Dietary Supplements & Quality Management

Develop, manufacture and market in a legally compliant manner

The market for dietary supplements is growing dynamically – at the same time, regulatory requirements are constantly increasing. Manufacturers of dietary supplements now operate in a complex environment encompassing food law, product safety, hygiene, advertising law, and quality management. Therefore, sound training on dietary supplements and robust quality management are essential for developing, manufacturing, and marketing products in compliance with the law.

This article provides a structured, practical overview: What are food supplements in a legal sense? Which laws apply to food supplements? What types of products are there? Which quality management systems are suitable for food supplement manufacturers – and which aspects are scrutinized most critically in audits and regulatory inspections?

What are dietary supplements?

In Germany, food supplements are legally considered Food – not as medicines. They serve the Supplement to general nutrition and contain nutrients such as Vitamins or minerals as well as other substances with nutritional or physiological effects, such as plant extracts or amino acids. Food supplements are marketed in dosed form, for example as capsules, tablets, powder portions, ampoules or drops.

The legal basis is the Food Supplements Regulation (NemV). In practice, the distinction between food products and medicinal products is particularly critical. Packaging, dosage, intended purpose, and advertising claims determine whether a product is still considered a food product or classified as a medicinal product. This is precisely where complaints from authorities or cease-and-desist letters under competition law frequently arise – a central issue in every Training on dietary supplements.

Our training offers for quality management of dietary supplements:

Practice Training LMS This addresses this need and offers specially developed training courses for manufacturers of dietary supplements to overcome current challenges and optimize processes:

HACCP Officer Training

Learn how to make your HACCP system efficient and optimize risk analysis. Use our preventive program templates to save time.

Food Safety Culture Training

Learn how to integrate legal requirements and standards such as FSSC or IFS into your corporate culture.

Internal Auditor Training

Improve your audit skills, learn the requirements of DIN 19011 and implement professional test plans.

Training Declarations of Conformity

Gain comprehensive knowledge of legal requirements for raw materials and packaging to ensure compliance with all standards.

Your advantages with practical training LMS

Practical content: Our training courses provide theoretical knowledge combined with practical examples that you can apply directly.
Experienced experts: Our trainers bring decades of experience in the areas of food safety, microbiology and quality management.
Flexibility: Choose between live online training, tailor-made courses or in-house training – tailored to your needs.
Certificate: After completing the training, you will receive a certificate confirming your competence in quality management.

What laws apply to food supplements?

The law governing food supplements is not based on a single regulation, but on several interlocking sets of rules.

General Food Law

These regulations apply to all foodstuffs and therefore also to food supplements:

Regulation (EC) 178/2002 – General principles of food law, responsibility of the food business operator, traceability, recall obligations
Regulation (EC) 852/2004 – Food hygiene, PRPs and HACCP principles
Regulation (EU) 1169/2011 (LMIV) – Labelling, mandatory information, allergen and nutritional labelling
LFGB – national framework law for foodstuffs in Germany

Specific law for food supplements

Directive 2002/46/EC – EU basis for food supplements
NemV – national implementation, regulations on approved vitamins, minerals, labelling and notification

Advertising and claims

Directive 2002/46/EC – EU basis for food supplements
NemV – national implementation, regulations on approved vitamins, minerals, labelling and notification

Other relevant legal areas

Depending on the product and recipe, the following may also apply:

Novel Food Regulation (EU) 2015/2283
Additives law (Regulation (EC) 1333/2008)
Contaminant law (Regulation (EU) 2023/915)

Types of food supplements and quality management risks

Dietary supplements can be usefully differentiated according to active ingredient groups, dosage forms and risk profiles.

Typical groups of active ingredients

Vitamins and minerals
Amino acids, proteins and collagen
Fatty acids and oils (e.g. Omega-3)
Botanicals and plant extracts
Probiotics and prebiotics
Complex products („Immune“, „Beauty“, „Sleep“)

Dosage forms

Capsules, tablets, softgels
Powders and portion sticks
Liquid forms (shots, drops)
Gummies and chewy candies

From the perspective of quality management for food supplements, the risk increases particularly with complex formulations, botanical raw materials, sensitive active ingredients, liquid products and strongly claim-driven concepts.

