New FDA ruling could jeopordize all supplements

[EasyEJL]

The FDA is actually trying to push this through- drug companies are pissed b/c their profits are down....


FDA SAYS "NO SHIPMENT ACROSS STATE LINES IF STUDIES ABOUT SUPPLEMENT HAVE EVER BEEN PUBLISHED!"
FDA, both domestically and through Codex, has been trying to make information about the relationship of food and food components to health forbidden speech. That includes supplements, of course.


As if that were not bad enough, they have come up with another ploy to make it illegal to ship supplements across state lines IF THERE HAVE BEEN ANY PUBLISHED HEALTH STUDIES ABOUT ANY INGREDIENT! And we have only 5 days to stop them.


This is a diabolical, but brilliant, drug company-inspired double whammy:

Whammy Number 1: Under proposed FDA/Codex rules you cannot tell anyone about what nutrients and supplement can do for them because they are, say the bureaucrats, not "supported" in the scientific literature (despite the science called "Biochemistry" and millions of peer-reviewed journal articles)

Whammy Number 2: You won't be able to get supplements if what they can do for you has ever been documented in the scientific literature, as part of any medical study.


It's Actually Even Worse Than That

In July, 2007, The FDA Amendments Act of 2007, Public Law 110-85, was adopted by the US. Congress. With your support, Natural Solutions Foundation Health Freedom advocates fought hard to convinced Senator Harkin (R-IL) to force inclusion of language exempting dietary supplements from the provisions in the law. That protective language is the law of the United States of America, enacted as section 1011, the DSHEA Product Rule of Construction.


The failed and corrupt FDA, however, in its relentless crusade to eliminate the rights of Americans to learn about or use the most significant economic competitor to pharmaceutical drugs has no respect for the law and no interest in either your freedom or your health. They are currently promulgating regulations which would make it illegal to ship supplements across state lines. This would accomplish both definitions of "Nutricide" as I have lectured and written about for years:

Nu tri cide (3 syllables):

1. The death of the body of knowledge about the relationship between health and nutrition

2. The death of large populations through the manipulation of the food [and supplement] supply.

URGENT ACTION REQUIRED NOW

Comments close on November 25, 2008 on a new regulatory sneak attack against supplements. FDA regulations will, if the FDA succeeds, make the shipment of supplements across state lines illegal - get this - IF THE SUPPLEMENT HAS BEEN THE SUBJECT OF A CLINICAL STUDY.

They're BAAAAAAACK!

If you value

Your access to supplements and nutrients

Your health

Your freedom to determine what goes into your body

Your First Amendment Rights
then I urge you in the strongest terms to click below NOW to help make sure that the FDA, at least this once, obeys the law of the land.


CODEX Action Alert

Last time the FDA tried something this awful, through the 2007 "Draft CAM Guidance", the Natural Solutions Foundation alerted health freedom lovers. Time was very short then, too but as a result, 588,000+ people came to our site to tell the FDA not to continue with its plan to turn nutrients into "untested drugs" and therefore make them all illegal. The FDA system "accidentally' crashed so "only" 198,000+ people got their comments in but FDA got the message and backed off.

We said at that time we counted their backing off as a triumph but that they would be back. Well, they are back and they are sneakier and meaner than ever.

We have enormous power in the aggregate. Now it is time to use it. Again.

Click the link below to use our power and back off the forces that are dedicated to taking away your right to use natural health options prevent and deal with illness - or even know what they can do for you - instead of high-profit drugs.

CODEX Action Alert

 

[EasyEJL]

Every administration does this, tries to pass "midnight resolutions" at the very end of their presidency to try and undo thing that the previous president did that they dont like, and to stick the new president with stuff that is hard to change any other way. So this is Bush's attempt to undo parts of the DSHEA that he doesn't care for...

 

[just93]

what do i do with the link bro....!!!! im gunna hope on this, its bull sh*t!

 

[just93]

never mind, can we swear in the message??
are we sending this to CODEX or what?

 

[ShiftyCapone]

I copied and pasted this to another forum i frequent. Cool?

