NOTICE ALERT: FDA Moving to Dismantle DSHEA

[Guest guest]

http://hfn-usa.com/articles/030425.html

April 25, 2003Smart PublicationsHealth & Wellness Update Dear Friends, As a

knee jerk reaction to the alleged ephedra-related death of Baltimore Orioles

pitching prospect Steve Becheler, the U.S. Senate is considering a new bill

called the " Dietary Supplement Safety " Act (S.722). Despite its title, it would

allow no more consumer protection than current law—the Dietary Supplement Health

and Education Act (DSHEA)—provides. It would, however, significantly undermine

the freedom that American consumers of dietary supplements cherish. Read this

week's e-mail to familiarize yourself with the issue, and then ask your Senate

and Congressional representatives to oppose any efforts to amend the Dietary

Supplement Health and Education Act. For your convenience, we've included a

form letter for you to send. But, please act soon! If you want to continue

using nutritional supplements without needing a prescription from your doctor,

it's vital!In good health,John MorgenthalerClick here to read: Act now to

protect your access to all safe nutritional supplementsFDA Moving to Dismantle

DSHEA The hard-won natural health freedoms ensured by the Dietary Supplement

Health and Education Act (DSHEA) of 1994 could be overturned! Using the adverse

media attention surrounding the herbal supplement ephedra as a lever, the Food

and Drug Administration (FDA), with the blessing of theDepartment for Health and

Human Services (HHS) and at the request of U.S. Senator Dick Durbin (D-IL), has

reopened the comment period on the DSHEA legislation. If the forces backing

this measure are successful, DSHEA may be amended so that any and all dietary

supplements can be banned!What is DSHEA?The FDA regulates nutritional

supplements (including ephedra) differently than " conventional " foods or drugs

(both prescription and over-the-counter medications). Under the terms of the

Dietary Supplement and Health Education Act of 1994, manufacturers are

responsible for establishing their own manufacturing practice guidelines and

making sure a dietary supplement is safe before putting it on the market. Once

a dietary supplement is marketed, the FDA must demonstrate that the product is

unsafe before it can take regulatory action against the dietary supplement.It is

interesting to note that DSHEA was enacted to assure consumers that nutritional

supplements are beneficial. It was enacted from the standpoint that if these

supplements help support health and fight disease, then the FDA should be

responsible for legislation to assure they are manufactured and labeled

properly. The laws relating to protecting consumers from dangerous foods have

existed for decades and also apply to supplements. Good manufacturing

practicesFollowing the DSHEA act, on November 20, 1995 representatives of the

dietary supplement industry submitted an outline for CGMP (current good

manufacturing practices) regulations for dietary supplements and dietary

supplement ingredients to the FDA. FDA representatives evaluated the outline

and determined that it provided a useful starting point for developing CGMP

regulations. Nonetheless, they believed that the industry outline did not

address certain issues that should be considered when developing a proposed rule

on CGMPs for dietary ingredients and dietary supplements. For example, the

industry outline did not address specific controls for automatic,

computer-controlled, or assisted systems.But while Congress considered it a

“national priority” to ensure public health and safety, the FDA has had its own

agenda of trying to put supplements into a “dangerous” category with GMPs that

are close to drug standards. If the FDA were sincere about making sure

consumers get what they pay for, it certainly would not have taken almost 8

years to come up with a new proposal. All that really needed to be done in the

first place was to add a method for substantiating label dosage claims to

existing food manufacturing GMPs. Simple.Now, instead of heeding the advice of

the dietary supplement industry, the FDA is listening with an open ear to the

editors of the nation's leading medical journals, who have joined the growing

chorus of voices from the pharmaceutical industry calling for changes in the way

dietary supplements are regulated.For instance, in a recent editorial that

appeared in the Journal of American Medical Association, the authors wrote, " If

dietary supplements have or promote such biological activity, they should be

considered to be active drugs. On the other hand, if dietary supplements are

claimed to be safe because they lack or have minimal biological activity, then

their ability to cause physiologic changes to support " structure /function "

claims should be challenged, and their sale and distribution as products to

improve health should be curtailed. " 1Chronology of events2• DSHEA was passed Oct

25, 1994.• Congress required the FDA to establish GMPs for the supplement

industry. • The supplement industry did its part within 13 months of DSHEA's

passage, and established GMPs.• The FDA took 87 months (almost 8 years!) to

create the final proposed regulation on March 13, 2003. • The final proposal is

now open for public review, as required, but we have less than 3 months to

respond! The FDA needs to get its act together!The FDA has the power to regulate

harmful supplements if they are proven to be harmful. Yet, it's important to

note that the FDA has never removed a dietary supplement from the market EXCEPT

tryptophan, which is still illegal despite its safety record. Why does the FDA

need more power if they already have the power to remove any supplement that is

proven unsafe? Adding more regulations to a bureaucracy that is somehow unable

to act on its own regulations is not the answer. Having this bureaucracy do

what we pay them for is step one. Having them not lie to the public about their

hands being tied would also help.The FDA has had an adversarial relationship

with the nutritional supplement industry for decades (why has it taken 8 years

for them to come up with proposed regulations for supplement GMPs?) and guess

why. Because of the potential competition with the pharmaceutical industry.

