FDA Compliance FAQ

An FDA US Agent is a person or company located in the United States who acts as the official point of contact between a foreign establishment and the FDA. If your company is located outside the United States and you manufacture, process, pack, or hold food, drugs, medical devices, or cosmetics that are exported to the US, you are legally required to designate a US Agent.

KECC FDA provides FDA US Agent service for $499/year with 1 business day. We handle all FDA correspondence on your behalf.

MoCRA (Modernization of Cosmetics Regulation Act) is a landmark US law signed in December 2022 that significantly updated FDA's authority over cosmetics. It requires all cosmetic product facilities to register with the FDA and list their products.

If you manufacture, process, pack, or hold cosmetic products for distribution in the US, MoCRA applies to you — including foreign manufacturers. The registration deadline was July 1, 2024. If you haven't registered yet, you should do so immediately to avoid enforcement action.

KECC FDA's MoCRA Cosmetics Package ($899) covers facility registration, product listing, and labeling review — delivered in 3 business days.

A 510(k) premarket notification is required for most Class II medical devices before they can be legally marketed in the US. The total cost varies:

• FDA user fees: ~$6,000–$12,000 for small businesses (reduced fees available)
• Consulting fees: $15,000–$80,000+ depending on device complexity
• FDA review timeline: 3–6 months after submission

KECC FDA provides 510(k) support with custom pricing based on device type and complexity. Contact us for a free scope assessment.

Amazon removes listings for several FDA-related reasons: unauthorized drug claims on labels, missing required label information, products that require FDA registration but lack it, or products considered unapproved drugs or devices.

The first step is to identify the exact reason for removal. KECC FDA can review your product label, identify compliance gaps, and help you correct them to reinstate your listing. Our Label Compliance Review ($299/SKU) provides a full analysis within 24 hours.

Dietary supplements do not require premarket FDA approval, but there are important requirements:

• Your manufacturing facility must be registered with the FDA (if domestic manufacturer)
• Product labels must comply with FDA labeling requirements: Supplement Facts panel, structure/function claim disclaimers, net quantity of contents
• Foreign manufacturers exporting to the US must designate an FDA US Agent

KECC FDA can review your labels and ensure full compliance before you list on Amazon.

FDA Registration means your facility or product is listed in the FDA's database. It does not mean the FDA has reviewed or approved your product.

FDA Approval (or Clearance for devices) means the FDA has reviewed your product and determined it is safe and effective for its intended use.

Most food, supplements, and cosmetics only require registration (or no registration at all), while prescription drugs and most medical devices require approval or clearance before marketing.

Yes. KECC FDA is a fully bilingual firm. All our consultants are fluent in both English and Mandarin Chinese. We can communicate with clients in Chinese, prepare Chinese-language summaries of FDA requirements, and serve as the bridge between Chinese manufacturers and the US FDA.

This is one of our core differentiators — we understand both the Chinese business context and the US regulatory environment.

Our standard Label Compliance Review turnaround is 24 hours. For urgent requests, we can often accommodate same-day reviews.

The review covers all FDA labeling requirements applicable to your product category (food, supplement, cosmetic, or OTC drug), identifies any non-compliant claims or missing information, and provides specific recommendations for correction.