21 CFR 111: Dietary Supplement CGMP for Brands Using a Contract Manufacturer

FDA COMPLIANCE · DIETARY SUPPLEMENTS

Updated November 2026. Most ecommerce supplement brands do not own a factory. They send a formula to a contract manufacturer, receive finished bottles and sell them on Amazon, Shopify, Walmart or TikTok Shop. When FDA inspects that factory, the observations often cite 21 CFR part 111, and the brand still has its own duties. This guide explains who the rule covers, what a brand owner must still do, and how that ties to facility registration and inspections. It is general information, not legal advice.

What is 21 CFR 111?

On June 25, 2007, FDA published the final rule that created 21 CFR part 111, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” The rule and a related identity-testing interim final rule became effective on August 24, 2007, with staggered compliance dates through June 25, 2010, based on company size. FDA’s Small Entity Compliance Guide restates those requirements in plain language.

The rule is organized in subparts that cover personnel, the physical plant, equipment, a production and process control system, quality control, components and labels, the master manufacturing record, the batch production record, laboratory operations, manufacturing, packaging and labeling, holding and distributing, returned products, product complaints, and records.

FDA defines “quality” in 21 CFR 111.3 to mean that the dietary supplement consistently meets the established specifications for identity, purity, strength and composition and limits on contaminants, and that it has been manufactured, packaged, labeled and held under conditions that prevent adulteration under the FD&C Act.

Who has to follow 21 CFR 111?

You are subject to the rule if you manufacture, package, label or hold a dietary supplement, including a foreign firm whose supplement is imported or offered for import into the United States (21 CFR 111.1(a)). You must follow the provisions that apply to the operations you actually perform.

Examples from FDA’s guidance:

• If you label a supplement that another firm manufactured, you still need a batch production record, personnel and plant controls, and holding controls, even though you are not weighing individual components.
• If you are a distributor who buys a packaged and labeled supplement and holds it in a warehouse for shipment to another location, the holding and distributing provisions apply, along with the related personnel and plant requirements.
• A retailer holding supplements at a retail store solely for direct sale to individual consumers is not subject to the holding requirements. That retail exemption does not cover a warehouse or other storage facility.

Ingredient suppliers are a narrower case. A firm that only sells a dietary ingredient to other manufacturers for further processing into a supplement is generally not subject to part 111. It is subject if it sells that ingredient to a firm that simply packages or labels it as a supplement, or if it sells the ingredient directly to consumers.

What does 21 CFR 111 require if you use a contract manufacturer?

Contractors who package, label or otherwise work on a supplement must follow the parts of the rule that cover the operations they perform. The brand does not step out of the rule by signing a contract.

FDA gives three working examples:

1. You manufacture, someone else packages and labels, and you then distribute. You are ultimately responsible for the supplement you release. You must determine whether the packaged and labeled product conforms to applicable specifications (21 CFR 111.127(d)) and you must approve its release (21 CFR 111.127(h)). Even though you did not do the packaging yourself, you have an obligation to know what was done and how, so you can make those decisions.
2. You hire a contractor to perform a task that is still your responsibility, such as calibrating equipment. You remain responsible for complying with the calibration requirements, even though the contractor did the work.
3. You are a distributor who contracts with a manufacturer to make a supplement that you then sell under your own label. You have an obligation to know what and how manufacturing activities are performed so you can decide whether the packaged and labeled product conforms to your established specifications and whether to approve and release it for distribution.

That third example is the usual ecommerce model: your name is on the label, a co-manufacturer makes the batch, and you decide whether it ships. Written quality agreements, access to batch records and test results, and a clear release decision are how most brands meet that obligation. FDA does not prescribe a particular contract form, but it does expect you to be able to make those decisions with knowledge of how the product was made.

What must be in the production and quality system?

The rule requires a production and process control system covering all stages of manufacturing, packaging, labeling and holding. Quality control personnel must review and approve that system. Among the core duties:

• Specifications. You must establish specifications for components, in-process production, labels and packaging, the finished batch, and the finished packaged and labeled product (21 CFR 111.70), and you must determine whether those specifications are met (21 CFR 111.75).
• Identity testing of dietary ingredients. You must conduct at least one appropriate test or examination to verify the identity of each dietary ingredient, unless FDA grants a petition for an alternative (21 CFR 111.75(a)(1)). A supplier’s certificate of analysis is not a substitute for that identity test.
• Other component specifications. For specifications other than the identity of a dietary ingredient, you may test yourself or rely on a qualified supplier’s certificate of analysis. Qualification means you confirm the supplier’s results, keep documentation, reconfirm periodically, and have quality control personnel approve the basis for qualification (21 CFR 111.75(a)(2)).
• Master manufacturing record. You must prepare and follow a written master manufacturing record for each unique formulation and batch size (21 CFR 111.205), including components, weights, theoretical yield, a representative label and written instructions.
• Batch production record. You must prepare a batch production record every time you manufacture a batch (21 CFR 111.255), with complete information on how that batch was produced and controlled.
• Quality control release. Quality control personnel approve or reject processes, specifications, tests and deviations, and they approve or reject the batch for distribution. Their quality control responsibilities must be distinct from their other duties (21 CFR 111.12(b)).
• Reserve samples. You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements you distribute, for one year past the shelf life date if you use one, or two years from the date of distribution of the last associated batch (21 CFR 111.83).
• Complaints and records. You must have written procedures for product complaints related to CGMP and keep the required records.

