Most people assume that a product sold in a pharmacy, next to medicines, was checked by someone before it reached the shelf. For medicines that is true: a regulator reviewed the manufacturing data, the clinical trials and the label before granting authorisation. For food supplements it is not true anywhere in the world. Supplements are legally foods, and foods are not approved — they are placed on the market under the manufacturer’s own responsibility and policed afterwards. Understanding this single fact changes how a buyer should read every label.
The legal architecture: food, not medicine
In the European Union, Directive 2002/46/EC defines food supplements as “foodstuffs the purpose of which is to supplement the normal diet.” The manufacturer must notify the national authority in most member states, use only permitted vitamin and mineral forms listed in the Directive’s annexes, and comply with general food law — but no authority evaluates the product’s safety, quality or efficacy before sale. In the United States, the Dietary Supplement Health and Education Act of 1994 placed supplements in a special food category; the FDA must prove a product unsafe after it is marketed in order to remove it, and manufacturers need no approval to launch (only “new dietary ingredients” not sold before 1994 require a pre-market notification, which is not an approval). In Georgia, supplements fall under the food-safety framework administered by the National Food Agency, with registration requirements that confirm the product is declared, not that it has been tested (the Georgian supplement market and what the law requires; what food-safety registration actually means). Japan, Australia, Canada and others have variants — some stricter on claims, some with listing systems — but none requires a supplement to prove it works before it is sold.
What “policed afterwards” looks like in practice
Post-market enforcement catches problems only after people have bought the product. US emergency departments record an estimated 23,000 visits per year attributable to adverse events from dietary supplements, about 2,150 of them leading to hospitalisation — a majority involving weight-loss and energy products in young adults, and swallowing problems or allergic reactions in older people (Geller et al. 2015). Between 2007 and 2016 the FDA identified 776 supplement products adulterated with unapproved pharmaceutical ingredients — mostly sildenafil analogues in sexual-enhancement products, sibutramine in weight-loss products and anabolic steroids in sports products; fewer than half were ever formally recalled (Tucker et al. 2018). The system is not absent; it is reactive, under-resourced and slow, and it relies heavily on consumers and clinicians reporting harm.
What this means for the buyer
Three consequences follow. First, the label is a self-declaration. The ingredient list, the amounts and the claims were written by the company selling the product, and nobody verified them before sale. Second, the burden of evidence has shifted to the manufacturer’s voluntary documentation. A company that wants to demonstrate quality must do so through Good Manufacturing Practice certification, third-party laboratory testing, and published certificates of analysis — none of which are required, all of which are available to a company that chooses to invest in them. Third, claims are regulated but content is not. In the EU, only health claims authorised under Regulation 1924/2006 may appear on the label (what EFSA health claims actually mean) — an important consumer protection — but a product can carry a perfectly legal authorised claim and still contain half the declared dose, because the claim regulation governs words, not milligrams.
The five-point checklist that replaces the approval nobody gave
1. Is the manufacturing site certified? Look for GMP (pharmaceutical or food-supplement GMP such as NSF/ANSI 173 or the US 21 CFR 111 standard), ISO 22000 or FSSC 22000, with HACCP (what these mean in practice). A certificate number you can verify with the certifying body is worth more than a logo. 2. Is there a lot-specific certificate of analysis from an accredited (ISO/IEC 17025) laboratory? This is the single most important document (how to read it). If it is not available, the product’s quality is unknown — to you and possibly to the seller. 3. Are the forms and doses defensible? Permitted forms (EU Directive annexes) and doses expressed against the Nutrient Reference Value (NRV explained); extreme doses of fat-soluble vitamins or minerals with narrow margins are a warning sign, not a selling point. 4. Are the claims authorised? In the EU, every health claim should correspond to an entry in the EU Register. “Cures,” “treats,” “boosts immunity” and disease names are illegal on a food and signal a seller who does not follow the rules that do exist. 5. Is there a named legal entity, address and lot number? Traceability is what makes a recall possible. Anonymous products from marketplaces with no responsible company are the products that show up in the adulteration statistics.
The clinical bottom line
No regulator in the world approves a food supplement before sale; the label is the seller’s declaration and enforcement happens only after harm or fraud is detected. The buyer’s protection is therefore documentary, not regulatory: a certified manufacturing site, a lot-specific certificate of analysis from an accredited laboratory, defensible forms and doses, authorised claims, and full traceability. A product that can show all five has done voluntarily what the law never required.
Primary sources
- Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements. eur-lex.europa.eu
- Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. eur-lex.europa.eu
- Geller AI, Shehab N, Weidle NJ, et al. Emergency department visits for adverse events related to dietary supplements. N Engl J Med. 2015;373(16):1531–1540. doi:10.1056/NEJMsa1504267
- Tucker J, Fischer T, Upjohn L, Mazzera D, Kumar M. Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Netw Open. 2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337
- Starr RR. Too little, too late: ineffective regulation of dietary supplements in the United States. Am J Public Health. 2015;105(3):478–485. doi:10.2105/AJPH.2014.302348
- US Food and Drug Administration. Dietary Supplement Health and Education Act of 1994 — overview and FDA responsibilities. fda.gov
Educational information on supplement quality and consumer protection, not medical advice.
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