What is a Deficiency Letter?

The FDA's level of food defects refers to foods that are not harmful to human health, natural or unavoidable defects. Some foods, even if produced in accordance with current good manufacturing practices, carry natural or unavoidable defects that are not harmful to human health at low levels. The FDA has set an upper limit for defects in these foods produced in accordance with current good manufacturing practices.

The FDA's level of food defects refers to foods that are not harmful to human health, natural or unavoidable defects. Some foods, even if produced in accordance with current good manufacturing practices, carry natural or unavoidable defects that are not harmful to human health at low levels. The FDA has set an upper limit level for defects in these foods produced in accordance with current good manufacturing practices ^[1]

When necessary and feasible, the FDA establishes a level of defects for food, which may change as new technologies develop or new information becomes available. Compliance with the defect level cannot be a reason for violating FDA food production company GMP (Good Manufacturing Practice) regulations, that is, food cannot be processed, packaged, or stored under unhygienic conditions; food manufacturers, sellers, and storage must comply with Good Manufacturing Practice requirements. Even if the level of natural or unavoidable defects is lower than the current level of defects, if the fact that the above requirements are proved to exist, will make the food an adulterated article within the meaning of the Act. Food manufacturers, sellers, and stockists must always use quality control practices to reduce natural or unavoidable defects to the minimum feasible. Regardless of the defect level of the finished product after mixing, foods higher than the current defect level are not allowed to be mixed with another batch of food, otherwise the mixed product will become an adulterated product within the meaning of the Act.

(1) Some foods, even if produced in accordance with current good manufacturing practices, may carry natural or unavoidable defects that are not harmful to human health at low levels. The FDA has established upper limits for defects in the production and processing of food in accordance with current good manufacturing practices, and uses these standards to determine whether legal action is required.

(2) When necessary and justified, the FDA will establish a level of defect action for food. These standards also change as new technologies develop or new information becomes available.

(3) Although food meets the level of deficient action, it shall not be used as an excuse to violate the provisions of Regulation 402 (a) (4), so that food cannot be produced, processed, packaged or stored under unhealthy conditions, or as proposed in this chapter Food manufacturers, sellers, and stockists must comply with the requirements of current good practices. Even if the level of natural or unavoidable defects in food is lower than the currently established level of defect action, if it turns out that there is a violation of the above requirements, then the food will become inferior products under the regulations. At all times, food manufacturers, sellers, and stockists must use quality control methods to minimize natural or unavoidable defects.

(4) Foods containing higher than the current level of defects must not be mixed with other foods. Regardless of the level of defects of the mixed foods, these mixed foods are considered to be inferior products as required by regulations.

(5) The Industrial Planning Division (HFS-565) of the Center for Food Safety and Applied Nutrition can send a letter to request a compilation of current standards for non-hazardous, natural or unavoidable defects in human food.