Many thousands of Americans flooded the Senate with objections to
a clause relating to the Reagan-Udall Foundation for the Food and Drug
Administration (FDA), which could be used to target dietary supplements
by evaluating them as drugs for safety purposes. While Senator Michael
Enzi (R-WY) refused to change the language, we created such an uproar
that assurances are officially in the Congressional Record that this
legislation is not to be used to harass dietary supplements.
And we headed off a potential attack by Senator Richard Durbin (D-IL) -- who
for some reason is always trying to get vitamins classified as drugs (more
safety hypocrisy). Key to this effort was myself writing for NewsWithViews.com;
Mike Adams, writing for NewsTarget.com; and John Hammell of the International
Advocates for Health Freedom. Support also came from many other groups who
forwarded the message. All our efforts resulted in the following testimony
on the floor of the Senate as reported in the Congressional Record:
May 2, 2007
Mr. HATCH. My office has been inundated by calls from people throughout
the country who believe that this legislation, specifically the provision
establishing a Reagan-Udall Institute, will overturn the Dietary Supplement
Health and Education Act of 1994. That has not been my reading of the
bill, but I wonder if other Senators have heard similar concerns?
Mr. HARKIN. Yes, I have received a good many calls as well. And, I
have to say that I would be very concerned, as I know the Senator from
Utah is, if anything in the bill we are considering, S.1082, would
overturn DSHEA, a law we fought side-by-side to see enacted.
Mr. ENZI. It might be helpful if I explained the provision you are
discussing, as my office has received many calls as well, and I believe
the callers are not informed about this matter. Subtitle B of title
II of S. 1028 establishes the Reagan-Udall Foundation for the Food
and Drug Administration. That simple purpose of that nonprofit Foundation
is to lead collaborations among the FDA, academic research institutions,
and industry designed to bolster research and development productivity,
provide new tools for improving safety in regulated product evaluation,
and, in the long term, make the development of those products more
predictable and manageable.
Mr. KENNEDY. That is exactly the purpose of the Foundation, which
was included in the drug safety legislation Senator Enzi and I introduced
last year. The Foundation will be financially supported by industry
and philanthropic donated funds. A chief scientist at FDA will promote
intramural research and coordinate it with efforts at the Foundation.
Mr. HATCH. That explanation is very helpful. What, specifically, would
the role of the Foundation be with respect to dietary supplements?
Mr. KENNEDY. Let me make absolutely clear that the Reagan-Udall Foundation
will in no way override, overturn, or conflict with the Dietary Supplement
Health and Education Act. Nothing in this bill would have that effect.
Mr. ENZI. Yes, we took great pains to make certain there would be
no conflict with DSHEA. Regarding foods and dietary supplements are
generally regulated as foods, the general directive of the Foundation
is to identify holes in the evaluation of food safety and identify
ways to address those deficiencies through collaborative research with
Mr. HARKIN. So to make this absolutely clear, what you are saying
is that the bill we are debating would in no way interfere with consumers'
access to dietary supplements?
Mr. HATCH. To add to that point, it seems that the language could,
in fact, help dietary supplement consumers, because it would allow
collaboration between government and industry to conduct research on
issues that might be helpful to supplement consumers?
Mr. KENNEDY. Yes, that is the case.
Mr. ENZI. I agree with Chairman Kennedy's assessment.
Mr. HATCH. I thank you for those assurances and that clarification.
Mr. HARKIN. This has been a very helpful discussion, because Senator
Hatch and I could never support legislation that would interfere with
DSHEA, and we are glad to receive the assurances of the chairman and
the ranking Republican on the committee.
May 1, we sent out another urgent call to action because Durbin was
planning an end run around DSHEA that would further attack
dietary supplements. Once
again, the people flooded the Senate, and on May, 3, 2007, Senator Hatch
responded to the concerns we raised. The Congressional Record states
HATCH. Mr. President, a number of questions
have been raised about how the Durbin amendment on food safety,
adopted yesterday by a unanimous
vote, would affect regulation of dietary supplements….
For the edification of my colleagues, section 201ff of the Federal
Food, Drug, and Cosmetic Act, FFDCA, contains the definition of dietary
supplements. That definition includes a proviso that supplements are
to be considered foods, except in the instance when a product makes
a drug claim. In other words, by Federal law, dietary supplements are
generally considered to be foods.
It is for this reason that the language of the original Durbin amendment
establishing a new adulterated food registry could have been read to
apply to dietary supplements.
This raised problems for me, and indeed for our colleague Senator
Harkin, since we had spent more than 2 [two] years working with Senators
Durbin, Kennedy, and Enzi to draft, pass and enact the Dietary Supplement
and Nonprescription Drug Consumer Protection Act, Public Law 109-462.
That law authorizes a new program so that reports of serious adverse
events related to the use of a dietary supplement or over-the-counter
drug would be reported to the Food and Drug Administration, FDA, on
a priority basis.
As I said, the Durbin amendment contemplates a new adulterated food
registry. Under the provisions establishing that registry, reports
of adulterated foods would be made by many, if not all, of the same
parties who are required to file reports of serious adverse events
associated with the use of dietary supplements under Public Law 109-462.
And so passage of the Durbin amendment could be seen to supersede the
law we enacted last year for supplements, which I am relieved to hear
was not the intent of our colleague, Senator Durbin.
Consequently, the amendment we adopted yesterday contains language
that Senator Harkin and I suggested to make certain that dietary supplements
would not be covered by the new food safety language and thus last
year's law would not be superseded. To reassure those who are interested
in the Dietary Supplement Health and Education Act, DSHEA, I wanted
to take a moment to outline those changes.
First, there is new language in the section establishing the adulterated
food registry to express the sense of the Senate that: (1) DSHEA has
established the legal framework to ensure that dietary supplements
are safe and properly labeled foods; (2) the Dietary Supplement and
Nonprescription Drug Consumer Protection Act has established a mandatory
reporting system of serious adverse events for nonprescription drugs
and dietary supplements sold and consumed in the United States; and
(3) the adverse events reporting system under that act will serve as
the early warning system for any potential public health issues associated
with the use of these food products.
In addition, language contained in the Durbin amendment modifies the
definition of supplement contained in 201ff of the FFDCA so that supplements
will not be considered foods for the purpose of the new adulterated
foods registry. This in no way would alter the time-honored conclusion
of the Congress that supplements are to be considered foods. On the
contrary, all it would do is exempt supplements from the registry.
These changes, all contained in the amendment which was approved yesterday,
make clear that there are no new dietary supplement requirements in
the Food and Drug Administration Revitalization Act. It is my hope
this will reassure the many who have expressed concern that Congress
was inadvertently repealing Public Law 109-462.
The voice of the people has been heard. Let us not forget these promises
nor let the FDA forget them -- as the questionable language regarding
the Reagan-Udall Foundation for the FDA still remains.
Waking up the American public to the larger issue of drug safety
is a much more challenging task. Kennedy and Enzi are claiming that
the Reagan-Udall Foundation for the FDA is nothing but a friendly non-governmental
research foundation. I will fully document in a subsequent article
that this is not the case. It is actually the tool by which Big Pharma
and Big Biotech will lock in their profits for the next 50 years, as
FDA joins them in the drug development and marketing business. This
is one of the greatest safety threats in the history of America.
The battle now moves to the House and then to a conference committee. The legislation
is being ram-rodded through before the general public knows what is happening.
Mainstream media, a primary client of Big Pharma, is intentionally failing
to explain the true meaning of S1082. There is still time for Americans to
determine their fate.