The FDA's CAM Guidelines: On Again, Off Again...
By Nurse Mark
In the last few issues of HealthBeat News we
have told you about the on again - off again tale of the FDA's CAM
Guidelines in which the FDA would like to say that things like fruit and
vegetable juices, hot rocks, and massage oils (in addition to vitamins,
minerals and supplements) would be treated like prescription drugs. They
announced a comment period that was too brief and against their own
rules, got caught, extended it, rescinded it, and have now extended it
yet again. You now have an opportunity again to give the FDA a piece of
Here is a direct link to the FDA's page
where you may enter your comments - believe me, this is not an easy
thing to find!
Cam Comments Link (click link to comment)
This whole CAM issue; the draft guidance for
industry entitled "Complementary and Alternative Medicine Products and Their
Regulation by the Food and Drug Administration." is incredibly confusing and the
FDA has done everything in their power to keep it that way. They really would
like to be able to slide this one past us, "under the radar" so-to-speak, and
put these guidelines into place quietly and quickly.
This is your chance to tell the FDA to leave
complimentary medicine alone - vitamins, minerals, herbs, fruit juices, massage
oils, and hot rocks are not drugs and cannot, must not be treated like drugs by
the FDA or any other government agency!
Here is text taken directly from the FDA site, in which they try to explain some
of the confusion...
FDA Full Text here:
In the Federal Register of February 27, 2007, (72 FR 8756),
announced the availability of a draft guidance for industry entitled
``Complementary and Alternative Medicine Products and Their Regulation
by the Food and Drug Administration.'' The term ``complementary and
alternative medicine'' (CAM) encompasses a wide array of health care
practices, products, and therapies that are distinct from practices,
products, and therapies used in ``conventional'' or ``allopathic''
In recent years, the practice of complementary and
medicine CAM has increased in the United States, and we have seen
increased confusion as to whether certain products used in CAM are
subject to regulation under the Federal Food, Drug, and Cosmetic Act
(the act) or Public Health Service Act (PHS Act). We have also seen an
increase in the number of CAM products imported into the United States.
Therefore, the draft guidance discusses when a CAM product is subject
to the act or the PHS Act.
The notice announcing the availability of the draft guidance
provided a 60-day comment period, so the comment period for the draft
guidance was scheduled to end on April 30, 2007. Unfortunately, due to
a typographical error in the draft guidance itself (which stated that
the comment period would be 90 days from the date of the notice's
publication in the Federal Register), we became aware that some members
of the public believed that the comment period would or should end on
May 28 or May 29, 2007. This confusion was compounded by another error
that appeared at one section of FDA's Web site; the error, which
appeared at the ``Dockets Open for Comment'' portion of the Web site
where electronic comments are submitted, stated that the comment period
would end on May 29, 2007. (In contrast, other sections of FDA's Web
site retained the April 30, 2007, date.)
Given the amount of confusion as to the comment period, we
announcing that we will consider all comments on this draft guidance
that are submitted through May 29, 2007. Previously submitted comments
do not need to be resubmitted.
Additionally, we are aware of considerable confusion about
content of the draft guidance, which has been widely misinterpreted.
Therefore, we want consumers and CAM practitioners to understand that
the draft guidance does not contain or propose any new regulatory
requirements for any complementary and alternative medicine CAM product
marketed in the United States and does not affect any state licensing
requirements for any CAM practitioner or any consumer's ability to buy
or receive a CAM product or be treated by any CAM practitioner.
Public concern based on misinterpretations of the draft
has generated a large volume of comments to the docket. The large
volume of comments has impeded our ability to identify and respond to
extension requests. Consequently, we are addressing those unanswered
extension requests by considering comments submitted through May 29,