FDA Registered: US Market Ready

The FDA's regulatory scope covers an enormous range of products including food products, dietary supplements, cosmetics, and over-the-counter drugs - all of which are commonly sold through Amazon.com and other US online marketplaces. The Food Safety Modernization Act (FSMA), the Dietary Supplement Health and Education Act (DSHEA), and the Modernization of Cosmetics Regulation Act (MoCRA) each impose distinct obligations on producers, importers, and distributors of these product categories. Understanding which FDA framework applies to your specific product is the first compliance step - and it is more complex than it appears. A product marketed as a 'health food' may be classified as a dietary supplement requiring DSHEA compliance. A product with structure-function claims may require FDA notification. A cosmetic with certain drug-like claims may be regulated as an OTC drug. We conduct product classification assessments for every product before beginning the registration process.

The Bioterrorism Act requires every facility that manufactures, processes, packs, or holds food for US consumption to register with the FDA. Foreign facilities shipping food products to the US must register before the first shipment and renew registration biennially (in even-numbered years). Registration must be completed through the FDA Industry Systems portal using specific data fields about the facility, its food categories, and its US agent. In addition to facility registration, all food articles imported into the United States require Prior Notice submission before the shipment arrives at the US port of entry. Prior Notice informs FDA of the incoming shipment and allows FDA to target inspections to high-risk shipments. Shipments without valid Prior Notice are subject to refusal, which creates costly hold delays and may result in return or destruction of the shipment at the importer's expense. We manage facility registrations for your overseas manufacturing facilities, prepare and submit Prior Notice for every incoming food shipment, and maintain registration records to ensure biennial renewals occur on schedule.

Dietary supplements occupy a regulatory space between food and drugs in the US - they are not required to be approved by FDA before marketing, but they must be manufactured under dietary supplement Current Good Manufacturing Practices (cGMPs), must not contain new dietary ingredients without prior notification, and cannot make drug claims that imply treatment or cure of disease. The labeling requirements for dietary supplements are detailed - including Supplement Facts panels, disclaimer statements, and serving size declarations formatted to FDA specifications. Violations of dietary supplement labeling requirements can result in FDA warning letters, product seizure, and Amazon listing removal without warning. Our dietary supplement compliance service reviews your product formulations against FDA's current dietary ingredient list, prepares correct Supplement Facts panels, reviews all label claims against FDA's permissible structure-function claim standards, and files required structure-function claim notifications with FDA within 30 days of first marketing as required by regulation.

FDA Import Alerts allow FDA to detain shipments from specific firms, geographic regions, or product categories without physical examination, placing the burden on importers to demonstrate compliance before their shipments are released. Import Alert detentions are one of the most disruptive compliance outcomes a food, supplement, or cosmetic importer can face - creating indefinite detention of shipments at US ports of entry and requiring documented evidence of corrective action before detentions are lifted. If your products or your suppliers' facilities appear on an FDA Import Alert, we manage the response process: reviewing the basis for the alert, coordinating the corrective actions required to address FDA's concerns, preparing the Voluntary Action Indicated (VAI) documentation package, and managing communications with FDA's Division of Import Operations to achieve removal from the alert. We also conduct proactive Import Alert risk assessments for new suppliers, identifying Import Alert history before supply relationships are established.