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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.

The Food Standards Agency (FSA) has launched new online guidance to help people buy and use food supplements with confidence, as many look to boost their health in the new year.

The FSA’s top tips for using supplements safely; 

• Check the label for dosage instructions and never exceed the recommended amount 
• Check safe levels of food supplements via the NHS website (Opens in a new window) and speak to your GP if you are considering taking higher dose supplements to ensure that you actually need them, and for advice on how long you should take them for 
• Speak to your GP or pharmacist before taking supplements if you are pregnant, breastfeeding, have a medical condition, or take prescription medicines 
• Be wary of online bargains – unusually cheap products may be counterfeit 
• Only buy from reputable sellers and take extra care buying from online marketplaces 
• If you feel unwell after taking a supplement, stop immediately and seek medical advice. 

Read full guidance.

Canada operates a statutory list of permitted supplemental ingredients (e.g. vitamins, minerals, amino acids) in food.  In addition, there is a temporary marketing approval (TMA) framework by exception, to use a specific supplement in a specific food.  The ongoing approval status of some of these TMA substances had been unclear.

This has now been clarified by a Health Canada notice.  It addresses this gap by issuing a table which provides information relevant to the use of these ingredients as conventional food ingredients and in supplemented foods, along with any data gaps that must be filled to establish safety as proposed supplemental ingredients.

In some cases, an ingredient has a history of safe use in food and is permitted as an ingredient (including in supplemented foods) on that basis. These ingredients may be used in all foods, including supplemented foods, according to the relevant provisions of the Food and Drug Regulations. Examples include certain food additives and flavourings. If use is proposed at levels higher than those with a history of safe use or if an ingredient has no such history, the ingredient would be considered a supplemental ingredient and require a pre-market assessment by Health Canada.

In this article the authors analysed the last decade of RASFF alerts relating to adulterated and unauthorised supplements and discussed the potential health impacts.  They conclude that health concerns rise in parallel with the rise in the popularity and market availability of these products.  

The most frequent pharmaceuticals for the adulteration of food supplements were phosphodiesterase-5 inhibitors (235 records); anorexics and laxatives (76), including sibutramine and its active metabolite N-didesmethyl sibutramine, phenolphthalein and 2,4-dinitrophenol.  There were also stimulants, among which 1,3-dimethylamine (97), and synephrine (53) were the most numerous.  Also included were nootropic drugs (24); anabolics and prohormones (16); and cannabinoid cannabidiol (14) (pending authorization as a novel food ingredient).

Over 65% of these notifications were classified as serious risks, and over 80% of these were alert or border rejection notifications, mainly generated as a result of official control on the market.

The authors recommend that a harmonized nutrivigilance system should be considered as a tool to detect and scrutinize the adverse health effects of food supplements, along with measures to improve their safety, quality, and testing.

Photo by Myriam Zilles on Unsplash