Food & Beverage Perspectives
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USP Proposes New Probiotic Monographs, Introduces Guidance

<p>The U.S. Pharmacopeial Convention (USP) is proposing new ingredients and probiotic monographs and introducing a Guidance on Food Fraud Mitigation to be included in its Food Chemicals Codex (FCC), Third Supplement to the Ninth Edition.</p>

The U.S. Pharmacopeial Convention (USP) is proposing new ingredients and probiotic monographs and introducing a Guidance on Food Fraud Mitigation to be included in its Food Chemicals Codex (FCC), Third Supplement to the Ninth Edition.

“USP proposes new ingredient monographs and methods in an effort to provide valuable resources to our stakeholders," said Markus Lipp, Ph.D., senior director for food ingredients at USP.

The FCC is a database of internationally recognized standards for the purity and identity of food ingredients, including food-grade chemicals, processing aids, flavoring agents, functional foods ingredients, foods (e.g., fructose, whey, vegetable oils, etc.), and other ingredients such as sucrose and essential oils. Monographs within the FCC provide information on ingredients such as chemical structure, chemical formula, definition, packaging, etc.

The larger portfolio of probiotic monographs includes:

  • Bifidobacterium animalis SSP. Lactis Bi-07, Bl-04 and HN019: These three strains of the B. animalis species have been historically used as functional ingredients in food products because of their purported benefit to digestive and immune health. All three strains for which monographs have been proposed in the FCC Forum have recently been notified as Generally Recognized as Safe (GRAS) to FDA for use in breakfast cereals, bars, cheese, milk drinks and milk products, bottled water and teas, fruit juices, fruit nectars, fruit “ades" and fruit drinks, chewing gum and confections.  
  • Lactobacillus acidophilus La-14 and NCFM®, Lactobacillus paracasei Lpc-37 and Lactobacillus rhamnosus HN001: As with the B. animalis species, these species and strains of the Lactobacillus genus have been used in foods for many years, especially in dairy products for their purported digestive health benefits. All species, except for L. paracasei Lpc-37, have been notified GRAS to the FDA for a variety of applications, ranging from the more traditional use in yogurt and cheese to more novel uses, such as snack foods (e.g., cookies, crackers, chips, granola) and condiments. 

In addition, the FCC Forum introduces a guidance document, designed to offers a framework for the food industry and regulators to develop and implement preventive management systems to deal specifically with economically-motivated fraudulent adulteration of food ingredients (EMA).

According to Lipp, “We believe [the guidance document] will enable both industry and regulators to combat food fraud with more confidence."

The guidance provides a comprehensive step-wise approach for preventing EMA at the ingredient level. It allows individual assessment of all the indicators and factors known to contribute to fraud vulnerabilities and impacts, as well as qualitative tools to make sense of the results. Contributing factors included in the tool go beyond fraud history and include economic and geopolitical anomalies, audit strategies, and supply chain and supplier characteristics. It also provides illustrative examples and references to publicly available information resources for carrying out vulnerability assessments.

Manufacturers and other parties are encouraged to comment on the proposed new monographs and guidance document, which are posted in the current FCC Forum. The proposed documents are available to public review for a 90-day comment period, ending March 31, 2015.

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