Dietary Supplement Testing

Other ingredients

• 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

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: Title 21 CFR 101 Part D & E lists 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)

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.

Label check

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.

Microbiological testing

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.

The following laboratories of the Tentamus Group offer dietary supplement testing:

This could also be of interest to you:

• Analysis

Chemical analyses
Molecular biological analysis
Sensory testing

• Product Categories

Nuts
Oils and fats
Honey
Dietary supplements
Hemp products

• Other Services

Sample logistics
Labeling
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