PQQ is a dietary supplement that is currently available in the United States. It is commonly found in green peppers and parsley. The chemical is also known as methoxatin, pyrroloquinoline quinone, or PQQ.
It is believed that it is a vitamin-like substance. It is produced by certain bacteria, including methylotrophic bacteria and acetobacter.
There are few studies on PQQ in humans. Dosage is based on the results of animal studies. However, it is important to obtain quantitative data on PQQ’s content in foods.
The applicant intends to market PQQ in food supplements for healthy adults and lactating women. They are also considering the possibility of marketing it for pregnant women.
The FDA panel reviewed the full application and considered it valid as of December 22, 2016. Some information is missing from the applicant’s file. For example, it did not provide data regarding the composition of its products. It also did not provide any toxicokinetic investigations.
Panel members noted that the applicant did not conduct a full toxicological assessment. They requested additional information from the applicant. In addition, they noted that the study was not conducted in accordance with US FDA GLP principles.
The Panel notes that the applicant failed to identify a safety margin for the NOAEL of 100 mg/kg bw/day. This margin is used to determine the safe dose for human consumption.
The Panel also noted that the study was conducted using a highly purified compound. Further, it noted that the study was not designed to assess renal function.