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FDA Regulation of Nanotechnology Products
       
FDA's Mission
- The mission of the Food and Drug Administration is, in part, to ensure that the drugs,
drug delivery systems, cosmetics, medical devices, vaccines, and food products reaching the
marketplace are safe and effective.
Figure 1 displays the breadth of products regulated by the FDA.
These products represent about 20 percent of consumer purchases in the domestic market. Another
measure of the impact of FDA's mission is its regulation of about $50 billion per year of medical sector
R&D.

Risk Management -- The FDA paradigm for regulation of these products is based on the concepts of
"risk management", i.e. risk identification, risk analysis, and risk control. To implement risk
management for nanotechnology products, we must acknowledge that the cells and molecules with
which FDAers work every day are "nano" in size. In particular, every degradable medical device or
injectable pharmaceutical generates particulates that pass through this size range during the processes of
their absorption by the body. FDA has not experienced an adverse reaction related to the "nano" size of
resorbable drug or medical device products.

FDA regulates on a "product-by-product" basis. Although the several pieces of enabling legislation have
established several formalisms for regulation with different names for each product type, they all
basically fall into three categories: Premarket Approval, Premarket "Acceptance" and Post Market
Surveillance.

Premarket Approval -- This process is that with which most people believe they are familiar. Prior to
introduction into the marketplace, new pharmaceuticals, high-risk medical devices, food additives,
colors, and biologicals require approval by FDA. Typically the producer/sponsor of the product
identifies and assesses the risks presented by the product and addresses each risk and how it will be
minimized in a product application. FDA staff then reviews these documents, often with the assistance
of an Advisory Committee. A per-approval inspection of the manufacturing plant is often required.

Premarket "Acceptance" -- In this general category are several similar authorities. For these
products, FDA receives and reviews some form of notice that the products will be marketed. These
products are often copies of similar products that were approved previously or are products prepared to
approved specifications. For example, pharmaceuticals that are manufactured to existing USP
Monographs and medical devices marketed with 510(k) Premarket Notifications. The review process of
these products is significantly more rapid than Pre-Market Approval.

Post Market Surveillance -- In this third category, FDA manages the risks of products like foods,
cosmetics, radiation emitting electronic products, and materials such as food additives and food
packaging that are "generally recognized as safe" (GRAS). For these products, market entry and
distribution are at the discretion of the manufacturer/producer. All these products are generally regulated
by the application of Good Manufacturing Practices. FDA monitors the behavior of these products and
takes regulatory action if adverse events occur that threaten public or individual health.

Coordination of Policy with Other Government Agencies -- Within FDA, the Office of Science and
Health Coordination (OC/OSHC), coordinates regular discussions on nanotechnology among the major
experts from every organizational entity within the Agency. In addition the Centers within FDA, e.g.
Drugs and Medical Devices, have organized similar regular discussion groups. The purpose of these
meetings is to share experiences with the review of the products, insure that each Center is aware of
product guidance that may be developing elsewhere within the Agency, and generally educate staff and
policy makers about nanotechnology. Safety issues are identified and studied.

In a similar manner, FDA coordinates knowledge and policy with the other US Government agencies as
a member of the Nanoscale Science and Engineering Technology (NSET) Subcommittee of the National
Science and Technology Council (NSTC) Committee on Technology. Also, FDA and NIOSH co-chair
the NSET Working Group on Nanomaterials Environmental and Health Implications (NEHI) to define
new test methods/protocols to define safety of these products. Finally, FDA is a direct contributor to
the evaluations of the toxicity of materials supported by the NIEHS and the National Toxicology
Program (NTP).

Current Issues in Nanotechnology - There are several issues under discussion in various forums
related to the FDA's regulation of nanotechnology products.

FDA expects many nanotechnology products that we regulate to span the regulatory boundaries
between pharmaceuticals, medical devices and biologicals. These will be regulated as "Combination
Products" for which the regulatory pathway has been established by statute. In such cases, FDA will
determine the "primary" mode of action of the product. This decision will determine the regulatory
framework for the product, i.e. a drug, medical device or biological product. The product application
will be managed by the appropriate FDA Center with consultations from the other Centers. It is valuable
to repeat here that FDA has traditionally regulated many products with particulate materials in this size
range. FDA believes that the existing battery of pharmacotoxicity tests is probably adequate for most
nanotechnology products that we will regulate. Particle size is not the issue. As new toxicological risks
that derive from the new materials and/or new conformations of existing materials are identified, new
tests will be required.

FDA regulates products, not technology. FDA, for example, regulates very few materials but many
types of products. This will affect the stage at which the FDA becomes engaged in the regulation of
nanotechnology and when, in the process, regulation takes effect. In addition, FDA regulates only to the
"claims" made by the product sponsor. If the manufacturer makes no nanotechnology claims regarding
the manufacture or performance of the product, FDA may be unaware at the time that the product is in
the review and approval process that nanotechnology is being employed. Within this issue is embedded
the definition of nanotechnology. It is quite likely that new therapeutic benefits are being derived from
products that are smaller than their traditional form but fall above the 100 nm size-range limit of
nanotechnology.

Finally, FDA has only limited authority over some potentially high-risk products, e.g. cosmetics. As we
noted earlier in this discussion, many products are regulated only if they cause adverse health-related
events in use. To date there have been comparatively few resources available to assess the risks of these
products. Other government agencies have different missions with regards to nanotechnology, e.g. to
solve environmental problems, improve technology to address disease, etc. Few resources currently
exist to assess the risks that would derive to the general population from the wide-scale deployment of
nanotechnology products.
Figure 1

  • Foods
  • All interstate domestic and imported, including produce, fish, shellfish, shell eggs, milk (not meat or poultry)
  • Bottled water
  • Wine <7% alcohol
  • Infant formula

  • Food additives
  • Colors
  • Food containers

  • Cosmetics
  • Dietary supplements
  • Animal feeds

  • Pharmaceuticals
  • Human
  • Animal
  • Tamper resistant packaging

  • Medical Devices
  • Radiation Emitting Electronic Products
  • Vaccines
  • Blood products
  • Tissues
  • Sterilants

from
http://www.fda.gov/nanotechnology/
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Mission -- Protect the public health by assuring safe and effective medical products and safe
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