Book your training for quality management of dietary supplements now!

With the training courses from Praxistrainings-LMS you get the expertise and tools to produce your products reliably and in compliance with the law. Contact us today to learn more about our training courses or book your course directly for sustainable quality improvement!

Quality management for food supplements: suitable systems

A functioning quality management system for food supplements is a prerequisite for legal certainty, audits and stable processes.

HACCP as a mandatory system

HACCP is mandatory based on Regulation (EC) 852/2004. Hazard analyses, control measures, verification and documentation form the foundation.

ISO 22000 / FSSC 22000

These standards combine HACCP with management systems and are widely used by industrial manufacturers.

IFS Food and BRCGS

Relevant for retail, private label, and international distribution. Strongly audit- and process-oriented.

ISO 9001

Useful as a supplement to the structured mapping of processes, complaints, training and continuous improvement.

Typical sources of error with dietary supplements

Marketing claims without legal review
Inadequate raw material specifications in botanicals
Changes without change control
Packaging compliance only "on paper"„
Lack of stability and durability concepts

These points are classic topics covered in a practical training course on dietary supplements.

Nutritional Supplement Training: In-house training for manufacturers

We support manufacturers of dietary supplements with practical in-house training courses – online or on-site. The aim is to convey legal requirements, the law on food supplements, and effective quality management for food supplements in a clear and practical way.

Our customers trust in practical training LMS

Practical training LMS is highly recommended

Rated 5 out of 5

FOOD SAFETY CULTURE TRAINING
Very well organized and conducted training with lots of practical relevance. The exchange was very enriching and my expectations were met. Big praise also goes to the speakers who moderated the training brilliantly.

TRAINING FSSC CHANGES VERSION 6
Very well organized and conducted training with lots of practical relevance. The exchange was very enriching and my expectations were met. Big praise also goes to the speakers who moderated the training brilliantly.

TRAINING UNDERSTANDING DECLARATION OF CONFORMITY
The training is practical and conveys all the important content on the subject of declaration of conformity. What I particularly liked is that the training is also suitable for beginners. You are well introduced to the topic so that you can quickly follow and understand the deeper and more complex content. All questions are answered in detail and directly during the training.

HACCP TRAINING FOR EXPERTS
Ms. Ziegler is a very experienced and friendly trainer. Your professional career is impressive. In the run-up to the training, she looked at my HACCP concept and gave me specific feedback and many valuable tips for implementation. In summary, the training was very successful for me and I recommend it at any time.

Frequently asked questions about quality management training for dietary supplements:

Are dietary supplements food or medicine?

In practice, for example: Regulation (EC) 178/2002, Regulation (EC) 852/2004, Food Information Regulation 1169/2011, Food Supplements Regulation, Health Protection Regulation 1924/2006 – plus Novel Food, food additive law and contaminant law depending on the product.

Which laws are most important for NEM (food additives)?

Which quality management certifications are common for NEM manufacturers?

HACCP-based, ISO 22000/FSSC 22000, IFS Food or BRCGS – supplemented by ISO 9001 depending on the business model and customer requirements.

Does packaging really play a big role in nutritional supplements?

Yes – especially for oils, fat-soluble vitamins, sensitive active ingredients, or high barrier requirements. The legal basis includes, among others, Regulation (EC) 1935/2004 and – for plastics – Regulation (EU) 10/2011.

What offers do you offer?

Practical training LMS offers the following offers:

Specialist and management training on food safety topics. As live online training or in-house.
E-learning for employees, for example for follow-up instructions IfSG § 42, 43, food hygiene, LMHV § 4, allergens and occupational safety

What differentiates practical training LMS from other providers?

With practical training LMS the focus is on practicality and interaction. Our training courses are therefore carried out exclusively by experts in your field. Our group sizes are limited to allow for exchange and questions. Modern moderation options help us with this.

What training content do you offer?

We offer training on current and well-known topics in the field of food safety. You can find all training courses here.

Our most popular training courses include:

Understand the declaration of conformity
Internal Auditor
Standard updates, e.g. IFS and FSSC
food safety culture
LukeSG
food fraud
food defence