FDA's product-focused regulation: the weak spots
Saturday, October 7, 2006
Movanet
Want to know if your nanotech-sunscreen creams should undergo an FDA review before they are cleared to enter the market? It is likely that the answer is negative. Cosmetic ingredients reviews are voluntary and is conducted by a non government -- but independent-- party.
Michael R. Taylor analyzes FDA’s ability in regulating the potential hazards associated with nanotechnology in a new report, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? The paper contained proposed nanolabelling of products containing nanomaterials. It also explained the pre and post marketing oversight phases and its effectiveness. The main issue presented on his paper is FDA's institutional capability-- in accordance with its jurisdiction -- in monitoring and regulating Nano products.
The categorization of products are as follows: (i) cosmetic ingridients, whole food, dietary supplement, GRAS food ingredient, food additive, food packaging, medical device, OTC drug and new drugs. FDA's jurisdcition is rated using gradient: none, weak, moderate and strong. None indicates that it has no jurisdiction and weak indicates that the process is voluntary.
Taylor founds that there are weak spots in which the FDA has no jurisdiction to inspect some of the products such as in whole foods (vegetables, fruits, etc, as opposed to its additional "ingridients"), dietary supplements and costmetics prior to its marketing. For whole foods, he admitted that the burden of proof rests on the producer and the FDA will only have a moderate authority to remove it from the market when something goes wrong. This is of course due to the natural production type of foods, where no pipeline investigation is possible (as they comes from soil). Nevertheless, FDA has the authority to inspect their warehouse. It is not clear how nanotech will be linked to whole foods production. Use of fertilizer will be EPA's authority and not FDA's. Howbout nano-engineered GMO food? That one we still don't know.
Keep in mind that the analysis used an institutional approach. There might be some parameters that he misses but as an overall, it provides a good, quick and simple overview in elaborating FDA's institutional capability in regulating the existing nano products.
Well, click here for the full report. Its an ought-to-know for nano lawyers and nano-manufacturers!
Michael R. Taylor analyzes FDA’s ability in regulating the potential hazards associated with nanotechnology in a new report, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? The paper contained proposed nanolabelling of products containing nanomaterials. It also explained the pre and post marketing oversight phases and its effectiveness. The main issue presented on his paper is FDA's institutional capability-- in accordance with its jurisdiction -- in monitoring and regulating Nano products.
The categorization of products are as follows: (i) cosmetic ingridients, whole food, dietary supplement, GRAS food ingredient, food additive, food packaging, medical device, OTC drug and new drugs. FDA's jurisdcition is rated using gradient: none, weak, moderate and strong. None indicates that it has no jurisdiction and weak indicates that the process is voluntary.
Taylor founds that there are weak spots in which the FDA has no jurisdiction to inspect some of the products such as in whole foods (vegetables, fruits, etc, as opposed to its additional "ingridients"), dietary supplements and costmetics prior to its marketing. For whole foods, he admitted that the burden of proof rests on the producer and the FDA will only have a moderate authority to remove it from the market when something goes wrong. This is of course due to the natural production type of foods, where no pipeline investigation is possible (as they comes from soil). Nevertheless, FDA has the authority to inspect their warehouse. It is not clear how nanotech will be linked to whole foods production. Use of fertilizer will be EPA's authority and not FDA's. Howbout nano-engineered GMO food? That one we still don't know.
Keep in mind that the analysis used an institutional approach. There might be some parameters that he misses but as an overall, it provides a good, quick and simple overview in elaborating FDA's institutional capability in regulating the existing nano products.
Well, click here for the full report. Its an ought-to-know for nano lawyers and nano-manufacturers!