Nutraceutical Manufacturer’s Regulations


Nutraceutical manufacturers have a unique space between the regulation of consumables and consumer products. The way people plan to use nutraceuticals should be considered a drug. However, the manufacture of food supplements is distinct from pharmaceuticals. For this reason, nutraceutical manufacturers must meet many compliance requirements. Quality control procedures must be followed during manufacturing. Manufacturers of nutraceutical products must follow all the implementations required by the competent bodies with regard to the ingredients used and all procedures. Food supplements have very strict requirements, especially for labeling and classification.

The resulting regulations are intended to help manufacturers deploy complete systems to manage and process the various data collections necessary for compliance. The regulations include:

  • Classification

Due to the sector, dietary supplements are carefully regulated in terms of the final ranking of marketed products. The definitions of each product category are strictly controlled by law. When a product makes claims during marketing, or after adding the ingredients used to create it, ordinary organisms may actually consider it mislabeled as a nutraceutical marketed as a drug, and vice versa.

  • Correct labeling

This is one of the most important regulations that must be respected by the manufacturers of nutraceuticals. Since dietary supplements are generally promoted for the health benefits that consumers can derive from them, they must have labeling indicating these conditions. It is important to indicate if effects may be felt when supplements are consumed beyond a given limit. It is always important that product labeling is informative and accurate.

Regulators also have additional rules for labeling certain factors. This includes special ingredients that have a minimum volume, which is recommended. Some raw materials also have very specific naming rules. This is important because the elements can be confused with others if proper labeling is not done. Nutritional claims must be made following very distinct guidelines.

  • The notifications

Manufacturers of nutraceuticals must send notifications when they create supplements containing new ingredients before they even start dispensing the product. They are also asked to provide all the data they used to determine whether the intended ingredient is actually safe for consumption. These findings are then reviewed to ensure they are accurate and consistent before a decision is made and the product is approved.

  • Good practices during manufacturing

Competent bodies establish what is considered good practice for the nutraceutical industry. These establish very specific guidelines for the production areas of the products. This includes things like sanitation standards and storage areas. This also implies the establishment of appropriate production and processing systems to ensure consistency of batch quality.

It is necessary for the nutraceutical manufacturer to have the best control and production systems. This includes the implementation of protection and correction action procedures. It is also necessary that the supplements can be traced and tracked according to their lot level.

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