Tag Archives: Torie Bosch

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Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.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Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food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Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products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The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology,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The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products.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//www.regulations.gov. 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.

Cyborg insects and trust

I first mentioned insect cyborgs in a July 27, 2009 posting,

One last thing, I’ve concentrated on people but animals are also being augmented. There was an opinion piece [no longer available on the Courier website] by Geoff Olson (July 24, 2009) in the Vancouver Courier, a community paper, about robotic insects. According to Olson’s research (and I don’t doubt it), scientists are fusing insects with machines so they can be used to sniff out drugs, find survivors after disasters,  and perform surveillance. [emphasis mine]

Today, Nov. 23, 2011, a little over two years later, I caught this news item on Nanowerk, Insect cyborgs may become first responders, search and monitor hazardous environs,

“Through energy scavenging, we could potentially power cameras, microphones and other sensors and communications equipment that an insect could carry aboard a tiny backpack,” Najafi [Professor Khalil Najafi] said. “We could then send these ‘bugged’ bugs into dangerous or enclosed environments where we would not want humans to go.”

The original Nov. 22, 2011 news release by Matt Nixon for the University of Michigan describes some of the technology,

The principal idea is to harvest the insect’s biological energy from either its body heat or movements. The device converts the kinetic energy from wing movements of the insect into electricity, thus prolonging the battery life. The battery can be used to power small sensors implanted on the insect (such as a small camera, a microphone or a gas sensor) in order to gather vital information from hazardous environments.

A spiral piezoelectric generator was designed to maximize the power output by employing a compliant structure in a limited area. The technology developed to fabricate this prototype includes a process to machine high-aspect ratio devices from bulk piezoelectric substrates with minimum damage to the material using a femtosecond laser.

Here’s a model of a cyborg insect,

Through a device invented at the University of Michigan, an insect's wing movements can generate enough electricity to power small sensors such as a tiny camera, microphone or gas sensor. (Credit: Erkan Aktakka)

This project is another example of work being funded by the US Defense Advanced Research Projects Agency (DARPA). (I most recently mentioned the agency in this Nov. 22, 2011 posting which features innovation, DARPA, excerpts from an interview with Regina Dugan, DARPA’s Director, and nanotherapeutics.)

There are many cyborgs around us already. Anybody who’s received a pacemaker, deep brain stimulator, hip replacement, etc. can be considered a cyborg. Just after finding the news item about the insect cyborg, I came across a Nov. 23, 2011 posting by Torie Bosch about cyborgs for Slate Magazine,

Though the word cyborg conjures up images of exoskeletons and computers welded to bodies, the reality is far more mundane: Anyone who has a cochlear implant, for one, could be termed a cyborg.  So is the resourceful fellow who made his prosthetic finger into a USB drive. In the coming decades, we’ll see more of these subtle marriages of technology and body, creating new ethical questions.

At the blog Cyborgology, P.J. Rey, a graduate student who writes about emerging technologies, examines the trust relationships we have with the technologies—and the people who develop them—that become engrained with our daily lives. [emphasis mine]

From P. J. Rey’s Nov. 23, 2011 posting about trust and technology on Cyborgology,

In this essay, I want to continue the discussion about our relationship with the technology we use. Adapting and extending Anthony Giddens’ Consequences of Modernity, I will argue that an essential part of the cyborganic transformation we experience when we equip Modern, sophisticated technology is deeply tied to trust in expert systems. It is no longer feasible to fully comprehend the inner workings of the innumerable devices that we depend on; rather, we are forced to trust that the institutions that deliver these devices to us have designed, tested, and maintained the devices properly. This bargain—trading certainty for convenience—however, means that the Modern cyborg finds herself ever more deeply integrated into the social circuit. In fact, the cyborg’s connection to technology makes her increasingly socially dependent because the technological facets of her being require expert knowledge from others.

It’s a fascinating essay and I encourage you to read it as Rey goes on to explore social dependency, trust, and technology. On a related note, trust and/or dependency issues are likely the source of various technology panics and opposition campaigns, e.g. nuclear, GMOs (genetically modified organisms), telephone, telegraph, electricity, writing, etc.

It’s hard to understand now that literacy is so common but in a society where it is less common, the written word is not necessarily to be trusted. After all, if only one person in the room can read (or claims they can), how do you know they’re telling the truth about what’s written?

As for cyborgs, I think we’re going to have some very interesting discussions about them and these discussions may not all occur in the sanctified halls of academe or in quiet conference rooms stuffed with bureaucrats. As I’ve noted before there is a whole discussion taking place about emerging technologies in the realm of popular culture where our greatest hopes and fears are reflected and, sometimes, intensified.