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quinta-feira, 26 de abril de 2012

Do the US FDA guidance documents for nanotechnology in food and in cosmetics matter?

The US Food and Drug Administration (FDA) has issued two documents that provide guidance to manufactures of food products and cosmetics according to the April 20, 2012 news item on Nanowerk,
Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.
Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics. [emphasis mine]

They might also have indicated food additives and other ingredients are covered in the guidance. I mention this because I noticed that some of the news coverage does not make that point and people are likely to believe that it covers only food packaging and not ingredients.

You can check out the guidance documents (both the one for foods and the one for cosmetics) for yourself,
Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives
Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products

This US FDA April 20, 2012 press announcement offers some details,
The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:
  • affect the identity of the food substance;
  • affect the safety of the use of the food substance;
  • affect the regulatory status of the use of the food substance; or
  • warrant a regulatory submission to FDA.
The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:
  • The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.
  • To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.
Both guidances encourage manufacturers to consult with the agency before taking their products to market. Such consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status.
Strong science is critical to FDA’s ongoing review of the products it regulates.  FDA is investing in an FDA-wide nanotechnology regulatory science program to further enhance FDA’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products.
“Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”
The FDA’s current thinking concerning nanomaterials for food and cosmetics uses, explained in the two guidance documents, is not intended to provide guidance to manufacturers about the use of nanomaterials in other products, such as drugs or medical devices, regulated by the FDA.

It’s still possible to comment on the guidelines as they are at a ‘draft’ stage, from the FDA’s April 20, 2012 press announcement,
In order to ensure that FDA considers comments on these draft guidances in developing the final guidances, electronic or written comments should be submitted within 90 days of the publication of the notices of availability in the Federal Register. The FDA will carefully consider all relevant, substantive comments during the development of the final guidance documents.
Electronic comments should be submitted to http// Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

It looks to me like this is an attempt to develop a relationship where the industry players in the food industry to police their nanotechnology initiatives with the onus being on industry to communicate with the regulators in a continuous process, if not at the research stage certainly at the production stage. That same request is being made to the cosmetics industry, from the draft guidance document for cosmetic products,
If you wish to use a nanomaterial in a cosmetic product, either a new material or an altered version of an already marketed ingredient, FDA encourages you to meet with us to discuss the test methods and data needed to substantiate the product’s safety, including chronic toxicity and other long-term toxicity data as appropriate.  Individuals outside the Federal Government may request a private meeting with a representative of FDA to discuss a matter, and FDA will make reasonable efforts to accommodate such requests (21 CFR 10.65(c)).  We encourage you to take advantage of this provision and contact us to discuss any aspect of the safety assessment of cosmetic ingredients or finished products.

You can read some additional commentary about both draft guidelines in the April 22, 2012 posting on redOrbit, the April 20, 2012 news item by Torie Bosch for Slate magazine, and  the April 20, 2012 Reuters article by Anna Yukhananov in the Chicago Tribune.

One odd thing I noticed in some articles and commentaries (e.g. Reuters article by Anna Yukhananov) is a reference to the European Union rules with regard to cosmetics products. The observers seemed to be under the impression that cosmetics companies with European production facilities and/or headquarters would operate under the same rules in North America. From the Yukhananov article,
The FDA does not require cosmetic companies to submit safety data before selling their products, and the guidance is unlikely to have a big impact on large cosmetic firms like Avon Products Inc, which already comply with European rules.

Why would Avon extend its compliance with European Union (EU) rules to its US operations? Companies routinely operate under different rules in different countries and regions.

Getting back to the question I asked in the headline, do these guidance documents matter? Yes, as stated earlier, I think this is an attempt to develop a relationship with open communication and where industry is being respected enough to manage/police itself. One hopes that this is not misplaced trust.

Fonte: FrogHeart