 

[just93]

yah, dont think it matters

 

[capnsavem]

Don't Make Me Hungry, Fda... You Wouldn't Like Me When I'm Hungry...

 

[SokVichet]

BUMP! What the motherf**k... There's no way... seriously? Could this possibly happen?

Don't Make Me Hungry, Fda... You Wouldn't Like Me When I'm Hungry...

LOL, I saw this yesterday, and loved it. Great re-do in my opinion. Can't wait for the followup!

 

[Rugger]

I'm thinking all one would have to do is produce a conflicting clinical study saying the supplement/ingredients were beneficial.

This is seriously the kind of thing that would make me leave the country, though, if it were to ever come true. ****ing despicable.

 

[SilentBob187]

This is seriously the kind of thing that would make me leave the country, though, if it were to ever come true. ****ing despicable.

x2.

 

[mikinTx]

Thanks Easy, just signed the petition (I always select Fax also so they get a hardcopy also). This is a constant problem with the FDA, doesn't matter which party is in power. Wouldn't hurt to email your Senators/Representative also since there's only 5 days. At any rate, very useful post bro!

 

[ShiftyCapone]

I'm thinking all one would have to do is produce a conflicting clinical study saying the supplement/ingredients were beneficial.

Then it would be illegal to send them over state lines, because there's a clinical study on it.....

 

[SokVichet]

Submitted mine, and drafting up something for my representatives. You can find yours at http://www.congress.org down in the My Elected Officials box. Seriously, there's no way this could be allowed to occur...

 

[djbombsquad]

So if the product has a double blinded clinical study on it not the raw materials but the actual product is it still okay?

 

[EasyEJL]

I think it depends on if the study shows a medical purpose. but when you have such vague definitions it means any jackass beaurocrat can do what he wants when he gets a wild hair up his ass, and suddenly stop creatine sales

 

[just93]

is Canada this f*cked up??

 

[jsp0785]

Then it would be illegal to send them over state lines, because there's a clinical study on it.....

why would they make it illegal to send over state lines if it was clinically studied? so they'd rather ship stuff that has never been tested and nobody knows the safety?

 

[Gtarzan81]

I'm thinking all one would have to do is produce a conflicting clinical study saying the supplement/ingredients were beneficial.

This is seriously the kind of thing that would make me leave the country, though, if it were to ever come true. ****ing despicable.

x3. I've always wanted to live in the U.K. anyhow...

 

[paint2100]

sent my email everyone should do it. If this passes......:frustrate

 

[Chuck Diesel]

"FDA SAYS "NO SHIPMENT ACROSS STATE LINES IF STUDIES ABOUT SUPPLEMENT HAVE EVER BEEN PUBLISHED!""


???

Studies showing what?

Thats pretty much everything sold today, and everything in Walgreens, etc, thats OTC.

 

[RoadBlocK]

Well I did the link thing and the email signup thing, and I added a comment thing:

Stay out of the health food and supplement industry and focus on safeguarding the american people from tainted beef, diseased poultry and e.coli tainted produce!

I think I did what I was supposed, it took me to the thank you page, so I guess that was it.

I wish I had ended with "contaminated produce!", I think it would have been more dramatic, oh well.

 

[severesoldier]

I hate government organizations.

 

[Gtarzan81]

I emailed all my senators, and representatives. Their offices will be getting calls from me on monday also.

 

[jsp0785]

I emailed all my senators, and representatives. Their offices will be getting calls from me on monday also.

good luck. i sent an e-mail to my sh!tty senator hillary clinton and i got nothin back. it's been a few months too

 

[Gtarzan81]

good luck. i sent an e-mail to my sh!tty senator hillary clinton and i got nothin back. it's been a few months too

I see 2 problems here:
Hillary:frustrate
New York:run:

 

[capnsavem]

BUMP! What the motherf**k... There's no way... seriously? Could this possibly happen?



LOL, I saw this yesterday, and loved it. Great re-do in my opinion. Can't wait for the followup!

good call!

and yes, this is total boolsheet by these beauraucrat (sp?)bloodsuckers.

