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Health & Dietary Supplements2019-03-19T16:30:46-07:00

About Enzymes – Health and Dietary Supplements

 

Foods modified by and containing (animal, plant and microbial) enzymes prior to ingestion have been consumed by man for millennia. Early examples of enzyme applications are cheese and bread-making, dry aging of meats, and a variety of fermentation processes including brewing, wine and vinegar production and lactic acid fermentations. Yeast has been used medically not only as a source of vitamins but also to combat constipation and to stimulate normal digestion by the action of yeast proteases and amylases.[1]

The enzyme industry as it exists today began in the late 19th century. By 1894, Dr. Jokichi Takaminehad been granted U.S. Patent 525,823 “Process of making diastatic enzyme” which detailed the process and extraction of amylases from koji (Aspergillus oryzae). His patented product, Taka-diastase, was marketed by Parke, Davis & Company as a digestive aid throughout the world.

By 1932, Dr. Edward Howell formed a company in Illinois to provide supplemental enzymes to replace those destroyed in cooking, canning and food processing. Dr. Howell’s 1947 survey “Status of Food Enzymes in Digestion and Metabolism” cites use of papain as an aid to digestion and a benefit to “digestive disturbances of widely different kinds.”[2]  Fungal amylase is similarly cited as used in digestive tract therapy, as are lipases and pancreatic extracts.[3]

The use of enzymatic digestive aids is documented in medical reference texts going back at least six decades. For example, in the 1948 Physician’s Desk Reference (“PDR”), 9 enzyme compounds were listed including products such as Winthrop Stearns “Stamyl,” containing trypsin, amylopsin, lipase and hemicellulase.[4]  By 1966, the PDR contained 37 “gastro-intestinal” use enzymes, with preparations that included proteases, plant derived amylases and cellulases.[5]  However, many enzyme supplements were available through health food and other non-pharmaceutical providers that are not captured in PDR references.

In his 1972 review, Dr. Irwin Sizer recognized that enzymatic “digestive aids effective in the small intestine have been extensively used for a long period of time.”[6]  Dr. Sizer noted that digestive aid enzymes were “most often fungal in origin” and preparations from Aspergillus oryzae and Aspergillus niger were most commonly used due to their high content of amylase and protease.[7]  Similarly, Dr. Sizer noted that cellulases were being used to aid digestion of foods containing indigestible cellulose fibers such as cucumbers, cabbage, and radishes. Cellulases from Aspergillus oryzae and Tricoderma viride are cited in publications dating to 1962.[8]  Lipases from Aspergillus oryzae or Candida lipolytica were taken orally by individuals with fatty stools as early as 1958.[9]

More recently, McGrath and Walsh list amylase, cellulase, invertase, alpha-galactosidase, papain, pepsin, bromelain, superoxide dismutase, lactase and pancreatin as enzymes widely used as digestive aids.[10]

The use of enzymatic digestive aids has continued to flourish to the present.

Based on industry estimates, in 1994 the market (wholesale) for enzymes used as digestive aids was U.S. $35 million in the U.S. and Japan each; U.S. $47 million in France/Italy/UK/Germany; and roughly U.S. $55 million for the rest of the world.[1]  According to the Nutritional Business Journal’’s 2011 supplement business report, digestive enzymes now rank as 20th of the top 100 nutritional supplements and make up 4% of the U.S. nutritional supplement market. The digestive enzyme category has grown consistently over the last 10 years from approximately U.S. $80 million in 2000 to U.S. $209 million in 2010.

Best Practices Guide – Enzyme Dietary Supplement Products

The Best Practices Guide was developed and published jointly by the Council for Responsible Nutrition and the Enzyme Technical Association to help promote the safe production and use of enzyme-containing dietary supplements and to facilitate transparency and uniformity in the dietary supplement and enzyme industries.  The Best Practices Guide was prepared with input from the dietary supplement and enzyme industries and takes into account the current U.S. laws and government regulatory requirements.  It reflects the most up-to-date science and industry thinking with regard to the safe handling of enzyme-containing dietary supplements and will be updated as best practices evolve.

The Best Practices Guide is not intended to be a substitute for consultation with legal and regulatory counsel in all jurisdictions, including in the United States.

ETA – CRN – Best Practices Guide for Enzymes as Dietary Supplements (PDF)

Canada – Natural Health Products

Dietary supplements are regulated inCanadaas natural health products. Prior to being sold each product must have a product license, which may be granted after evaluation of the safety, efficacy and quality by the Natural Health Product Directorate (NHPD). Product licensing requires submission of detailed product information including ingredients, source, dose, potency, and recommended use. Manufacturing, packaging, labeling and import facilities must also have site licenses which require compliance with appropriate cGMPs.

NHPD has defined “pre-cleared” information which can be referenced in the registration process to speed evaluation. This information is published as single ingredient monographs, product monographs, or abbreviated labeling standards (AbLS). For most digestive enzymes, NHPD has published pre-cleared information in the form of AbLS monographs. Use of non-monographed enzymes and/or source organisms as well as formulation outside the monographed parameters may necessitate a Class II evaluation. The AbLS monographs define dosage, labeling standards, source organisms, claims and other relevant aspects of use. The existing monographs detail the use of enzymes as digestive aids by adults. The complete monographs can be found on the Health Canada website:

[1] Market estimate by ETA member in 1994.

[1] 15, IRWIN W. SIZER, MEDICAL APPLICATIONS OF MICROBIAL ENZYMES; ADVANCES IN APPLIED MICROBIOLOGY, (D. Perlmaned.) (1972).

[2] EDWARD HOWELL, THE STATUS OF FOOD ENZYMES IN DIGESTION AND METABOLISM (The National Enzyme Company 1946).

[3] Id.

[4] PHYSICIAN’S DESK REFERENCE (J. Jones et al. eds. Medical Economics Inc.) (1948).

[5] PHYSICIAN’S DESK REFERENCE (H. Bull et al. eds. Medical Economics Inc.) (12th ed. 1966).

[6] 15, IRWIN W. SIZER, MEDICAL APPLICATIONS OF MICROBIAL ENZYMES; ADVANCES IN APPLIED MICROBIOLOGY, (D. Perlmaned.) (1972).

[7] Id.

[8] Id.

[9] Id.

[10] GARY WALSH, DIRECTORY OF THERAPEUTIC ENZYMES 278-279 (Barry M. McGrath ed. 2006).