Although these three categories fall under different legal frameworks (separate sections of the FD&C Act, MoCRA, DSHEA), Turkish manufacturers and brand owners tend to make surprisingly similar mistakes when entering the U.S. market. Here are the five most common, each illustrated with concrete examples from all three categories.
1. Skipping or Getting Product Classification Wrong
This is the earliest and most expensive mistake, because every step that follows: registration, labeling, safety documentation depends on classification.
- Cosmetics: A moisturizer claiming SPF, or a cleanser claiming to “treat acne,” is automatically regulated as a drug in the U.S., regardless of formulation (21 CFR § 700.35). Registering it as a cosmetic risks rejection at customs as an unapproved drug.
- Dietary supplements: Failing to check whether an ingredient qualifies as a New Dietary Ingredient (NDI) is the most common mistake. A botanical extract not on the U.S. market before October 15, 1994, used without notification, automatically renders the product adulterated (21 U.S.C. § 342(f)).
- Medical devices: Misjudging the device’s risk class (Class I, II, or III) leads either to an unnecessarily heavy approval process (PMA) or to marketing a device without the required 510(k) submission.
2. Mistaking Registration for Approval
Companies often assume “I registered with FDA, so I’m approved.” This is wrong across all three categories:
- Cosmetic facility registration and product listing (MoCRA §607) is purely an administrative notification FDA does not conduct premarket approval of cosmetics.
- Food facility registration is similarly administrative and doesn’t indicate the product is safe or compliant.
- For medical devices it’s slightly different but equally misunderstood: establishment registration does not mean the product is approved that only happens once the specific device has 510(k) clearance, PMA approval, or de novo classification.
Using “FDA approved” on labeling or marketing materials is inaccurate in all three categories and carries misbranding risk.
3. Shipping Formulations or Materials Without Checking U.S.-Specific Restrictions
Something approved in Turkey or the EU may be banned or restricted in the U.S. and discovering this after production is complete is costly.
- Cosmetics: Mercury, chloroform, methylene chloride, and similar substances are banned or tightly restricted in the U.S. (21 U.S.C. § 361; 21 CFR Part 700).
- Dietary supplements: Certain dosage levels or ingredient combinations may be considered “adulterated” in the U.S. even if freely sold in the EU.
- Medical devices: Material biocompatibility, sterilization method, or electrical safety standards may be subject to U.S.-specific testing requirements (e.g., ISO 10993, IEC 60601) a CE mark doesn’t substitute for these tests.
4. Skipping the U.S. Agent / Responsible Person Requirement
All three categories share a common requirement: a foreign manufacturer must designate a point of contact FDA can reach.
- Cosmetics: Every product must have a “responsible person.”
- Dietary supplements: Foreign facilities must designate a U.S. Agent someone physically based in the U.S.; a mailbox or answering service doesn’t qualify.
- Medical devices: Similarly, a foreign establishment must have a U.S.-based representative, who also helps coordinate FDA inspections.
Skipping this step, or designating the wrong party (e.g., only a freight forwarder), leaves registration incomplete.
5. Copy-Pasting Labels and Claims From Other Markets
Directly carrying over an EU or Turkish label into the U.S. is the most common practical mistake across all three categories.
- Cosmetics: English language requirements, INCI naming, manufacturer address, and net quantity format (oz/fl oz) differ from EU standards (21 CFR Part 701).
- Dietary supplements: The EU’s “Nutrition Declaration” format doesn’t map directly onto the U.S. Supplement Facts panel; and any structure/function claim requires the mandatory FDA disclaimer (21 CFR § 101.93).
- Medical devices: Instructions for use, warnings, and indications must be adapted to the U.S. format under 21 CFR Part 801 CE labeling text can’t simply be translated and reused.
The Common Thread
Across all three categories, the root cause is the same: assuming U.S. regulation works the same way as EU or Turkish regulation. Classification, registration, restricted substance/material screening, designating a local representative, and adapting labeling these five checkpoints need to be cleared before shipping, regardless of which product category you’re in.
Sources: FD&C Act §§601, 602, 607 (21 U.S.C. §§ 361, 362, 364c); 21 U.S.C. § 342(f), § 350b (NDI); 21 CFR Parts 700, 701, 101, 807, 860; FDA Guidance for Industry — Registration and Listing of Cosmetic Product Facilities and Products; FDA Guidance for Industry — Dietary Supplements: New Dietary Ingredient Notifications.
This content is for general informational purposes and does not constitute legal advice. For product-specific evaluation, confirm current requirements at FDA.gov and eCFR.gov.
