Regulation of food supplements is aimed at ensuring the safety, efficacy and labeling of these increasingly popular products. In Europe, Directive 2002/46/EC sets strict standards to ensure the conformity of food supplements before they are placed on the market, while variations exist internationally.
Find out in this article about nutraceutical regulations around the world (Canada, Japan, USA, Australia, Brazil and Europe), as well as the rules to follow for successful marketing of your dietary supplements!
Update on nutraceutical regulations
What are dietary supplements?
Food supplements are defined by European Union Directive 2002/46/EC as “foodstuffs the purpose of which is to supplement the normal diet and which constitute a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms of presentation such as capsules, pastilles, tablets, pills and other similar forms, as well as sachets of powder, ampoules of liquid, dropper bottles and other similar forms of liquid or powder preparations intended to be taken in measured units of small quantity” [1].
Nutraceuticals can play an important role in our diets, providing vitamins, minerals or other active ingredients to consumers seeking to improve their well-being, health or beauty, or to overcome specific nutritional deficiencies.
The global nutraceuticals market
The global dietary supplements market is booming, with a value of $182 billion by 2023. This booming sector is dominated by the United States, which holds almost a third of the market share [2].
In Europe, the dietary supplements market is estimated at $21.6 billion in 2024 and is expected to reach $33.3 billion by 2029, with growth of 9.01% over the period 2024-2029 [3].
In France, the nutraceutical market will reach around €2.7 billion in 2023 [4]. Dietary supplements have become very popular among French consumers, with 61% having consumed them in the last two years [5].
Global demand for dietary supplements is rising steadily, driven by a holistic, preventive approach to health management through alternative nutritional solutions.
Regional specificities, particularly in terms of regulations, greatly influence the diversity of products offered on international markets.
World tour of dietary supplement regulations
In the world
On an international scale, the Codex Alimentarius, created by the FAO (Food and Agriculture Organization) and the WHO (World Health Organization), sets global food standards. Codex provides guidelines for the safety and labeling of food supplements, particularly vitamins and minerals.
Regulation of dietary supplements varies considerably from region to region, but certain legislative frameworks have a major influence on international dynamics.
United States: Dietary Supplement Health and Education Act (DSHEA)
In the USA, the Dietary Supplement Health and Education Act (DSHEA) of 1994 governs the dietary supplement sector. It defines nutraceuticals as “vitamins, minerals, herbs, amino acids and other nutritional substances” [6].
Unlike drugs, the marketing of dietary supplements does not require prior FDA (Food and Drug Administration) approval. The responsibility of nutraceutical manufacturers is therefore central: even before marketing, they must ensure that their products are safe and comply with current standards.
Health claims made by manufacturers must be supported by scientific evidence. The FTC (Federal Trade Commission) monitors advertising claims to prevent deception.
Finally, food supplements must be fully labeled, with precise information on ingredients, recommended daily doses and precautions for use, guaranteeing maximum transparency for consumers.
Other countries
In Canada, dietary supplements are classified as natural health products and require prior authorization from Health Canada before being marketed. 
In Australia, the Therapeutic Goods Administration (TGA) regulates supplements classified as therapeutic, with strict rules governing their production and marketing.
Japan imposes special regulations on food supplements classified as FOSHU (Food for Specified Health Uses), requiring government approval before they can be marketed.
In Brazil, the regulation of dietary supplements is overseen by ANVISA (National Sanitary Surveillance Agency), responsible for guaranteeing product quality, safety and efficacy. Authorized ingredients, health claims, pre-market registration of nutraceuticals and quality controls are all subject to rules laid down by this agency.
In Europe
The European Union, through Directive 2002/46/EC, aims to harmonize the regulation of food supplements, particularly those containing vitamins, minerals and other active substances.
This directive imposes strict regulations on several key aspects, notably labeling, but also the risk assessment linked to the introduction of new ingredients carried out by EFSA (European Food Safety Authority). This body also validates health claims made by manufacturers, which must be based on reliable scientific evidence.
