Legislation of Dietary Supplements
United States The United States Food and Drug Administration (FDA) stipulates that dietary supplements are intended to add to, or supplement, the diet and are therefore different from conventional food. The US Congress defines ‘dietary supplement’ as “a product intended for ingestion that, among other requirements, contains a ‘dietary ingredient’ intended to supplement the diet.” Meanwhile, a product intended to treat, diagnose, cure, or prevent diseases is regarded as a drug in the US, even if it is labelled as a dietary supplement [31]. The FDA regulates both finished dietary supplement products and dietary ingredients under the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA places dietary supplements in a special class within the general categorisation of ‘foods’, unless the product meets the definition of a drug (e.g. because it is labelled to treat a disease). These are different to the set of regulations that cover conventional food and drug products. In addition to establishing regulations, the FDA operates a system of official Warning Letters to notify companies of law violations, and instruct them on necessary corrective actions. These have been issued to multiple companies for selling adulterated dietary supplements that contain, in some cases, novel or new dietary ingredients for which the FDA has not received the required notifications or, sometimes, unsafe food additives [32]. DSHEA: Key Points • Products cannot be represented as “for use as a conventional food or as a sole item of a meal or the diet” • Products are not required to obtain pre-market approval • Products do not have to be proven safe or effective prior to being marketed • To remove supplements from the marketplace, the FDA must demonstrate that a product is related to a “significant or unreasonable risk of illness or injury” • Establishes labelling rules for the product category (e.g. that dietary supplements cannot make disease prevention or treatment claims) • Outlines good manufacturing practices that need to be upheld • Describes the formal adverse event reporting process [33]
European Union In the General Food Law Regulation (EC) No 178/2002, food supplements are considered as food: meaning that the food business operator placing the product on the market is responsible for its safety. Directive 2002/46/EC establishes both lists of substances permitted as food supplements, and rules for the labelling of vitamins and minerals used in dietary food supplements. [34] Commission Regulation (EU) 2023/915 regulates the maximum levels of various contaminants which may be present in food supplements (for example, lead at 3 mg/ kg, cadmium at 1-3mg/kg, and mercury at 0.1 mg/kg, with polycyclic aromatic hydrocarbons (PAHs) at 10 μg/kg for benzo[a]pyrene and 400-500 μg/kg for pyrrolizidine alkaloids). However, there are aspects of food supplement legislation that are not harmonised across the EU [35].
9
lgcstandards.com/AXIO
Made with FlippingBook Digital Proposal Creator