Herbal Supplements and alternatives are under attack!! Take Action

Citziens for Health ^ | 06.04.04

[kcvl]

Let's take for example this one "healthy natural herbal supplement"...

Coleus forskohlii

Principal Proposed Uses

Allergic Condition; Asthma; Eczema; Allergies; Muscle Contraction; Asthma; Menstrual Cramps; Irritable Bowel Syndrome (Spastic Colon); Bladder Pain; Hypertension; Glaucoma

Other Proposed Uses
Psoriasis

digestive remedy for flatulence, bloating, and abdominal discomfort and as an aid against vaginal and urinary infections. Coleus's principal constituent, the diterpene forskolin, first isolated in the 1970s, is a cardiotonic and an inhibitor of platelet aggregation. Forskolin is used for circulatory problems like heart failure and high blood pressure and for respiratory problems such as bronchial asthma. Coleus has also been shown to relieve pressure within the eye, a major symptom of glaucoma.

Traditional uses Coleus is a traditional herb in India for a wide range of digestive problems. Coleus is given to relieve gas, bloating, and abdominal discomfort.

- Circulatory remedy An important heart and circulatory tonic, coleus is used to treat congestive heart failure and poor coronary blood flow. Coleus also improves circulation of blood to the brain.
- Respiratory problems Its antispasmodic action makes coleus valuable for respiratory complaints, including asthma and bronchitis.
- Glaucoma Coleus is used topically in treatments to relieve glaucoma (excess pressure within the eye, which, if untreated, can result in loss of vision).
- Potential use Judging by the therapeutic effects of the constituent forskolin, coleus may be of use in combination with other herbs, such as hawthorn, in helping to reduce high blood pressure.

Left out is this...

Interactions You Should Know About

If you are taking blood pressure medications such as beta-blockers, clonidine, or hydralazine, or blood-thinning drugs such as Coumadin (warfarin), heparin,Plavix (clopidogrel), Ticlid (ticlopidine), or Trental (pentoxifylline),Coleus forskohlii should only be used under the supervision of a physician.

Research into the herb as a whole has not been researched.

[Prime Choice]

That's all well and good, but nowhere have I seen that any agency is going to start regulating herbs. Indeed, from what I've seen, the only thing that's going to get regulated is the ridiculous marketing done using said herbs, roots and -- for all we know -- bat guano.

There's no doubt in my mind that some herbs in their organic state have some beneficial properties. That's just common sense. What bends my crank is when specific herbs are touted as remedying a laundry list of common ailments that normally go away over time anyway. And I have precisely the same reaction to the overmedication of people that's hyped by pharmaceutical companies day-in and day-out in TV, radio and magazine advertisements. Those agencies are restricted from making ridiculous claims about the health benefits of their products. Why should herbalists get a free pass?

[kcvl]

I don't think they should. That was my point. The claims are ridiculous.

[ETERNAL WARMING]

Surprise, surprise. The Drug companies spend millions treating our politicians to luxurious vacations, R&R extravaganzas, etc. They contribute large bucks to their election campaigns.

What they want is to keep the American citizens dependent on their extortionist, high cost drugs.

We have the best politicians Corporate money can buy.

[sixmil]

For one thing, they are trying to ban the 'steroid' that McGuire was taking. Actually it is just a natural compound that slightly raises testosterone levels (does nothing), unlike the synthetic testerone that McGuire and most athletes actually use.

About tens years ago, the Japanese produced some contaminated tryptophan (an essential amino acid (one your body can't produce)) which lead the gov't to ban all tryptophan. This would be the equivalent of banning all beef in the US after mad cow was discovered.

Forget about all the illegals invading the country, let's ban vitamins!

[Wolfie]

The industry can regulate itself as it has for many years.

That's a laugh. Pick up a bodybuilding magazine, and see just how the supplement industry is "regulating" itself. Do I think the law should be changed? No. But the supplement companies have brought this down on themselves with their absurd claims and questionable ingredients.

