Introduction
What are dietary supplements?
Directive 2002/46/EC
Regulation 1924/2006
Dietary Supplement Production and the FDA
Dietary Supplement Health and Education Act (DSHEA) of 1994 granted by the U.S. Food and Drug Administration (FDA) the power to establish rules Good Manufacturing Practices (GMP) for dietary supplements. Before DSHEA, supplements were not subject to the same regulations as prescription drugs, which raised concerns about product quality and safety.
DSHEA defined dietary supplements as a separate product category, distinct from drugs and food, creating a regulatory framework that requires manufacturers to ensure their products are safe, properly labeled, and manufactured in accordance with GMP. Key requirements include:
- Accurate labeling – supplements must be labeled accurately, providing information about the identity, purity, strength, and composition of the product. More information on labeling requirements can be found at Dietary Supplement Labeling Guide.
- Product safety – manufacturers must have evidence that their products are safe and any adverse events related to their use must be reported to FDA MedWatch.
- Conformity of statements – all health claims must be true and not misleading to consumers. Claims must comply with regulations Structure/Function Claims.
- New ingredients – Before new ingredients can be introduced to the market, the FDA must receive evidence of their safety. More about new ingredients on the website New Dietary Ingredients.
- GMP compliance - producers must comply with the rules GMPto ensure product quality and compliance.
In 2007, the FDA issued final regulations regarding GMP for dietary supplements, which specify minimum requirements for the production, packaging, labeling, and storage of supplements. Manufacturers must follow written procedures at every stage of production, from sourcing raw materials to final testing and product introduction to market.
Regulation FDA The dietary supplement regulations introduced under DSHEA and GMP are intended to ensure high quality and safety of products, which contributes to increased consumer confidence in the U.S. dietary supplement industry.
Production of dietary supplements in the European Union
Directive 2002/46/EC established a legal framework for regulating dietary supplements in the European Union. Before its introduction, dietary supplements were not subject to uniform regulations in the Member States, which caused problems with quality and safety. This directive defined dietary supplements as a separate category of products, different from food and medicines, creating regulations aimed at ensuring their safety, quality and compliance with EU standards. The provisions introduced by the directive impose on manufacturers the obligation to:- Accurate labeling: Supplements must be labeled precisely, including information about ingredients, purity, strength, and their safe use. Each product must have appropriate labeling in accordance with Regulation 1169/2011 regarding the labelling of food products, which imposes specific requirements on supplements.
- Following the rules GMP (Good Manufacturing Practices): Manufacturers must adhere to GMPs, which ensure strict quality control at every stage of supplement production – from sourcing raw materials, through the manufacturing process, to packaging. These rules are designed to ensure that supplements are free from contaminants and meet specific quality standards.
- Reporting new ingredients: Before new ingredients can be introduced to the European market, manufacturers must provide evidence of their safety. These ingredients are assessed by European Food Safety Authority (EFSA), which is responsible for assessing the risks associated with new ingredients and health claims on supplements.
- Compliance with cleanliness standards: Food supplements in the EU must be free from harmful substances such as pesticides, heavy metals and chemicals that could harm the health of consumers. These standards are detailed by EFSA.
- Health claims: All health claims used on dietary supplement labels must comply with regulations Regulation (EC) No 1924/2006, which specifies what claims can be made about the health benefits of a supplement. Before such claims can be used, they must be approved by EFSA. The manufacturer must provide scientific evidence of the ingredient's effectiveness, on the basis of which EFSA makes its assessment.
The production process of dietary supplements
The production of dietary supplements is a multi-step process that requires a meticulous approach at every stage. From sourcing raw materials, through quality control, formulation and production process, to final packaging – each step must comply with European Union regulations to ensure the safety and effectiveness of the product. Here is what the process looks like in detail.
The production of dietary supplements can vary depending on the specific product, but here are the general steps typically taken during production:
1. Acquisition of raw materials
The first step in production of dietary supplements is to obtain raw materials such as vitamins, minerals, herbs and other natural substances. These raw materials are carefully selected from certified suppliers to ensure their high quality and purity. In IOC we make sure that all ingredients comply with European standards and come from reliable sources.
2. Testing
Once the raw materials are sourced, rigorous testing is conducted to ensure they meet standards for purity, potency, and identity. Advanced analytical methods such as chromatography, spectroscopy, and microbiological analysis are used in this testing to ensure that each ingredient is held to the highest standards.
