Guidance on food fraud mitigation and probiotics monographs


The US Pharmacopeial Convention (USP) is proposing new monographs and introducing a Guidance on Food Fraud Mitigation to be included in its Food Chemicals Codex (FCC)

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

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 free, online vehicle for public review and comment on draft FCC standards. The proposed documents are available to public review for a 90-day comment period, which ends on 31 March 2015.

'USP proposes new ingredient monographs and methods in an effort to provide valuable resources to our stakeholders,' said Markus Lipp, PhD, senior director for food ingredients at USP. 'For this FCC Forum we are also introducing something new, a guidance document, which we believe will enable both industry and regulators to combat food fraud with more confidence. The comments we receive in the FCC Forum are invaluable to our work in this area.'

The current FCC Forum highlights a larger portfolio of probiotic monographs, including

  • Bifidobacterium animalis SSP. Lactis Bi-07, Bl-04 and HN019 — These three strains of the B. animalis species have been historically used in 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 Recognised as Safe (GRAS) to the US Food and Drug Administration (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 yoghurt and cheese to more novel uses, such as snack foods (cookies, crackers, chips, granola) and condiments. (; and

Of note in the current FCC Forum, is a Guidance to Food Fraud Mitigation, the first-of-its-kind guidance document that 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).

'What is challenging about EMA is its unpredictable nature, and our guidance represents a leap forward in overcoming this hurdle. The output from implementing this tool provides users with a basis for making informed, vulnerability based decisions on how to deal with EMA within their organisations,' said Jeff Moore, PhD, senior scientific liaison at USP.

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.

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Contributing factors included in the tool to 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, such as the USP Food Fraud Database, launched in 2012.