How to Produce a Dietary Supplement? Advanced Technologies, Requirements and Business
Production of dietary supplements is a complex process that requires simultaneous consideration of modern manufacturing technologies, restrictive legal requirements and well-thought-out business strategies. In an era of growing health awareness, consumers from different countries expect supplements of high quality, effectiveness and safety. Below we present key aspects of dietary supplement production – from advanced technological methods (microencapsulation, freeze-drying, nanotechnology) through legal requirements on the EU, US and Asian markets, to strategies for running this business and the latest trends in the industry.
Advanced technologies for the production of dietary supplements
Modern production technology allows for the creation of dietary supplements with better bioavailability and stability. Companies reach for innovative methods to increase the effectiveness of active ingredients and consumer convenience. Here are the most important ones:
Microencapsulation
It involves surrounding microscopic particles of active ingredients with a protective coating. Thanks to this, sensitive vitamins or plant extracts are protected from external factors (e.g. moisture, oxidation, high temperature) and are released only in the desired place in the body. Microencapsulation also prevents premature degradation of ingredients and masks their taste or smell. Importantly, this technology allows for the reduction of the so-called "production overdose" - the manufacturer does not have to add excessive amounts of the ingredient to compensate for losses during production, because the encapsulated ingredient maintains stability. This means lower costs and more precise doses in each tablet or capsule. An additional advantage is the ability to design capsules so that they dissolve only in a specific environment (e.g. in the stomach or intestine), which ensures controlled release of the substance.
Lyophilization (freeze-drying)
An advanced method of drying ingredients, which involves freezing them and then evaporating the water under very low pressure. As a result, a dried product is obtained with preserved structure and composition. Freeze-drying is used, among others, to produce probiotics, enzymes or herbal extracts. Why is it so valuable? Because it preserves maximum nutritional value - low temperature protects vitamins and enzymes from decomposition, thanks to which they remain biologically active.. Lyophilized ingredients are more concentrated and easier for the body to absorb.. Additionally, removing moisture from a product extends its shelf life (the lack of water inhibits the growth of microorganisms and spoilage) and makes it easier to store (lyophilized products do not require refrigeration and their mass is reduced). For example, freeze-dried bacterial cultures (probiotics) remain highly viable in a capsule, and after consumption, they "come to life" in the digestive tract. Freeze-dried fruits or herbs in supplements also provide a concentrated dose of antioxidants and phytochemicals.
Nanotechnology and liposomal delivery systems
Miniaturizing nutrients into nanoparticles or encapsulating them in nano-capsules (e.g. liposomes) can increase the bioavailability of difficult-to-absorb substances. Many valuable compounds (e.g. curcumin, vitamin C, some herbal extracts) have limited solubility in water or disintegrate in the digestive tract. Liposomes – microscopic vesicles made of phospholipids – allow the active molecule to be surrounded by a fatty shell that protects it from stomach acid and enzymes, while also facilitating penetration through cell membranes. Thanks to this, the ingredients reach the place of absorption intact, which significantly improves their effective use by the body. . Studies show that, for example, liposomal vitamin C or glutathione reach much higher concentrations in the blood than traditional forms. Nanoparticles can also transport ingredients directly to specific tissues (so-called targeting), which increases the effectiveness of action and reduces the required dose. Reducing the size of particles to the nano-scale improves their solubility and penetration through biological barriers. . In other words, nanotechnology in supplements allows you to achieve the same health effect with a smaller dose because more of the substance is actually absorbed and reaches the target cells.
Innovative forms of administration
The supplement industry is also dynamically developing new forms that increase the convenience of use and attractiveness of products. For example, instant powders for dissolving in water (creating a tasty vitamin or isotonic drink) or sublingual strips (thin strips that dissolve in the mouth) are becoming increasingly popular. Sublingual strips deliver vitamins or other compounds through the oral mucosa - just place the strip under the tongue, where it dissolves quickly. This method of administration bypasses the digestive system and liver, allowing the ingredients to enter the bloodstream faster.. Thanks to this, the supplement starts working almost immediately, and often a smaller dose is enough - for example, vitamin B12 taken sublingually can achieve a comparable effect to a much larger dose swallowed in a tablet.. It is also a friendly solution for people who have difficulty swallowing capsules. Other innovative forms include supplements in the form of chewing gums, oral aerosols or controlled-release granules. All of these innovations have one goal: to increase the effectiveness and convenience of supplementation, responding to the diverse needs of consumers.
