Hello Mr. Richard,
Typically presenters only have 5, 10 or 15 minutes at the most;
unless it is someone they want to make their case. In a short time an
overview could be given to remind those in the hearing that DSHEA was
in response to FDA's attempts to limit consumer access. This point
could be made by quoting directly from the Federal register in which
FDA made their proposals to limit dosages of vitamins to 150% of the
RDA and make amino acids and botanicals drugs, as well as citing
numerous attempts to take otherwise safe products off the market. I
have these quotes readily available (I believe). Most in Congress do
not have this reference point.
Also, the benefits regarding DSHEA could be clearly articultaed:
* Allowed for warnings on labels (prior to DSHEA FDA disallowed this).
* Allowed for FDA to develop more appropriate GMPs for supplements
(which they have done and the industry is responding to)
* Allowed for the dissemination of third-party information to
consumers about the health benefits of supplements (prior to DSHEA
FDA prohibited it); such a right has been upheld by numerous Supreme
Court judgements regarding Free Speech.
* Required that any claim on a supplement label be "truthful and not
misleading" and be based on a review of the "totality" of information
(prior to DSHEA this requirement was not clearly articulated).
* Established the Office of Dietary Supplements which conducts
independent unbiased research on supplements which has led to the
development of the IBIDS database; the fundings of numerous studies;
and the development of numerous quality cotntrol initiatives. In
other words, DSHEA is working very well.
The primary issue would be to remind people that laws require time to
mature; that DSHEA was not a bad law; just bad implementation on the
part of the FDA and clearly separate the responsible marketing of
supplements from the irresponsible marketing of supplements;
encouraging appropriate regulatory actions by both FDA and FTC. It
could also be used to remind Congress of statments by Jane Heney
(former FDAer) and McClellan; both of whom before Congress testified
that they felt they had enough regulatory authority; and that most
products are being marketed responsibly. Lastly, not to allow this
law to be overturned or reopened based on sensationalistic media hype
that has focused on a few isolated cases.
Just some ideas. I believe we have to cease every opportunity to
present our case before Congress or they will run over us. There is
no one else that I know of with a strategy to actively go after these
opportunities. AHPA is doing some good door to door lobbying; DSEA is
doing a little something-I am not sure what; I do not know what NNFA
is doing.
Just my 2�. If I can provide any background information, I would be
happy to do so-Roy
Back to top of document
