10 Things to Know about New Regulations for Nanoparticles in Cosmetics

Recently, the FDA released a report on nanotechnology in cosmetic products. In case you didn’t know, the FDA is the governmental body in the US that is responsible for regulating cosmetics.

The report is meant for people to read and give comments and it is not yet binding. This is the way things work with the FDA. They release a draft report, let people comment on it, make some changes, then issue a final report. The whole process can take a long time but things eventually get done.

Nanoparticles in cosmetics

The report on cosmetics is rather short and I encourage you to read it. But in case you just want the summary points, here are the highlights.

1. The FDA does not take a position on a formal defintion of nanotechnology but they mention that it is most commonly used to refert to materials that range in size from 1 to 100 nanometers. They do point to the National Nanotechnology Initiative Program for guidance.

2. The FDA makes no blanket judgement about whether nanotechnology is intrinsically benign or harmful. They will make judgements on a case-by-case basis.

3. FDA says you should meet with them to discuss test methods you need to follow to substantiate your product’s safety.

4. Nanoparticles have to be assessed for safety for each application. This is different than chemicals which can often be saftey tested outside a formulation.

5. You need to fully characterize the nanoparticles you work with. (name, size, structure, formula, etc.)

6. Traditional toxicology tests need to be modified when testing nanoparticles.

7. Toxicology tests need to consider different routes of exposure including skin absorption and inhalation.

8. FDA still recommends in vivo (animal) testing for toxicity evaluation. Some in vitro methods are being considered but have not been suitably validated.

9. Clinical testing of the material in human volunteers under controlled conditions is recommended.

These regulations and testing requirements may make it difficult for small cosmetic companies to use nanotechnology any time soon. But if there is a big enough benefit, you can bet the big companies will be launching more products in the future. That is, if the chemical fearmongers don’t scare everyone away from what could be radically better cosmetic products.

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