Legal and regulatory requirements – production of dietary supplements in different countries
The dietary supplement industry is subject to strict regulations, which vary by country or region. Production of dietary supplements – legal requirements include both quality and safety standards for production, as well as rules for introducing the product to the market, its registration and labeling. Before starting production, it is necessary to familiarize yourself with the applicable regulations to ensure the product is legal and avoid its withdrawal from the market. Below is a discussion of the most important requirements and regulatory differences in the European Union, the United States and selected Asian countries.
European Union (EU)
In the EU, dietary supplements are treated as special purpose foods (not medicines), but their production and distribution are regulated by several legal acts. The legal basis is Directive 2002/46/EC of the European Parliament and of the Council, which defines what a dietary supplement is and harmonizes the general requirements for their composition and labeling in the Member States.. This directive establishes lists of permitted vitamins and minerals and their chemical forms that can be used in supplements to ensure consumer safety. Other EU regulations, such as Regulation 1924/2006 on nutrition and health claims, regulate what can be declared on the label (e.g. the ban on attributing disease-curing properties to supplements). The European Food Safety Authority (EFSA) assesses the safety of new ingredients and the scientific validity of health claims. Under EU law, supplements do not require a pre-market authorisation unless the ingredients used are new. In the case of so-called Novel Food – ingredients not used before May 1997 – the manufacturer must obtain authorisation under Regulation 2015/2283, which results in the new ingredient being entered on the EU list of permitted substances. Each EU country may require notification (notification) of a new supplement to the appropriate national authority (e.g. in Poland to GIS), but the principle of mutual recognition facilitates trade - a product legally sold in one EU country should be able to be sold in another. There are also uniform GMP (Good Manufacturing Practice) and HACCP standards for food production plants, including supplements, throughout the EU, which are intended to ensure that production is carried out in accordance with high standards of hygiene, quality and control. Voluntary certifications are also important, such as ISO 22000 (food safety management system) or the Ecological certificate (if the product is to be marked as organic). Meeting these standards is not only a legal requirement, but also a condition of consumer trust.
United States (USA)
In the U.S., dietary supplements are regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Unlike drugs, they do not require premarket approval, which is prior approval from the FDA before they can be sold.. However, the manufacturer bears full responsibility for the safety and quality of the supplement. They must follow good manufacturing practices (cGMP) as defined in 21 CFR Part 111 – this regulation requires strict control of the production process, quality of ingredients, purity, proper labeling, record keeping, etc. . The FDA verifies products only after they are placed on the market, monitoring reports of adverse reactions and inspecting manufacturing plants. An important requirement in the US is the NDI (New Dietary Ingredient) notification – if a supplement contains a new ingredient, not present on the market before 1994, the manufacturer is required to notify the FDA and present data on its safety 75 days before the planned sale.. The mere fact of filing a report does not mean formal “approval,” but the lack of FDA objections allows for legal sale. Supplements in the US must be labeled with, among other things, a statement that they are not approved by the FDA for diagnosis, treatment, etc. (in the case where the manufacturer includes so-called structural-functional statements about the effect on the body). The label must also include the full composition, doses, nutritional information, manufacturer/distributor data, and directions for use. Advertising and marketing of supplements are subject to supervision by the FTC (Federal Trade Commission) – declarations must be true and not misleading. In practice, the US market is more liberal than the European one in terms of permitted ingredients or claims, but the consequence is a strong emphasis on self-control by manufacturers and voluntary certifications (e.g. USP Verified, NSF for athletes) in order to gain consumer trust.
