From Testing Confusion to Compliance Confidence: How Our Experts Help Supplement Manufacturers Meet cGMP Standards
Compliance is the backbone of a successful operation in the dietary supplement industry. The rules are becoming more complex, the expectations are rising from retailers and consumers alike, and many small manufacturers are struggling to keep up. At cGMP Consulting, our subject matter experts (SMEs) bridge this gap, helping clients understand and apply dietary supplement regulations like 21 CFR Part 111 with clarity and confidence, and respond to and remedy regulatory actions.
From Confusion to Compliance: Critical Quality Attributes under 21 CFR Part 111
One common challenge we see with our dietary supplement clients? A lack of understanding around test methods and specifications—specifically, how to ensure identity, purity, strength, and composition of the finished product. A recent client came to us unsure of how to properly test their ingredients and final products. They had test methods in place but didn’t know what those methods were telling them.
Our SME explained how High-Performance Liquid Chromatography (HPLC), High-Performance Thin Layer Chromatography (HPTLC), and Fourier Transform Infrared Spectroscopy (FTIR) work—what each method measures, and which is appropriate for different materials. Once the client understood the science, they could make informed decisions. This shift alone elevated their quality program.
The Right Method for the Right Material
This dietary supplement manufacturer used HPTLC to test all its materials—botanicals, extracts, and even flavors. While HPTLC is excellent for whole or coarse botanicals, it’s not suitable for extracts or flavor systems. Our SME identified the mismatch and recommended switching to HPLC for extracts and FTIR for flavors.
This wasn’t just an internal fix. Our SME spearheaded the development of a technical report and submitted it to the FDA to justify the method changes. The FDA accepted the update, and the client avoided rework, delays, and the risk of noncompliance. These changes, along with supporting communication, justification, and data to the FDA were the boost this client needed to move forward.
The Limitation Hurting Small Manufacturers
A recurring issue in this industry is a lack of expertise in this area. Many small supplement manufacturers don’t have the time, resources, or staff knowledge to understand what they need to test—or how to test it. This leads to incorrect or incomplete data, and in many cases, regulatory trouble.
Our approach is simple: educate first. We make sure clients understand not just what to do, but why it matters. Then we hand off the tools and knowledge they need to carry that work forward. This empowers their team, strengthens their compliance, and reduces long-term risk.
Staying Ahead of the Curve
Regulatory expectations under 21 CFR Part 111 don’t stand still. That’s why staying current is imperative. Our team follows the latest FDA updates through the perspective of numerous clients, participates in industry working groups, and keeps a close eye on shifting standards in cGMP supplement practices. This ongoing learning directly benefits our clients, who often don’t have the time or resources to track these changes themselves.
Bridging Teams, Fills Gaps
In cross-functional settings, our SME usually steps in as the technical expert. But collaboration is tough when internal teams don’t have a strong foundational understanding of dietary supplement regulations. We work to align everyone—QA, QC, R&D, and operations—by grounding the strategy in clear science and real-world application.
Helping Clients Avoid Pitfalls
Most of our clients are operating under pressure—limited budgets and staff, tight timelines, and the need for continued sales and revenue. In many cases, our expertise has helped avoid costly rework and delays. Identifying an incorrect test method before it causes a failed batch or flagging a gap in a specification before an audit can prevent months of costly consequences.
What Clients Don’t See Coming
One thing that consistently surprises clients? How much the industry has changed in the past decade. Many assume they’re operating within compliance, only to find out they’re working with outdated practices. Some have received Form 483 observations from the FDA and have responded with inadequate or incorrect CAPAs or haven’t responded leading to escalation. This is especially common among companies that haven’t updated their understanding of quality attribute testing or cGMP supplement requirements since the industry exploded.
A Growing Industry, A Growing Responsibility
In 2012, the United States dietary supplement industry was worth around $32 billion. Today, it’s approaching $68 billion. That kind of growth attracts major players like Nestlé, Abbott, Cargill to name a few, but also leaves smaller manufacturers scrambling to keep up with GMPs, test methods, and regulatory expectations. The gap is widening, and it’s more imperative than ever to apply smart strategy and expert guidance.
Whether you’re reviewing your specifications, prepping for an FDA or supplier audit, or unsure if your test methods are still compliant, our team is here to help. Contact us to talk through your next step.
