Nutraceutical Business: 9 Laws & Practices to Keep In Mind

The nutraceutical industry is growing at an unprecedented rate that it takes more than just a revolutionary product to survive in such a competitive marketplace. In fact, the most successful nutraceutical businesses incorporate these five best practices that help meet their needs, keep their consumers satisfied and mitigate risks:

1. Proper formula management

At the core of every successful nutraceutical business is product consistency and you can only guarantee this if you have proper formula management within your system.

Since the government heavily regulates nutraceutical businesses, it would help to keep a record of all the ingredients and formulas used in your products including property calculations, quality control results, manufacturing instructions and revisions.

You should also keep a record of overhead, material and labor expenses for easy calculations of manufacturing costs.

Due to the sector they have, these dietary supplements are cautiously regulated regarding the classification of advertised products. The FD&C Act has strict control on the classification and definition of all items covered by the Act, which were legally added as a classification by the FDA.

2. Good manufacturing

With the Dietary Supplement Health and Education Act of 1994 amending the FD&C Act for the nutraceutical manufacturing sector, you need to follow specific guidelines in the production of your nutraceutical products.

This includes proper quality control, sanitation, processing and storage. You have to implement good manufacturing practices consistently if you want to keep consumers satisfied and your cash flow going.

The DSHEA – Dietary Supplement Health and Education Act amended the FD&C Act to form CGMP- Current Good Manufacturing Practices for the nutraceutical businesses. The DS CGMP provides clear instructions for all the processes involved in the manufacturing and production of all nutraceutical items. These guidelines include hygiene standards for processing and storage, implementation of process control systems to make sure reliable quality.

3. Regulatory compliance

Aside from following good manufacturing practices, it’s also very important to adhere to other industry regulations and comply with the latest requirements stipulated by the government for nutraceutical businesses. This will help you avoid violations and issues from payment processors later on, which could cause serious problems in your business. Use a tool to keep tabs on FDA audits, cGMP requirements, electronic signatures and software validation.

4. Proper classification and labeling

Nutraceutical products are carefully regulated where the FD&C keeps a watchful eye on the definitions of product categories. This means that you have to properly identify all the ingredients and formulations used in your product to avoid wrong categorization.

You also need to ensure proper product labeling, which is the most important regulatory requirement for nutraceutical businesses. Make sure that your label contains all the information that’s consistent with your claims.

It’s also very important to learn about different labeling rules as indicated by the FDA, especially with particular ingredients and their recommended volumes.

Maintaining precise product labelling is also a vital regulatory obligation of nutraceutical businesses in indicating compliance with FDA regulations. Usually, manufacturers promote these dietary supplements for their benefits, so they should also reflect and prove this in the labelling of the package labelling.

5. Continued research and development

If you’re going to be competitive in the nutraceutical market, you have to invest in continuous product development where you could come up with new formulations or make adjustments to cater to any consumer trends. R&D should be given its specific area in your facility where specialists could create, test and regulate new products without affecting your current production.

Once these new products are approved for manufacturing, you can then transition them into your production floor without causing a disruption in your operations.

6. Corrective and Preventive Action

Part of process control systems in nutraceutical businesses involves making and implementing correct and protective procedures. These protective procedures are among the best practices in multiple manufacturing units. Therefore, all Nutraceutical businesses are part and should adhere to CAPA procedures

7. Tracking and Traceability

DS CGMP also states that all nutraceutical businesses should have the ability to trace products by the lot, and can go deeper if required. This is usually done by assigning a unique identifier to the packing that makes it traceable. In this regard, no specific identifier is imposed by the FDA. Though, item serialization is the acceptable and best practice that ensures compliance.

8. Record keeping

FDA also states that all the nutraceutical businesses or manufacturers must maintain records of the production and process that they implement, including those implemented to maintain compliance. Proper documentation is a must for raw materials, equipment inspections, and quality control procedures.

9. Notification Process

Nutraceutical businesses and makers must submit notifications for products containing any new ingredients 75 days before that item goes for distribution. They must also mention all the information which states that a particular added ingredient is safe for consumption.

The Bottomline

Although the nutraceutical industry is highly competitive and strictly regulated by the government, these five best practices will surely help you gain that advantage over your competition. After all, this market isn’t only about innovation but also in consistent practices that keep you going no matter what the demand is.

Finding a nutraceutical business merchant account is just a step in the process.