Asia (examples: China and Japan)
Asian countries have their own regulations, often more similar to the pharmaceutical model. China classifies supplements as so-called "functional food" (health food). Each supplement (domestic or imported) must undergo a registration or notification procedure with the State Administration for Market Regulation (SAMR) and obtain a so-called "Blue Hat" certificate., before it goes on sale. The process is meticulous – it requires the submission of safety and efficacy test results, and an approved product receives a license number (for 5 years) and a blue hat symbol on the label. To simplify procedures, China has introduced a catalog of permitted vitamins and minerals – if a supplement contains only these standard ingredients (e.g. vitamin C, calcium) in specific doses, it can be subject to a simpler filing process (simplified registration), while products with ingredients not listed or claiming special health functions require full registration . Japan, on the other hand, distinguishes the FOSHU category (Foods for Specified Health Uses) – these are products (including capsules or drinks) officially approved by the government to declare specific health benefits. Obtaining FOSHU status involves conducting research and assessment by the Ministry of Health, and approved products receive a special logo. This is a costly and time-consuming process, which is why many supplements in Japan are sold as so-called Foods with Function Claims – the manufacturer conducts research independently and applies for permission for a health claim, which after 60 days without objection can be used. In other Asian countries, the regulations are different: for example, India has separate regulations for nutraceuticals (FSSAI), and ASEAN countries are striving to harmonize requirements in their own region. However, the common denominator is increasing control – GMP requirements, the obligation to register production plants, assessment of the composition in terms of local lists of permitted substances, and control of advertising. A manufacturer planning global operations must therefore adapt the product and documentation to the requirements of each target market.
Certification requirements and quality: Regardless of the country, certain standards remain universal. Good Manufacturing Practices GMP are the basis - many jurisdictions (USA, EU, China) require compliance with them by law, and a GMP certificate is often a condition of cooperation (e.g. pharmacy chains require supplement suppliers to have a GMP certificate). HACCP (Hazard Analysis and Critical Control Points) is mandatory in the EU and many other places - the company must identify and control risk points in the process to ensure food safety. ISO 9001 (quality management) or ISO 22000 (food safety) are voluntary standards that increase the manufacturer's credibility. For products targeted at specific groups, it is worth considering Halal or Kosher certificates if we plan to export to countries with Muslim or Jewish communities. Organic certificates are also becoming increasingly important (e.g. EU Organic, USDA Organic) - in order to be able to mark a supplement as organic, the entire supply and production chain must meet the rigorous requirements of organic farming and the lack of synthetic additives. Meeting all these requirements is a challenge, but also a necessity to compete in the global supplement market.
Business Strategies – Dietary Supplement Production as a Business
The production of dietary supplements is not only a technological process, but also a business venture. Entering this market can be very profitable due to the growing demand - global sales of supplements reach hundreds of billions of dollars and are still growing dynamically. At the same time, competition is fierce and customers are demanding, so it is crucial to plan an effective business model, cost control and effective distribution channels.
Production costs and margin optimization
The cost of producing a supplement includes, among other things, expenses for raw materials (e.g. standardized plant extracts, vitamins in specific forms), the production process (energy, machine depreciation, salaries of qualified personnel), quality and stability tests, packaging, as well as the costs of ensuring compliance with regulations (e.g. documentation for offices, certifications, laboratory tests of each batch). Initially, a large outlay is the development of the formula and possible tests confirming the effect (which is particularly important for unique mixtures or innovative ingredients - some companies invest in clinical trials to distinguish their product scientifically). The entrepreneur must decide whether to build their own production plant or outsource contract production to a specialized manufacturer. Contract production (white label/private label) lowers the entry threshold - you do not have to invest millions in a factory, you use the processing capacity of the partner - but it is associated with a lower unit margin, because the contract manufacturer adds its commission. On the other hand, your own factory means high fixed costs, which will pay off only on a large scale of production.