3. Formulation
The next step is to formulate the product by combining the ingredients in precise proportions. Depending on the type of supplement, this may involve mixing powders, combining liquids, forming tablets or capsules. In IOC We formulate supplements that are tailored to individual customer needs, based on the latest scientific research.
4. Production
Once the formula is developed, the supplement is manufactured, which can involve various processes such as mixing, milling, granulating, or drying. IOC we use modern technologies such as nano-micellization and liposomal capsules to maximize the bioavailability of ingredients. Production is carried out in accordance with the principles GMP (Good Manufacturing Practice), which guarantees constant quality and purity of the products.
5. Quality control
A quality checklist is used throughout the manufacturing process to ensure that the product meets all manufacturer specifications and regulatory requirements. Testing includes analysis of purity, potency, and identity of ingredients to ensure that the finished product is compliant and safe for consumers. More about quality control of supplements you can read on our website.
6. Packaging and labeling
Once the supplement has been manufactured and tested, the product is packaged and labelled in accordance with EU regulations such as Regulation 1169/2011. The label must include information such as the product name, serving size, list of ingredients and any health claims. In IOC we make sure that the packaging not only protects the product, but is also visually attractive and contains all the necessary information.
7. Storage and distribution
The finished product is stored in controlled conditions that ensure its stability and potency. The supplements are then distributed to retailers or directly to consumers. Storage and transportation are carried out according to strict guidelines to ensure the highest quality at every stage.
Detailed Description of Individual Production Stages in IOC
1. Acquisition of raw materials
The first and most important stage of the production of dietary supplements is the acquisition of raw materials. It is the quality of the raw materials that determines the final value of the product, which is why it is so important that they comply with the highest quality standards. In the European Union, regulations on dietary supplements, such as Directive 2002/46/EC, clearly define what ingredients can be used and what standards must be met by the raw materials used to produce supplements. Dietary supplements can contain a variety of ingredients, including vitamins, minerals, amino acids, plant extracts and other bioactive substances that are intended to support health and supplement the diet. All of these ingredients must be carefully selected and their origin must be fully controlled to ensure that they meet the strict quality standards that apply in Europe. In the company IOC we attach great importance to ensuring that raw materials are obtained only from certified sources. We work with suppliers from around the world who meet the highest quality requirements and compliance with European regulations. Each batch of raw materials, before reaching our production plants, undergoes thorough tests that confirm its purity, identity and effectiveness. This approach ensures that the supplements we produce not only meet legal requirements, but also consumer expectations in terms of effectiveness.EU quality standards
In Europe, raw materials for the production of dietary supplements must meet very strict quality standards. Directive 2002/46/EC and other EU regulations clearly define requirements for the safety and purity of ingredients used in supplements. Raw materials must be free of contaminants, pesticides and other substances that could negatively affect the health of the consumer.
Additionally, producers of dietary supplements in the EU they must follow the rules Good Manufacturing Practice (GMP), which imposes the obligation to control raw materials at every stage - from the moment of their purchase, through transport, to their introduction to the production process. In IOC We have implemented advanced quality control procedures that allow us to continuously monitor every step of sourcing and processing raw materials.
Every raw material we use in production is not only compliant with EU standards, but also meets the highest international standards. This means that our dietary supplements are safe, effective and tailored to the needs of the most demanding consumers.
US Quality Standards
In the United States, regulations regarding raw materials for the production of dietary supplements are regulated by US Food and Drug Administration (FDA) based on the law Dietary Supplement Health and Education Act (DSHEA) in 1994. DSHEA defines supplements as products other than drugs and sets requirements for their quality, safety and purity. Manufacturers must ensure that raw materials are free of contaminants such as pesticides and heavy metals and that they meet standards for purity, identity and potency.
As in Europe, supplement manufacturers in the US must comply GMP (Good Manufacturing Practices), which define quality standards at every stage of production, from raw material sourcing, through manufacturing processes, to finished product testing. GMP rules are designed to ensure that supplements are manufactured under conditions that minimize the risk of contamination and noncompliance.
In the US, manufacturers must also submit new ingredients to the FDA before they are introduced to the market, which requires providing evidence of the ingredients’ safety. Each ingredient must meet quality and purity requirements, and health claims must comply with regulations Dietary Supplement Labeling Guideto avoid misleading consumers.
