Dietary Supplement Testing
Importance of dietary supplements
Dietary supplements are foods that serve to supplement one’s diet. These are usually offered in the form of tablets or capsules. In this way, the body can be supplied with additional vitamins or minerals which it does not receive through diet, due to lifestyle or individual diet needs. For example, pregnant women often take folic acid in the form of a dietary supplement. Vegans supplement their diet with vitamin B12, and people who spend little or no time outdoors supplement with vitamin D.
Dietary supplements have become increasingly important in recent years. In Germany, about one in three people consumes dietary supplements. In the USA, it is one in two.
The most popular dietary supplements include magnesium, vitamin C, vitamin B12, calcium and iron supplements. Currently, there is no EU-wide regulation for the maximum amount of vitamins, minerals or other substances with a nutritional effect in food supplements.
Typical ingredients of dietary supplements
Vitamins are among the most commonly used dietary supplements. Adequate vitamin intake is particularly important for a functioning metabolism. Dietary supplements containing the following vitamins are mainly sold:
- Vitamin A
- Vitamin D
- Vitamin E
- Vitamin K
- Vitamin C
- Folic acid
- Pantothenic acid
A mineral is a micronutrient found in plant and animal foods. Minerals perform various functions in metabolism and here the following are sold especially in the form of dietary supplements:
- In the field of sports, creatine is often taken as a dietary supplement to build muscle, because it is an amino acid that provides muscle tissue with energy.
- Another amino acid compound that is often used as a dietary supplement is L-carnitine. It is composed of lysine and methionine and plays an important role in energy metabolism.
- Another popular dietary supplement is coenzyme Q10, which is responsible for the production of energy in the mitochondria.
- Omega-3 fatty acids belong to the unsaturated fatty acids and are often taken as a dietary supplement, especially when consuming little fatty fish, as well as certain vegetable oils.
- Dietary supplements with chondroitin sulfate are often taken by people with osteoarthritis, as this is a substance that is formed in the cartilage cells and is supposed to relieve the symptoms.
Typical analyses of dietary supplements within the U.S. market include, but are not limited to:
- DSHEA compliance review
- Claims reviews
- Ingredient reviews
Legal requirements for dietary supplements
1. Food Information Regulation (FIC)
EU: Regulation (EU) No. 1169/2011 contains the general labeling requirements for all foods and therefore also food supplements. Thus, the mandatory information such as a list of ingredients, the best-before date, the filling quantity and the name of the manufacturer must also be provided. However, the mandatory declaration of nutritional values according to Article 29-35 does not apply to food supplements.
USA: Title 21 CFR 101 Part A contains the general labeling requirements for all foods and therefore also food supplements. Thus, the mandatory information such as the statement of identity (name of the dietary supplement), the net quantity of contents statement (amount of the dietary supplement), the nutrition labeling, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor. However, some elements/requirements listed are specific to food and some are specific to supplements.
2. Directive 2002/46/EC of the European Parliament and of the Council
EU: Directive 2002/46/EC specifies which vitamins and minerals may be used in food supplements. However, according to Article 6 of the regulation, other nutrients such as amino acids, essential fatty acids, dietary fiber, and plant and herbal extracts are also permitted as ingredients. However, these are not yet regulated here.
USA: There are no specific requirements for vitamins, however for additives in general:
- Title 21 CFR 170 covers all regulations for additives used in food and dietary supplements.However, only non-dietary ingredients added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for their intended use.The Food Drug and Cosmetic Act (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).) specifies that any manufacturer wishing to use “new dietary ingredients” (ingredients not in use prior to October 15, 1994) must notify the FDA of such ingredients.
3. Regulation on nutrition and health claims
EU: Regulation (EC) No. 1924/2006 lists the nutrition and health claims that may be made on the packaging of a product under food law. A health claim is a claim that establishes a relationship between a food product and health.
USA: Regulation on nutrition content claims and health claims
- Title 21 CFR 101 Part D & Elists the nutrition content and health claims that may be made on the packaging of a product under food law. A health claim is any claim […] that expressly or by implication […] characterizes the relationship of any substance to a disease or health-related condition.