If a required specification is not met, the finished batch is generally rejected and not packaged or labeled for distribution unless quality control personnel approve a treatment, in-process adjustment or reprocessing, as 21 CFR 111.77 allows. A component that fails its identity specification must be rejected and not used.

The rule does not require you to set an expiration date. If you put a shelf life or “best if used by” date on the label, FDA says you should have data to support it.

How does 21 CFR 111 relate to 21 CFR 117 and facility registration?

Dietary supplements are food under the FD&C Act. Facilities that make, process, pack or hold them for U.S. consumption generally must register with FDA. A facility that is in compliance with 21 CFR part 111 and with serious adverse event reporting is exempt from the hazard analysis, preventive controls and supply-chain program requirements in 21 CFR part 117, subparts C and G (21 CFR 117.5(e)). The facility still follows the CGMP provisions in part 117, subpart B, unless a provision conflicts with part 111, in which case part 111 controls.

Registration of the facility is not the same as following CGMP, and neither one is product approval. Our FDA registration and U.S. Agent guide covers the filing itself. If a new dietary ingredient is involved, see our NDI notification guide.

What happens when FDA inspects a supplement facility?

Investigators can review the procedures, batch records, test results, complaints and reserve samples required by part 111. Observations that may violate the FD&C Act are written on a Form 483. Our FDA Form 483 guide explains the 15-business-day response window, the difference between a 483 and a warning letter, and what to do when a co-manufacturer is the one that receives the form.

If you are the brand, ask for the 483 and the response, check whether your lots are affected, and review whether your own release decisions and records would hold up. If you import components or finished supplements, FSVP duties can sit next to part 111.

How Eva Commerce helps

Eva Commerce does not act as your lawyer or quality consultant and does not write 21 CFR 111 procedures, audit a contract manufacturer or respond to a Form 483 for you. We handle the FDA filings and label work that sit next to CGMP: food and supplement facility registration ($240, renewed every two years), U.S. Agent service for foreign facilities ($250 a year), Prior Notice for imports, and supplement label review ($340 for a basic formatting review, $590 for a full compliance review). Published prices are on our FDA compliance services page.

Because Eva also runs Amazon, Walmart, TikTok Shop and Shopify growth, listing copy can stay consistent with the label and with what your filings actually support. Book a call or call 858-315-2020 to map the filings around your contract-manufactured supplement.

Frequently asked questions

Does 21 CFR 111 apply if I only use a contract manufacturer?

Yes, for the operations you perform. If you distribute a supplement under your own label, FDA says you must know how manufacturing was done so you can decide whether the product meets your specifications and whether to release it. The contract manufacturer must also follow the parts of the rule that cover the work it does.

Is a certificate of analysis enough under 21 CFR 111?

Not for the identity of a dietary ingredient. You must conduct at least one appropriate identity test or examination, unless FDA grants a petition for an alternative. For other component specifications, you may rely on a supplier’s certificate of analysis after you qualify that supplier and quality control personnel approve the documentation.

Does FDA certify supplement GMP or issue a GMP certificate?

No. FDA inspects facilities and can issue a Form 483, but it does not issue GMP certificates. A third-party audit is not a substitute for complying with 21 CFR part 111, and it is not an FDA certification.

Do I still need facility registration if I follow 21 CFR 111?

Registration and CGMP are separate. Facilities that manufacture, process, pack or hold supplements for U.S. consumption generally must register with FDA, and they must also follow the applicable CGMP rules. Registration is not approval of the product or the facility.

How long do I have to keep reserve samples?

FDA requires reserve samples of each lot of packaged and labeled dietary supplements you distribute, held for one year past the shelf life date if you use one, or two years from the date of distribution of the last associated batch.

Can Eva Commerce write my 21 CFR 111 procedures?

No. Eva handles FDA registrations, U.S. Agent service, Prior Notice and label review, and can keep marketplace listings aligned with the label. We do not write CGMP procedures or 483 responses. Book a call or call 858-315-2020.

Sources: FDA, Small Entity Compliance Guide for Dietary Supplement CGMP (21 CFR part 111); eCFR, 21 CFR part 111; FDA, CGMPs for Food and Dietary Supplements; FDA, FSMA FAQs (dietary supplements and 21 CFR 117.5(e)); FDA, Dietary Supplements Guidance Documents and Regulatory Information. General information, not legal advice.

Related Eva guides: FDA compliance services, FDA Form 483 guide, are dietary supplements FDA approved, NDI notification guide, structure/function claims, FDA registration and U.S. Agent guide, FDA registration and Amazon launch for a supplement brand, Certificate of Free Sale and FDA export certificates.