[A. Pole]

The primary thrust of SB 722 is to place the so-called "Natural Supplements" under requirements similar to those met by other products marketed as drugs or medicine; namely that they be demonstrated as safe,

To demonstrate it you need to spend many millions of dollars. How will you include this cost in the price of naturally growing plant? Only by giving a licence/patent to sell to those who paid for the testing. Others growers/producers will be prohibited from selling and the price will be comparable to the commercial syntethic medication.

Besides most of remedies/medications have some side effects if incorrectly used, so the logical step will be allowing them on prescription only. It create another illegal market for illegal natural "prescription medications" as the reform will make them expensive and many will not be able to afford them. A boon for exploding prison industry.

that they be accurately labled, that they adhere to strict purity standards, and that any claim made for the product be substantiated.

You cannot "substantiate" all claims even on many of "scientific" (synthetic) medications/supplements.

The end result will be that after cutting off the last affordable alternative (assuming that generic/Canadia medications are also not available) many millions will become a lobby for socialized medicine. So the greedy CEO's/owners/lobbists will cut the branch on which they sit.

[timberlandko]

Poppycock and blather, A. Pole; every argument you pose is specious. The expense involved with proving the safety and efficacy of any product is a natural and just concomitant to the responsible marketing of said product; if the expense cannot be borne, the product fails, period. Do the regulations pertaining to milk hinder thousands of independent dairies? Of course not ... they comply, and submit to verification, inspection, and testing.

Some of, even key among, the problems with unregulated herbal supplements precisely are the issues of product content and purity, side effects and interactions. The public is placed at great risk by the paucity of information in such regard. To lobby for the continuance of such a state of affairs borders on criminal disregard of minimal acceptable good practice.

Your assertion " ... You cannot "substantiate" all claims even on many of "scientific" (synthetic) medications/supplements." is totally preposterous; an FDA-approved substance by definition must demonstrate it is what it says it is and does what it claims to do. If that requirement is good enough for aspirin, maple syrup, or toothpaste, its good enough for herbal supplements. If something doesn't qualify, it shouldn't get to play. Its not a matter of greed or cronyism or anything of the sort; it merely is responsible. The chief objection of those opposed to regulating herbal supplements specifically is rooted in the unwillingness to be held responsible.

Again, many producers of herbal supplements are diligent and responsible; they will suffer no significant ill effect from SB 722. It is the others, the snake oil purveyors, that will be sorely inconvenienced. Inconvenience does not absolve one from responsibility; it is a legitimate cost of doing business. This is as it should be.

[LibertyAndJusticeForAll]

Thanks for posting.

[Clintonfatigued]

Herbs are grown out of the earth, not made in a laboratory. So it is logical to conclude that they are here for a logical purpose. Many primitive cultures have used such medicine for centuries, and their benefits are proven. Don't let the medical establishment have a monopoly over every aspect of medical care!

[A. Pole]

The expense involved with proving the safety and efficacy of any product is a natural and just concomitant to the responsible marketing of said product; if the expense cannot be borne, the product fails, period.

You are very wrong. The herb is not a PRODUCT. It grows on its own and was not invented by the people.

If one corporation proves for example that mint tea helps for settle and sooth the stomach (this is a truth known for millenia), it will incures a substantial expense which will be a pure financial loss.

Why? There is no way to pass this cost to the customer since the competition will charge MUCH, MUCH less while benefiting from the demonstration. Growing mint is cheap and almost everyone can do it.

The only way is give the exclusive right to this corporation and CRIMINALIZE unlicenced use/sale.

Now what about all other foods - dairy, poultry, fish, beef, vegetables, fruits known for centuries - they all have some effects known to the general public. Do they have to be legalized, proven and licenced too? Can we breath without permission of government and without paying some corporation. Are we corporate/government property?

