If you’re a sports nutrition company, the answer is, “yes.” If this is news, you’re not alone.
Recent reviews of Current Good Manufacturing Practices for Dietary Supplements (GMP) inspections suggest sports nutrition companies are still confused about when and how the GMPs apply to their business. The GMPs specify the obligations for categories of dietary supplement operations including manufacturing, packaging, labeling, warehousing, and distributing. The categories provide guidance, but may not lend themselves easily to common sports nutrition business models. This can add to the challenges for companies attempting to fulfill their obligations under detailed, stringent, and at times confusing GMPs.
With this two-part series, I will provide insight into when and how the GMPs apply to your sports nutrition business.
I’m not responsible for good “manufacturing” practices because I don’t “manufacture” my own products.
If it’s your product, it’s your responsibility. The preamble to the final cGMP rule states that companies are responsible for the GMPs for the operations they perform. Yet, some sports nutrition companies may not perform all or any of the regulated operations.
The preamble to the final GMP rule, however, clarifies that companies must not only meet their individual GMP obligations, but they also have a duty to ensure any contractors they use meet their own obligations. A sports nutrition company’s primary duty is to ensure their products are not adulterated. A dietary supplement that is not manufactured, packaged, or labeled in compliance with the GMPs is adulterated. (See 21 CFR 111).
Ultimately, if it’s your product it’s your responsibility to ensure the product delivered to the customer is safe and manufactured in compliance with the GMPs.
Am I a “manufacturer,” “labeler,” “packager,” or “holder”?
The answer to that question matters less than you may think. A company that merely distributes or markets its own label must still understand the relevant obligations, practices, and procedures of all those involved to provide effective oversight to ensure their product is not adulterated.
Sports nutrition companies can utilize nearly infinite combinations of potentially regulated operations and activities to create a finished product. Given the complexity of business practices and the cGMPs, it’s never good practice to assume you’re meeting your GMP obligations.
My manufacturer handles the GMP compliance.
A company can contract out some responsibility for complying with specific requirements under the GMPs; but the label owner retains the ultimate responsibility.
For example, if you formulate a product and source your raw ingredients for your product, you are responsible for the GMP requirements for those operations, as well as ensuring your contract manufacturer is compliant with the GMP requirements and other laws that pertain to your product.
Understanding the dietary supplement GMPs is no easy task. But a sports nutrition company that gets it can take control of all operations in their supply chain to deliver safe products and avoid the pitfalls that land too many sports nutrition companies in the press.
In Part 2, we will explore ways to manage the cGMP responsibilities within the sports nutrition supply chain.