What Are cGMPs for Dietary Supplements?

Direct answer

Current Good Manufacturing Practices (cGMP) for dietary supplements are the FDA regulations at 21 CFR Part 111. They apply to anyone who manufactures, packages, or labels a dietary supplement. Their holding requirements also apply, except to holding at a retail establishment for direct sale to individual consumers (21 CFR 111.1). The “c” stands for “current.” The rule covers personnel, the physical plant, equipment, production and process controls, quality control, and records.

FDA does not approve manufacturing facilities. In the words of FDA's consumer guidance on what the agency approves, it “does not approve manufacturing facilities independently” and inspects them for compliance with current good manufacturing practices. FDA registers facilities under the Food Facility Registration program, an investigator can issue a Form 483 listing observed conditions at the end of an inspection, and FDA issues Warning Letters for what it believes are significant violations. For dietary supplements, FDA's export certification FAQ states that FDA “does not issue any certification to indicate CGMP compliance at the conclusion of or at any time after those inspections.”

Third-party organizations (NSF, NPA, USP) operate separate GMP certification and verification programs with their own audits and certificates. Those programs are private-sector, not “FDA certification.”

Three separate cGMP frameworks

Understanding which cGMP applies to your product prevents common confusion.

A manufacturer claiming “cGMP compliant” without specifying which cGMP is either confusingly broad or produces across categories. Ask which rule applies to their work on your specific product.

What 21 CFR Part 111 covers

Part 111 is organized by Subparts, each covering a specific area of supplement manufacturing. Read the current text on eCFR rather than relying on a third-party summary.

• Subpart A (General provisions): who is subject to the rule, and its definitions. The holding requirements do not apply to holding supplements at a retail establishment for direct sale to individual consumers (21 CFR 111.1(b)).
• Subpart B (Personnel): hygienic practices, personnel qualifications, and supervision.
• Subpart C (Physical plant and grounds): sanitation, including pest control, water supply, and plumbing (21 CFR 111.15), and the plant's design and construction.
• Subpart D (Equipment and utensils): equipment design, calibration of instruments and controls, and maintaining, cleaning, and sanitizing contact surfaces (21 CFR 111.27).
• Subpart E (Production and process control system): a system of production and process controls covering all stages from manufacturing through holding (21 CFR 111.55). Before using a component, you must “conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing” (21 CFR 111.75(a)(1)(i)). Other components can be confirmed by testing or, under set conditions, by a qualified supplier's certificate of analysis (21 CFR 111.75(a)(2)). Subpart E also covers in-process monitoring and verification that finished batches meet specifications (21 CFR 111.75(b) and (c)). Subparts H through K add the master manufacturing record, the batch production record, and laboratory and manufacturing operations.
• Subpart F (Quality control): quality control personnel approve or reject the processes, specifications, and tests that may affect the dietary supplement (21 CFR 111.105(a)), and approve and release, or reject, each finished batch for distribution (21 CFR 111.123(a)(8)).
• Subpart L (Packaging and labeling operations): requirements for packaging and labels, packaging and labeling operations, and repackaging and relabeling. (The incoming components, packaging, and labels you receive are governed upstream by Subpart G.)
• Subpart M (Holding and distributing): holding materials and reserve samples, and distributing dietary supplements.
• Subpart N (Returned dietary supplements): receiving returns and deciding whether a returned supplement is destroyed, salvaged, or reprocessed.
• Subpart O (Product complaints): review and investigation of product complaints, with quality control personnel approving whether to investigate (21 CFR 111.560).
• Subpart P (Records and recordkeeping): retention, record format, and FDA access. Under 21 CFR 111.605, written records required by Part 111 are kept for one year past the shelf life date, if shelf life dating is used, or two years beyond the date of distribution of the last batch associated with those records.

How to verify a manufacturer's cGMP status

1. FDA Food Facility Registration

Facilities that manufacture, pack, or hold dietary supplements for consumption in the United States must register with FDA (21 CFR 1.225) unless an exemption in 21 CFR 1.226 applies, through the Food Facility Registration program. Ask for the facility's registration number and confirm registration is current. Registration is not FDA approval: FDA says that although manufacturing facilities are frequently required to register, the agency “does not approve manufacturing facilities independently.”

