Brand Owner Duties When a Contract Manufacturer Makes Your Supplements

Aaron Lyon

26 minutes ago

8 min read

Most dietary supplement brands in the United States do not own a factory. They develop a formula, choose a contract manufacturer, design a label and sell the finished product online, through retailers or through practitioners. Many of these companies assume that because the contract manufacturer is "GMP certified", the manufacturing rules belong to the manufacturer.

FDA does not see it that way. If your company's name is on the label and you release the product for sale, you are responsible for making sure it meets the dietary supplement good manufacturing practice rule, 21 CFR Part 111. FDA has issued warning letters to own-label distributors who could not show that they had specifications, reviewed batch records, or approved the product before it was sold.

This guide explains what stays with the brand owner, what you can rely on your contract manufacturer to do, and how to document the split so that an FDA investigator, a retailer or an auditor can see it.

Why the brand owner is responsible

21 CFR Part 111 applies to any person who manufactures, packages, labels or holds a dietary supplement. In the preamble to the 2007 final rule (72 FR 34752, June 25, 2007), FDA explained that a firm which contracts out manufacturing but then places the product into commerce under its own name is responsible for ensuring that the product is made in accordance with Part 111. Contracting out an operation does not contract out the responsibility.

Several other parts of the Federal Food, Drug, and Cosmetic Act (FD&C Act) also point to the company named on the label:

Serious adverse event reporting. Under FD&C Act section 761, the "responsible person" is the manufacturer, packer or distributor whose name appears on the label. That company must report serious adverse events to FDA within 15 business days.
Labeling and claims. Misbranding under FD&C Act section 403 is judged on the label and labeling, which the brand owner controls. Structure/function claims must be notified to FDA within 30 days of first marketing (21 CFR 101.93(a)).
Domestic contact information. The label must carry a domestic address or domestic phone number through which serious adverse events can be reported (FD&C Act section 403(y)).
New dietary ingredients. The duty not to market an adulterated product, including one containing a new dietary ingredient without a premarket notification (FD&C Act section 413; 21 CFR 190.6), applies to whoever introduces the product into interstate commerce.

In short, a brand owner is not a passive buyer. It is the company FDA will contact first.

What the brand owner must do under Part 111

The duties below are the ones most often found missing during FDA inspections of own-label distributors. Each one can be performed partly by the contract manufacturer, but the brand owner must have its own written procedure and records showing that it controlled the activity.

1. Set the product specifications

Section 111.70 requires specifications for each component, each point in the process where control is needed, and the finished dietary supplement: identity, purity, strength and composition, plus limits on contaminants. Specifications are also required for packaging, labels and for product received for packaging or labeling.

The brand owner decides what the product is. A finished product specification that exists only in the manufacturer's files, written by the manufacturer, does not show that you defined your product. Approve the specification yourself, and make sure every label claim (for example "500 mg turmeric root extract, standardized to 95% curcuminoids") has a matching specification and a test method.

2. Make sure identity testing is done on every dietary ingredient lot

Section 111.75(a)(1) requires at least one appropriate test or examination to verify the identity of each dietary ingredient before it is used. This is one of the most frequently cited Part 111 sections. Your contract manufacturer will usually perform the test, but you must confirm that it is done, that the method is appropriate for the ingredient, and that the results are part of the batch documentation you review. Our guide to identity testing under 21 CFR 111.75 explains the rule in detail.

3. Approve the master manufacturing record

Sections 111.205 and 111.210 require a master manufacturing record (MMR) for each unique formulation and each batch size. The MMR lists every component and its amount, the theoretical yield, the control points, and the instructions and specifications at each step.

The manufacturer writes it, because the manufacturer knows its equipment. The brand owner should review and approve it, because the MMR is where the formula, overages and finished product specifications are fixed. Any later change to the MMR should come back to you for approval through the quality agreement.

4. Review the batch record and release the product

Section 111.123(a)(4) requires the quality control unit to approve or reject the release of each finished batch for distribution. When the batch leaves the contract manufacturer, it has usually been released by the manufacturer's quality unit for shipment. That release does not replace yours.

Before you sell the batch, your own quality function should review:

the completed batch production record (111.255 and 111.260), including any deviations;
the finished product test results against your specification (111.75(c));
the certificate of analysis supplied with the batch;
the label used and the label reconciliation.

Record your decision. A small brand may have only one or two people in quality, and that is acceptable. What matters is that a qualified person independent of sales makes and documents the decision.

5. Control your labels and claims

Even when the contract manufacturer prints and applies the labels, the content is yours. Each label should be reviewed before printing against 21 CFR 101.36 (the Supplement Facts panel), 21 CFR 101.93 (structure/function claims, the disclaimer and its placement), the allergen declaration and the domestic contact information. Keep the substantiation for each claim on file, and keep the date of each 30-day claim notification.

