The Food
and Drug Administration’s (FDA) Center for Food Safety and
Applied Nutrition (CFSAN), the agency responsible for regulating
dietary supplement products, has released its annual list of
“work product expectations” for fiscal year 2004. The federal
fiscal year runs from October 1 of one year through September 30
of the following calendar year. In keeping with the FDA’s
bureaucratic inefficiency, the 2004 program priorities were
released seven months after the start of the current fiscal
year. The good news is that there are only five months left in
the current year.
Some of the CFSAN initiatives have been around for several years
in the agency’s Strategic Plan for Dietary Supplements. One
policy factor that changes from year to year is the level of
“priority” assigned to program and regulatory actions. According
to CFSAN Director, Robert Brackett, the guiding FDA principle
for “priority” assignment is focusing on the question: “Where
can we do the most good for consumers and the overall public
health?” I would submit that there are hundreds of millions of
Americans who, if presented with this question, would respond
with - Nowhere at anytime!
The CFSAN Director says that the FDA is “working harder than
ever to make sure the information consumers receive is
scientifically valid and easily understood.” With regard to
implementing the Dietary Supplement Health and Education Act (DSHEA),
this same CFSAN Director testified before Congress in April that
the FDA had not yet effectively implemented the 1994 law. Is
there a trend here? Seven months late this year, and ten years
late on DSHEA.
The 2004 plan includes 168 "A-list" activities. The goal is to
complete at least 90 percent of these "A-List" items by the end
of the current fiscal year, September 30, 2004. Americans can
rest assured that this target will not be met. Activities on the
"B-list" are those the FDA plans to make significant progress on
but which may not be completed before the end of this fiscal
year. Many of these are multi-year efforts that will eventually
make the A-list. Some of the following can be expected to
materialize this year or in the near future. On the other hand,
it should be hoped that many do not materialize, given the FDA’s
previous history of not doing “the most good for consumers”, and
interfering with Americans’ health care freedom choices.
Notable
Level A Priority Activities
To enhance consumer health information for better nutrition by
publishing a regulation and requesting public comments on a
regulatory strategy for qualified health claims for dietary
supplements. Related to this is a project to conduct and analyze
consumer research to help ensure that qualified health claim
messages in the labeling of foods and dietary supplements are
not misleading to consumers. The FDA is, in fact, already moving
to issue a regulation. However, this has been on the Level A
List for the past four years.
Regarding the regulation of new dietary supplement ingredients,
to review the current pre-market (75-day) notifications for new
dietary ingredients within statutory timeframe. And, review the
30-day post market notifications for supplement claims in a
timely manner. There is also the development of a Guidance
Documents for industry on submissions of 75-day
pre-notifications for new dietary ingredients. And, the related
publishing of a Guidance Document on substantiation of
structure/function claims for dietary supplements.
In the category of “Protecting and Promoting Public Health with
Agency Initiated Actions” is the goal of publishing a final rule
for dietary supplement Good Manufacturing Practices (GMPs). And,
“Continue efforts in conjunction with the Federal Trade
Commission, to take action against unsubstantiated claims on
dietary supplements.” The FDA issued the latest draft of GMP
regulations in April of 2003. There is a good chance that a
final regulation will be issued before the end of this year. The
“one size fits all” model the FDA is proposing for GMP
compliance will increase costs for small dietary supplement
manufacturers and consumers of supplements because of the
proposed and unnecessary bureaucratic report filings.
Notable Level B Priority Activities
In the future, the FDA could publish a final rule on "per day"
labeling for dietary supplements. The agency also wants to
continue to develop standard operating procedures (SOPs) to
enhance timely identification and clinical assessment of dietary
supplement adverse events. Related to this is the development of
FDA reporting mechanisms to enhance agency adverse event
investigations. In short, more bureaucratic interference and
attempt to regulate common sense as it relates to human
behavior, as interpreted by numerous FDA bureaucrats.
Health freedom advocates, their friends, neighbors, and
co-workers, and dietary supplement consumers in general NEED to
stay actively involved in responding to FDA regulatory and
public policy initiatives either to the Congress or when FDA
regulations are issued. Without proactive counter measures to
prevent the further interference of the FDA into individuals'
rights to choose to consume healthy food, take supplements and
use alternative therapies without government restrictions, it
will be guaranteed that federal bureaucrats who believe that
only they know what is best for the taxpayers who pay their
federal salaries will continue to have their way in decisions
that will impact everyone’s freedom of choice, now and in the
future