The European Federation of Associations of Health Product Manufacturers (EHPM) is a European organization of health product manufacturers and distributors. It is the leading European trade association representing the dietary supplements sector. It helps companies to comply with EU laws and to ensure the production of compliant, high-quality products.
Despite this Europe-wide harmonization, national variations remain. Some EU countries apply specific restrictions on the use of ingredients such as herbal extracts, or even subject them to a pharmaceutical monopoly, resulting in differences in the marketing of food supplements from one state to another.
In France
In France, the regulation of food supplements is governed by Decree no. 2006-352, which transposes European Union Directive 2002/46/EC. This legislative framework is designed to guarantee product safety and conformity prior to marketing.
Synadiet (Syndicat National des Compléments Alimentaires) is the French trade association representing companies in the dietary supplements sector. This organization plays a key role in informing and raising awareness among manufacturers, ensuring that they comply with current standards.
Food supplement regulations: 5 golden rules for product launches
Determine nutraceutical composition
Each ingredient used in dietary supplements must be authorized and registered on specific lists specifying maximum authorized doses and conditions of use. These rules take into account recommended nutritional intakes and safety limits based on scientific studies. For example, the maximum quantities of vitamins and minerals in a product are determined on the basis of recommended daily intakes, while taking into account contributions from other food sources.
Compliant labeling
The labeling of food supplements must include mandatory information. In Europe, labels must include the EU organic logo and the name of the certification body if the product is certified organic (or if over 95% of the ingredients are of organic origin). Other essential information includes graphic representation, trade name, net weight, date of minimum durability or use-by date, batch number, person responsible for placing the product on the market, specific precautions for use, caffeine content if present, composition table and recommended daily portion. Ingredients and allergens must also be listed in bold. Certain information, such as the product name and net weight, must appear in the same visual field [7].
According to Directive 2000/13/EC, labelling must also bear the following mandatory indications: a warning against exceeding the indicated daily intake, a statement to avoid food supplements being used as substitutes for a varied diet, and a warning that products should be kept out of the reach of young children [1].
Optional information, such as nutritional and health claims, the legal sales name (which may be supplemented by “herbal”), or the Agriculture Biologique logo, may also appear on the label [7].
Guaranteeing the efficacy of dietary supplements
Claims for nutraceuticals, whether they appear in advertising, in-store advice or on labels, are strictly regulated. Before using a new claim, a manufacturer must submit an application to EFSA (European Food Safety Authority). If EFSA’s opinion is favorable, the European Commission may adopt a regulation validating or rejecting the claim. Claims are regulated by Regulation (EU) 1924/2006, which sets out the rules for nutrition and health claims in Europe [7].
Two types of claim can appear on food supplements:
– Nutritional claims, such as “Source of” or “Rich in”, highlight the presence of a specific nutrient.
– Health claims, such as “Magnesium helps reduce fatigue”, indicate that an ingredient has health benefits.
Declaring your dietary supplements before marketing them
Before being marketed, dietary supplements must be examined by the relevant authorities. In France, it is compulsory to declare all food supplements on Compl’Alim. The DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes) has set up this new online platform (formerly Téléicare) for the declaration of food supplements before they are placed on the market. This procedure enables manufacturers to submit product composition, precautions for use and labeling. The DGCCRF then has two months to examine the compliance and safety of the food supplement before issuing its opinion: approval, request for modification or rejection [7].
Ensuring the safety of food supplements
The safety of nutraceuticals is ensured by inspections carried out by the DDPP (Directions Départementales de la Protection des Populations). These inspections cover several aspects, including label conformity, verification of claims and product composition, often via laboratory analysis. If any irregularities are found, the authorities may impose administrative or penal sanctions, depending on the seriousness of the offences [7].
