Selling a beauty or skincare line in the U.S. means meeting FDA's cosmetics rules under MoCRA, keeping product claims on the right side of the line between cosmetic and drug, and having a plan if a product is challenged. MDRXLaw guides foreign producers and their U.S. importers through registration, listing, labeling, and claims review, responds to FDA notices, and protects brands through U.S. trademarks and distribution agreements.
Importing Cosmetics into the U.S.: FDA & MoCRA Lawyers
OUR EXPERIENCE
Legal Counsel for Foreign Cosmetics Producers and U.S. Importers
Launching a skincare or beauty line in the U.S. is not a simple export. Since MoCRA became law, FDA oversight of cosmetics has grown. A product that sells freely abroad may need new registration, listing, labeling, or claims changes before it can be sold here.
We work with producers, brand owners, and importers of skincare, hair care, color cosmetics, and personal care products to meet FDA requirements, avoid regulatory surprises, and protect their brands once the product is on shelves and online.
What FDA Expects Before You Sell
These are the main MoCRA obligations, and what each means for a foreign company:
Requirement | What it means for you |
Facility registration | Facilities that make or process cosmetics for the U.S. register with FDA, and foreign facilities name a U.S. agent |
Product listing | Each product is listed with FDA, including its ingredients |
Responsible person | The company named on the label is accountable for compliance |
Safety substantiation | You hold records showing the product is safe for its intended use |
Adverse events | Serious events are reported to FDA, and records are kept |
Labeling | U.S. ingredient list, warnings, and a domestic contact for adverse event reports |
Small business exemptions | Some smaller companies are exempt from certain duties, and we check whether you qualify |
Cosmetic or Drug? Claims That Change the Rules
What a product says it does can matter as much as what is in it. Under U.S. law, a product that claims to treat or prevent a condition, or to change how the body works, may be regulated as a drug, not just a cosmetic. Sunscreens, acne treatments, anti-dandruff shampoos, and products claiming to affect skin structure often fall in this category.
What the product says | How FDA is likely to treat it |
Cleanses, moisturizes, scents, or colors | Cosmetic |
Protects against sunburn (SPF) | Drug (sunscreen) |
Treats or prevents acne | Drug |
Controls dandruff | Drug |
Repairs skin at a cellular level to reduce wrinkles | Often a drug claim, depending on the wording |
These examples are illustrative. The result depends on the full label, the website, and the marketing around the product.
We review product names, labels, websites, and social media claims to help clients keep products in the right category, avoid FDA warning letters, and handle drug requirements where they apply. This is common for foreign brands, because claims that are routine abroad can be treated as drug claims in the U.S.
If You Receive an FDA Notice
Deadlines are short, so the order of steps matters. Here is how we handle a detention, refusal, or warning letter:
Send us the notice right away
, with any deadline it states.
Hold off on shipping, relabeling, or replying
until we have reviewed it.
We identify the issue
: registration, labeling, an ingredient, or a claim.
We prepare the response
, including any relabeling, reformulation, or request to release the product.
We advise on what follows
, such as recalls, adverse event reports, and consumer or regulatory claims in the U.S.
Protecting Your Brand and Your U.S. Business
A cosmetics brand is built on its name, so protecting it early matters. We help clients with:
U.S. trademark searches and registration
for foreign brands. Applicants based outside the U.S. must be represented by a U.S.-licensed attorney.
Importer, distributor, and private label agreements
, including exclusivity, quality control, recall duties, indemnity, and insurance.
Grey market and counterfeit issues
, including unauthorized resale of genuine products and online marketplace takedowns.
Advertising and influencer marketing review
for the U.S. market.
Why MDRXLaw
Our New York office combines FDA regulatory and trademark experience with litigation, so one team can prepare your market entry and defend it if a product, label, or claim is challenged. We explain U.S. requirements in plain terms for clients new to the market. Our team speaks several languages, making it easier for our clients to communicate with us, and for us to review documenation in foreign languages.
Frequently Asked Questions
Does a foreign cosmetics company have to register with FDA?
Under MoCRA, facilities that manufacture or process cosmetics for the U.S. market generally must register, and foreign facilities must name a U.S. agent. Some small businesses are exempt from certain requirements.
What is a responsible person?
The responsible person is the company whose name appears on the label as the manufacturer, packer, or distributor. It is accountable for product listing, safety substantiation, and adverse event reporting.
Can my product claims turn it into a drug?
Yes. Claims to treat or prevent a condition, or to affect the body's structure or function, can make a product a drug subject to additional rules, even if it is sold as a cosmetic abroad.
Can a foreign company register a U.S. trademark?
Yes. A foreign-based applicant must use a U.S.-licensed attorney for the application.
Talk to Us
If you plan to sell cosmetics in the United States, import them, or have received a detention, refusal, or warning letter, contact us for a confidential consultation.
contact
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New York, NY 10004Phone: (212) 668-0200Fax: (212) 668-0222
General email: info@mdrxlaw.com