While the pharmaceutical market is typically considered to be exclusively about drugs, food supplements are included as a product category within the broader pharmaceutical sector.
Directive 2002/46/EC defines ‘food supplements’ as foodstuffs designed to “supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.
The regulatory authorities within Europe responsible for developing guidance on food supplements are the European Food Safety Authority (EFSA) and the European Commission.
Food supplements are managed by two main stakeholders – one on the company side and one from the authorities. From the industry side, the ‘food business operator’ (FBO) is the natural or legal person responsible for ensuring that the requirements of food law are met within the food business under their control. The Ministry of Health for each member state is responsible for the evaluation and approval or rejection of the dossier for the product for products that fall under the National Procedure. Novel foods that fall under the Centralized Procedure must be submitted to the European Commission and EFSA.
While the directive is issued by the European Parliament and is based on the approximation of laws of the Member States relating to food supplements, there are important differences in relation to concepts, principles and procedures between the food laws of the Member States. When Member States adopt measures governing food, these differences may impede the free movement of food, create unequal conditions of competition, and may therefore directly affect the functioning of the internal market.
Several regulations affect the assessment, authorization, and free movement of food supplements, including:
- Regulation (EU) 2015/2283 and regulation 2018/456, concerning the placement and use of novel food in the EU.
- Regulation (CE) 1334/2008, which concerns flavorings and food ingredients with flavoring properties
- Regulation (EU) 396/2005 which concerns the levels of pesticides in or on food and feed of plant and animal origin
- Directive (CE) 32/2009, which concerns extraction solvents used in the production of foodstuffs and food ingredients
- Law 238 of April 30 1962 – Hygienic regulation of the production and sale of foodstuffs
Managing the supplement dossier
The first step for the submission of the food supplement dossier is to properly analyze the product to classify it in the correct category. The best practice to manage this process is to ask specific questions about the product, such as:
- What is the final use of the product that we want to submit?
- Does the product have therapeutic properties?
- Does the product have cleaning properties?
Having the correct category is key to adopting the right regulatory strategy, since an inaccurate assessment could jeopardize the product’s regulatory outcome.
Protecting the consumer
The priority with any pharmaceutical – whether drug or food supplement – is to ensure the safety of consumers. Regulation (EC) 178/2002, which lays down the general principles of food law with regards to safety. The regulation prohibits the commercialization of a product considered to be either dangerous or unsafe to consumer health. It is the responsibility of the health authority, with the help of the EFSA, to evaluate and detect any possible risk to the health of the consumer or environment or, in the case of a veterinary product, the health of an animal. To ensure high-level protection of the end user, companies are expected to develop a risk assessment program that carefully considers:
- Available scientific evidence
- The results of the risk assessment and, in particular, the opinion of the regulatory authority. If the assessment determines a risk, companies are required to take action to protect human or animal health.
In addition, companies must adhere to principles laid out in regulation EU 2019 /1381 concerning the transparency and the sustainability of the EU risk analysis in the food chain by:
- Ensuring transparency and inclusive communication to strengthen trust that the risk analysis is focused on protecting consumers
- Strengthening cooperation and coordination with competent bodies and collaborate with scientific experts
- Developing continuous and inclusive communication throughout the risk analysis
Another important point to consider in the wide range of the regulatory requirements is the hygiene of foodstuffs, which is covered under Regulation (CE) 852/2004. The regulation comprises 18 articles and two annexes that describe production activities, including the transport, storage and handling of primary products and, where relevant, the transport of live animals. The aim of the regulation is to monitor all the general hygienic requirements in terms of facilities, the handling of waste, management of and the provisions related to the packaging of foodstuffs and any heat treatment processes.
The rights of the consumer are further protected under Regulation 1169/2011, which requires that consumers are adequately informed about the food products they consume. To that end, the EU has established rules on food labeling. The legislation is applicable to all the organizations involved in each stage of the supply chain and the manufacturer is responsible for providing accurate, clear and understandable information.
Regulation 1924/2006 further lays down requirements with regards to nutritional and health claims made on food, and notes that products must be adequately labeled to protect consumers with diseases that require them to avoid or limit certain foods, for example, reduced fat or no added sugar.
The label must not:
- Contain false, ambiguous, or misleading information about the safety of product.
- Encourage an abuse of the supplements
- Mislead consumers trying to make healthy choices with regards to a balanced diet
- Make reference to the amount of weight loss
- Make reference to an explicit medical opinion
Regulating food additives
Another area that has a bearing on food supplements is the use of food additives. Regulation 1333/2008 states that ‘food additive’ shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods.
Only approved food additives can be sold and used in foodstuffs. Such additives must be safe for public health, have benefits for consumers, be added in the lowest quantity possible and not be used in foodstuffs intended for young children.
Another type of foodstuff to include in the list are novel foods, meaning any food that was not used for human consumption to a significant degree within the Union before May 15, 1997, irrespective of the dates of accession of Member States to the Union.
- food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before May 15, 1997
- food consisting of, isolated from or produced from microorganisms, fungi or algae
- food consisting of, isolated from or produced from material of mineral origin
- food consisting of, isolated from or produced from plants or their parts
- food consisting of, isolated from or produced from animals or their parts
- food resulting from a production process not used for food production within the Union before May 15, 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances
- food consisting of engineered nanomaterials or vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013.
Another key consideration for companies is the advertising of the foodstuffs, which is regulated by the Dlgs. 21.5.2004 n°169 of the directive 2002/46/CE, and the marketing communication, including claims that are determined by Regulation 1924/06. This refers to any message or representation that is not mandatory under European Commission or national legislation, including pictorial, graphic or symbolic representation in any form, which states, suggests or implies that a food has particular characteristics, such as:
- A statement, suggestion or implication that a food has particular benefit.
- A statement, suggestion or implication that a relationship exists between a food category, a food or one of its constituents and health.
- A statement, suggestion or implication that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.
As with any pharmaceutical product, when a food supplement receives marketing approval, companies must continue post-marketing surveillance. This is the responsibility of the FBO, who is expected to collect all the data and information on the product, including how it might interact with other substances, (e.g., signals coming from consumers, pharmacists, doctors, and other scientific evidence).
The FBO evaluates the risk and where appropriate, triggers the action needed to protect consumer health. The FBO can expect full support and cooperation from the authorities in this regard, for example with the use of tools such as the EFSA’s Compendium of Botanicals, a database of botanicals that are reported to contain naturally occurring substances of possible concern for human health when present in food, EMA monographs, the rapid alert system for food and feed (RASFF), as well as insights from the other member states, and other authorities to support food safety.