Methionine, L-

This abbreviated labelling standard is intended to serve as a guide to industry for the preparation of a Product Licence Applications (PLAs) and labels for natural health product market authorization. It includes generalized claims and is not intended to be a comprehensive review of the medicinal ingredient. Wording of the claim on the PLA and label must therefore be identical to this labelling standard.

Date

2009-09-08

NHPID Name

L-Methionine (Jellin 2008)

Proper Name(s)

• L-Methionine (NLM 2009)
• S-2-Amino-4-(methylthio)butanoic acid (NLM 2009)

Common Name(s)

L-Methionine (NLM 2009)

Source Material(s)

DL-Methionine (Dekker and Fruton 1947)

Route(s) of Administration

Oral

Dosage Form(s)

The acceptable pharmaceutical dosage forms suited to oral administration include, but are not limited to, chewables (e.g. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons. This labelling standard is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

• A factor in the maintenance of good health (IOM 2006, Shils et al. 2006)
• Helps to support liver function (Seyoum and Persaud 1991, Benevenga 1984)

Dose(s)

Adults:

Dose(s): 108.5 - 1000 Milligrams per day (IOM 2006, Health Canada 2005, IOM 2002)

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s)

No statement is required

Contraindication(s)

No statement is required

Known Adverse Reaction(s)

No statement is required

Non-medicinal Ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

• A Finished Product Specifications Form must accompany the application. The product must comply with the requirements of the most recent published version of the "Evidence for Quality of Finished Natural Health Products" guidance document.
• The medicinal ingredient may comply with the specifications outlined in the following pharmacopoeial monographs: 'Methionine' and 'DL-Methionine' in the British Pharmacopoeia (BP), 'Methionine' and 'DL-Methionine' in the European Pharmacopoeia (Ph. Eur.), and 'L-Methionine' in the U.S. Pharmacopoeia (USP).

References Cited

• Benevenga N.J. 1984. Evidence for Alternative Pathways of Methionine Catabolism. Advances in Nutritional Research 6:1-18
• BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
• European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
• Health Canada 2005: Health Canada. Addition of Vitamins and Minerals to Foods: Health Canada's Proposed Policy and Implementation Plans. Ottawa (ON): Health Canada; 2005. [Accessed 2009-05-11]. Available from:http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/nutrition/foritfication_final_doc_e.pdf
• IOM 2002: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board, Institute of Medicine. Washington (DC): National Academy Press; 2002.
• IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.
• NLM 2009: United States National Library of Medicine. ChemIDplus advanced [online]. Chemical name. RN: 000-00-0. Bethesda (MD): Specialized Information Services, United States National Library of Medicine, National Institutes of Health, United States Department of Health & Human Services. [Accessed 2009 May 19]. Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?CHEM
• Seyoum GG, Persaud TV. 1991. Can methionine and zinc prevent the embryopathic effects of alcohol? Medical Hypotheses 34(2):153-156
• Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.
• USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

References Reviewed

Cave M, Deaciuc I, Mendez C, Song Z, Joshi-Barve S, Barve S, McClain C. 2007. Nonalcoholic fatty liver disease: predisposing factors and the role of nutrition. Journal of Nutritional Biochemistry 18(2007):184-195