CPGShield resources · Federal cosmetic labeling
Your manufacturer has a finished formula, a sample label and a production slot. It is tempting to treat the remaining work as adding your logo and choosing a carton.
Before approving that carton, settle a more important question: who has checked the information that will appear under your brand's name?
Private label manufacturing does not, by itself, settle responsibility for your label. A useful launch agreement identifies who supplies each piece of information, who reviews it and who can authorize the final artwork.
The Modernization of Cosmetics Regulation Act defines the responsible person by reference to the manufacturer, packer or distributor named on the label. The brand can therefore have that role even when another company makes the product. The responsible person also has duties concerning safety substantiation and serious adverse event reporting. FDA's explanation of the cosmetics law describes those responsibilities.
For ordinary business identification, a company named on a cosmetic label that did not manufacture the product needs wording that accurately describes its relationship, such as “Distributed by.” Review the actual arrangement before choosing that phrase. FDA's Cosmetics Labeling Guide explains the requirement.
Put the proposed business line in your label brief early. Your designer should receive the agreed wording instead of having to infer the commercial relationship from an invoice.
A supplier's example ingredient list is a starting document. Ask which formula version it represents and whether it covers your selected fragrance, shade and other modifications.
Before the production order, request:
If proprietary information needs protection, agree on a practical review arrangement with the supplier. The goal is to give the people checking the product access to the information their review actually requires.
A manufacturer may point to its facility registration when you ask about compliance. That answers a different question from whether your particular label has been checked.
FDA states that facility registration and product listing do not signify product approval. Certain small businesses have exemptions from registration and listing, but the exemption has conditions and product exclusions. FDA's registration and listing guidance is the place to check the applicable route.
Ask your manufacturer what work its quoted service includes. “Compliance included” is too vague to use as a launch handoff. Does it cover ingredient naming, claims, business details, your target markets and the final printed layout? Ask for the reviewed version and any unresolved items.
For safety support, agree who maintains the records, what your brand can access and how quickly that information can be supplied. Do the same for the evidence behind specific performance claims. A study about a supplier ingredient and a study about your finished product are different documents; record which one supports the statement you want to use.
Also assign an owner for customer complaints and the contact route printed on the package. Our guide to cosmetic adverse event contact information covers the label side of that workflow.
Keep a small release folder containing the formula identifier, approved label copy, final artwork, review comments and the date of authorization. Record the bottle and carton versions separately when both exist.
For example, if the fragrance changes after the designer finishes the carton, flag the artwork for another review. Do not let a verbal “same product” assurance silently become approval of an older ingredient panel. The formula-change label guide walks through that situation.
Yes, you can include that work in the engagement. Specify its scope, the product version and the written result you expect to receive.
Use it as a reference. First confirm that the formula, business details, claims, package size and market match your own launch.
Make sure every open review comment has an owner and that the person approving production is looking at the exact artwork the printer will use.
Once your supplier information is assembled, run your cosmetic label through CPGShield free. Use the results to organize the questions you take back to your manufacturer and designer before printing.
This article addresses U.S. cosmetics and provides general education. Responsibility and review scope depend on the actual product and business arrangement.
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