 

[TexasLifter89]

I saw this when we got the email. absolutely nus

 

[BodyWizard]

I echo the urge to email the Congressional types - but CALL THEIR OFFICES, too! Email counts, but it's easy - phone calls count more...and letters are weighted more heavily still.

Don't cuss - but it's okay to express anger and outrage; just be polite!

Maybe the new administration won't put Big Pharma in charge of the FDA....

 

[thebigt]

Well I did the link thing and the email signup thing, and I added a comment thing:

Stay out of the health food and supplement industry and focus on safeguarding the american people from tainted beef, diseased poultry and e.coli tainted produce!

I think I did what I was supposed, it took me to the thank you page, so I guess that was it.

I wish I had ended with "contaminated produce!", I think it would have been more dramatic, oh well.

the fda's biggest excuse for allowing contaminated food is a shortage of manpower. all the dumba$$es will accomplish is another black market they have neither the capacity or willpower to control.

 

[jeffh3c]

I sent my email/fax. This is scary. Herbal suppliants etc have been used safely for years. Having experience with how the f a a likes to word things, the wording looks to be purposefully vague as to allow them to pick and choose where they choose to enforce. This is dangerous legislation for the obvious reasons, but also would set a precedent of them interpreting more and more laws the way they see fit. Similar would be the FAA's regulation of "due deference" where if there is a question on if a law is to be interpreted this way or that in an enforcement action, the faa will always get the upper hand (interpretation - the law means what WE say it means).

scary.

 

[just93]

why the hell are supplements, products that are used to promote healthy life styles, our governments biggest worries, are they f*cking retarded??

 

[djbombsquad]

I am glad the FDA is finally stepping in.

 

[Irish Cannon]

I am glad the FDA is finally stepping in.

:think:

 

[TexasLifter89]

I am glad the FDA is finally stepping in.

So you cant get any supplements across borders? :frustrate

 

[SilentBob187]

So you cant get any supplements across borders? :frustrate

 

[TexasLifter89]

what is a troll in the forums? Ive always seen it but not really sure what it is?

 

[brk_nemesis]

"FDA SAYS "NO SHIPMENT ACROSS STATE LINES IF STUDIES ABOUT SUPPLEMENT HAVE EVER BEEN PUBLISHED!""


???

Studies showing what?

Thats pretty much everything sold today, and everything in Walgreens, etc, thats OTC.

exactly what i was thinking. No way that this could pass,.... in the end if it passes,...... its not just supplement shops, but all otc vitamins, and meds, that'll be in the gutter,...... thats a crap load of $$ not being made,...idk, its kinda hard to believe, but who knows.

 

[djbombsquad]

I get all the majority of stuff threw doctors any way.

 

[djbombsquad]

Lovaza is a prescription for me any way.

 

[djbombsquad]

Fosomax is for my vitamin D.

 

[jeffh3c]

why the hell are supplements, products that are used to promote healthy life styles, our governments biggest worries, are they f*cking retarded??

for the most part, yes.

I agree though that so long as it doesnt slip under the radar it will get defeated.

Email your congressman. Go to the site above, fine. But a well thouht out, professionally written, unique (non form letter) is most likely to be read and acted upon. You can go to congress.org and enter your zip to find your congress/senate/state reps. then just go to contact and email the, I wrote it out in word and pasted it for the ones who only had ontact me forms, I cut and pasted email addresses a andsent emails to those who had email address listed.

 

[noobster]

Excuse my skepticism, but are there any sources for that claim?

The link in the OP doesn't name any sources, it only links to a website called healthfreedomusa.org which happens to sell supplements, homeopathic bs and "biomagnets" as well as e-books and DVDs about the alleged government threats. They're also blatantly anti-vaccination, which makes me doubt their understanding of - well, pretty much anything.

So, does anyone else claim that the government is trying to ban vitamins, or just the crazy quacks on that website? Any proof at all?

