Natural Foods Merchandiser

NanoNaturals: Will FDA regulate new nanotech products?

Counselor's Corner

Q: What is a multibillion dollar industry based on particles that are one-billionth of a meter?

A: Nanotechnology.

"Nanotech" is now used in the development and production of foods, food and color additives, dietary supplements, cosmetics, drugs and medical foods. But just what is nanotechnology, and what are its applications, opportunities, challenges and risks? We'll discuss that, but first we need to understand how small a nanometer is.

A nanometer is 10-to-the-ninth meter, or one-billionth of a meter, or one 25-millionth of an inch. A nanoparticle is defined as any molecular particle that is less than 100 nanometers in size. Here are some scientists' graphic descriptions of nanoparticles: If you "spread a drop of water over a square meter, it would form a thin film of roughly one nanometer." "Think of the metal film layered onto tinted sunglasses: A nanometer is one-tenth that thickness." "The edge of a sheet of paper is 100,000 nanometers thick." For a frame of reference, consider that a DNA molecule is 2.5 nanometers in width.

The National Nanotechnology Initiative, a research and development coordinating program, defines nanotechnology at www.nano.gov as "the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications." Because of their tiny size, nanometers have an extremely high ratio of surface area to volume. This means that nanotech materials often have different chemical or physical properties compared with larger particles.

According to the U.S. Food and Drug Administration in a Federal Register notice of Aug. 11, 2006, "Such differences include altered magnetic properties, altered electrical or optical activity, increased structural integrity, and increased chemical and biological activity." Because of these unique properties, nanotech materials have potential for use in myriad consumer products—but also have unknown, and possibly harmful, effects.

Nanoparticles play a role in dozens of products many Americans already use. Scientists estimate between 350 and 700 products manufactured in at least 17 different countries on the market employ nanotech. As of October 2006, the FDA estimates that more than 60 cosmetics and 20 dietary supplements employ nanotech, but these numbers have probably already been surpassed. Here's a sampling of what is currently marketed or on the horizon:

Supplements that are more bioavailable: Israeli researchers have uncovered ways to increase the bioavailability of enzyme Co-Q10 in drugs and dietary supplements. At the November SupplySide West show in Las Vegas, a new supplement for blood-lipid health was introduced, using "nanodispersion" of policosanol and omega-3 fatty acids, called Nanocosanol.

Functional foods: A major application of the technology could be a time-release mechanism in functional foods that would allow certain molecules to be activated when the body's levels of a nutrient are especially low. In this way, nanotech would enable a biofeedback process at the molecular level.

Food packaging and safety detection: One group of researchers is developing packaging in which nanoparticles embedded in plastic film can detect whether the food product inside has decomposed. A potential application of this technology would be to prevent or detect acts of bioterrorism on the nation's food supply.

Cosmetics: Nanotech sunscreen uses nanoparticles of zinc oxide to eliminate the usual white pasty appearance of sunscreens. Cosmetics use nanoparticles to increase stability and to modify the release and penetration of ingredients. Some nanotech skin creams are claiming to actually remove wrinkles, which, of course, raises the issue of possible fraudulent advertising claims if the nano nature of the product or ingredients does not actually have the effect claimed.

Over the past few years, the FDA has been striving to understand the health benefits, safety risks and regulatory implications of these tiny particles. This may be the year in which the FDA decides it is prudent to initiate rulemaking for nanotech products, including "nanonaturals." The FDA recognizes that special safety issues arise when scientists add submicroscopic particles to otherwise safe products like foods, supplements, cosmetics and even packaging. The agency is now struggling to find a balance between encouraging this nascent, revolutionary and promising technology without putting public health at risk. The FDA has held several public meetings to discuss a regulatory strategy for nanotech products.

Specifically, the FDA has expressed concerns about the safety of nanoparticles, particularly because as particle size gets smaller, there may be negative or unanticipated effects on biochemical activity. Those size-specific effects could involve nanoparticles gaining access to tissues and cells that would be impenetrable by larger particles, or nanoparticles remaining in human tissues for unknown periods of time. The FDA is also concerned that scientists don't yet know how nanoparticles are cleared from tissues and blood, or how different particles might affect different types of cells. Finally, how might various nanoparticles interact with one another, and is there a maximum number of nanoparticles that the human body can tolerate?

As of November 2006, the FDA had received no adverse-event reports associated with nanotech products. However, the agency is collaborating with the National Institutes of Health to examine the skin absorption and phototoxicity of nano-sized titanium dioxide and zinc oxide used in sunscreens; the FDA itself is planning additional studies to examine the effects of select nanoparticles on skin penetration. These concerns are likely to compound as nanoparticles appear increasingly in foods, supplements and cosmetics, especially those in which the nanoparticles pass through the skin. This last point raises an interesting linguistic and regulatory issue, too: Is a nano skin cream still "topical," or might its transdermal action place such a cream or lotion into the drug category?

The FDA's Web site has an FAQ page at www.fda.gov/nanotechnology, in which the agency raises the following new issues:

  • The likelihood that many of the nanotechnology products that the agency regulates will be combination products (i.e., drug-device, drug-biologic or device-biologic products). [These must be preapproved by the FDA's special Office of Combination Products.]
  • Because the FDA regulates products based on their statutory classification rather than the technology they employ, the FDA's regulatory consideration of an application involving a nanotechnology product may not occur until well after the initial development of that nanotechnology. [Emphasis added.]
  • Because the FDA has limited regulatory authority over certain categories of products, the agency may have limited authority over the use of nanotechnology related to those products. For example, with the exception of color additives, there is no premarket approval of cosmetic products or their ingredients. [Analogously, this same point applies to dietary supplements.]

Finally, the FDA has pointed out in a policy statement that it "regulates only the 'claims' made by the product sponsor. If the manufacturer makes no nanotechnology claims regarding the manufacture or performance of the product, the FDA may be unaware at the time that the product is in the review-and-approval process that nanotechnology is being employed." While the FDA earlier stated that it is aware of no or few products making nanotech claims, this has changed almost overnight. Such "nanoclaims" (e.g., claiming greater bioavailability of nanonutrients) are becoming more frequent in the food, supplement and cosmetics markets.

There is currently no international regulation of nanotech products. Nationally, however, a few groups coordinate the activities and policies of various U.S. government agencies, which the FDA participates in: the National Science and Technology Council, the Subcommittee on Nanoscale Science, Engineering and Technology and its Nanotechnology Environmental and Health Implications working group. In August 2006, the FDA signed a memorandum of understanding with the National Cancer Institute and the National Institute of Standards and Technology? mainly to work together on nanotechnology-related issues through a collaboration known as the Nanotechnology Characterization Laboratory. The mission of this laboratory is to research nanoparticles in a preliminary, pre-clinical setting to help advance nanotechnology's application to clinical, medical products. The lab mainly focuses on how nanoparticles can be used to help treat cancer, and on how to develop an "assay cascade" that will characterize nanoparticles' physical attributes.

The memorandum will include new agreements, including a process for material transfer that will allow and facilitate scientists' sharing information about materials being analyzed and studied under the agreement, as well as data sharing. The agreement also explicitly states that proprietary information will not be shared among the federal entities; thus, commercial companies can be assured that information submitted to the FDA under the agency's regulatory role would not become public, nor disclosed to the lab.

Also in August 2006, acting FDA Commissioner Andrew von Eschenbach created an internal Nanotechnology Task Force to help the agency evaluate the increasing use of nanotech materials in FDA-regulated products. One of the major legal issues is: Does the FDA have the Congressional authority to regulate nanotech products, given that the agency does not have the power to govern the technology used, and also given that many products (including most natural products) do not require premarket approval? One of the major scientific issues is whether the benefits of nanotech products outweigh their risks.

On Oct. 5, Michael Taylor, a former FDA deputy commissioner for policy and now a professor at the University of Maryland, issued a report on nanotechnology days before a meeting of the NTF on Oct. 10. In his report, Taylor argued that both the FDA's budget constraints and gaps in its legal authority hinder its ability to oversee and manage nanotechnology's potential risks. Ultimately, he concluded that the FDA needs more resources, not more rules. Others agree that a viable regulatory framework already exists. For example, at the meeting, Milton Philbert, Ph.D., said that the benefits of using nanomaterials greatly outweigh the risks, and suggested that the real risk might be over-regulation.

This column is not meant, and should not be construed, as a legal opinion, or legal advice, but rather is intended to provide general information and principles as to one aspect of FDA or FTC law.
On the other hand, a lawyer attending the meeting warned that this very discussion of regulating nanotech products was at least 10 years overdue. Once again, scientific progress outpaces the measured steps of federal agencies. The task force will use information from the October meeting along with other scientific sources to prepare a report, due in nine months with recommendations, to von Eschenbach on the state of nanotechnology in the United States. Thus, in July 2007, new regulatory ideas on nanonaturals will be born. Whether they represent a brainchild or a monster remains to be seen.

Susan Brienza is an attorney in the Denver office of the Washington, D.C., law firm Patton Boggs LLP. She practices in the area of regulatory compliance, in FDA law (including DSHEA) and FTC law. Her e-mail address is [email protected]. Christa Rock, also of Patton Boggs LLP, assisted with this article.

Natural Foods Merchandiser volume XXVIII/number 1/p. 36, 38

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