Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts
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Weak regulation on cosmetics a time bomb

Thursday, February 22, 2007

Voluntary regulatory system in US cosmetic industry can be a time bomb:
Now, new nanotechnologies are being widely deployed in cosmetics products, despite evidence of serious potential health risks. Moreover, the physical application of some of the nanotechnologies to the body in cosmetics makes these uses uniquely prone to skin penetration, inhalation and ingestion of the nanotech materials.

List of cosmetics using nano products:
  • Penetration enhancer - Encapsulating or suspending key ingredients in so-called nanospheres or nanoemulsions, increases their penetration into the skin
  • L’Oreal (which ranks No. 6 in nanotechnology patent holders in the U.S.) 75 has used polymer nanocapsules to deliver active ingredients, e.g. retinol or Vitamin A, into the deeper layers of skin. In 1998 the company unveiled Plentitude Revitalift, an anti-wrinkle cream using nanoparticles.
  • Freeze 24/7, a new anti-wrinkle skincare line is planning to incorporate nanotechnology in future products.
  • La Prairie’s product, the Dollars 500 Skin Caviar Intensive Ampoule Treatment, claims to minimize the look of uneven skin pigmentation, lines and wrinkles in six weeks using nanotechnology. La Prairie’s vice president of retail marketing and training, Holly Genovese, says the nanoemulsions in the product “optimize the delivery of functional ingredients into the skin and allow these materials to get to the site of action quicker”.
  • Procter & Gamble’s Olay brand was designed with nanoemulsion technology in 2005.
  • Other companies using nanotech in their skin products as of 2005 include: Mary Kay and Clinique from Lauder; Neutrogena, from Johnson & Johnson; Avon; and the
  • Estee Lauder brand.
  • Hair products – using nanoemulsions to encapsulate active ingredients and carry them deeper into hair shafts.
  • PureOlogy began experimenting with nanoemulsions in 2000 when the company’s founder set out to create a product line especially developed for color treated hair.Sunscreens – the zinc and titanium in sunscreens are “micronized”, making them transparent, less greasy, less smelly and more absorbable into the skin.
  • DDF planned more nanotech-enhanced anti-aging products as of 2004.
  • Colorescience markets a product named Sunforgettable, a powder which contains titanium dioxide nanoparticles.
  • Paris-based Caudalie launched its Vinosun Anti-Aging Suncare, a sunscreen and anti-aging treatment that relies on “nanomized” UV filters and antioxidants, in the US in 2003.
I guess although the heading is "cosmetic", when nanoproducts are used, examination mechanism shall not be voluntary. Download IEHN report here.

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Regulating nanotech in food packaging

Wednesday, January 3, 2007

Nanologue has completed its interview research conducted at the sponsorship of the EU. This post will highlight the part of the research discussing regulaiton of nanotech in food packaging.

According to the research, nanotech in food packaging will bring benefits in the form of (i) Reduced usage of energy and raw materials (polymers) (ii) improvement of the mechanical properties of biodegradable polymers (iii) beneficial for reusable packaging due to improved mechanical strength and (iv) help to reduce the amount of packaging waste and save resources at the same time. There are however, risks associated with this. The first type of the risk deals with inconclusive research on impacts and lack of effects data: (i) Knoweldge about the effects of engineered nano-materials in the environment is still insufficient (ii) Risk of environmental pollution by nanoparticles (persistence and unknown catalytic effects) whereas the rests of the risks are common risks also found in normal chemicals which relates to pollution and waste: (a) Release of nano particles into the environment during the production and disposal phases of a product, (b) Uncontrolled incineration of nanocomposites could cause emissions of nanoparticles into environment and (c) Nanocomposite materials could disturb plastic recycling processes. Recyclers will have to deal with nanoparticular fillers, which eventually will be found in recycled materials.

Now, let's compare this with FDA's institutional capacity as has been discussed in my previous post. Taylor divided supervision mechanisms (on food packaging and other products) into pre marketing and post marketing.

Pre marketing. He reported that FDA's authority to inspect product on the pipeline is 'weak'. However, it has the strong capacity to (i) enforce safety and testing requirements, (ii) place burden to prove safety to sponsor and (ii) review safety prior to marketing. Post marketing. FDA has only moderate capacity to inspect facilities and safety records and it has 'no' capacity to requiry timely adverse event reporting or in requiring producers to conduct post market monitoring and testing. It has however, strong authority to remove unsafe products from the market -- of course!

The Nanologue's concerns with regards to "food packaging" is more toward its environmental risks (I suppose it means the use of nano-bags in replace of paper bags) while Taylor's report concerns more to its health impact. I think the nanologue should have also highlighted more on the implications of nano-food packaging to human, although food packaging undeniably have important side-effect towards the environment. When it comes to Taylor's proposal, then the recommendation is relatively simple: move the gradation of FDA's authority from 'none' or 'moderate' to 'strong'. This can provide a good balancing when a weaker precautionary approach is selected.

In my next post, I will try to highlight the regulation of nano-food packaging in the European Union. Meanwhile, you can read Nanologue's report here.

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On Michael Taylor's report

Friday, November 17, 2006

A few weeks ago I provide you with a link and analysis to Michael Taylor's paper criticizing FDA's institutional capability in supervising nano product. Recently, David Berube discuss this paper in his blog.

He considered these to be the primary question in Michael's paper. (1) 1. Should the FDA be given more responsibilities or is it time to break it into smaller entities to consider different issues? and (2) Should all nano-formulations (drugs) and sometimes drug/devices be treated as new for purposes of regulation? and (3) Should the burden to demonstrate safety be precautionary (in a strict sense)?

He provided the answers in his blog.


Be careful with what you put on your face

Saturday, November 11, 2006

There is an interesting news that the US FDA had so far banned only nine ingridients for cosmetic product, a sunking comparison with EU's one thousand. Is this the effect of a voluntary product testing regulation?
And seemingly more-straightforward labels calling items are “natural,” “organic” or “hypoallergenic” can be misleading. That’s because the FDA hasn’t established official definitions for these terms. “So companies can use them on cosmetic labels to mean anything or nothing at all,” according to the FDA’s Web site.Critics note that consumers use dozens of personal-care products daily and argue that potentially hazardous chemicals shouldn’t be used in the first place. The European Union has banned more than 1,000 ingredients considered unsafe for use in cosmetics. The FDA has banned nine.
And analogical interpretation of rules:
There also are concerns about the increased use of nanotechnology—compounds thousands of times smaller than the width of a human hair. Because of their size, there’s potential for these nano-sized ingredients to penetrate human cells and tissues. The technology is already being used in anti-aging creams and sunscreens—but the labels don’t have to specify its use. In the absence of stricter regulations, California lawmakers adopted the Safe Cosmetics Act of 2005. It requires cosmetic manufacturers to give the state a list of ingredients in their products that can cause cancer or reproductive harm. Washington has a program for reducing exposure to select hazardous chemicals, but nothing specific to safeguards for cosmetics.
The news further reported that chemicals used in cosmetics may be related to cancer and birth defect.