6. Hold reserve samples, or make sure someone does

Section 111.83 requires reserve samples of each lot of packaged and labeled dietary supplement, held for 1 year past the shelf life date, if dating is used, or for 2 years from the date of distribution of the last batch. The sample must be in the same container-closure system as the product sold. The quality agreement should say who holds them and how you get access.

7. Handle complaints and serious adverse events

Product complaints must be reviewed by a qualified person, investigated where warranted and recorded (111.553 to 111.570). Complaints that involve a health effect may be adverse events. If one is serious, you, as the responsible person on the label, must submit it to FDA within 15 business days. Your contract manufacturer must forward anything it hears about your product to you promptly. One business day is a sensible requirement in the quality agreement.

8. Hold and distribute under control

If you hold inventory in your own warehouse or a third-party logistics warehouse, the holding and distribution rules in Subpart M (111.453 to 111.475) apply to that operation. Products must be held under conditions that protect them against contamination and deterioration, and distribution records must let you trace each lot to its customers. A warehouse that holds food for U.S. consumption also needs food facility registration under 21 CFR Part 1 Subpart H.

9. Manage returns and recalls

Returned dietary supplements must be quarantined until the quality control unit decides what happens to them (111.503 to 111.535). Recalls are run under 21 CFR Part 7 and, for a mandatory recall, FD&C Act section 423. The brand owner leads both, because it owns the customer list.

10. Keep the records

Part 111 records must be kept for 1 year past the shelf life date, if used, or 2 years past distribution of the last batch (111.605). Adverse event records must be kept for 6 years (FD&C Act section 761(e)). Records must be available to FDA for inspection and copying. If key records are held only by your contract manufacturer, the quality agreement must give you access on short notice, because FDA will ask you for them.

What you can rely on the contract manufacturer to do

You do not have to duplicate everything your manufacturer does. A well-qualified contract manufacturer should handle:

the physical plant, equipment, cleaning, pest control and water supply (Subparts C and D);
personnel hygiene and training of its own staff (Subpart B);
receiving, quarantine and testing of components in its plant (Subpart G and 111.75);
manufacturing, packaging and labeling operations (Subparts K and L);
laboratory operations, or management of its contract labs (Subpart J);
its own release from the plant.

What makes reliance acceptable is evidence. Qualify the manufacturer before you place the first order, audit it (on site or by a documented remote audit), and monitor its performance through batch record reviews, complaint trends and periodic confirmation testing of finished product.

Put it in a quality agreement

The single most useful document for a brand owner is a written quality agreement with each contract manufacturer, packager, laboratory and warehouse. FDA investigators routinely ask for it. A good agreement:

lists each Part 111 activity and says who performs it, who approves it and who keeps the record;
names the specifications and the MMR version for each product;
requires notice before any change to the formula, process, site, subcontractor, supplier or test method;
requires adverse events and complaints to be forwarded within one business day;
requires notice of FDA inspections, 483 observations and warning letters that affect your product;
gives you the right to audit and to receive records on request;
prohibits subcontracting without your written approval.

A matrix that sets out "brand owner", "contract manufacturer" and "joint" for each activity makes the agreement easy to read and easy to check during an audit.

A practical starting point

If you are an own-label supplement company without a written quality system, start here:

Write or approve a finished product specification for each product, with test methods.
Put a signed quality agreement in place with your contract manufacturer.
Set up a batch review and release step before product is sold, and record each decision.
Review every label and claim against 21 CFR 101.36 and 101.93, and confirm your 30-day notifications.
Set up a way to receive, assess and report adverse events within 15 business days.
Run a Part 111 gap assessment against your current operation and fix what it finds.

How A.P. Lyon can help

The Supplement Brand Owner Compliance Pack contains 39 editable procedures, forms and lists built for own-label companies, including a Dietary Supplement Quality Agreement, a Brand Owner Responsibilities Matrix, label and claims review, serious adverse event reporting, specifications, identity testing review and a Part 111 gap assessment checklist.

If you manufacture, package or hold product yourself, the Dietary Supplement cGMP Quality System includes all 112 documents for a complete 21 CFR Part 111 quality system.

References

21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (FDA final rule, 72 FR 34752, June 25, 2007; current edition at www.ecfr.gov)
Federal Food, Drug, and Cosmetic Act, sections 403, 413 and 761 (21 U.S.C. 343, 350b and 379aa-1)
21 CFR Part 101, Food Labeling, sections 101.36 and 101.93
FDA, Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (December 2010)
FDA, Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (September 2013)
21 CFR Part 7, Subpart C, Recalls (Including Product Corrections)

Official sources: 21 CFR Part 111 (eCFR).