Cooperation with certified suppliers
One of the key elements of our strategy is close cooperation with suppliers who have the appropriate quality certificates. Raw materials are obtained from trusted suppliers who meet both EU and global standards, including FDA and GMP requirements. This ensures that the ingredients that go into our supplements are compliant with regulations and support consumer health.
Each batch of raw materials is rigorously tested before being released for production. Testing includes microbiological purity, heavy metal analysis, and rigorous identity testing to ensure that each ingredient is what it claims to be. This ensures the highest standards of quality and safety in both regions.
2. Raw material testing and quality control
Testing raw materials before they are used in the production process of dietary supplements is one of the key steps in ensuring consumer safety. In Europe, there are strict regulations that require a thorough inspection of each batch of raw materials before they are allowed to be produced. Regulations such as GMP (Good Manufacturing Practice) and HACCP (Hazard Analysis and Critical Control Points) require manufacturers to thoroughly test raw materials to eliminate the risk of contamination and health hazards. In IOC we adhere to the highest quality control standards to ensure that every raw material used in our products meets EU standards. This process includes a series of tests that allow us to identify ingredients, confirm their purity and assess their potency.Raw Material Testing Steps:
- Identity Analysis: Each ingredient must be identified to ensure it is exactly what it claims to be.
- Tests for contamination: Raw materials are tested for the presence of heavy metals, pesticides and microorganisms.
- Power rating: Active ingredients are tested for their potency to ensure their effectiveness.
- Stability analysis: Stability tests are carried out to ensure that the raw materials retain their properties throughout the storage and processing period.
3. Supplement formulation
Creating the right formula for a dietary supplement is one of the most important stages of production. This is where it is decided what ingredients will be combined, in what proportions and how they will act on the body. In the formulation process, it is crucial that the ingredients are not only effective, but also safe and compliant with European Union regulations. In IOC we treat each order individually. Working with our clients, we strive to develop supplement formulas that are precisely tailored to their needs and expectations. We base the formulation process on the latest scientific research, which allows us to create products tailored to the specific requirements of the market and consumers.Steps in creating a supplement formula:
- Selection of ingredients: At this stage, we select appropriate nutrients, such as vitamins, minerals, plant extracts and amino acids, according to customer needs and market requirements.
- Evaluation of ingredient synergy: It is important that the ingredients in the formula support each other and work effectively together.
- Determination of dosage: Precise dosage determination is crucial for the supplement to be effective and safe for the consumer.
- Stability and bioavailability tests: We conduct stability and bioavailability tests to ensure that the ingredients are properly absorbed by the body and retain their properties throughout the storage period.
4. Production process
Production of dietary supplements in IOC takes place in modern plants that meet all the requirements of European regulations and GMP (Good Manufacturing Practice) standards. The production of supplements includes several key stages that differ depending on the form of the product - whether they are capsules, tablets, liquids or other forms.Production of supplements in various forms:
- Capsules: The capsule manufacturing process involves precisely filling gelatin or vegetable capsules with the appropriate ingredients. Capsules are an excellent form when the supplement requires protecting the ingredients from light or air.
- Pills: Tablet production involves compressing ingredients into appropriately selected forms, which allows for convenient dosing of supplements. Tablets can be coated to facilitate swallowing and improve the stability of ingredients.
- Liquids: Liquid supplements require advanced technology to ensure the stability and bioavailability of ingredients. They are ideal for people who have difficulty swallowing tablets or capsules.
Technologies used in IOC:
- Nano-micellization: This technology allows for the breakdown of active ingredients to nano-size, which increases their absorption by the body. This is particularly effective in the case of ingredients that are difficult to dissolve in water.
- Liposomal capsules: This innovative technology involves enveloping active ingredients in a lipid layer, which protects them from destruction in the digestive tract and ensures better absorption.
- Micronization technologies: During the micronization process, ingredients are reduced into smaller particles, which increases their surface area and therefore improves their bioavailability and effectiveness.
