| |
The FDA
regulates dietary supplements under a
different set of regulations than those
covering "conventional" foods and drug
products (prescription and
Over-the-Counter). Under the Dietary
Supplement Health and Education Act of 1994
(DSHEA), the dietary supplement manufacturer
is responsible for ensuring that a dietary
supplement is safe before it is marketed.
FDA is responsible for taking action against
any unsafe dietary supplement product after
it reaches the market. Generally,
manufacturers do not need to register their
products with FDA nor get FDA approval
before producing or selling dietary
supplements. Manufacturers must make sure
that product label information is truthful
and not misleading.
FDA's post-marketing
responsibilities include monitoring safety, e.g.
voluntary dietary supplement adverse event reporting,
and product information, such as labeling, claims,
package inserts, and accompanying literature. The
Federal Trade Commission regulates dietary supplement
advertising.
GMP Compliance
The FDA also sets forth a set of rules
that manufacturers must follow called "Good
Manufacturing Practices" often referred to as GMP. The
current Good Manufacturing Practice (GMP) requirements
set forth in the Quality System (QS) regulation are
promulgated under section 520 of the Food, Drug and
Cosmetic (FD&C) Act. They require that domestic or
foreign manufacturers have a quality system for the
design, manufacture, packaging, labeling, storage,
installation, and servicing of finished medical devices
intended for commercial distribution in the United
States. The regulation requires that various
specifications and controls be established for devices;
that devices be designed under a quality system to meet
these specifications; that devices be manufactured under
a quality system; that finished devices meet these
specifications; that devices be correctly installed,
checked and serviced; that quality data be analyzed to
identify and correct quality problems; and that
complaints be processed. Thus, the QS regulation helps
assure that medical devices are safe and effective for
their intended use. The Food and Drug Administration
(FDA) monitors device problem data and inspects the
operations and records of device developers and
manufacturers to determine compliance with the GMP
requirements in the QS regulation.
Manufacturers should use good judgment
when developing their quality system and apply those
sections of the QS regulation that are applicable to
their specific products and operations, 21 CFR 820.5 of
the QS regulation. Operating within this flexibility, it
is the responsibility of each manufacturer to establish
requirements for each type or family of devices that
will result in devices that are safe and effective, and
to establish methods and procedures to design, produce,
and distribute devices that meet the quality system
requirements. FDA has identified in the QS regulation
the essential elements that a quality system shall
embody for design, production and distribution, without
prescribing specific ways to establish these elements.
Because the QS regulation covers a broad spectrum of
devices and production processes, it allows some leeway
in the details of quality system elements. It is left to
manufacturers to determine the necessity for, or extent
of, some quality elements and to develop and implement
specific procedures tailored to their particular
processes and devices.
Information on this page has been taking
directly from FDA.gov.
|
 |