2. Third-party GMP certification

Several non-governmental organizations operate supplement-GMP audit and certification programs:

• NSF/ANSI 455-2 dietary supplement GMP certification. A GMP standard for dietary supplements; NSF offers audits and certification to it for facilities that manufacture, package, or warehouse and distribute dietary supplements. Certification is to the standard, and an accredited certification body performs the audit, so check the certifying body's accreditation and the facility's own listing separately. NSF lists certified facilities at info.nsf.org and requires at least an annual audit to maintain certification. NSF also offers separate GMP registration services “for manufacturers and packagers of dietary ingredients and nutritional supplements sold in the Chinese market, as well as for distribution and warehousing companies.”
• Natural Products Association (NPA). NPA, a trade association, operates the NPA GMP Certification Program. Since January 2015 its program with UL has used the NPA GMP standard with audits conducted by UL. NPA publishes a list of GMP certified companies.
• U.S. Pharmacopeia (USP) Verification. A product-level verification program for finished dietary supplements. The USP Verified Mark requires a manufacturing facility audit against 21 CFR Part 111 and USP's own manufacturing-practices chapter, a review of quality control and manufacturing documentation, and laboratory testing of product samples.

Ask for current certificates with expiration dates.

Checking the registry matters. In Inventory Ready's certification verification gap study, 56.6% of 747 certification claims published by the 381 active companies in the Inventory Ready directory cite credential types with no public registry where anyone can check them.

3. FDA Warning Letter history

Search the FDA Warning Letters database by facility name. A Warning Letter in the past two years warrants scrutiny: what did FDA cite, what remediation did the facility commit to, and what evidence do they have that the remediation is complete.

4. FDA inspection observations

FDA issues a Form 483 at the conclusion of an inspection when an investigator has observed conditions that may constitute violations. FDA says a Form 483 is not a final agency determination; the agency weighs it with other evidence and decides what further action, if any, is appropriate. See FDA's inspection observations page for the framework. Ask the manufacturer for its recent Form 483s and its written responses to them.

5. On-site audit (for significant orders)

For larger orders or long-term supply relationships, commission an on-site facility audit by a qualified third-party firm. Amazon's US dietary supplements policy, for example, lists GMP programs from NSF, Eurofins, UL, USP, and SGS among the third-party programs it accepts. Request quotes directly from the audit firm for current pricing.

Common cGMP claim mistakes

“FDA-certified cGMP compliant” or “GMP certified by FDA.” FDA does not approve manufacturing facilities, and for dietary supplements it says it issues no certification to indicate cGMP compliance, so this wording is factually wrong and potentially deceptive. A supportable version: “FDA-registered facility, produced under 21 CFR Part 111 cGMP.”

“GMP-certified” without naming the certifier, or a certifier's logo without active certification. If the certifier is NSF, reference the specific standard. For a supplement manufacturer that is “NSF/ANSI 455-2 certified.” If USP, write “USP Verified.” If there is no third-party certifier, write “operated under cGMP” without implying certification. Marks follow each certifier's own rules: NSF describes NSF/ANSI 455 as a process certification and does not allow its GMP mark or logo on finished products, labels, or packaging, while the USP Verified Mark comes only through USP's verification program.

Claiming pharmaceutical-grade cGMP on supplement products. Pharmaceutical cGMP (21 CFR Parts 210/211) is a different rule from supplement cGMP (21 CFR Part 111); for example, it requires a quality control unit with authority to approve or reject all components and drug products (21 CFR 211.22(a)). Ask which rule the facility actually works under for your product.

Red flags in manufacturer claims

• “Passed FDA inspection last quarter” without documentation. An inspection without issued 483 observations is plausible, but the burden is on the manufacturer to show specific documentation.
• “Our facility is cGMP compliant” without specifying which cGMP. Ask: 21 CFR Part 111, 21 CFR Part 117, or 21 CFR Parts 210/211? If they cannot answer, they do not fully understand which rule applies.
• No one identified as responsible for quality control. Part 111 requires you to identify who is responsible for quality control operations, and those people must have “distinct and separate responsibilities” when performing them (21 CFR 111.12(b)); quality control personnel approve and release, or reject, each finished batch (21 CFR 111.123(a)(8)). That can be one designated person, or someone outside your organization (21 CFR 111.3). FDA's compliance guide says the people you identify may also perform other functions, such as production, and recommends that, whenever practical, a different person check the operation under review. A separate quality unit is the drug rule (21 CFR 211.22(a)), not Part 111. If a facility cannot tell you who holds that authority, it cannot support a cGMP-compliance claim.

Frequently asked questions