How to make cosmetics and supplements in Mexico: a guide for new brands

Cosmetics and supplements are two of the most popular categories for new direct-to-consumer brands, and also two of the most regulated. A brand doesn't need its own plant: most start with a contract manufacturer that formulates, fills, and packs the product. The skill is choosing a manufacturer that can pass the paperwork as well as make a good product.

This guide covers both categories, since they share the same basic path and differ in the rules. It's an overview, not legal or regulatory advice.

Three ways to start

Model	What it means	Good for
Private label (stock formula)	You choose a formula the manufacturer already makes, add your name, packaging, and label	The fastest, lowest-cost first product
Custom formula	The manufacturer's chemists develop or adjust a formula to your brief	A product that is meaningfully different
Full-service	The manufacturer handles formulation, sourcing, filling, packaging, labeling, and testing	Founders who want one partner

Stock formulas are not unique to you, and other brands can sell them. A custom formula costs more and takes longer, but it's yours to the extent your agreement says so. Put that in the contract.

What Mexican manufacturers offer

Mexico has a large personal care and pharmaceutical industry, serving its own market and exporting. Contract manufacturers can fill creams, serums, shampoos, soaps, lotions, and makeup, and make capsules, tablets, powders, and gummies for supplements. Our cosmetics directory lists companies by location, and you can filter for those with relevant certifications.

Mexico also has distinctive ingredients that brands build stories around, including agave, nopal, aloe, cacao, and native botanicals. Make sure any claim about an ingredient is something you can support.

Rules that decide who you can work with

Cosmetics (U.S.)

The Modernization of Cosmetics Regulation Act (MoCRA) set new federal requirements for cosmetics sold in the U.S. In broad terms, it covers facility registration, product listing, a designated responsible person, safety substantiation, adverse event reporting, and labeling. Your manufacturer's facility generally has to be registered with the FDA, and you or your manufacturer must handle product listing and safety records. Ask exactly who does what, and get it in writing. The FDA's guidance and deadlines have been phased in, so check the current requirements.

Dietary supplements (U.S.)

Supplements aren't approved by the FDA before they're sold, but manufacturers must follow current good manufacturing practice (cGMP) for dietary supplements, label products as required, and be able to substantiate what they claim. The rule that matters most: a claim that a product treats or cures a disease turns it into an unapproved drug. Work with a regulatory consultant on your claims and label. The facility should be FDA-registered and able to show how it tests identity, purity, and strength.

Selling in Mexico

If you also sell in Mexico, COFEPRIS, the health regulator, has its own requirements, including product notification or registration and Spanish labeling. This is a separate process from the U.S. one.

Certifications and what to ask

• GMP / cGMP: the baseline. Ask for the audit or certificate and who issued it.
• ISO 22716 (cosmetics GMP) is a recognized standard for cosmetics plants, and some hold ISO 9001.
• Third-party GMP certificates (for supplements) from recognized certifiers.
• FDA registration of the facility. Registration is not approval, but it's required.
• COFEPRIS license for the plant, relevant for anything sold in Mexico.
• Organic, kosher, halal, or vegan certifications if you plan to make those claims.

Ask every candidate:

1. What are your minimums per product and per batch? Many contract manufacturers set minimums in the hundreds to thousands of units.
2. Do you do stability and microbial testing, and who pays for it?
3. Who sources ingredients and packaging, and from where?
4. Will you sign an NDA and a formula ownership agreement?
5. What's your batch record and traceability system, and what happens in a recall?
6. Can you share a recent audit, and can I visit?

Development, samples, and testing

The usual sequence is brief, formula or sample selection, lab samples, revisions, stability testing, and a pilot batch before the first production run. Stability can take months, and changing a formula restarts parts of it, so lock your brief before you begin. Test the finished product, in its final packaging, with a third-party lab.

Packaging and labeling

Packaging is a second supply chain: bottles, jars, pumps, boxes, and labels. Ask if the manufacturer sources it or you do, and confirm compatibility with the formula. Labels in the U.S. need specific information for each category, such as ingredient lists in a standard order, net contents, the responsible party, and for supplements a Supplement Facts panel. Have the final label reviewed before printing.

Importing

Cosmetics and supplements entering the U.S. are subject to FDA oversight at the border, and shipments can be held if paperwork or labels are wrong. Work with a customs broker who handles FDA-regulated goods. See how to import goods from Mexico and how to find a customs broker. Temperature-sensitive products may also need refrigerated or climate-controlled freight.

Before you commit

Verify the company, ask several for quotes with the same brief (RFQ template), and compare them on total cost, including testing, packaging, and minimums.