 

[BodyWizard]

Here is the root text of concern, straight from the Federal Register:

[Federal Register: July 29, 2008 (Volume 73, Number 146)]

[Notices]

[Page 43937-43940]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy08-61]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0389]


Food and Drug Administration Amendments Act of 2007; Prohibition
Against Food to Which Drugs or Biological Products Have Been Added;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting
comments relevant to the implementation of section 912 of the Food
and Drug Administration Amendments Act of 2007 (FDAAA). Section 912
of FDAAA establishes section 301(ll) in the Federal Food, Drug, and
Cosmetic Act (the act), which prohibits the interstate shipment of
certain foods to which an approved drug or a licensed biological product
has been added.

Section 301(ll) also prohibits the interstate shipment of foods containing
an added drug or a biological product that has been the subject of substantial
clinical investigations, the existence of which has been made public. FDA
requests that interested persons submit data,
information, and comments that will help provide a context for the
agency's decisions on implementation of this provision. To encourage
responsive comments, FDA is including a series of questions for
interested persons to consider in preparing comments.

DATES: Submit written or electronic comments by October 27, 2008.

ADDRESSES: Submit written comments, data, and other information to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to redirect.

FOR FURTHER INFORMATION CONTACT: Catherine L. Copp, Center for Food
Safety and Applied Nutrition (HFS-4), Food and Drug Administration,
301-436-1589, e-mail: catherine.copp@ fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (Public Law 110-85) (FDAAA) was enacted. Section 912 of
FDAAA establishes section 301(ll) in the Federal Food, Drug, and
Cosmetic Act (the act), 21 U.S.C. 331(ll), which adds the following
prohibited act to section 301.21 U.S.C. 331:
The introduction or delivery for introduction into interstate
commerce of any food to which has been added a drug approved under
section 505, a biological product licensed under section 351 of the
Public Health Service Act, or a drug or a biological product for which
substantial clinical investigations have been instituted and for which
the existence of such investigations has been made public, unless--
(1) such drug or such biological product was marketed in food
before any approval of the drug under section 505, before licensure
of the biological product under such section 351, and before any
substantial clinical

[[Page 43938]]

investigations involving the drug or the biological product have been
instituted;(2) the Secretary, in the Secretary's discretion,
has issued a regulation, after notice and comment, approving the
useof such drug or such biological product in the food;(3) the use
of the drug or the biological product in the food is to enhance the
safety of the food to which the drug or the biological product is
added or applied and not to have independent biological or
therapeutic effects on humans, and the use is in conformity with--
(A) a regulation issued under section 409 prescribing conditions
of safe use in food;(B) a regulation listing or affirming
conditions under which the use of the drug or the biological product
in food is generally recognized as safe; (C) the conditions of use
identified in a notification to the Secretary of a claim of
exemption from the premarket approval requirements for food additives
based on the notifier's determination that the use of the drug or the
biological product in food is generally recognized as safe, provided
that the Secretary has not questioned the general recognition
of safety determination in a letter to the notifier;(D) a food
contact substance notification that is effective under section
409(h); or(E) such drug or biological product had been marketed for
smoking cessation prior to the date of the enactment of the Food and
Drug Administration Amendments Act of 2007; or
(4) the drug is a new animal drug whose use is not unsafe under
section 512.
Section 301(ll) makes it a prohibited act to ship in interstate
commerce certain foods to which an approved drug or a licensed
biological product has been added. Section 301(ll) also prohibits the
interstate shipment of certain foods containing an added drug or a
biological product that has been the subject of substantial clinical
investigations, the existence of which has been made public. Under the
act, persons who commit a prohibited act may be enjoined, 21 U.S.C.
332, or prosecuted criminally, 21 U.S.C. 333. In addition, a food which
may not, under the provisions of section 301(ll), be introduced or
delivered for introduction into interstate commerce, is subject to
seizure and forfeiture, 21 U.S.C. 334, and under 21 U.S.C. 381, a food
offered for import into the United States that appears to be prohibited
from introduction or delivery for introduction into interstate commerce
under section 301(ll) is subject to refusal of admission.
The language of section 301(ll) has a number of parallels to, as
well as significant differences from, the language of a similar
provision in section 201(ff)(3)(B) (21 U.S.C. 321(ff)(3)(B)), which is
part of the act's definition of ``dietary supplement.'' Although there
is legislative history of FDAAA, including a report from the House
committee with jurisdiction (H. Rep. No. 225, 110th Cong., 2d Sess.
(2007)), section 301(ll) is not addressed in that legislative history.
The Secretary of Health and Human Services has delegated to the
Commissioner of Food and Drugs the principal responsibility for
administering the act. As the administering agency, it is FDA's
responsibility generally to implement amendments to the act, including
the amendments made by section 912 of FDAAA.
Section 301(ll) presents a number of questions of statutory
interpretation for FDA to consider. The scope of the agency's
discretion to interpret section 301(ll) is defined by the Supreme
Court's decision in Chevron U.S.A., Inc. v. Natural Resources Defense
Council, Inc., 467 U.S. 837 (1984). Under Chevron, if the language of a
statute makes Congressional intent on a particular question clear and
unambiguous, the agency charged with administering the statute must
give effect to that intent. Chevron, 467 U.S. at 842-43. If the statute is silent or ambiguous on the question, however, the agency is
permitted to give the statute a reasonable construction, Chevron, 467
U.S. at 844-845, and that construction is entitled to deference.
Chevron, 467 U.S. at 844.

