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Formula Risks2026-04-14Will

FDA Pre-review Notes: Why are 80% of prepared dishes rejected at the formula stage?

#Formula Risks#Thailand FDA#Field Notes
Many founders say, “We sell well in China and all our paperwork is complete.” In the eyes of Thailand FDA, that still does not mean the formula is compliant.

Many prepared food founders begin with the same sentence: “We already sell well in China and all of our paperwork is complete.” In the eyes of Thailand FDA, however, GB standards are not the same as Thailand standards. Once a case enters pre-review, what often gets blocked first is not company size, but whether the formula itself fits the regulatory logic on the Thai side.

The most common issues are additive usage, ingredient naming, blended formulation logic and the way formula data connects to labeling. A product that is legal in China cannot simply be copied into Thailand. If the formula language conflicts with local standards, every step that follows will slow down, and the case may be rejected in the first round.

That is exactly why I place formula review at the first station of the five-stage entry model. The point of pre-review is not to add another layer of process. It is to prevent the rest of the filing path from being built on the wrong starting point.

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