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.

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We just completed a very large Homeopathic tablet order that required involvement from 4 different facilities. There was nobody else in the country that was willing to help us that we called until we found superior. First shipment came last week and we couldn’t be happier or more impressed with the team. Thank you Justine, Phil, Stephenie you are the best!

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I was choosing between two companies to create a formulation, and it came down to their level of service, expertise and confidence in their ability to execute. After speaking to Phil, their lead guy who knows all things supplements and is very easy to communicate with, was enthusiastic and helped to create a strategy to see my vision through. The last thing you want is a transactional relationship in this industry, so whether you’re a first timer or a veteran, these guys know how to add value no matter what level you’re at. Highly recommend Superior and their team to get the job done.
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When they say “Superior” they aren’t kidding. Of over 100 companies on our NSF list that we called, and over 20 that we talked to, Superior was the ONLY one that consistently answered their phones, worked incredibly diligently to problem solve and R&D an incredibly complex patented proprietary product, and consistently was two or three steps ahead of us, the landscape and their competitors. Looking forward to a long relationship Superior!
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We’ve been using Superior for over 5 years. We came to them because our last manufacturer stopped making the capsule size I needed. I looked everywhere for a replacement. Luckily, I found Superior. They quoted me a fair price and sourced a hard to find ingredient quickly. In the 5 years we’ve had them make our product, which is a custom formulation, they have never delivered late once. Quality control is very high and I get constant updates from Phil our point person while it is being manufactured. I cannot recommend them enough.
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Our previous manufacturer was 3 months late on a production and barely spoke with us. We have run many runs with Superior and as with all manufacturing, there was an order that was a little late because of poor crop growth. Not only did they warn us ahead of time they showed us the list of suppliers they were calling day and night to try to find replacement material. Best company ever!
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Jake, Justine and Phil are just a few of the team members we have had the pleasure of working with at Superior. As a marketing agency working in the supplement industry, we work with many suppliers on behalf of our clients. I especially appreciate Superior Supplements Manufacturing because of their dedication to customer relationships. They go to extreme measures to ensure quality ingredients, fair pricing and great turn around times. The staff is also extremely knowledgeable. I would highly recommend this team.