Made in USA claims for medical products and supplements

“Made in USA” shows up on supplement bottles, brace packaging, scrub sets, dental products and the websites of companies that sell to practices. Buyers read it as a quality signal, and some clinics and purchasing managers prefer American products when they can get them. The claim also carries a legal standard that is stricter than many sellers expect: the FTC asks that a product called Made in USA without qualification be all or virtually all made in the United States, and since 2021 a false Made in USA label can bring civil penalties.

This guide covers origin claims only. Claims about what a product does are covered in our guides to medical device marketing claims, selling supplements in a medical practice, DME supplier marketing and prosthetics and orthotics marketing. Warranty terms on the same products are covered in our guide to warranty rules for health devices and products. Claims about the evidence behind a product are covered in our guide to clinically proven and doctor recommended claims. Natural, organic and eco-friendly wording is covered in our guide to natural, organic and eco-friendly claims. Label and reporting duties for products sold under your own brand are covered in private-label supplements and skincare.

The short version

• No federal law makes most products say where they were made. If you choose to make a U.S. origin claim, the FTC standard applies, according to the FTC guide.
• An unqualified Made in USA claim needs final assembly or processing in the U.S., all significant processing in the U.S., and all or virtually all ingredients or components made and sourced in the U.S., 16 CFR 323.2.
• The Labeling Rule covers labels and any seal, mark, tag or stamp in online or mail order promotions, 323.2 and 323.3. Other claims in ads, websites and social posts are judged under the FTC Act and the FTC’s 1997 policy statement.
• Implied claims count: U.S. flags, maps and references to American factories can make an origin claim, depending on the overall impression.
• Products that do not meet the standard can use truthful qualified claims, such as “Made in USA of U.S. and imported parts” or “Assembled in USA”, if they meet the conditions for those claims.
• A knowing violation of the Labeling Rule can bring civil penalties under 15 USC 45(m)(1)(A), with the amount adjusted for inflation each year under 16 CFR 1.98.

What counts as a Made in USA claim

Section 323.1(a) defines Made in the United States broadly: any unqualified representation, express or implied, that a product or service, or a specified component thereof, is of U.S. origin, including a representation that it is “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America. The FTC guide gives “Made in USA,” “Our products are American-made,” “USA,” “Manufactured in USA” and “Built in USA” as examples of express claims.

Implied claims are judged by the overall impression. The guide says U.S. flags, outlines of U.S. maps, or references to U.S. locations of headquarters or factories may convey a claim of U.S. origin, alone or with other words and images. Its example is an ad in which a manager praises the “true American quality” of work at the company’s American factory, which the FTC says is likely to convey U.S. origin even without the words Made in USA. For a health company, a product page with a flag banner and the line “proudly made by American workers” makes the same kind of claim.

Some things do not, on their own. The guide says the FTC ordinarily will not treat an American brand name or trademark by itself as an origin claim, unless the name itself denotes U.S. origin, and is not likely to treat a non-prominent U.S. address on a package as a Made in USA label. Claims about a whole line are a trap: the guide says not to say “Our products are made in USA” when only some products in the line meet the standard.

The all or virtually all standard

Section 323.2 makes it an unfair or deceptive act or practice to label any product as Made in the United States unless the final assembly or processing of the product occurs in the United States, all significant processing that goes into the product occurs in the United States, and all or virtually all ingredients or components of the product are made and sourced in the United States. The FTC guide restates this as: the product should contain no, or negligible, foreign content. The United States here includes the 50 states, the District of Columbia and U.S. territories and possessions.

The guide lists the factors the FTC weighs once final assembly is in the U.S.:

• How much of the product’s total manufacturing cost comes from U.S. parts and processing, using cost of goods sold or inventory costs of finished goods: materials, direct manufacturing labor and manufacturing overhead.
• How far removed any foreign content is from the finished product. An imported raw material several steps back matters less than an imported part one step back.
• How important the foreign content is to the product’s form or function. The guide’s example is a watch made in Nevada with an inexpensive Swiss movement: the movement is a small part of the cost, but without it the watch cannot tell time, so an unqualified claim is likely deceptive.

Applied to health products, the questions are concrete. A supplement encapsulated in a U.S. facility from an imported active ingredient has foreign content that is one step from the finished product and central to what it does. A knee brace sewn in the U.S. with an imported hinge has the same problem if the hinge is what makes it a brace. Packaging does not change origin: the guide says a Korean computer packed in an all-American box cannot be called Made in USA, though “Computer made in Korea. Packaging made in USA” would be fine.

Substantiation and supplier information

The FTC guide says a marketer making an unqualified claim must have, and rely on, a reasonable basis: competent and reliable evidence that the product is all or virtually all made in the U.S. The duty continues. If a company starts sourcing parts overseas, it must update its marketing materials.

You can rely on supplier information given in good faith, the guide says, but should ask for the specific percentage of U.S. content rather than assume an American supplier’s part is 100 percent domestic. Its example is a food processor maker whose U.S. supplier assembles the motor in the U.S. from imported parts; because the motor is half the cost, the appliance is not all or virtually all American-made. The guide also gives the model of a purchase order that requires suppliers to certify the percentage of U.S. content, which the company generally could rely on. For a private label supplement or a device made by a contract manufacturer, ask for that certification for each ingredient or component that matters, and keep it with the product file.

Qualified claims: assembled in USA and U.S. and imported parts

A product that falls short of the standard may still say something true about its U.S. content. The guide calls these qualified claims and gives examples such as “60% U.S. content,” “Made in USA of U.S. and imported parts” and an item “assembled in USA” from named foreign materials. It warns that even qualified claims can imply more domestic content than exists, so they should be used only when the product has a significant amount of U.S. content or processing.