[GovernmentShrinker]

Yes, regulation is certainly needed -- SELF-regulation by consumers. Anyone who is stupid enough to be popping a variety of self-prescribed pills without ascertaining exactly what they contain, deserves to be poisoned. Just like people who go hiking in the woods and start eating whatever mushrooms they find. The only proper role for government here is to facilitate the identification and prosecution of supplement manufacturers whose products' contents differ from the labelled contents.

[A. Pole]

Anyone who is stupid enough to be popping a variety of self-prescribed pills without ascertaining exactly what they contain, deserves to be poisoned.

BTW, there are over-the-counter medications which will kill you if you overdose. There are basic household/kitchen things which will do the same. (I will not give the names, just in case).

[mollynme]

Consumers would find it easier to "self-regulate" if they were given the information they need - such as maximum safe dosages, potential side effects and drug interactions. This is the kind of information they get from regulated medications. Herbal drug makers are not going to scare potential customers away if they don't have to. Then again, if they haven't tested these "natural" chemicals in controlled settings, they may not have that information themselves.

[A. Pole]

Then again, if they haven't tested these "natural" chemicals in controlled settings, they may not have that information themselves.

Testing is extremely expensive. It makes sense only in two sitiations:

1. In privatized model when the food, plant/herb, a synthetic chemical substance is patented/lincenced to the corporation which paid for testing. This is appriopriate for artificial/invented drugs.

2. In socialized model when the cost is shared by society/taxpayers and when everyone is permitted to benefit/profit from the result. This is the model used in government sponsored research.

When private corporations lobby for control of natural remedies, they unwittingly help second model to prevail.

[XBob]

18 - "Shaklee is doomed. DOOMED I say"

LOL

[PreviouslyA-Lurker]

It's a good idea in theory, but in practice it will allow the phamacutical companies to indefinitely stop the sale of supplements. There are lots of drugs that are approved for use that have terrible side affects but they make a lot of money for the phamacuetical companies so they continue to be sold. Example: RU486, women have been dying from it, but it's use has not been suspended. One death from a diet supplement has pulled it from the shelves. RU486 was fast-tracked for approval, i.e. it didn't go through all the usual tests. RU486 is the only drug that was fast tracked whose purpose is not to save a life.

[timberlandko]

"Consumers would find it easier to "self-regulate" if they were given the information they need - such as maximum safe dosages, potential side effects and drug interactions ..."

Yup, that's the whole point. That the purveyors of these nostrums object so strenuously to being held to responsible practice condems their cause unambiguously. All SB 722 requires is that they honestly label their product. The hype and hysteria comprising their assertions is prima facie evidence of their malintent. For those who doubt this, following is the text of the bill itself.

108th CONGRESS 1st Session S. 722 To amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements submit to the Food and Drug Administration reports on adverse experiences with dietary supplements, and for other purposes.

IN THE SENATE OF THE UNITED STATES

March 26, 2003

Mr. DURBIN introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements submit to the Food and Drug Administration reports on adverse experiences with dietary supplements, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE. This Act may be cited as the `Dietary Supplement Safety Act of 2003'.

SEC. 2. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.

(a) IN GENERAL- Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following: `SEC. 416. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.

`(a) DEFINITIONS- In this section:

`(1) ADVERSE DIETARY SUPPLEMENT EXPERIENCE- The term `adverse dietary supplement experience' means an adverse event that is associated with the use of a dietary supplement in a human, without regard to whether the event is known to be causally related to the dietary supplement. `(2) SERIOUS ADVERSE DIETARY SUPPLEMENT EXPERIENCE- The term `serious adverse dietary supplement experience' means an adverse dietary supplement experience that-- `(A) results in-- `(i) death; `(ii) a life-threatening condition; `(iii) inpatient hospitalization or prolongation of hospitalization; `(iv) a persistent or significant disability or incapacity; or `(v) a congenital anomaly, birth defect, or other effect regarding pregnancy, including premature labor or low birth weight; or `(B) requires medical or surgical intervention to prevent 1 of the outcomes described in subparagraph (A). `(b) REPORTING AND REVIEW- `(1) SERIOUS ADVERSE DIETARY SUPPLEMENT EXPERIENCES- `(A) IN GENERAL- Each manufacturer of a dietary supplement, and each packer or distributor of a dietary supplement the name of which appears on the labeling of the dietary supplement-- `(i) shall develop written procedures for-- `(I) surveillance, receipt, and evaluation of information on adverse dietary supplement experiences associated with use of the dietary supplement; and `(II) submission to the Secretary of reports under this subsection; `(ii) as soon as practicable after, but in no event later than 15 calendar days after, initial receipt of nformation with respect to a serious adverse dietary supplement experience, shall submit to the Secretary-- `(I) the information; and `(II) a copy of the current labeling for the dietary supplement; `(iii)(I) shall promptly investigate the adverse dietary supplement experience; and `(II)(aa) if additional information is obtained, shall submit to the Secretary a report describing the information-- `(AA) not later than 15 days after obtaining the information; or `(BB) at the request of the Secretary; or `(bb) if no additional information is obtained, shall maintain records of the steps taken to seek additional information. `(B) ELIMINATION OF DUPLICATIVE REPORTING- `(i) IN GENERAL- To avoid duplicative reporting under this subsection, the Secretary may establish a procedure under which-- `(I) a packer or distributor of a dietary supplement may submit a report to the manufacturer of the dietary supplement; and `(II) the manufacturer shall transmit the report to the Secretary. `(ii) REQUIREMENT- A procedure under clause (i) shall ensure that the Secretary receives reports within the applicable period of time specified in subparagraph (A). `(C) CLINICAL EVALUATIONS BY THE SECRETARY- `(i) IN GENERAL- The Secretary shall conduct a clinical evaluation of each serious adverse dietary supplement experience with a patient that is reported to the Secretary under subparagraph (A). `(ii) UNWILLING PATIENT- The Secretary is not required to conduct a clinical evaluation under clause (i) to the extent that any unwillingness of the patient (or the next of kin for the patient, as the case may be) to cooperate with the evaluation makes it impracticable to conduct the evaluation.

`(2) PERIODIC ADVERSE DIETARY SUPPLEMENT EXPERIENCE REPORTING- A manufacturer of a dietary supplement shall annually (or at such shorter intervals as the Secretary may require), in accordance with such requirements as the Secretary may establish, submit to the Secretary a report that discloses all information received with respect to adverse dietary supplement experiences not previously reported under paragraph (1).

`(3) REVIEW REGARDING ADVERSE DIETARY SUPPLEMENT EXPERIENCES- `(A) IN GENERAL- Promptly after a manufacturer of a dietary supplement receives from a consumer, or obtains by any other means, any information on an adverse dietary supplement experience, the manufacturer shall review the information. `(B) APPLICABILITY- Subparagraph (A)-- `(i) applies to information without regard to the source of the information, foreign or domestic; and `(ii) includes information derived from sources such as-- `(I) commercial marketing experience; `(II) postmarketing investigations; `(III) postmarketing surveillance; `(IV) studies; `(V) reports in the scientific literature; and `(VI) unpublished scientific papers.

`(4) ADDITIONAL REPORTING REQUIREMENTS- In addition to the requirements of paragraphs (1) and (2), the Secretary may establish such requirements regarding the reporting of information on adverse dietary supplement experiences as the Secretary determines to be appropriate to protect the public health.

`(5) WAIVERS- The Secretary may grant a waiver from the requirement of paragraph (1), (2), or (3) with respect to a dietary supplement if the Secretary determines that compliance with the requirement is not necessary to protect the public health.