Focus: regulations governing beauty supplements
Measures of efficacy
The regulation of beauty claims for food supplements is a crucial framework for operators in this sector. Unlike health claims, governed by Regulation (EC) No. 1924/2006, beauty claims must be justified by solid evidence, such as clinical studies. Whether these studies concern wrinkles, skin elasticity and hydration, or hair strength and resilience, they must be rigorously conducted on a representative population and comply with precise inclusion and exclusion criteria. The use of in vitro models, while useful for the initial phases of research, must be complemented by clinical trials to validate the efficacy of active ingredients. A well-chosen evaluation methodology is essential to guarantee the relevance and reliability of claims [8].
Communication about beauty
As the notion of beauty is subjective, claims relating to appearance must be formulated with care to avoid confusion with health claims.
To ensure rigorous communication practices, Food Supplements Europe recommends that industry players draw up a dedicated document summarizing the data justifying claims. This document can be presented to the authorities during inspections, in addition to the clinical study report and/or published scientific literature. Companies must ensure that the information communicated is clear, precise and comprehensible, while respecting the ethical rules of the sector.
To help players in the nutraceuticals sector define beauty claims for their dietary supplements, examples have been compiled below, based on guidelines and opinions published by EFSA [8] :
Health claims for the skin
Examples of correct beauty claims for the skin
– Improve/maintain/increase (based on clinical trial results) the appearance of wrinkles (wrinkle reduction)
– Contribute to improving skin elasticity, skin surface structure
– Contribute to improving skin tone, skin firmness (based on clinical trial results)
Examples of health claims requiring authorization before use
– Maintenance (i.e. reduction of loss) of skin barrier functions
– Maintenance of the skin’s permeability barrier function
– Protects skin against dehydration
– Protects the skin (cells and molecules such as DNA, proteins and lipids) against oxidative damage, including photo-oxidative (UV-induced) damage
– Reduced DNA damage after exposure to UV rays
– Increased net collagen formation or reduced net collagen degradation, leading to maintenance (i.e. reduced loss) of tissue function(s) (e.g. bone, cartilage, gums, skin, tendons and blood vessels)
Health claims for hair
Examples of correct beauty claims for hair
– Improve/maintain/increase (based on clinical trial results) hair appearance or structure (strength, volume and thickness, shiny hair, silky hair)
Examples of health claims falling within the scope of the Natural Health Products Directive and requiring authorization before use
– Reduction of excessive hair loss: EFSA has identified the maintenance of normal hair growth as a beneficial physiological effect.
Health claims for nails
Examples of correct beauty claims for nails
– Improve/maintain/increase (based on clinical trial results) the appearance or structure of nails (strength, thickness, shiny nails)
BCF Life Sciences is committed to proven performance
Numerous scientific studies and publications demonstrate the efficacy of the ingredients offered by BCF Life Sciences. Our range includes ingredients whose efficacy has been clinically proven. For example, clinical and in vitro studies have been carried out on Kera-Diet® and Cysti-White®.
Proven performance of Kera-Diet®: results of the clinical study conducted in 2023 (study conducted on 3 groups of 33 healthy women whose daily intake of Kera-Diet® was 500 mg with no other ingredients added)
Find out more about the proven performance of our nutraceutical ingredients
The company’s high standards bring real added value to dietary supplement manufacturers, enabling them to combine proven efficacy with respect for consumer expectations in terms of nutraceutical safety and quality.
BCF Life Sciences has provided a list of beauty claims for Kera-Diet®. To find out more, please contact us!
Contact BCF Life Sciences
SOURCES :
[1] DIRECTIVE 2002/46/CE DU PARLEMENT EUROPÉEN ET DU CONSEIL of June 10, 2002 on the approximation of the laws of the Member States relating to food supplements
[2] Nutrition Business Journal, conference held at Vitafoods 2024
[3] Mordor Intelligence. Analysis of the size and share of the European dietary supplements market – Growth trends and forecasts(2024-2029)
[4] Synadiet. Les Français et les compléments alimentaires en 2023.
[5] Synadiet. Baromètre 2024 de la consommation des compléments alimentaires
