The food supplements market has grown significantly in recent years, and more and more people are turning to these products to support their overall health and well-being. As dietary supplements grow in popularity, it is important to understand the regulatory framework surrounding these products. This article aims to provide a comprehensive survey of dietary food supplement regulations, covering various aspects from their regulation to promotion and enforcement.

How are food supplements regulated?

Many countries, including the United States and the European Union, have specific regulations to ensure the safety, quality and effectiveness of dietary food supplements. Regulatory agencies such as the US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) oversee the regulation of dietary food supplements. In these regulations, dietary supplements are usually defined as concentrated sources of nutrients or other nutritionally or physiologically effective substances intended to complement a normal diet. They are not considered traditional foods and are not intended to replace a balanced diet.

Why are food supplements regulated?

Dietary food supplement regulations exist to protect consumers from potential health risks and misleading claims. The main objectives of these regulations are:

Ensuring the safety of consumers: By regulating food, authorities try to prevent the distribution of dangerous products that may contain harmful substances or unsuitable nutrients.

Product quality assurance: The regulations establish standards for manufacturing, packaging and labeling of dietary food supplements to ensure that consumers receive products that are accurately identified, properly formulated and free from contamination or adulteration.

Providing accurate information: The regulations require that labeling and advertising of food additives must provide consumers with clear and truthful information to enable them to make informed decisions about purchase and use.

What is regulated under food law?

• Dietary supplement regulations cover various aspects of these products, including their composition, labeling, claims and safety. The rules usually contain provisions for: Ingredients and Composition: Authorities determine the types of ingredients used in dietary food supplements and set acceptable limits for certain substances such as vitamins and minerals. This ensures that the composition of the product is safe and meets certain quality standards.

• Labeling requirements: The regulations define the information that must be included on the product label, such as the product name, ingredients, recommended daily amount and any necessary warnings or precautions. Clear and accurate labeling helps consumers understand what they are buying and how to use the product safely.

• Health claims: Health claims refer to claims about the positive effects of a product on health. Dietary supplementation of food regulations often limit the types of claims they make and require scientific evidence to support these claims. This prevents misleading or false information being given to consumers.

What about traditional herbal remedies (THRs)?

Traditional herbal preparations, derived from plants and used to maintain health or treat minor illnesses, are often subject to separate regulation. Some jurisdictions, such as the EU, have specific regulations governing the marketing and sale of traditional herbal products. The purpose of these regulations is to ensure their safety, quality and proper use.

As dietary food supplements, traditional herbal products must meet certain criteria, including evidence of traditional use and a positive assessment of their safety and effectiveness. Regulatory authorities evaluate traditional use and scientific knowledge to determine whether traditional herbal medicine can be granted Traditional Herbal Registration (THR).

Can food products make medicinal claims?

Foods, including dietary food supplements, are generally not allowed to make medical claims unless they are licensed as medicinal products. Medical claims suggest that a product can prevent, treat or cure a disease and require rigorous scientific evidence to prove their effectiveness and safety.

However, some dietary food supplements may contain general health claims that suggest the maintenance of good health or the role of certain nutrients in growth, development, maintenance or normal body functions. These claims must be supported by scientific evidence and must meet specific regulations issued by regulatory agencies.

How are claims about dietary food supplements regulated?

Claims for dietary supplements, including general health claims, are subject to strict regulations to ensure accuracy and avoid misleading information. Regulatory agencies evaluate these claims based on scientific evidence provided by manufacturers or distributors.

For example, in the European Union, the health claims of food additives must receive prior approval from the EFSA. EFSA assesses the scientific basis of the claims and determines whether they are supported by sound evidence. Only approved health claims may be used on product labels and promotional materials. In the United States, claims made about dietary food supplements are regulated by the FDA. Manufacturers are responsible for ensuring that the claims made on their product labels and marketing materials are true and not misleading.

FDA may take enforcement action if a claim is found to be unfounded or misleading. It is important that manufacturers and traders have a strong scientific basis for their claims and follow the specific regulations of the jurisdiction where the product is sold.

How is the advertising and promotion of food supplements regulated?

The advertising and promotion of dietary supplements is strictly regulated to prevent misleading or deceptive practices and to ensure that consumers are properly informed about the products. Regulatory agencies monitor advertising standards and can take action against companies that violate these standards.

Regulations often require that advertisements for dietary supplements be truthful, clear and not misleading. They may restrict the use of certain terms or images that suggest medicinal properties or exaggerate the benefits of the product. Promotional material must also meet specific labeling requirements, including accurate product information and claims supported by scientific evidence. Enforcement agencies monitor advertising and promotional activities in a number of ways, such as reviewing product labels, monitoring online platforms and media, and responding to consumer complaints. Violating companies may be subject to penalties, fines or other enforcement measures to ensure compliance.

How is food supplements legislation enforced?

Dietary supplement legislation is enforced through a combination of regulatory oversight, industry demands and consumer vigilance. Regulatory agencies have the power to conduct inspections, request product samples and review documents to ensure compliance.

Manufacturers and distributors of dietary supplements are responsible for regulatory compliance and compliance of their products. This includes conducting appropriate testing and quality control procedures, accurately labeling products, and making permissible claims based on scientific evidence.

Consumer vigilance also plays a key role in the implementation of dietary supplements legislation. Consumers are encouraged to report any concerns or complaints about product safety, labeling or claims to the appropriate regulatory authorities. These reports provide valuable information to regulators so that they can investigate and take necessary action against non-compliant companies.

Conclusion

Dietary supplement regulations play a key role in ensuring the safety, quality and effectiveness of these products. By regulating their composition, labeling, claims and advertising, regulatory agencies seek to protect consumers from potential health risks and misleading information. Manufacturers, marketers and consumers have a role to play in enforcing and enforcing these regulations, fostering a marketplace where consumers can make informed choices about their health and wellness dietary supplements.