4. Regulation setting maximum levels for contaminants
EU: Regulation (EC) No. 1881/2006 sets maximum levels for certain contaminants in food. This ensures that food supplements do not contain undesirable concentrations of e.g. heavy metals.
USA: There are no specific regulations regarding maximum amounts, only Good Manufacturing Process Guidelines and Compliance Policy Guidelines (CPGs)
- Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- Dietary Supplement Health and Education Act of 1994 (DSHEA)
Testing of food supplements by Tentamus Group
The laboratories of Tentamus Group are specialized in the analysis of food supplements. We analyze samples for their marketability and other parameters, depending on the customer’s requirements. Our laboratories are your competent partner for the analysis of characteristic ingredients, as well as possible residues and contaminants. We also offer microbiological testing and take over the labeling of your preparations.
Determination of ingredients
Tentamus Group laboratories analyze your dietary supplement for the containing vitamins, minerals, amino acids, etc. This ensures that you comply with the limits and that there is not too little or too much of an ingredient in your product. The maximum amount ensure that too much of a vitamin or mineral will not have a detrimental effect on health and that the beneficial nutritional effect can be achieved.
The international labeling team of the Tentamus Group checks the entirety of all information on your labels or label designs for their conformity with the applicable food law requirements. Included in the testing of the labeling is the testing for health claims. These are scientifically substantiated and only health claims approved in Regulation (EC) 1924/2006 or Title 21 CFR 101 may be used.
Further information can be found here: Tentamus Labelling
The Tentamus Group offers all the microbiological analyses required to verify the safety of your food supplements. Here, the laboratories rely on both conventional methods and novel analytical techniques to determine spoilage agents and pathogens.
For more information, click here: Microbiological testing
Testing for residues and contaminants
Residues are remnants of substances that were used in the manufacture of products and may still be present in the final product. Contaminants can enter a dietary supplement during the individual processing steps, during storage or through contamination from the environment.
Tentamus Group offers comprehensive analysis of your products for residues and contaminants to ensure they do not exceed limits. Among the substances analyzed are:
- Dioxins, PCBs and dioxin-like PCBs
- Crop protection products (over 600)
- Heavy metals
- Mineral oil residues
- Polycyclic aromatic hydrocarbons (PAHs)
- Veterinary drug residues
Have your dietary supplements analytically tested so you can bring safe, high-quality products to market.
Overview of Analytical Laboratories for the Analysis of Dietary Supplements of the Tentamus Group
The following laboratories of the Tentamus Group offer dietary supplement testing:
- Laemmegroup – Moncalieri – www.laemmegroup.it
- Renolab – San Giorgi di Piano – www.renolab-glp.com
- Tentamus Agriparadigma – Ravenna, Signa & Syracusa – www.agriparadigma.it
- BAV INSTITUT – Offenburg – www.bav-institut.de
- bilacon – Berlin und Rheda-Wiedenbrück – www.bilacon.de
- BLS Analytik – Bad Kissingen – www.bls-analytik.de
- QSI – Quality Services International – Bremen – www.qsi-q3.de
- TentaMedix – Karlsruhe – www.tentamedix.com
- Tentamus Greater China – Shanghai, Hainan, Fuzhou, Taipei, Kaohsiung – www.tentamus.com/china/
- Labocor Analitica – Madrid – http://www.labocoranalitica.es
- Laboratorio Control – Madrid – www.laboratoriocontrol.es
- bilacon Labor für Lebensmittel und Hygiene – Rotterdam – https://www.bilacon.de/
- SMS Labs – Wellington – http://www.smslab.co.uk
USA & CANADA:
- Adamson Analytical Laboratories – Corona, CA (USA) – www.adamsonlab.com
- AFL – Grand Prairie, TX – https://afltexas.com
- American Testing Lab – San Diego, CA – www.american-testing.com
- ARL – Lehi & Washington, UT; St. Petersburg, FL – www.analyticalresource.com
- Labofine – Pointe Claire (CAN) – www.labofine.com
- Nova Biologicals – Conroe, TX – www.novatx.com
- QSI America – Corona, CA – www.qsi-america.com
- Tentamus North America – Fredericksburg, VA – www.tentamus.com
Please get in touch with our experts. We’re happy to help: +49 30 206 038 230 / firstname.lastname@example.org