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All You Need to Know About Supplement Manufacturing, the FDA, and Product Labeling

All You Need to Know About Supplement Manufacturing, the FDA, and Product Labeling


Whether you are just starting out in the nutraceutical industry, or you have been around for years, it is always a good idea to refresh with the most up to date information regarding what will help jumpstart or help safeguard the potential success of your supplement business in terms of safety and quality.

We Do the Heavy Lifting

You do not need to commit the below information to memory because as a GMP-compliant company, Makers Nutrition abides by the FDA’s regulations that work to ensure the safety and quality of all the products we manufacture. However, it is important for you to know that if we did not have a compliance department, and did not strive for absolute accuracy, your private label supplement brand could be in jeopardy. This is why we urge you to work with a supplement manufacturing service provider that is equipped to support its claims. You should be able to rely on us to walk the walk and not just talk the talk.

Where does the FDA Stand with Supplements?

Although the bottle may read “These statements have not been evaluated by the Food and Drug Administration…” that does not mean the FDA simply allows whichever kind of vitamin or dietary supplement to be manufactured and sold. At any moment, the FDA can walk into a store or go online, find say, a mislabeled probiotic supplement, and initiate an investigation. This may yield a recall, warning letter, and fines. Supplement brands could be banned, business squashed for good.

Now, think of the money that would have been wasted, the time lost because you manufactured vitamins and supplements with a service provider that did not prioritize FDA registration and GMP compliance. You would not have that experience with Makers! We are 100% FDA registered, compliant with all regulations. We ensure that your supplements are manufactured to meet high-quality standards, up to specification, and void of contaminants.

Label Requirements

What is just as important as what is inside the bottle? What is ON the bottle. By this, I mean the product label. Ingredients listed in the Supplement Facts panel should match exactly what is in your dietary supplements. If there is elderberry powder in your Immune Power product, then elderberry must be in the container. If your label lists gluten free, no artificial sweeteners, and non-GMO, then if tested, the supplement itself should correspond completely. The FDA is no stranger to false and/or misleading labels, so it is crucial that you choose a partner that manufactures supplements to the highest of standards and does not cut corners just to gain your business. While we welcome your custom formulas and will be happy to explain our process to you, we are not afraid to reject a project if it is does align with our health and safety standards. Our goal is to provide superior supplements for brands looking to help their customers as much as possible, which is why accuracy and transparency is key on all fronts. Good for your customers and good for your brand!

Regulations Matter

So, remember, the FDA does not “approve” dietary supplements since it does not approve foods. However, the FDA does indeed monitor supplement manufacturing and labeling, and regularly inspects companies to ensure they are complying with all regulations—not just claiming it on their websites and marketing material. If the FDA finds that a supplement company is not complying with FDA regulations, and, as most things come full circle, the FDA will ban it from selling their product. Don’t be that company.

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Our Response to COVID-19

Our Response to COVID-19

Makers Nutrition would like to take a quick moment to update you all that we are still in full operation and functioning at normal pace at this stressful time as the Department of Homeland Security declares supplement manufacturers an essential service (See Here).

As the outbreak of COVID-19 continues to unfold, we would like to inform you of the measures we have/are taking to ensure the best possible support to our customers, the health and safety of our employees, and the continuity of our business.

Support to our Customers

Meeting the needs of our customers has always been the highest of our priorities. In the uncertain future of what is to come, we are utilizing our great supplier relationships, overstocking commodities to supply our manufacturing demands, and relying on our industry experience to provide the best possible support in this unfortunate circumstance humanity faces.

Health and Safety of our Employees

The health of our employees is what keeps us at peak operating capacity. Makers Nutrition’s facility is an FDA-regulated environment. Our employees have been trained to follow the protocols outlined in our Standard Operating Procedures (SOPs). These procedures cause us to operate in a manner that prevents the spread of any illness that can affect our manufacturing processes. As extra precautionary measures, we have implemented further procedures:

Makers Nutrition plays a major role in our network in providing major retailers (including Amazon) and customers all over the United States for their essential needs such as Nutritional Proteins, Meal Replacements, Multivitamins, Super Greens, Electrolytes, Vitamin C, as well as other supplements to assist and aid consumers’ immune systems’ ability to help eliminate pathogens and recover faster.

We understand the weight of our role and responsibility as a manufacturer. We will do everything in our power in these uncertain times. We will stay optimistic and hope to work through this together. We thank you for all your business and support. Should anything else change in our establishment, we will notify all of our customers and vendors. All of our customer sales executives are available to you 24/7 to help assist you with your needs, so please feel free to reach out as you normally would.

Thank you all

Be safe and be kind to one another

Jason Provenzano
President, CEO

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