The profitability of the supplement business can be high – the gross margin on the product is often 40–60%, and net margins (after deducting marketing, distribution and administration costs) of 10–20% are considered healthy. Of course, much depends on the segment: premium supplements, sold directly to consumers, can generate higher profits than mass products sold through intermediaries. Cost optimization can include wholesale purchase of raw materials (negotiating prices with suppliers, choosing cheaper equivalents while maintaining quality), automation of packaging processes, or reducing losses of raw materials. Interestingly, modern technologies such as microencapsulation can contribute to savings - by protecting ingredients from losses, they reduce the need to add their surplus (overage), which translates into significant savings on raw materials for expensive vitamins or probiotics. Another important element is setting the right price – it should cover costs and leave a margin, but at the same time be acceptable to the customer and competitive with other brands. Some companies use the premium pricing model (high price based on quality features), while others go for volume and price competition.
Distribution models
How a supplement reaches the customer is of great importance for financial success. Currently, several sales channels dominate the market:
Direct Sales and E-Commerce (D2C) – thanks to the Internet, the manufacturer can sell directly to consumers through an online store or platforms like Amazon. This model is gaining importance – in the US, e-commerce has already become the single largest channel for selling supplements. This gives the manufacturer a higher margin (bypasses the retailer's margin), allows for building a direct relationship with the customer and, for example, offering subscription programs (monthly shipments of supplements) or personalized packages. The COVID-19 pandemic has accelerated the trend of online shopping and there are many indications that consumers have come to like the convenience of ordering supplements with home delivery. To be successful in e-commerce, a company must invest in online marketing, a clear website, paid advertising on social media and ensure efficient logistics (fast shipping, good packaging). Subscription models are increasingly used, where the customer signs up for regular deliveries (which increases loyalty and repeat revenue).
B2B Partnerships and Stationary Sales – the traditional model is wholesale to distributors, pharmacies, drugstores, herbal stores or fitness chains. In this case, the manufacturer operates B2B (business-to-business), selling large batches of its product at wholesale price to intermediaries, who then offer them to retail customers. The advantage is obtaining a wide reach – presence on the shelves of pharmacies or popular stores increases the credibility of the brand and availability for people who prefer traditional shopping. The disadvantage is sometimes a lower margin (each intermediary adds their own margin, so the manufacturer's price must be correspondingly lower) and the need to adapt to the requirements of partners (e.g. having appropriate certificates, expiration dates, unified barcodes, often also listing fees for entering the retail chain). Nevertheless, many customers still buy supplements on the occasion of a visit to a pharmacy or store, so presence in offline channels ensures reaching a wider group of recipients. A certain variety of the B2B model is private label production – the company can produce supplements on behalf of another brand (e.g. for a chain of drugstores under their own brand). This ensures a constant flow of orders, although it builds the brand of the client, not the manufacturer.
Traditional Direct Selling (MLM) – some supplement companies operate in the network marketing model (multi-level marketing). Independent distributors (consultants) buy products from the manufacturer and sell them in their environment, building a network. Examples include global brands such as Amway, Herbalife. This model can be controversial, but it still functions – its advantage is the involvement of salespeople who reach customers through recommendations. From the manufacturer's perspective, MLM means the need to support the network (training, marketing materials) and maintain an attractive commission system, which affects the price calculation.
In practice, many companies combine channels – for example, they sell online in their own store, but are also present on Amazon and in several chains of specialist stores. Omnichannel is a direction that allows for maximizing customer reach. It is worth analyzing which channel gives the best return and concentrating efforts there.
Marketing and branding
In such a competitive industry, standing out is essential. An effective marketing strategy should combine scientific credibility with an attractive message. Key elements include:
Branding and brand trust: Consumers must believe that the product is safe and effective. This is facilitated by clear communication of values (e.g. “natural ingredients”, “developed by scientists”, “GMP certified quality”), as well as certificates and tests confirming the purity of the product (publication of laboratory test results, seals of third-party organizations). The brand should have a consistent visual identity – from the logo, through the packaging design, to the presence in social media – building a professional image.
