Supplement Manufacturing Regulation Considerations

The most nerve-racking aspect of starting a nutritional supplement company is understanding the various levels of regulation. While you, of course, want to comply with the FDA’s regulations, you may not know how to begin. In an effort to help reduce your stress and improve your confidence, we present … frequently asked questions regarding the regulations that nutritional supplement companies face.

fda vitamin and supplement regulationsWhat are FDA Good Manufacturing Practices?
In 2007, the FDA began implementing and enforcing Good Manufacturing Practices (GMPs). The final stage of that implementation process occurred in 2010 and was the phase that most directly affected small nutritional supplement companies and their manufacturers.

In essence the FDA’s GMPs are a set of good business practices that ensure the safety of the supplement manufacturing process. When the regulations were implemented, many quality manufacturers faced few issues and were able to continue their previous business practices, while others weren’t prepared and faced many issues during the transition. Those that faced issues also caused many setbacks for their customers.

How do FDA regulations affect the marketing of my supplements?
Much money will be funneled into the marketing of your nutritional supplements; after all, this brand image is what will set you apart from competitors. However, before building the company’s marketing image, you must be aware of the FDA’s regulations regarding supplement marketing.

You aren’t allowed to market how your product may affect disease, as this would classify your supplements as drugs rather than as foods. Much care should be put into developing FDA-compliant labels, because even a minor labeling mistake can lead to problems.


Do your research upfront to avoid future supplement regulation headaches.

How do I find a compliant manufacturer?
Ask a lot of questions before selecting a manufacturer for your nutritional supplement company. Ask about whether or not the manufacturer has ever received any FDA non-compliance warnings. Also, ask if the manufacturer is able to provide certificates of analysis with ingredients.

Will regulations affect the supplement ingredients I select?
Never before have you had such vast access to ingredients for creating supplements. However, as you will quickly discover, not all ingredients are created equal. A commitment to selecting only the highest quality of ingredients from a trusted manufacturer will help to ensure you remain FDA compliant now and in the future, and will also help to build consumer confidence in your company. Utilize all available assistance from your manufacturer during the ingredient selection process and conduct research on potential ingredients to ensure the best options are chosen.

While the process of starting a nutritional supplement company may seem daunting, it needn’t be. With a trusted and experienced manufacturer such as Superior Supplement Manufacturing by your side, each step of building your nutritional supplement company is simplified, even the process of becoming FDA compliant.