The Council for Responsible Nutrition (CRN) , the dietary supplement industry’s leading trade association, and the Enzyme Technical Association (ETA), the trade association that represents manufacturers and marketers of enzyme products in North America, announced the release of their voluntary guidelines for enzyme-containing dietary supplements: the “Enzyme Dietary Supplement Products Best Practices Guide.”
“These new voluntary guidelines provide ingredient suppliers and manufacturers in this growing category clear science-based best practices for delivering safe, high-quality enzyme supplement products to customers and consumers,” said CRN’s Duffy MacKay, N.D., vice president of scientific and regulatory affairs. “These guidelines demonstrate responsible industry’s dedication to step up, self-regulate, and ensure that this high-potential category lives up to its potential, providing the very highest quality products to our consumers.”
The use of enzymes in dietary supplements is not new, but the enzyme category is experiencing an increase in growth and interest. Enzymes play a role in thousands of metabolic processes and specific enzymes can be used to support bodily functions such as digestion. Enzymes present unique manufacturing issues because of their fragile composition and therefore must be handled properly in order to remain effective.
“We commend the companies that participated in this process—it’s clear that they care about setting and following the highest standards,” Anthony T. Pavel, ETA general counsel and secretary, noted. “We anticipate widespread acceptance of these best practices. The working partnership between CRN and ETA that established these best practices will help ensure that more companies using enzymes in their products will be aware of how these active ingredients must be stored, handled and labeled.”
CRN and ETA prepared the voluntary “Enzyme Dietary Supplement Best Practices Guide” to promote the safe production and use of enzyme-containing dietary supplements and to facilitate transparency and uniformity in the dietary supplement and enzyme industries. Over the course of the project, which began in Fall 2012, CRN and ETA gathered input from the dietary supplement and enzyme industries, taking into account the current U.S. legal and regulatory requirements. The Guide reflects the most up-to-date science and industry thinking with regard to the appropriate handling of enzyme-containing dietary supplements. As best practices evolve, the guidelines will be updated.
The “Enzyme Dietary Supplement Best Practices Guide” includes information on handling practices for enzymes, as well as stability, storage and expiration dating. In addition, the guide discusses enzyme identity specifications, safety and microbiological testing, and considerations for New Dietary Ingredient notifications. There is also guidance on appropriate labeling of dietary supplement products containing enzymes. The Guide is available free of charge on CRN’s and ETA’s websites.
“We appreciate the opportunity to work closely with the Enzyme Technical Association and its member companies, particularly as there is some company overlap within our mutual membership ranks, and both organizations place emphasis on the self-regulatory process as a complement to government regulation,” CRN President and CEO Steve Mister said, noting that CRN member companies are expected to comply with the association’s guidelines. The publication of this document is one of a series of CRN self-regulatory initiatives that sets apart those responsible companies who comply. CRN released “Recommended Guidelines for Caffeine-Containing Dietary Supplements” in April and will soon publish a revised document on “Recommendations & Guidelines for Voluntary Dosage Limits and Labeling.”