`(6) SYSTEM FOR COORDINATION OF REPORTS RECEIVED BY THE SECRETARY- With respect to reports of adverse dietary supplement experiences submitted to the Secretary (whether required under this subsection or otherwise), the Secretary shall establish a system to-- `(A) receive the reports; `(B) refer the reports to the appropriate officials within the Food and Drug Administration; `(C) store and retrieve the reports; `(D) store and retrieve records of activities carried out in response to the reports; and `(E) carry out such other administrative functions regarding the reports as the Secretary determines to be appropriate.

`(7) DATA COLLECTION BY SECRETARY- `(A) IN GENERAL- The Secretary shall carry out a program to collect data on serious adverse dietary supplement experiences, in addition to receiving reports required in this subsection. `(B) COOPERATION- In carrying out the program, the Secretary shall seek the cooperation of appropriate public and private entities, including entities that respond to medical emergencies.

`(8) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to carry out this subsection $10,000,000 for fiscal year 2003 and each fiscal year thereafter. `(c) POSTMARKET SURVEILLANCE- `(1) AUTHORITY TO REQUIRE SURVEILLANCE- The Secretary may by order require a manufacturer of a dietary supplement to conduct postmarket surveillance for the dietary supplement if the Secretary determines that there is a reasonable possibility that a use or expected use of the dietary supplement by a significant number of consumers may result in serious adverse experiences.

`(2) SURVEILLANCE PLAN- `(A) IN GENERAL- Not later than 30 days after receiving from the Secretary an order under paragraph (1) to conduct surveillance for a dietary supplement, a manufacturer shall submit to the Secretary, for the approval of the Secretary, a plan for the required surveillance. `(B) QUALIFICATIONS REGARDING SURVEILLANCE; DATA REGARDING ADVERSE DIETARY SUPPLEMENT EXPERIENCES- Not later than 60 days after a plan is submitted to the Secretary under subparagraph (A), the Secretary shall determine whether-- `(i) the person designated to conduct the surveillance has appropriate qualifications and experience to conduct the surveillance; and `(ii) the plan will result in the collection of useful data that will disclose adverse dietary supplement experiences or other information necessary to protect the public health. `(3) SURVEILLANCE PERIOD- In consultation with a manufacturer of a dietary supplement that is required to conduct surveillance under paragraph (1), the Secretary may by order require a prospective surveillance period for the manufacturer of not more than-- `(A) 3 years; or `(B) such longer period as may be determined-- `(i) by agreement between the Secretary and the manufacturer; or `(ii) if the Secretary and the manufacturer cannot agree, through a dispute resolution process established by the Secretary by regulation. `(d) SAFETY REVIEW FOR POSSIBLY DANGEROUS DIETARY SUPPLEMENTS- `(1) IN GENERAL- If a clinical evaluation by the Secretary of 1 or more serious adverse events indicates that a dietary supplement or a dietary ingredient contained in a dietary supplement appears to present a significant or unreasonable risk of illness, the Secretary may require the manufacturers of the dietary supplement, or of a dietary ingredient contained in a dietary supplement, to submit to the Secretary data demonstrating that the dietary supplement containing the dietary ingredient is safe. `(2) APPROVAL OR DISAPPROVAL OF CONTINUED MARKETING- As soon as practicable after receiving data required under paragraph (1), the Secretary shall review the data and issue a determination that-- `(A)(i) the dietary supplement is safe; and `(ii) the continued marketing of the dietary supplement is approved; or `(B)(i) the dietary supplement is not safe or has not been shown to be safe under ordinary or frequent conditions of use; and `(ii) the continued marketing of the dietary supplement is disapproved.'. (b) PROHIBITED ACTS- Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following: `(hh) ADVERSE DIETARY SUPPLEMENT EXPERIENCES- `(1) FAILURE TO COMPLY- The failure of a person to submit a report or comply with any other requirement under section 416. `(2) DISAPPROVAL OF CONTINUED MARKETING- The continued marketing of a dietary supplement by any person after the Secretary issues a determination under section 416(d)(2)(B) that-- `(A) the dietary supplement is not safe or has not been shown to be safe under ordinary conditions of use; and `(B) the continued marketing of the dietary supplement is disapproved.