II. Questions Presented

FDA believes that a fuller understanding of the impact of various
interpretations of section 301(ll) would be beneficial as the agency
considers how to implement this new provision. Accordingly, FDA is
requesting that interested persons submit data, information, and other
comments regarding possible approaches to implementation. To guide
those submissions and responses, the agency has prepared the following
questions. FDA suggests that, in preparing responses to this request
for comments, interested persons consider the following:

A. Food

Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of certain ``food.'' Under
section 201(f), ``food'' means articles used for food or drink for man
or other animals, chewing gum, and articles used for components of such
articles. Food includes human food, including infant formula, medical
foods, and dietary supplements; food contact substances, including food
packaging; and animal feed, including pet food and feed ingredients.
Consistent with the broad definition of ``food'' in section 201(f), FDA
seeks information about the impact of section 301(ll) on food in all
its forms, including food ingredients, categories of food, and finished
food products.

1. What types or categories of food would likely be subject to the
prohibition of section 301(ll)? What types or categories are likely to
be unaffected by section 301(ll)? If possible, please provide specific
examples of these foods.

2. What is the likely impact of applying section 301(ll) to infant
formula? Are there substances used or potentially used in infant
formula that would be prohibited from such use by section 301(ll)?

3. What is the likely impact of applying section 301(ll) to dietary
supplements? Are there substances used or potentially used in or as
dietary supplements that would be prohibited from such use by section
301(ll)? What would be the advantages and disadvantages of applying
both section 301(ll) and section 201(ff)(3)(B) to dietary supplements?
Would such an approach lead to more effective regulation or less
effective regulation of these products, and why?

4. What is the likely impact of applying section 301(ll) to animal
feed? Are there substances used or potentially used in animal feed,
including pet food and feed ingredients, that would be prohibited from
such use by section 301(ll)?

5. What is the likely impact of interpreting ``food'' in section
301(ll) to include food contact substances, including packaging
components that meet the definition of a food additive? Are there
substances used or potentially used in food packaging or other food
contact substances that would be prohibited from such use by section
301(ll)?

 

[BodyWizard]

Actually, that was Part One (sucker is LONG!)



B. Previously Marketed Foods Now Barred from Interstate Commerce

Section 301(ll) identifies a category of foods that can no longer
be introduced or delivered for introduction into interstate commerce
although these foods were allowed in interstate commerce before the
enactment of FDAAA. Specifically, if a food contains a substance that
is an approved drug, that is a licensed biological product, or that has
been the subject of substantial clinical investigations that have been
made public, and if the substance was added to the food to have an
independent biological or therapeutic effect on the person consuming
it, rather than to enhance the safety of the food, the food is now
barred from interstate commerce if any substantial clinical
investigations of the substance were instituted, or the drug was
approved or the biologic was licensed, prior to the first marketing of the
substance in food. FDA seeks information on foods in this category that
were legally marketed prior to the enactment of FDAAA but that are now
barred from interstate commerce.

