status, and the labeling requirements of applicable federal regulations. This Guideline complements USP General Chapter <1121> Nomenclature and the Nomenclature Guidelines cited therein (1). This DS Guideline describes how either common names or scientific names of articles are selected for use in the monograph title. For complex articles of botanical or animal origin, the DS Guideline will explain which details should be in the monograph title versus in the Definition section with regard to species and subspecies or variety names and common synonyms, the part of the organism and its processed form, type of extract, and composition of partially purified natural complexes. The DS Guideline will also discuss assignment of titles for single chemical entity monographs and for monographs describing the article in a particular finished oral dosage form. The examples provided herein are drawn from monographs in the USP–NF and proposed Guideline monograph titles that illustrate the results of applying this guidance. However, it should be noted that this Guideline applies to USP DS monograph titles and not to NF or other non-DS monograph titles. Each monograph shall have a title that is consistent with its Definition section and that avoids ambiguity as much as possible yet is concise. A DS monograph title must accurately identify the article whose quality specifications it describes. If the title is not reflective of how the article is best known in commerce, that can be clarified in the Definition. The DS monograph title should help guide manufacturers in meeting the identity aspects of labeling for dietary ingredients and finished DS products. G01.17-01 Page 1 of 44 EFFECTIVE DATE 03\17\ 2020 Guideline for Assigning Titles to USP Dietary Supplement Monographs Many DS monograph titles were adopted before the establishment of the current title formats and nomenclature policies. Many of these existing monograph titles are aligned with current nomenclature practices, but those existing monograph titles that are not aligned with current nomenclature practices should not be interpreted as precedents for future monograph titles. Furthermore, it is preferable that existing monograph titles that do not follow the DS Guideline should be revised only on an as-needed, case-by-case basis. In this Guideline, USP–NF monograph titles are distinguished from other text by being in bold font. Hypothetical DS monograph titles illustrating the application of these guidelines are in bold and enclosed in quotation marks to distinguish them from titles of existing monographs or approved titles of monographs currently under development. Titles of monographs currently in the Food Chemicals Codex (FCC) or Herbal Medicines Compendium (HMC) are not in bold to reduce the chance of confusion between the different compendia. The DS Guideline was developed by the USP Dietary Supplements and Herbal Medicines Nomenclature Joint Subcommittee (DSHM Nomenclature JS) with input from the USP Nomenclature and Labeling Expert Committee (NL EC), the Botanical Dietary Supplements and Herbal Medicines Expert Committee (BDSHM EC), and the Non- Botanical Dietary Supplements Expert Committee (NBDS EC). All titles of dietary ingredient monographs and DS monographs have been approved by the Nomenclature and Labeling EC with the concurrence of the appropriate EC, based on USP staff research and the best scientific judgment of the ECs. GENERAL CONSIDERATIONS Historical Practice The first Pharmacopoeia of the United States of America, published in 1820 (2), included monographs of articles that today may be marketed as DSs. These articles include some minerals (medicinal and nutritional) and many botanicals. During its first 100 years, from 1820 through 1920, around 875 botanical monographs were published in the USP. Vitamin monographs were incorporated later – the USP established a Vitamin Advisory Board in 1932, and the very first USP reference standards distributed were Vitamins A & D in Cod Liver Oil. In 1993, in response to the Nutrition Labeling and Education Act (NLEA) of 1990, a separate compendium section titled Nutritional Supplements was created to contain monographs for vitamins and minerals. DS monographs were started in 1995 in response to the Dietary Supplement Health and Education Act of 1994 (DSHEA) and included some monographs for botanicals that G01.17-01 Page 2 of 44 EFFECTIVE DATE 03\17\ 2020 Guideline for Assigning Titles to USP Dietary Supplement Monographs were originally placed in the NF. The Nutritional Supplements section was active through the publication of USP 26–NF 21 in 2003. In 2004, a new section, Dietary Supplements, was introduced into USP 27–NF 22 to replace the Nutritional Supplements section. The Dietary Supplements section includes monographs for ingredients and dosage forms of DSs as defined by DSHEA. Some monographs for botanical articles originally in the NF were also migrated to this new DS subsection of the USP. However, many monographs for articles that continue to have excipient purposes remain as NF monographs, e.g., Peppermint, Peppermint Oil, and Peppermint Water; Licorice Root Fluidextract; and Cardamom, Cardamom Oil, and Cardamom Tincture. It should be noted, however, that other botanical articles in the USP–NF are not necessarily DSs. They may be classified as drugs (prescription or non-prescription), medical devices, or excipients. For example, Aloe, Belladonna Leaf, Digitalis, Elm, Ipecac, Opium, Podophyllum, Psyllium Husk, Rauwolfia Serpentina, Senna Leaf, and Senna Pod remain in the drug section of the USP [Note: Monograph titles are indicated in bold font]. There is a USP monograph for Gutta Percha, which is used as a medical device material for endodontic (root canal) treatment. Other articles for purposes such as flavors, fragrances, and other excipients, e.g., Rose Oil, are placed in the NF. The creation of monograph titles for vitamin and mineral articles is more straightforward than for botanical articles. Vitamin and mineral articles are mostly comprised of single ingredients with titles formulated in a manner similar to those for drugs. Guidance to develop botanical monograph titles was provided in the first USP in 1820, in which the guideline approach was to adopt a nomenclature to “…be conformable to the present language of science, divested of as much of its prolixity as can be done consistently with clearness and distinctness. It is conceded that the essential properties of names ought to be expressiveness, brevity and dissimilarity.” The intent was that the monograph title “…expresses the medicine, and nothing else; …needed to be short and explicit, and does not require to be mutilated in practical use, as long names will inevitably be” (2). Thus, a monograph title was to be brief and distinct; a single word sufficed if that word was expressive and unambiguous. DS Monograph Titles and DS Product Label Regulatory Requirements Paragraph 3(a) of DSHEA states that a DS shall be deemed to be a food (i.e., neither an over-the-counter nor prescription drug) within the meaning of this Act. The Act defines a DS as: “(1) 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) G01.17-01 Page 3 of 44 EFFECTIVE DATE 03\17\ 2020 Guideline for Assigning Titles to USP Dietary Supplement Monographs a mineral; (C) a 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).”1 The Act also requires the label of a DS to identify the name of each ingredient. As set out in the Code of Federal Regulations Title 21 (21 CFR) section 101.4 (h)2, the “common or usual names of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition” (HoC1) (3). Although DS monograph titles are not subject to DSHEA and federal product labeling requirements, to make the monographs as useful as possible to stakeholders, USP is assigning titles to DS monographs in a manner as consistent as possible with DSHEA and HoC. This includes the use of HoC Standardized Common Names (SCNs) of botanicals utilized in North American commerce and the use of common or usual names appearing in commerce when there is no SCN or HoC Other Common Name (OCN). It should be noted that USP’s DS monograph titles are required on labels of products purporting to be USP grade, but other titles may be used on labels of products not purporting to be USP grade as long as they are compliant with the federal regulations. Since the incorporation of HoC1 by reference into 21 CFR 101.4 (h), a second edition, HoC2, was published in 2000 (4). Some changes from HoC1 to HoC2, beyond the addition of more herbs of commerce, include revisions to common names and Latin binomials and the dropping of hyphens from Pinyin Names (Pinyin is the standard system of Romanized spelling for transliterating Chinese).