SEC. 3. STIMULANTS. (a) DEFINITION OF STIMULANT- Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following: `(nn) STIMULANT- The term `stimulant' means a dietary ingredient that has a stimulant effect on the cardiovascular system or the central nervous system of a human by any means, including-- `(1) speeding metabolism; `(2) increasing heart rate; `(3) constricting blood vessels; or `(4) causing the body to release adrenaline.'. (b) PREMARKET APPROVAL- Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) (as amended by section 2(a)) is amended by adding at the end the following: `SEC. 417. STIMULANTS. `(a) IN GENERAL- No person shall introduce or deliver for introduction into interstate commerce a dietary supplement containing a stimulant unless an approval of the dietary supplement under this section is in effect. `(b) APPROVAL- The Secretary shall approve an application for premarket approval of a dietary supplement containing a stimulant if the manufacturer of the stimulant demonstrates that the dietary supplement is safe under ordinary or frequent conditions of use. `(c) COMBINATIONS OF STIMULANTS- In the case of a dietary supplement that contains a combination of stimulants, the Secretary, in determining the safety of the dietary supplement, shall consider the interaction of the various stimulants contained in the dietary supplement. `(d) ACTION ON APPLICATION- The Secretary shall approve or disapprove an application for premarket approval of a dietary supplement containing a stimulant not later than 180 days after receiving the application.'. (c) ADULTERATED FOOD- Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following: `(i) DIETARY SUPPLEMENTS CONTAINING A STIMULANT- If the food is a dietary supplement containing a stimulant for which the Secretary has not granted premarket approval under section 417. `(j) EFFECT OF SECTION- Nothing in this section affects any other law (including a regulation) applicable to caffeine used as a food or drug.'. (d) REGULATIONS- Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance for implementing the amendments made by this section. (e) EFFECTIVE DATE- (1) IN GENERAL- Except as provided in paragraph (2), the amendments made by this section-- (A) apply to dietary supplements manufactured before, on, or after the date of enactment of this Act; and (B) take effect on the date that is 180 days after the date of enactment of this Act. (2) ALREADY-MARKETED DIETARY SUPPLEMENTS- The amendments made by this section do not apply to a dietary supplement that has been marketed before the date of enactment of this Act until the date that is 2 years after the date of enactment of this Act.

SEC. 4. STEROID PRECURSORS. (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT- Section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(1)) is amended by striking `(other than tobacco)' and inserting `(other than tobacco or a product that bears or contains an anabolic steroid (including a substance that is chemically and pharmacologically related to testosterone but not including an estrogen, progestin, or corticosteroid))'. (b) CONTROLLED SUBSTANCES ACT- (1) DEFINITION OF ANABOLIC STEROID- Section 102(41)(A) of the Controlled Substances Act (21 U.S.C. 802(41)(A)) is amended-- (A) by striking `that promotes muscle growth, and includes--' and inserting `that promotes muscle growth or is advertised or used to promote muscle growth. `(B) The term `anabolic steroid' includes--'; and (B) by striking `(B)(i)' and inserting `(C)(i)'. (2) EXCLUSION FROM SCHEDULE- Section 201(g)(1) of the Controlled Substances Act (21 U.S.C. 811(g)(1)) is amended by striking `if such substance' and all that follows and inserting `if the substance-- `(A) is approved as being safe and effective for its intended use under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or `(B) is lawfully marketed under an over-the-counter monograph issued by the Food and Drug Administration.'.

SEC. 5. AGENCY EXPERTISE AND AUTHORITY. Section 402(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(f)(1)) is amended by striking the matter following subparagraph (D).

Now, what is so onerous about being required to openly and honestly disclose the makeup and effect of a product? To claim the costs and burdens of responsible practice render responsible practice impracticable is patently absurd. Only scoundrels would lay such a claim.