Nutraceutical manufacturers have a unique space between consumables regulations and consumer products. How people intend to use the Nutraceutical has to be considered as drugs. However, manufacture of dietary supplements is separate from pharmaceuticals. For this reason, the Nutraceutical manufacturers have many compliance requirements that they have to meet. Quality control procedures need to be adhered to during manufacturing. Nutraceutical manufacturers should keep track of all implementations required by the relevant bodies with regard to the ingredients used and all procedures. Dietary supplements have very strict requirements, especially for labeling and classification.
The regulations that are set out are meant to assist the manufacturers to deploy systems that are comprehensive to manage and process different data collection necessary to be compliant. The regulations include:
Because of the sector, dietary supplements are regulated carefully in terms of ultimate classification of the items marketed. There are strict controls on the definitions of every category of products as covered by the law. When a product makes claims during marketing, or after adding the ingredients used in creating it, the regular bodies can actually rule it as being mislabeled as a Nutraceutical marketed like a drug and vice versa.
- Correct Labeling
This is one of the most important regulations that have to be followed by the Nutraceutical manufacturers. Since the dietary supplements are usually promoted for purposes of the health benefits that consumers can reap from them, they need to have a package labeling that reflects this. It is important to display whether any effects may be felt when the supplements are consumed over a given limit. It is always important the product labeling be informative and precise.
Regulatory bodies also have additional rules for labeling for some factors. This includes particular ingredients that have a minimum volume, which is recommended. There are some raw materials that also have some very specific rules pertaining to the naming. This is important because the items can be confused with others if proper labeling is not done. Nutritional claims need to be done following very distinct guidelines.
Nutraceutical manufacturers need to submit notifications when they create supplements with new ingredients before they even start distributing the product. It is also required of them to give all data, which they used in determining that the intended ingredient is actually safe for consumption. These findings are then reviewed to ensure that they are accurate and consistent before a decision is made and the product approved.
- Good Practices during Manufacture
Relevant bodies establish what is considered good practices for the Nutraceutical industry. These lay out very specific guidelines for the production areas of the products. This includes things like sanitation standards and storage areas. It also involves the implementation of proper production systems and processing to guarantee that the batch quality is consistent.
It is necessary for the Nutraceutical manufacturer to have the best process control and production systems. This includes the implementation of protective and correction action procedures. It is also necessary that the supplements should be able to be traced and tracked according to their lot level.