1. How many and what types of foods would be affected? What would
be the impact on businesses that produce and sell these foods?

2. What would be the impact on consumers who currently use the
products?

3. If possible, please provide specific examples of affected foods.

C. Drug

Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of food to which has been added a
``drug approved under section 505.''
Implementing section 301(ll)'s restrictions on adding approved
drugs to food will require FDA to consider how the identity of a
``drug'' is to be determined for purposes of section 301(ll).

1. What would be the impact of deeming two substances to be
identical if they are chemically identical?

2. Are there approved drugs that cannot be identified by their
chemical structure? If so, what would be a scientifically accurate and
technically feasible way for FDA to determine the identity of the
``drug approved under section 505'' or ``drug * * * for which
substantial clinical investigations have been instituted'' and consider
whether that drug was marketed in food before the drug's approval by
FDA or before the initiation of the substantial clinical
investigations? Which drugs or classes of drugs cannot be identified by
their chemical structure?

D. Biological Product

Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of food to which has been added a
``biological product licensed under section 351 of the Public Health
Service Act.'' Under section 351(i) of the Public Health Service Act
(PHS Act) (42 U.S.C. 262(i)), a ``biological product'' means ``a virus,
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or
derivative, allergenic product, or analogous product, or arsphenamine
or derivative of arsphenamine (or any other trivalent organic arsenic
compound), applicable to the prevention, treatment, or cure of a
disease or condition of human beings.''
What are the special concerns, if any, related to
determining whether a biological product that is added to food has
previously been licensed under section 351 of the PHS Act?

E. Clinical Investigations

Section 301(ll) prohibits the introduction or delivery for
introduction into interstate commerce of food to which has been added a
``drug'' or a ``biological product'' for which ``substantial clinical
investigations have been instituted'' and for which ``the existence of
such investigations has been made public,'' unless the drug or the
biological product was ``marketed in food * * * before any substantial
clinical investigations involving the drug or the biological product
have been instituted.''

1. What is the likely impact of interpreting ``clinical
investigations'' to refer exclusively to studies in humans?

2. What is the likely impact of interpreting the existence of
substantial clinical investigations of a substance in humans to prevent
the addition of such substance to animal feed, including pet food and
feed ingredients?

3. What factors should FDA consider in deciding whether clinical
investigations of a substance are ``substantial?''

4. What factors should FDA consider in determining whether
substantial clinical investigations ``involv[ed] the drug or the
biological product?''

5. Could this provision operate as a disincentive to conduct
clinical studies of substances intended for use in products to be
marketed as conventional foods or dietary supplements? If so, is there
an approach to implementation that could minimize or eliminate this
disincentive?

6. To the extent that this provision discourages clinical
investigations of substances added to food and the public disclosure of
such investigations, what is the likely impact of this provision on so-
called self-determinations of the general recognition of safety (GRAS)
of substances added to food?

F. Marketed

Under section 301(ll)(1), a food containing an approved drug or a
licensed biological product may be shipped in interstate commerce if
the drug or the biological product was ``marketed in food'' prior to
the approval of the drug, the licensing of the biological product, or
the initiation of substantial clinical investigations of the drug or
biological product. Section 201(ff) contains a similar provision.
Section 201(ff) uses the phrase ``marketed as a dietary supplement or
as a food,'' however, while section 301(ll) uses the phrase ``marketed
in food.'' In the context of section 201(ff), FDA has evaluated whether
a substance has been ``marketed'' within the meaning of that provision
by considering: (1) Whether the substance itself has been sold or
offered for sale, either as a finished product or as an ingredient; (2)
for substances that are not sold separately but are components present
in a marketed product, whether the component itself was marketed to
prospective purchasers through, e.g., labeling or advertising for the
product that made claims about the component or otherwise highlighted
its presence. See Pharmanex v. Shalala, 2001 WL 741419, at *4 & n.5 (D.
Utah March 30, 2001).

