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The Mexico Ministry of Health (COFEPRIS) have published a non-regulatory guide to the classification of food supplements.

A food supplement must satisfy each of four separate legal requirements in order to be marketed, otherwise it must fall into a different regulatory catetory.

• The General Health Law, which states that supplements must be based on herbs, plant extracts or traditional foods, aimed at complementing the diet, and free of restricted ingredients.
• The Regulation on the Sanitary Control of Products and Services, which incorporates criteria on composition, exclusion of substances with pharmacological action and, especially, strict rules on labelling, prohibiting therapeutic indications or misleading information.  The guide prohibits the marketing of substances with a pharmacological or therapeutic action as food supplements.
• The Decree determining additives and adjuvants in food, beverages and food supplements, their use and sanitary provisions, published in the Official Gazette of the Federation (DOF) on December 15, 1999, and its amendments published on September 5, 2013 and May 16, 2016, and the Decree determining the prohibited or permitted plants for teas, infusions and edible vegetable oils, published in the DOF on December 15, 1999, which delimit the substances that can be used and the specific conditions applicable, including labeling requirements in the case of certain ingredients.

This guide establishes the possibility of using the Herbal Pharmacopoeia of the United Mexican States as a reference in the development of food supplements, since it lists plants and their derivatives that can cause unwanted effects, have interactions with other plants and medications,or can be toxic or allergenic.

This aligns Mexico’s marketing approval regulation more closely with that of Europe, but is a reminder that manufacturers and sellers (particularly online sellers) of supplements and botanicals must be highly cognisant of the specific regulations in each country of sale.

This thought-provoking research was presented by Kwesi Boateng, a Nottingham University student, at the “Making Pharmaceuticals” show last month in Coventry, UK.  Contact details are on the poster.  It is a reminder that not all insight into food fraud risks comes from the insular bubble of the food industry, regulators and academics.

One premise of the research is that B-2-B end customers who specify “sustainable” production of botanicals to fulfil their orders, when they have no detailed knowledge of the supply chain, are almost making fraud inevitable.  At the bottom of the supply chain are small scale producers.  Sustainable supplies of botanicals are extremely limited.  If a small producer is given an order to fulfil, with no consultation and a quick delivery date, then there is a clear motive to make up any shortfall with “unsustainable” production, lying about the carbon accounting (or – even worst – bulk out the order with an adulterant).

The solution is for the end customer to understand, appreciate, and communicate with, their whole supply chain and not to introduce stresses by giving short notification orders that are difficult to fulfil.

This application note from Canadian testing company Purity-IQ builds upon published methods to describe the use of proton NMR in authenticity testing of herbs and spices.  Proton NMR, with non-targeted metabolomic profiling, can be used for botanical species authentication but also to detect product anomalies.  It is particularly useful for detecting dyes, as both natural and synthetic dyes tend to contain spectrally-distinctive aromatic ring structures.  In this application, the principle was demonstrated by the clear differentiation of paprika spiked with Sudan dyes, turmeric spiked with metanil yellow, and beet/grape extracts spiked with black rice extract.

Image from the application note.