5. Packaging and labeling
Packaging and labeling of dietary supplements is the last but very important stage of the production process. Appropriate packaging not only protects the product from losing its properties, but also plays a key role in providing consumers with the necessary information in accordance with European regulations.The importance of proper packaging:
Packaging of dietary supplements must meet strict requirements for product protection. The materials used for packaging must protect the supplements from external factors such as moisture, light or air, which can affect the stability of the active ingredients. In IOC We use advanced packaging technologies that ensure maximum product protection and extend their shelf life.Labelling in accordance with EU regulations:
In the European Union, the labeling of dietary supplements is strictly regulated by regulations such as Regulation 1169/2011. It requires that the label contain accurate information about ingredients, nutritional values and possible health claims. Each label must be clear and legal so as not to mislead consumers. In IOC we ensure that all of our supplements are properly labeled, with complete information on ingredients, dosages, and health claims. We work with our customers to create labels that not only meet legal requirements but are also attractive to consumers.Key information on a dietary supplement label:
- List of ingredients: Detailed information about each ingredient used in the product, along with the amount per serving.
- Nutritional values: Information about the nutritional value of the product, such as the content of vitamins, minerals and other active ingredients.
- Health claims: If a supplement makes health claims, they must be consistent with EFSA regulations (European Food Safety Authority) and be based on scientific evidence.
- Expiration date: Supplements must have a clearly marked expiration date to ensure consumer safety.
Profitability of dietary supplement production
Manufacturing dietary supplements can be very profitable, especially in Europe, where growing demand for health-supporting products is driving the market. Choosing the right manufacturing partner, such as IOC, allows brands to not only reduce koszty production, but also increase their competitiveness on the market.
Key factors affecting profitability:
- Production scale: The larger the number of orders, the lower the unit costs. Contract manufacturing in IOC allows you to take advantage of economies of scale, which reduces the costs of raw materials and production processes. More about how reduce the cost of producing supplements.
- Innovative technologies: Using advanced technologies such as liposomal capsules or nano-micellization increases the effectiveness of supplements. Products created using such technologies can be sold at higher prices, which translates into higher margins.
- Raw material cost optimization: Thanks to cooperation with many certified suppliers, IOC is able to negotiate better prices for raw materials, which reduces the cost of producing supplements. Read more about production costs of dietary supplements in 2024.
- Consumer confidence: High quality production and compliance with EU standards such as GMP and HACCP build consumer trust in the brand, leading to greater loyalty and increased sales.
Thanks to these key factors, the production of dietary supplements can be highly profitable, especially when modern technologies are used and costs are optimized at every stage of production. See more about how to optimize production costs.
Need a quick quote for supplement production?
Want to know the real costs of producing supplements?
The Future of the Dietary Supplement Industry
The dietary supplement industry is developing dynamically, and its future will be shaped by a number of technological innovations and changing consumer needs. Personalization of supplements, sustainable development and new technologies will be key trends in the coming years.
Key future trends:
- Personalization of supplements: Consumers are increasingly looking for products tailored to their individual health needs. The future of dietary supplements is personalized products based on health and lifestyle data, which increases their effectiveness and value to users.
- Technological innovations: Technologies such as nano-micellization, liposomal capsules, and 3D printing have the potential to transform the way supplements are delivered to the body, maximizing their effectiveness and accessibility to a wide range of consumers.
- Ecology and sustainable development: More and more consumers are paying attention to ecology. Dietary supplements will be produced with increasing emphasis on sustainable sources of raw materials and ecological packaging. Companies that focus on sustainable development will gain a competitive advantage on the market.
- New supplement categories: The growing interest in mental health, immunity and healthy lifestyle will influence the development of new categories of supplements. Supplements supporting mental health and immunity will play an increasingly important role in the market.
Companies that invest in these innovative technologies and approaches will be able to benefit from the rapidly growing dietary supplement market in Europe and worldwide. Learn more about trends in supplement production.
Useful links on our website
- The actual costs of producing supplements
- Contract production of dietary supplements
- Custom production in the company IOC
- Cost of producing the supplement
- Introduction of dietary supplements to the market
- Producing private label supplements – costs and benefits
- Start-up Guide for the Supplement Industry
- Safety and effectiveness of dietary supplements
- How to choose the right contract manufacturer of dietary supplements?
Useful external links
- Directive 2002/46/EC – Regulation of food supplements in the EU
- FDA: Dietary Supplement Health and Education Act (DSHEA) – US Regulations
- GMP – Good Manufacturing Practice (EMA)
- Regulation 1169/2011 – Labelling of dietary supplements
- EFSA – Health claims on dietary supplements
- FDA: Good Manufacturing Practices (GMP) for Dietary Supplements in the US
- New Ingredients in Dietary Supplements – FDA Regulations
- Council for Responsible Nutrition – Information on dietary supplements