1. What would be the likely impact of interpreting the term
``marketed'' the same way in section 301(ll) as in section 201(ff)?
What could be the regulatory significance, if any, of the differing
phrases ``marketed in food'' (section 301(ll)) and ``marketed as a
dietary supplement or as a food'' (section 201(ff))?

2. What could be the significance, if any, of the marketing in food
of an approved drug or a licensed biological product outside the United
States?

3. What factors should be considered the indicia of being
``marketed in food?'' What types of evidence should FDA consider in
deciding whether a substance has been ``marketed in food?''

G. Enhance The Safety of The Food Supply

Section 301(ll)(3) provides an exception to the prohibition of
adding a drug or biological product to a food if use of the drug or
biological product is ``to enhance the safety of the food * * * and not
to have independent biological or therapeutic effects on humans.''

1. What factors should FDA consider in determining whether the use
of a substance in food is to ``enhance the safety of the food'' within
the meaning of section 301(ll)?

2. What would be the likely impact of each of the following
possible interpretations of what kinds of uses ``enhance the safety of
the food?''
The addition of a substance to a food enhances the safety
of the food only if such addition reduces a risk not inherent in the
food itself, such as the risk of microbial or other contamination.
The addition of a substance to a food enhances the safety
of the food if such addition reduces either a risk inherent to the food
itself, such as inherent toxicity or a risk that derives from the
nutritional content of the food (e.g., high saturated fat content), or
a risk not inherent in the food itself, such as the risk of microbial
or other contamination.

[[Page 43940]]

H. Independent biological or therapeutic effects on humans

As noted, section 301(ll)(3) provides an exception to the
prohibition of adding a drug or biological product to a food if use of
the drug or biological product is ``to enhance the safety of the food *
* * and not to have independent biological or therapeutic effects on
humans.''
1. What factors should FDA consider in determining whether the use
of a substance in food is to have a ``biological'' effect on humans?

2. What factors should FDA consider in determining whether the use
of a substance in food is to have a biological effect on humans that is
``independent?''

3. What factors should FDA consider in determining whether the use
of a substance in food is to have a ``therapeutic'' effect on humans?

4. What factors should FDA consider in determining whether the use
of a substance in food is to have a therapeutic impact on humans that
is ``independent?''

I. In the Secretary's Discretion

Section 301(ll)(2) permits the addition of a drug or biological
product to a food ``if the Secretary, in the Secretary's discretion,
has issued a regulation after notice and comment, approving the use * *
* in food.'' As noted, the Secretary has delegated his authority under
the act to the Commissioner of Food and Drugs.
1. What factors should the Commissioner consider in exercising his
discretion under section 301(ll)(2)?
2. What should be the impact, if any, on the exercise of the
Commissioner's discretion where use of the drug or biological product
in food has been the subject of another statutory or administrative
process (e.g., a food contact substance notification that is effective
under section 409(h))?

III. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at redirect.

Dated: July 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17356 Filed 7-28-08; 8:45 am]

BILLING CODE 4160-01-S

 

[BodyWizard]

FOLLOW-UP

I've been a student of nutrition and supplementation for more than 40 years; by a roundabout route, that's how I ended up here @ AM. There has been tension between the FDA & the ADA (dieticians) (and to a lesser extent, the AMA) on the one hand, and physiologists & nutritionists on the other, for many years.

The most recent - and in many ways, the most successful - bulwark against federal control of what we can eat & use for supplementation is DSHEA - the Dietary Supplement Health and Education Act of 1994 . A lot of the bros who were around FOUR YEARS AGO will certainly remember the preservation of DSHEA being a real big deal in this community; they may even remember this website: http://www.saveoursupplements.org/

The outgoing administration is pushing through a bunch of 'midnight regulations', as happens, sadly @ the end of *any* administration; the purpose of these moves is to set in place ideological changes that couldn't pass legislative muster. In any event, they typically represent a big ol' F-U to the incoming administration, and are an end-run around due process in every sense (look! A *real* bi-partisan issue!!!)

