At a Glance
- The FDA requires all dietary supplement manufacturers to comply with current Good Manufacturing Practices (cGMPs) under 21 CFR Part 111, with both contract manufacturers and brand owners sharing responsibility for compliance.
- Warning letters continue to be issued to supplement companies for basic cGMP violations, making manufacturer selection and ongoing audits critical for brand protection.
- Key qualifications to evaluate include FDA registration status, third-party certifications such as NSF and USP, inspection history, testing protocols, and quality agreement documentation.
- Brands that fail to properly vet their contract manufacturing partners risk product recalls, regulatory action, and lasting damage to consumer trust.
One of the most persistent myths in the dietary supplement industry is that it operates without oversight. In reality, supplement manufacturers must adhere to a comprehensive framework of federal regulations designed to ensure product safety, identity, purity, strength, and composition. For brands working with contract manufacturers to bring products to market, understanding these requirements is not optional. It is essential for protecting both consumers and the long-term viability of the business. Sawgrass Nutra and other established contract manufacturers invest heavily in compliance infrastructure, but the responsibility for selecting a qualified partner ultimately falls on the brand owner.
The regulatory foundation for dietary supplement manufacturing was established by the Dietary Supplement Health and Education Act of 1994, commonly known as DSHEA. This legislation created a distinct regulatory category for supplements and outlined the responsibilities of manufacturers and distributors. In 2007, the FDA published detailed current Good Manufacturing Practice regulations under 21 CFR Part 111, providing extensive requirements for controls, records, and testing throughout the manufacturing process. “Compliance is not something that happens by accident,” said Scott Teagle, CEO of Sawgrass Powder Manufacturing. “It requires deliberate investment in facilities, equipment, personnel, and systems. When brands evaluate potential manufacturing partners, they need to look beyond price and lead times to understand the quality infrastructure that supports every batch of product.”
Shared Responsibility Under the Law
A critical point that many emerging supplement brands overlook is that cGMP compliance is not solely the contract manufacturer’s responsibility. The FDA has made this clear through numerous warning letters issued to own-label distributors, stating that firms which introduce dietary supplements into interstate commerce have “an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement cGMP requirements.”
According to guidance published by the FDA, manufacturers and distributors of dietary supplements are prohibited from marketing products that are adulterated or misbranded. This means brand owners must have substantiation that any claims made on product labels are truthful and not misleading. It also means they must verify that their contract manufacturer is following proper procedures for ingredient testing, batch records, equipment calibration, sanitation, and dozens of other operational requirements.
This shared responsibility model has practical implications for how brands should approach manufacturer selection. Rather than simply placing an order and waiting for finished goods to arrive, brand owners should establish quality agreements that clearly define roles and responsibilities. They should conduct initial and ongoing audits of manufacturing facilities. And they should maintain documentation demonstrating their oversight of the production process.
What to Look for in a Contract Manufacturer
When evaluating potential manufacturing partners, brands should begin with basic due diligence on regulatory standing. Is the facility registered with the FDA? What is its inspection history? Have any warning letters or Form 483 observations been issued, and if so, how were they resolved? This information provides a baseline understanding of the manufacturer’s compliance track record.
Third-party certifications offer additional assurance of quality systems. Certifications from organizations like NSF International and the United States Pharmacopeia indicate that a facility has been audited against recognized standards and found to meet specific requirements for Good Manufacturing Practices. Some manufacturers also hold FSSC 22000 certification for food safety, which represents a globally recognized standard in the food and supplement industry. While certifications are not a guarantee of perfect compliance, they demonstrate a commitment to continuous improvement and external accountability.
Testing protocols represent another critical evaluation area. A qualified contract manufacturer should conduct identity testing on all incoming ingredients to verify that raw materials match what is stated on the certificate of analysis. Potency testing confirms that active ingredients are present at label claim levels. Microbiological testing screens for harmful bacteria, yeast, and mold. Heavy metal testing checks for contaminants like lead, arsenic, cadmium, and mercury that can pose health risks even at low levels.
“Testing is where many manufacturers cut corners, and it is where problems often emerge,” said Alan Ragatz, VP of Sales at Sawgrass Nutra Labs. “We test every batch of raw materials and finished products because that is what the regulations require and what our brand partners expect. When you skip testing or rely solely on supplier certificates of analysis, you are taking a gamble with product quality and consumer safety.”
The Audit Process
Conducting an on-site audit of a potential contract manufacturer is one of the most effective ways to evaluate compliance and operational capability. During an audit, brand representatives can observe production processes, review documentation systems, interview quality personnel, and assess the overall culture of the organization. A facility that welcomes audits and responds transparently to questions is generally a better partner than one that creates barriers to access.
Key areas to examine during an audit include receiving and warehousing procedures for raw materials, production area cleanliness and organization, equipment maintenance and calibration records, batch production records and deviation handling, laboratory capabilities and testing documentation, and personnel training programs. The goal is to verify that written procedures exist for all critical operations and that those procedures are actually being followed on the production floor.
For brands that lack the internal expertise to conduct thorough audits, third-party audit services are available. These services employ experienced professionals who can evaluate facilities against cGMP requirements and provide detailed reports on findings. Some brands also require their contract manufacturers to participate in certification programs that include regular third-party audits as a condition of maintaining certification.
Documentation and Quality Agreements
The relationship between a brand and its contract manufacturer should be formalized through a written quality agreement. This document defines the responsibilities of each party for various aspects of production, testing, release, and complaint handling. It should address topics such as raw material specifications, in-process controls, finished product testing, stability studies, change control procedures, deviation and investigation protocols, and communication requirements.
A well-drafted quality agreement protects both parties by establishing clear expectations and accountability. It also provides documentation that can be presented to regulators if questions arise about the brand’s oversight of its manufacturing partner. According to FDA guidance on contract manufacturing arrangements, quality agreements should allow brand owners to evaluate and audit contract facilities to ensure cGMP compliance for specific operations.
Beyond the quality agreement, brands should maintain records of all communications with their contract manufacturer regarding product specifications, test results, deviations, and corrective actions. This documentation creates an audit trail demonstrating active engagement in quality oversight rather than passive reliance on the manufacturer.
New Dietary Ingredients and Label Compliance
Contract manufacturers have responsibilities that extend beyond production quality. They must also ensure that products do not contain new dietary ingredients that have not been properly notified to the FDA and that labels do not include claims that would cause the product to be classified as an unapproved new drug.
The new dietary ingredient notification process requires manufacturers to submit safety information to the FDA at least 75 days before marketing a supplement containing an ingredient that was not sold in the United States before October 15, 1994. Failure to comply with this requirement can result in the product being deemed adulterated.
Label compliance is equally important. Structure and function claims, which describe how an ingredient affects the body’s structure or function, are permitted on supplement labels but must be truthful, not misleading, and substantiated by competent and reliable scientific evidence. Disease claims, which suggest that a product can diagnose, treat, cure, or prevent disease, are not permitted and can cause a supplement to be regulated as an unapproved drug.
Building a Long-Term Partnership
Selecting a contract manufacturer is not a one-time decision but the beginning of an ongoing relationship that requires attention and maintenance. Market conditions change, regulatory requirements evolve, and production needs fluctuate. The best manufacturing partnerships are built on open communication, mutual respect, and shared commitment to quality.
Brands that invest time in proper manufacturer selection and ongoing oversight position themselves for sustainable growth. Those that take shortcuts may find themselves facing regulatory action, product recalls, or consumer complaints that damage their reputation. In an industry where trust is paramount, compliance is not just a legal obligation. It is a competitive advantage.
