supplements (2)

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.

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12293454853?profile=RESIZE_400xIn 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

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