The short answer
Bulgaria is famous for rose oil and rose water, and exports cosmetics, essential oils, yogurt, white brined cheese, honey and sunflower oil to the U.S. Cosmetics and essential oils need the most care with claims.
What Bulgarian exporters should watch for
🌹 Rose oil cosmetics
Facilities making rose creams, rose water and other cosmetics need MoCRA registration and product listing. Fragrance ingredients can be listed as “fragrance”, but labels need an English ingredient list and a U.S. contact for adverse event reports.
💧 Essential oils
Oils sold for perfume or skin use are cosmetics; oils sold as flavorings are food. Claims such as “relieves anxiety” or “heals wounds” make them unapproved drugs, which is a common reason for FDA warning letters.
🧀 Yogurt and white cheese
Dairy plants register with FDA. Brined white cheese made from raw milk must be aged at least 60 days. Products must not borrow U.S. standardized names unless they meet the standard.
🍯 Honey and sunflower oil
Honey is tested for drug residues and adulteration, so keep lot test results. Oil mills and bottlers register, and both need U.S. labels with Nutrition Facts.
Common reasons Bulgarian shipments are stopped
- Drug claims on essential oils or rose products
- No MoCRA registration or listing
- Raw-milk cheese aged under 60 days
- Residues or adulteration in honey
- Bulgarian-only labels
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Do Bulgarian rose oil cosmetics need FDA registration?
Yes. Under MoCRA, the facility that makes the cosmetic must register with FDA and the responsible person must list each product. Labels need English ingredients and a U.S. contact for adverse event reports.
Are essential oils cosmetics or drugs in the U.S.?
It depends on the claims. Oils sold for fragrance or skin care are cosmetics; oils claimed to treat or prevent conditions are drugs and cannot be sold without drug approval or a monograph route.
Sources
- FDA — Registration & Listing of Cosmetic Product Facilities and Products
- FDA — Is it a cosmetic, a drug, or both?
- eCFR — 21 CFR Part 133, Cheeses and related cheese products
- FDA — Import Alerts by Publish Date
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.