Public comments on FDA "guidance document" to close April 30

[Occulus]

I just found out that the FDA will on April 30th close public comments on a guidance document (.pdf link) which apparently could do some very devastating things to the non-BigPharma health industry, if the guidelines the FDA is taking comments on remains unchanged from its present state.

From the FDA guidance document link (all emphasis is mine):

# "Dietary Supplement"

Section 201(ff) of the Act (21 U.S.C. 321(ff)) defines the term "dietary supplement" as follows:

The term "dietary supplement" -

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

Vitamins? Minerals? HERBS?? Vitamin C, soon to be available by prescription only?

It gets better:

To illustrate how a CAM product might be a "dietary supplement" under section 201(ff) of the Act, consider botanical products used in naturopathy. (Naturopathy is a CAM whole medical system that views disease as a manifestation of alterations in the processes by which the body heals itself.21 ) For example, naturopathic cranberry tablets might be labeled for use to maintain the health of the urinary tract. In this example, the cranberry tablets generally would be regulated as "dietary supplements" under section 201(ff)(1) of the Act if they were labeled for use to "maintain the health of the urinary tract" rather than "prevent urinary tract infections." The cranberry tablets would be regulated as "drugs" under section 201(g) of the Act if they were labeled for use to "treat urinary tract infections" even if they were labeled as dietary supplements.

It sounds to me that cranberry tablets would be regarded as a "drug", regardless of how they're labeled. I'd like to be wrong about that.

Here's another gem, which appears almost immediately after the one above:

It is possible that certain products used in conjunction with CAM practices may be "cosmetics" under the Act. For example, if a CAM practice involves massage with a moisturizer, the moisturizer could be a "cosmetic" to the extent that it is "rubbed, poured, sprinkled, or sprayed on" the body for beautification or appearance-altering purposes. However, if the moisturizer's intended use is also for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, then it may also be subject to regulation as a drug. Other examples of drug/cosmetic combinations are deodorants that are also antiperspirants, moisturizers and makeup marketed with sun-protection claims, and shampoos that also treat dandruff.

The public comments close on the 30th of THIS MONTH. To date, I have not heard a single word from the media on these rule changes. Maybe it was posted here on DU, but if it was, it slipped right by me. Whit exactly is the FDA trying to do, here? I don't think it's too alarmist to talk about "prescription Vitamin C", because they themselves list vitamins in their "guidance document".

If the FDA has a desire to impose rules regulating claims made by the natural/organic/homeopathic health industry, that's one thing, as this industry is one that does need regulation to one extent or another, but these rules appear to go a very great deal further than merely that (such as their own example of cranberry tablets, above). Perhaps this is simply an issue having to do with how these treatments are labeled and/or marketed, but these rules seem to go beyond that.

Does anyone else here know anything more about this? Is there legitimate cause for concern, or are the concerns just a bunch of :tinfoilhat: nonsense?

MAJOR CAVEAT: I did some cursory looking around for articles on this topic. At first, I could find only a link to worldnetdaily- no, I won't link to that site here. However, a couple Google searches returned some interesting results.

[kestrel91316]

1. This again? Already?

:popcorn: