Anyway…

Connie took the time to make an interesting comment to my last post on this FDA and CAM issue. Go and read it, I’ll wait….

Ok, one last time – in my opinion this thing the FDA is doing is not significant and does not warrent the hysteria that is being generated.

I’m not saying the FDA is either a good thing or a bad thing or is capable or incapable of generating truly onerous rules and regulations.

In her comment Connie references something called CODEX. This is apparently the Codex Alimentarius Commission:

The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.

Here’s the CODEX in full

Here’s the Democracy in Action petition, copy it into your editor, make sure the wording agrees with your understanding, copy it back into the form, and send it. or not.

The FDA Proposal

Nap time…

—snip—

….

We’ve researched the information from the link you provided below, as well as the Food & Drug Administration’s recently issued Draft Guidance for Industry on “Complementary and Alternative Medicine (’CAM’) Products and their Regulation by the Food and Drug Administration” (the “Draft Guidance”), and we can assure you there is no need for concern in this case.

The information about the Draft Guidance that various activist organizations are circulating on the web is inaccurate and misleading. While it’s true the FDA issued the Draft Guidance almost three (3) months ago (this is NO secret, as it was published in the Federal Register for public comment), it’s completely untrue that the FDA is using the Draft Guidance as a means of “legal trickery” to limit consumers’ access to natural health products (like vitamins, minerals and herbs) or natural health therapies.

The FDA’s intent in issuing the Draft Guidance is only to address industry confusion as to when certain CAM products are subject to regulation under the Food, Drug & Cosmetic Act (the “FD&C Act”) or the Public Health Safety Act (the “PHS Act”).

The Draft Guidance, when finalized, will not have the binding effect of a law or regulation, and it’s very clear it will not directly or indirectly limit consumers’ access to natural health products. In fact, the Draft Guidance merely confirms that foods (including dietary supplements) are already regulated under the FD&C Act (as foods), and unless an individual or company makes medicinal or drug claims about these food products, the FDA will continue to regulate such products as foods under the FD&C Act.

If an individual or entity were to market a food (including a dietary supplement) as a CAM product, the FDA could stop the sale of the product as a food because it is being marketed as an unapproved drug; but the FDA already has the authority to do this, and the Draft Guidance does not affect the Agency’s authority in this regard.

In light of this information, we don’t believe there’s any need for our Associates to be concerned about the Draft Guidance or to take any action regarding it. Rest assured we’ll continue to monitor this situation carefully through our industry trade associations, and if they believe it’s necessary to engage our Associates in any grass-roots efforts relating to this matter, we’ll take necessary action to involve our field in the most effective way possible.

…

—snip—

USANA has been around for a few years and is a publicly traded company (USNA, on the Nasdaq.) Their analysis mirrors that of my own (not that I know anything) and that of my own attorney (who I married 10 years ago.)

So let’s all chill, take a deep breath, and relax. This issue isn’t going anywhere.

That said, always do keep on eye on what your government is doing (U.S. or anywhere.) Its workings are always in someone’s interests, but those interests might not be yours.

edit: The quoted material in this post came from a mailing list that I subscribe to. The owner of the list had sent a question to the USANA legal staff, regarding the FDA proposal, and the reply was posted to the list.

As it turns out the proposal is in regards to complimentary and alternative medicine products. So far it doesn’t look like CAM practice is in the pipeline, though I’m sure someone is thinking about it.

Now I’m no fan of government regulation, but we all need to know what is and isn’t and base our opinions from there. I don’t know where the FDA will go with this proposal, but the trend, as with all bureaucracies, is for more and more regulation. I’m still in favor of sending the petition (mentioned in the other post,) but make sure you like its wording, first.

Here’s the FDA Proposal, it’s pretty short and fairly clear. Check it out. Basically they say they want to clear up confusion regarding CAM products.
The FDA dockets page is here, and their home page is here.

Here are a couple of books from Amazon on the FDA (there are a number of others, as well.) I haven’t read these, though the first is in my shopping cart for future reference.

• Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat – This one looks like a good, objective look at the FDA, whiat it does, and the reasons behind it’s decisions and policies.
• Fight for Your Health: Exposing the FDA’s Betrayal of America - This is for those of you who hate the FDA. I have no idea if this book is totally accurate (it’s getting good reviews) or is total BS.

Update: Here’s an article from the Santa Cruz Sentinel which provides some background to the proposal.

Here’s a post from OrganicConsumers.org analyzing the proposal.

Here’s one from WND.com that discusses related topics, such as other efforts to ban supplements. (warning – this site isn’t safe for those on the left side of things.) WND gets a little paranoid at times, but I guess that puts it in the same class as the TV news shows.

The libertarian in me thinks that we have WAY more than enough government interference in our lives and in business. My nanny state friends will argue that the FDA protects us from the shady practices of the vile corporations.

Obviously there are a few other opinions out there.

Here’s the email I received. If this is of interest to you (and what our government does should be of interest to you) click on through to the site and sign the petition.

Speak Up For Health Freedom
by Owen Waters

You wouldn’t think it could happen in the USA.

“The land of the brave and the free” is about to become a lot
less free unless enough of the brave stand up and voice their
opinions by April 30th.

The Food and Drug Administration plans to pass laws to
“protect” you from alternative health care, complementary
medicine and natural supplements.

If the FDA passes these proposed laws, you will no longer be
able to buy vitamins, visit a chiropractor, acupuncturist or
massage therapist… UNLESS you first obtain permission from a
medical doctor.

Now, I don’t know how much your M.D. knows about natural
health care. Most of the doctors that I’ve met so far know
nothing beyond how to select the most capable, poisonous drug
to SUPPRESS the symptoms of illness. I have yet to hear one
talk about actually CURING an illness.

If this legislation passes, you will no longer be free to make
your own natural health care choices. The medical doctor from
whom you will HAVE to seek permission will have no knowledge
whatsoever of the many natural therapies which actually help to
CURE illnesses.

Make no mistake about it. While medicine has made great
strides in the last few decades, we are still very much in the
MEDICAL DARK AGES.

Alternative and complementary medicine IS the future. It is
from these fields that the miracle cures of tomorrow will
emerge… unless these emerging alternatives are squashed and
you are left in the tender care of the poisonous drug industry
and their Medical Doctor sales force.

In fact, this thinly-disguised ploy for power over your body
sounds more like the brainchild of a greedy drug industry
rather than the public servants whose duty it is to protect
you. With this legislation, they plan to protect you so
vigorously that, should you try to work around it, you will
face fines and prison.

Time is running out. The period for public comments on this
proposal ends on April 30, 2007.

The Health Freedom USA organization has made the public
comments process easy with a pre-defined petition to the FDA.
Just add your name to the list and you’ll be joining hands with
millions of caring people just like yourself.

Either visit their web site at www.HealthFreedomUSA.org or,
better yet, use this direct link to their active campaign

There is a petition already filled out for you to send. If you know something about the subject you might want to edit it a bit, so that not everyone sends the same canned response. Adds credibility that way.

Comments?