For the last 8 years, the FDA has been increasing its efforts to smash the core of DSHEA- that is, the GRAS category; they have been working internationally through the Codex process to have everything considered effective classified as a drug - and therefore banned from non-prescription sale. Many OTC vitamins are no longer available OTC in many parts of the world for this reason.

With the end of the 43 administration comes also the end of Big Pharma executives in controlling roles @ the FDA (don't believe me: look it up) - and the end of their efforts to put any effective supplements under the control of the pharmaceutical industry.

Many fear (and I'm one of them) that the current round of midnight regulations will accomplish that very thing. If you use any kind of supplement, you should be concerned enough to contact your representatives and tell them to not let that happen - he!!, if you eat "vitamin-enriched "cereal (which is pretty much all cereal) with "vitamin-D-enriched" milk (which is practically all milk) - you'll be impacted.

Too stupid to worry about? Now that the election is over do you guys suddenly trust government regulators who are notoriously cozy w/ the industries they're supposed to regulate? The surest way to see the impossible happen is to assume that it can't.

Don't be a dork: call somebody in Congress & tell 'em NO.

 

[noobster]

Thanks for posting that. I think the supplement market desperatly needs more regulation, as there are way too many mislabeled or contaminated products, bogus claims and lack of QC. However, this is definately the wrong way to go about it. The proposition looks completely absurd to me and I'd hope that it won't stand any chance to be implemented in this or any similar form. I'm not a US citizen and therefore not too familiar with your legislative process, but this looks just too ridiculous to make it into the law. Ban interstate commerce of Flintstone vitamins? I deal with law (specifically health/medical law) every day and I've never encountered anything as nonsensical as the above.




EDIT:

Too stupid to worry about? Now that the election is over do you guys suddenly trust government regulators who are notoriously cozy w/ the industries they're supposed to regulate? The surest way to see the impossible happen is to assume that it can't.
Don't be a dork: call somebody in Congress & tell 'em NO.

Can't disagree with that.

 

[BodyWizard]

We have (roughly) two kinds of law in the US: legislative law or "law in fact" (voted on, passed, signed, enacted), and regulatory law (simple administrative fiat, mostly without an open and accessible process, at the hands of persons unaccountable to the public).

What we're talking about here is the second kind, a regulatory ruling imposing rules and restrictions that can only be overturned by resort to the (time-consuming & fraught-with-peril) legislative path.

In the specific case of the FDA, the head of the agency has been either a Big-Pharma lobbyist or a Big-Pharma executive: judging them by their fruits, I think it's clear they they've held their "duty" to their industry higher than any obligation to the public.

In our old folk tradition, we call that "the fox guarding the henhouse"...and 'farmers' (or Presidents, or Secretaries) who would do such a thing are generally considered lazy, careless, or fools - of course translating this to the governmental sphere gives us another, less-folksy option: corruption, and abdication of responsibility.

There are in fact two *other* sorts of law 'round here, too: judicial mandate, and executive order; personally, I think they should ALL be subordinate to the legislative process - then, when we throw the bums out, it's actually the responsible bums we're throwing...it's called ACCOUNTABILITY, and was the whole point of the system.

 

[noobster]

We have (roughly) two kinds of law in the US: legislative law or "law in fact" (voted on, passed, signed, enacted), and regulatory law (simple administrative fiat, mostly without an open and accessible process, at the hands of persons unaccountable to the public).

What we're talking about here is the second kind, a regulatory ruling imposing rules and restrictions that can only be overturned by resort to the (time-consuming & fraught-with-peril) legislative path.

Thanks again. Very interesting that a ruling which inhibits the commercial freedom of action to such a high degree can be decreed by regulatory law in the US.

 

[BodyWizard]

it decreases commercial freedom-of-action *generally* - but expands the market control of the large-scale (& therefore politically powerful) players.

That's what some here call "capitalism". :toofunny:
(by "here", I mean "in the USA")

 

[noobster]

That's a very curious state of affairs. Not only from a legal point of view, but also culturally.

I can't really blame the pharma companies, they're just looking out for their interests. But politicians, voters, consumer groups and supplement companies just bending over and taking it is quite disconcerting. It will be interesting to watch how this develops.