The guide’s treadmill example draws the line. A treadmill assembled in the U.S. from imported major parts, with U.S. parts making up about three percent of parts cost, may not say “Made in USA of U.S. and Imported Parts”, because the U.S. parts are negligible. It could say “Made in U.S. from Imported Parts” or “Assembled in U.S.A.”

“Assembled in USA” has its own conditions. The guide says it may be used without further qualification when the principal assembly takes place in the U.S., the assembly is substantial, and the product’s last substantial transformation occurred in the U.S. A simple screwdriver assembly of imported components at the end of the process usually does not qualify.

Claims about one process or part must name it. The guide accepts “Designed in USA, Made in Finland” as a specific claim, but calls “Created in USA” for a product invented in Seattle and made in Bangladesh deceptive, because consumers read created as made. It also warns that general words such as “produced” or “manufactured” in the U.S. are unlikely to convey a message limited to one step. A supplement company that formulates in the U.S. and manufactures abroad should say “Formulated in the USA, made in [country]”, not “Produced in the USA.”

Labels, websites and ads: which rule applies

The Labeling Rule is narrower than the FTC’s overall standard. Section 323.2 applies to labeling a product Made in the United States, and 323.3 extends it to mail order catalogs and promotional material, which 323.1(b) defines to include electronic materials soliciting purchase by mail, telephone, email or another method without examining the product, to the extent they include a seal, mark, tag or stamp labeling the product Made in the United States. A Made in USA badge on a product page in an online shop is the clearest example. The statute behind the rule, 15 USC 45a, says it only applies to such labels.

Other origin claims, such as a sentence in a blog post, a social caption or a sales deck, are judged under section 5 of the FTC Act and the FTC’s 1997 Enforcement Policy Statement on U.S. Origin Claims. The guide says the policy statement applies to claims on products and labeling, advertising, other promotional materials and all other forms of marketing, including internet, email and social media. The standard is the same all or virtually all test. The difference is the remedy: rule violations bring civil penalties, as covered below.

For imported products, U.S. Customs and Border Protection requires a foreign country of origin marking, which the guide explains is based on where the last substantial transformation occurred. The guide adds that a CBP decision that a product needs no foreign marking does not by itself make it acceptable to call the product Made in USA, and that website or ad claims that differ from the required foreign marking may mislead buyers.

Other laws and other agencies

Section 323.5 says the rule does not supersede other federal country of origin laws, and does not supersede state origin labeling laws except where they are inconsistent with it; a state law that gives consumers greater protection is not inconsistent. The guide also notes that a competitor damaged by a false designation of origin can sue under the Lanham Act. If your product is a medical device or a dietary supplement, FDA labeling rules also apply to the package; we have not reviewed FDA origin requirements for this guide, so ask your regulatory consultant whether any apply to your product. Scrubs and other textile products have separate origin labeling rules under the Textile Fiber Products Identification Act, which the guide mentions.

What a violation can cost

Section 323.4 says any violation of the Labeling Rule is treated as a violation of a rule under 15 USC 57a. Under 15 USC 45(m)(1)(A), a knowing violation of such a rule can bring a civil penalty of up to 10,000 dollars per violation as written in the statute. The FTC adjusts that figure for inflation each year: 16 CFR 1.98(d) sets 53,088 dollars for penalties assessed after January 17, 2025. The FTC guide says marketers are now subject to civil penalties if they use an unqualified Made in USA label on a product that is not all or virtually all made in the U.S., including in catalogs or online.

An illustration

This example is invented. [Company name] sells a private label line of compression socks and ankle braces to podiatry and physical therapy practices, and its website carries a flag banner and the line “American made, American quality.” A new marketing manager asks the contract manufacturers for content certifications. The socks are knit and finished in North Carolina from U.S. yarn. The braces are sewn in Ohio, but the stays and hinges come from overseas and are a large share of the parts cost and central to what the brace does.

The company keeps “Made in USA” on the socks, with the certifications filed. It removes the flag banner and the sitewide line, because they imply the whole catalog is American. The brace pages now say “Sewn in Ohio from U.S. fabric and imported hinges and stays.” The company adds a supplier certification line to its purchase orders and a yearly review of origin claims to its calendar. Because socks are a textile product, it also asks its attorney about the textile labeling rules.

Checklist

• List every place you say or show U.S. origin: labels, packaging, product pages, badges, ads, social posts, sales decks and trade show signs.
• Look for implied claims too: flags, maps, “American made” taglines and factory references.
• For each product with an unqualified claim, confirm final assembly and all significant processing in the U.S., and document the U.S. content of each significant ingredient or component.
• Get written U.S. content certifications from suppliers and contract manufacturers, with percentages, and review them when sourcing changes.
• Replace claims you cannot support with specific, truthful qualified claims, such as “Assembled in USA from imported components” where the assembly is substantial.
• Avoid line-wide claims unless every product in the line meets the standard.
• Check CBP marking for anything imported, and make sure your web copy does not contradict it.
• Have an attorney review origin claims and any state law that applies before packaging is printed.

How we help

We build websites, local and organic search, Google Ads and lead generation and an AI front desk for independent practices and the companies that serve them. For origin claims, that means product pages and badges that say only what your supplier records support, and copy that names the step done in the U.S. when the whole product is not. We are not a healthcare provider and we do not give legal or medical advice. Read our guide to healthcare marketing rules for the wider picture.

Sources

• 16 CFR part 323: Made in USA Labeling (eCFR, up to date as of October 29, 2026)
• FTC: Complying with the Made in USA Standard (July 2024; read in an Internet Archive capture of October 19, 2026)
• 15 USC 45a: Labels on products
• 15 USC 45: Unfair methods of competition unlawful (subsection (m)(1)(A))
• 16 CFR 1.98: Adjustment of civil monetary penalty amounts

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