Tuesday, July 11, 2006

FDA should put in more face time

The confusion continues over nanoparticles in cosmetics. This uncertainty over safety is one of many reasons why nanobio researchers wish the Beauty Industrial Complex would find a different marketing term and the U.S. Food and Drug Administration would get more aggressive in sorting out safely engineered nanoparticles from untested, nanosized zinc oxide.

The FDA does not have as much authority over cosmetics as it does over, well, food and drugs. An argument can be made, however, that the more-sophisticated cosmetics out there -- L’Oreal's nanosomes, for example -- could qualify as drug delivery devices.

Update: Shopping for answers: Nanotechnology: Another concern for cosmetics users? (By Leigh Grogan, Sacramento Bee)

Straight-up info on nanotech regulation
Friends of the Earth releases nanotox report
FDA tries to get a virtual grip on nano
Nerd American Idol


Richard Jones said...

Howard, the border between cosmetics and pharmaceuticals is both well demarcated and well policed, and the cosmetics companies are very well versed in staying on the right side of it (even if you don't always get this impression from their marketing). This may in the future get more problematic as the idea of "cosmeceuticals" moves from marketing to reality. As for nanosomes, my guess is that the L'Oreal ones are made from the naturally occurring phospholipids lecithin. This would indeed be essentially the same chemistry as is used in the delivery devices used by drugs like DaunoXome. But for L'Oreal's nanosomes to count as a drug, (a) they'd need to contain some pharmaceutically active ingredient, and (b) you'd need evidence that they would be able to pass through the skin into living tissue. I don't think either condition is met.

Howard Lovy said...

Hello, Richard,

Sorry about the belated response. It's good to "hear" from you again.

While the border between cosmetics and pharmaceuticals might be well demarcated from your (scientific) perspective, it is not so clear from a regulatory standpoint. At least, that is the case in the United States. Maybe Mother England has done a better job?

I have heard, albeit anecdotally only, nanobio researchers and entrepreneurs complain about cosmetics companies use and promotion of nanoscale ingredients that have not gone through the same kind of rigorous approval process required of nanobio. I only assume that my sources are not fooled by marketing and that the concern is legitimate. However, as we know, the nanotech business community is finally acknowledging the impact of public perception on their ability to do business.

As for cosmeceuticals like L'Oreal's nanosomes, well, what exactly are "pharmaceutically active" ingredients? Why do the current ingredients not qualify? (This is not a rhetorical question, by the way. I'm playing "reporter" here and I'd love to have this explained to me). And shouldn't the burden be on the companies to prove that they do not pass through into living tissue?

In any case, if both conditions were met, then they would be an entirely different animal in the eyes of the FDA: A Combination Product, or drug and drug delivery device all wrapped up in one.

I recently came across a blog from a couple of patent attorneys. I thought their explanation made sense:

"However, the FDA only regulates certain categories of products. Though existing requirements may be adequate for most nanotechnology products, many of the nanotechnology products will be Combination Products (i.e., drug-device, drug-biologic, or device-biologic products). The current policy regarding combination products helps prevent duplication of effort and a protracted approval process. If the product meets the definition of a combination product, it will be assigned to an Agency center that will have primary jurisdiction for its regulation. The assignment of a lead center is based upon a determination of the primary mode of action (PMOA) of the combination product. For example, if the PMOA of a combination product is that of a biological product, then the combination product would be assigned to the Agency component responsible for premarket review of that biological product."

Here are the FDA rules on Combination Products.

Isn't it all perfectly clear now, Richard?