Cosmetic shipments entering the U.S. pass through joint oversight by Customs and Border Protection (CBP) and FDA. When a shipment is detained or refused entry, it almost always comes down to two core FD&C Act concepts: “adulterated” and “misbranded.” Below are the eight most common reasons this happens in practice.
1. Missing Facility Registration or Product Listing (MoCRA)
Under Section 607 of the FD&C Act (21 U.S.C. § 364c), every facility that manufactures or processes cosmetics for distribution in the U.S. must be registered with FDA, and every product must be separately listed. Failing to meet this requirement is a prohibited act under Section 301(hhh) of the FD&C Act. A shipment from an unregistered facility can be detained on this basis alone.
2. Labeling Deficiencies (Misbranding)
Under 21 U.S.C. § 362 (FD&C Act Section 602), a cosmetic is misbranded if its labeling is false or misleading, or if it’s missing required information, including:
- English language requirement: under 21 CFR § 701.2(b), all information required by law to appear on the label must be in English. A product labeled only in Turkish violates this rule.
- Ingredient declaration: under 21 CFR § 701.3, every product must list its ingredients in descending order of predominance.
- Manufacturer/distributor name and address: under 21 CFR § 701.12, the label must show the name and business address of the manufacturer, packer, or distributor.
- Net quantity declaration: under 21 CFR § 701.13, the net weight, volume, or count must be accurately stated in the required format.
- Statement of identity on the principal display panel: under 21 CFR § 701.11, the label must clearly state what the product is.
If any of this information is missing, hidden in small print, or misleading, the product is considered misbranded and can be detained at the border.
3. Prohibited or Restricted Ingredients (Adulteration)
Under 21 U.S.C. § 361 (FD&C Act Section 601), a cosmetic is adulterated if it contains a poisonous or deleterious substance that may injure users. FDA has either banned outright or tightly restricted specific ingredients in cosmetics, including:
- Mercury: except in eye-area products, mercury above 1 ppm renders a product adulterated (21 CFR § 700.13).
- Chloroform: prohibited as a cosmetic ingredient (21 CFR § 700.18).
- Methylene chloride: prohibited in aerosol products such as hair spray (21 CFR § 700.19).
- Chlorofluorocarbon (CFC) propellants: prohibited as aerosol propellants (21 CFR § 700.23).
- Halogenated salicylanilides: prohibited as antimicrobial agents due to photosensitization risk (21 CFR § 700.15).
- Unapproved color additives: a product containing a color additive not deemed safe by FDA is adulterated under 21 U.S.C. § 361(e).
An ingredient approved in Turkey or the EU may be banned or restricted in the U.S. — checking your formulation against the U.S. list before shipping is critical.
4. The Product Is Actually Regulated as a Drug
If a cosmetic’s labeling claims to prevent or treat a disease, or to affect the structure or function of the body, it meets the FD&C Act definition of a drug — regardless of the formulation. For example, any product claiming an SPF/sunscreen benefit is automatically treated as a drug (21 CFR § 700.35). Claims like “treats acne,” “anti-aging,” or “reduces inflammation” carry the same risk. If a product is legally a drug but isn’t registered or listed as one, it can be detained as an unapproved new drug.
5. Missing Safety Substantiation
MoCRA added a further requirement: under 21 U.S.C. § 361(g), every cosmetic product and each of its ingredients must have adequate safety substantiation. A product marketed without this substantiation can be deemed adulterated.
6. Non-Compliance With Good Manufacturing Practice (GMP)
Under 21 U.S.C. § 361(f), cosmetics not manufactured in accordance with the GMP requirements established under MoCRA are also considered adulterated. Being able to document your manufacturing facility’s compliance with these standards matters.
7. Missing Tamper-Resistant Packaging
Certain categories — liquid oral hygiene products and vaginally-used products — require tamper-resistant packaging under 21 CFR § 700.25. Failing to meet this requirement can render a product both adulterated and misbranded.
8. Prior Violation History / Import Alert
If a company or product has previously been refused entry, received a warning, or been placed on an Import Alert list, subsequent shipments are automatically subject to stricter scrutiny — including Detention Without Physical Examination (DWPE).
What This Means for Turkish Cosmetic Brands
To reduce the risk of customs detention, run through this checklist before shipping:
- Is facility registration and product listing complete under MoCRA?
- Is the label in English, with a correctly ordered ingredient list, manufacturer/distributor information, and accurate net quantity?
- Does the formulation contain any ingredient banned or restricted in the U.S.?
- Does the label or marketing material make an unintentional drug claim (e.g., SPF, “treats”)?
- Is safety substantiation documentation ready for the product and its ingredients?
- Does the manufacturing facility meet GMP requirements?
- Is the packaging tamper-resistant where required for the product category?
Sources: FD&C Act Section 601 (21 U.S.C. § 361), Section 602 (21 U.S.C. § 362), Section 607 (21 U.S.C. § 364c); 21 CFR Part 700 (General Cosmetics Rules) and Part 701 (Cosmetic Labeling); FDA Guidance for Industry — Registration and Listing of Cosmetic Product Facilities and Products.
This content is for general informational purposes and does not constitute legal advice. For product-specific evaluation, confirm current requirements at FDA.gov/cosmetics and eCFR.gov.