Content Marketing and Education: It is a good idea to share expert knowledge, e.g. running a blog about health, publishing guides, webinars with dieticians or doctors. This positions the company as an expert and improves SEO (so that potential customers, searching for phrases such as "how to produce a dietary supplement" or information about vitamins, end up on the manufacturer's website). Educating customers also builds trust - someone who understands why a given ingredient is needed is more likely to reach for it. However, it is important that the message remains in line with the regulations (e.g. you cannot promise a miraculous cure for a disease with a supplement).
Social Media Marketing: Platforms like Instagram, Facebook, YouTube and TikTok are now full of wellness content and are a natural environment for promoting supplements. Influencer marketing plays a huge role – recommendations from popular fitness trainers, dietitians and even celebrities can drive sales. In the US, it is observed that supplement trends often start online – it is on social media that interest in a specific ingredient or niche grows before the product reaches mass sale . That is why brands invest in cooperation with influencers and their own profiles, presenting results (e.g. transformations, customer stories) and lifestyle related to their products (e.g. activity, beautiful skin, more energy - depending on the promised benefits). However, you have to act authentically - today's consumers, especially younger ones, will quickly spot falsehood or intrusive advertising.
Advertising and promotions: In addition to social media, classic channels such as Google ads (AdWords), participation in trade fairs, or sponsored articles in the trade press can help reach recipients. In the case of beauty or sports supplements, cooperation with gyms, beauty salons, diet clinics is popular - a product recommended by a professional inspires greater trust. Loyalty programs, discounts for regular customers, packages (e.g. 3 for the price of 2) are ways to retain customers in the long term.
Scaling the business
When thinking strategically, a company should plan how to expand its offering (e.g., additional products that complement each other – cross-selling), how to enter new foreign markets, and how to reinvest profits. Often, strategies are encountered to build an entire portfolio of brands – one company can create different lines of supplements aimed at different groups (e.g., a separate brand for athletes with protein supplements, a separate premium line with adaptogens for those in stressful jobs, etc.). It is important to monitor trends and flexibly adapt – which brings us to the next part.
Trends and innovations in dietary supplements
The supplement market is constantly evolving, driven by new scientific discoveries, changing lifestyles, and consumer expectations. Currently, we can observe several clear trends that shape the development of new products and services in the industry:
Supplement Personalization and AI
More and more people are looking for supplements tailored to their individual needs. Instead of ready-made, universal preparations, customers want to receive a product tailored to their health profile, diet, lifestyle or even genetics. The development of technology makes this possible - there are DNA tests, intestinal microbiome tests, applications that track diet and health. On this basis, companies offer personalized supplement packages, often in the form of monthly sets of sachets or boxes with a daily portion. Algorithms and artificial intelligence help analyze customer data (test results, well-being surveys) and recommend a mixture of vitamins, minerals, herbs that is ideally suited to a given person.. For example, someone with a confirmed MTHFR gene polymorphism can receive vitamin B9 in its active form (methylated folate) instead of regular folic acid. Someone else living in a climate with little sunlight will receive a package with a higher dose of vitamin D3, etc. Personalization goes hand in hand with the subscription model - the customer receives new sets every month, and AI can modify the formula based on reported well-being or changing needs (e.g. it will recommend different supplements in winter, others in summer). This trend is particularly popular in the US and Western Europe. Companies are also investing in mobile applications that accompany supplementation - reminding about doses, tracking progress, and even integrating with wearable devices (fitness bands, smartwatches) to monitor health parameters. In the future, artificial intelligence can increasingly accurately predict which micronutrients a given person is lacking based on huge sets of data and research - which will further personalize nutritional recommendations.
