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Sunscreen Ruling by US FDA - nanoscale Ingredients are not absorbed

On 14 June 2011 the US Food and Drug Administration (FDA) released a new statement about the labelling of the sunscreen products entitled FDA Announces Changes to Better Inform Consumers About Sunscreen. In order to provide a better consumer awareness of the over the counter sunscreen products FDA also established a consumer website to explain the changes in labelling and functionality of common sunscreen products.

Common sunscreens protect against the ultraviolet A (UVA) and ultraviolet B (UVB). UVA and UVB contribute to sunburn, skin cancer and premature skin aging. Sunburn is caused primarily by UVB. The new FDA's regulation would only allow products to be branded as "Broad Spectrum" is they provide adequate protection against both UVA and UVB.

The FDA's recommendation is to use Broad Spectrum products with a Sunscreen Protection Factor (SFP) of 15 or more. Any products with broad spectrum qualities, but SPF from 2 to 14 will be required to have a warning that 'the product has not been shown to help prevent skin cancer or early skin aging'. The regulation also limits the use of the term 'broad spectrum' and prohibits the use of terms like 'sunblock', 'waterproof' and 'sweatproof' and mandates use of the Drug Facts labelling format. 76 Fed. Reg. 35620. from 18 June 2012.  

The FDA has also issued three guidelines related to the sunscreen products:

In an additional statement, the FDA confirmed its stance on the active ingredients that in most cases are TiO2 or ZnO in micro and nano-form: 'To ensure that sunscreen products meet modern safety standards, FDA is also currently reexamining the safety information available for active ingredients included in sunscreens marketed today. The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use'. It could be argued that the above statement does not explicitly specify that the regulation applies to nano-form of TiO2 and ZnO, but in a webcast interview by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), stated that the CDER investigated the nanoparticle penetration into the animal skin and found no penetration. She also noted that their findings were in line with a number of scientific publications on the subject.  

The new regulation will take a year to come into force with smaller suppliers with sales of less than USD 25000 having 2 years to comply. The Guide for industry - Enforcement Policy:

  • OTC Sunscreen Drug Products Marketed Without an Approved Application' is only draft of non-binding obligations. 'Unless the failure to pursue regulatory action poses a potential health hazard to the consumer, we do not intend to object to the marketing without an approved application of OTC sunscreen products that have all of the following characteristics:
  • Contain only the active ingredients or combinations of active ingredients listed in Section II of this guidance (previously included in 21 CFR 352.10 and 352.20, which are now stayed)
  • Do not make claims addressed in 21 CFR 201.327(c)(3) and (g) and 310.545(a)(29)(ii)
  • Comply with the requirements for OTC drugs under 21 CFR part 201 and 330.1, requirements for adverse event reporting for OTC drugs, and provisions of the FD&C Act addressing adulteration, and
  • Follow labeling and testing requirements in § 201.327 (in accordance with the effective date and compliance dates established in the 2011 final rule) except as specific recommendations of this guidance address below'


For more information please follow this link to the main sunscreen FDA website or directly to the guide for industry document Q&A section of the website is also available.

News item was produced by NIA in association with BREC Solutions.

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