Brands entering the US in categories regulated by the FDA tend to plan their launch timeline around the wrong dates. They focus on when the registration application is submitted, when the product is manufactured, and when the first shipment lands. They miss the waiting periods that exist between these milestones, and those waiting periods are usually the difference between hitting a launch date and missing it by a quarter.

For food and dietary supplements, the most overlooked waiting period is facility registration with the FDA. A manufacturer must register its facility before any product can be shipped to the United States, and the registration is renewed every two years. The registration itself is fast, but the verification process if the FDA inspects or audits can introduce delays of weeks to months. Brands using a contract manufacturer should confirm facility registration status at the contract signing stage, not at the launch stage.

For cosmetics, the MoCRA registration requirements introduced in late 2023 created a new compliance layer that many brands have not fully internalized. Product listings, responsible person designation, and adverse event reporting structures all need to be in place before launch. The timeline from initial compliance review to fully registered product is six to ten weeks for a first time submission.

For medical devices, the 510k process can run six to nine months from submission to clearance, and that is for a straightforward predicate device. A novel device pathway can extend the timeline to eighteen months or longer. Brands attempting to compress this timeline with an aggressive launch plan are setting themselves up for product on the dock with nowhere to ship it.

For OTC drugs, monograph compliance is faster than NDA pathways, but label review and ingredient verification still take eight to twelve weeks for a first submission. The clock on shelf life starts at manufacture, so a four month registration delay can eat a meaningful portion of the saleable shelf life of the first production run.

The fix is to build the regulatory timeline backward from your committed retail launch date, with appropriate buffers at every step. If you cannot afford the buffer, you cannot afford the launch date you have committed to.