Natural and organic ingredients, adaptogens and postbiotics
Consumers are paying more and more attention to the origin and quality of ingredients. The clean label trend means avoiding artificial additives, fillers, and dyes, and preferring natural, organic ingredients from sustainable sources. Plant-based and vegan supplements are gaining popularity – e.g. pea protein instead of whey, cellulose capsules instead of gelatin, or vitamin D from lichen instead of lanolin. Adaptogens are another hot trend: these are plants and fungi that help the body cope with stress and maintain balance (homeostasis). Classic adaptogens, known for centuries in Eastern medicine, such as ashwagandha, ginseng, rhodiola, reishi, or schisandra, have stormed into the mainstream of Western supplements. They are added to mixtures for immunity, mood improvement, increased energy, or cognitive functions. In 2025, the adaptogen market is expected to continue to grow – more and more supplements for people stressed by work or living in big cities will contain these anti-stress herbs. Similarly, nootropics – substances supporting brain function (memory, concentration) – are gaining popularity not only among students or e-sports players, but also among the general public concerned about mental fitness. Here, too, natural ingredients are often used: extracts from bacopa monnieri, gotu car, ginkgo (Ginkgo biloba), as well as choline, various forms of B vitamins, and the functional mushrooms mentioned above (lion's mane, cordyceps).
Postbiotics, on the other hand, are a new term that is starting to appear on labels. While probiotics are live bacteria, prebiotics are the fiber that provides food for them, postbiotics are beneficial metabolites produced by intestinal bacteria (or inactivated cells of these bacteria), which also have a positive effect on health. Examples of postbiotics include short-chain fatty acids (e.g. butyrate), fragments of bacterial cell walls, or fermentation products with anti-inflammatory effects. Scientists are discovering that sometimes dead bacteria or their extracts can modulate the immune system and bring benefits similar to live probiotics, but are more stable (they do not need to be kept alive). That is why manufacturers are experimenting with adding postbiotics to supplements aimed at gut health and immunity. Preparations containing, for example, neutralized cultures are already available Lactobacillus with documented effects on reducing symptoms of irritable bowel syndrome. This trend is part of a broader interest in the microbiome – awareness of the huge impact of intestinal flora on health translates into a boom not only in probiotics, but also synbiotics (a combination of pro- and prebiotics) and postbiotics. Manufacturers communicate a comprehensive approach: “feed your microbiome and benefit from its good by-products”. According to analyses, the segment of products supporting the health of the digestive system (including probiotics, prebiotics, postbiotics) will be one of the fastest growing in the coming years.
Biohacking and the Future of Supplementation
More futuristic directions are also appearing on the horizon. Biohackers – people experimenting on themselves in order to optimize their bodies – are paving the way for the use of new substances and approaches. Thanks to them, peptides (short chains of amino acids that affect regeneration, sleep, muscle building), compounds supporting longevity (such as nicotinamide mononucleotide – NMN, nicotinamide riboside – NR, considered NAD+ precursors that delay cellular aging) are now available in the common supplement offer.), or senolytics (substances that are supposed to eliminate so-called zombie cells in the body). For now, many of these products are niche or sold as “research only” to bypass regulations, but growing interest may force the creation of safe supplement versions. We also see the integration of supplementation with health tracking techniques: apps or devices may suggest increasing the dose of magnesium when our sleep is poor quality, or replenishing electrolytes after an intense workout, based on data from sensors. Perhaps the future lies in smart supplements – e.g. a capsule with a sensor that recognizes the level of a substance in the blood and doses it accordingly (this is more of a science fiction vision, but technology is developing quickly).
The direction of development of supplements will certainly be increasingly linked to personalized medicine and health prevention. Society is aging, so supplements supporting seniors (e.g. for joints, memory) will be in demand, as will products for children or pregnant women (where the highest quality and safety are required). We can also expect further penetration of nutritional trends - for example, the popularity of the keto diet has resulted in supplements with MCT oil and ketones, the fashion for running has increased demand for gels and supplements for runners, etc.
summarizing, the production of dietary supplements is a rapidly developing sector that combines science, rigorous standards and a creative business approach. To produce a dietary supplement that will be successful globally, you need to use advanced technologies to ensure high product quality, meet all legal requirements in the target markets and develop a solid business and marketing plan. At the same time, it is worth keeping your finger on the pulse of trends and innovations, because they often decide which products will win the hearts (and health) of consumers in the coming years. By combining these elements, the production of dietary supplements can be a profitable and rewarding business - contributing to the improvement of health and well-being of people around the world.