Hey, who wants a healthy population when the sick need drugs? Improving one's

health with nutritional supplements decreases profits for the drug industry, the

biggest industry in the world. Ironically, a study just published in the April

17 issue of The New England Journal of Medicine found that one in four people

who walk out of the doctor's office with a prescription may be headed for

trouble from an adverse drug event, and that more than a third of those unwanted

and potentially dangerous side effects could have been prevented with better

prescribing practices and doctor-patient communication. The FDA should put more

attention on safeguarding consumers from the drug industry—which is where the

real danger lies—and on working with the AMA (American Medical Association) to

encourage better communication between the pharmaceutical companies and

physicians, and between physicians and patients.Rather than introduce new laws,

which would unnecessarily expand the authority of the Food and Drug

Administration and restrict the ability of consumers to access a variety of safe

and beneficial supplements, Congress should instead investigate and oversee ways

in which the Food and Drug Administration can make full use of its current and

more-than-adequate authority as granted by the Dietary Supplement Health and

Education Act (DSHEA). And it should certainly pay more attention to the

manufacturing of dangerous pharmaceuticals.Act Now!We encourage you to send an

email, a fax or a letter to your Senate and Congressional representatives, to

the FDA and to HHS and demand that your constitutional and fundamental human

health rights not be restricted by a government agency that is heavily

influenced by lobbyists for the pharmaceutical industry. Comments are being

accepted until June 11, 2003, so do it soon!Ask yourself this: Who would benefit

from the proposed amendments to DSHEA? Your health and right to natural

therapies or the pharmaceutical companies who profit from disease? If the FDA

manages to ratify the legislative changes they are seeking, alternatives to

unsafe, ineffective and expensive patented drugs will be restricted. Instead,

the multi-billion dollar pharmaceutical " business with disease " will continue to

grow … and you might eventually need a prescription for your nutritional

supplements. Here's a sample letter for your use, made available by the

National Nutritional Foods Association. NNFA is recognized for its strong,

aggressive lobbying presence in Washington, D.C., where it serves as the

industry watchdog on regulatory and legislative matters. :Dear –––––––,As your

constituent, I urge you to oppose any efforts by your fellow Senators to pass S.

722, the so-called Dietary Supplement " Safety " Act, recently introduced by

Senator Richard Durbin. I am deeply concerned that rather than passing this new

act ˜ which would unnecessarily expand the authority of the Food and Drug

Administration - Congress should instead investigate and oversee ways in which

the Food and Drug Administration can make full use of its current and

more-than-adequate authority as granted by the Dietary Supplement Health and

Education Act of 1994.I have read that the Durbin bill, despite its title, would

allow no more consumer protection than current law provides. It does, however,

contain new and discretionary enforcement powers that would significantly

undermine many of the freedoms that American consumers of dietary supplements

like myself hold dear.If adopted, this bill would subject nearly all vitamins,

minerals, herbal products and other supplements to a level of scrutiny that is

both unwarranted and unnecessary. Products that have been used safely and

beneficially for hundreds—and in some cases, thousands—of years would be subject

to clinical evaluation using standards that are at the complete discretion of

the FDA.I am concerned that this bill, by questioning the safety of any dietary

supplement that receives even one complaint, will result in potentially hundreds

of products being removed from the marketplace. Under this new legislation, the

FDA has complete discretion to make this determination, regardless of whether

the product was used under conditions cautioned against by the manufacturer on

the label.By almost every measure, and by a wide margin, dietary supplements can

be used more safely than conventional foods and OTC drugs. Yet this legislation

exempts foods in these product categories from being classified as stimulants.

Specifically, the bill unfairly excludes the most common " stimulant " ingredient

in foods—caffeine.I ask you to oppose this extreme and unnecessary legislation

and instead take the opportunity to encourage and support the FDA in fully

utilizing its enforcement powers as granted by DSHEA.I look forward to hearing

your thoughts on this important matter.Sincerely,Your nameContact your

representatives now before it's too late!Secretary of Health and Human

ServicesTommy G. Thompson200 Independence Avenue, SWWashington, D.C.

20201202-690-7000http://www.dhhs.govHHS can be contacted at:

http://www.hhs.gov/ContactUs.htmlFood and Drug AdministrationMark B. McClellan,

M.D., Ph.D.Commissioner of Food and DrugsU. S. Food and Drug Administration5600

Fishers LaneRockville, MD 20857-00011-888-INFO-FDA (1-888-463-6332)The FDA can

be contacted at: http://www.fda.gov/comments.htmlContact your local senate and

congressional representatives.Log on to http://www.house.gov and

http://www.senate.gov and enter your zip code in the field located on the top

left-hand side of the web page. In some districts, you must enter your full

nine-digit zip code, but the web site provides a link to the United States

Postal Service. After entering your zip code, follow the online instructions

for contacting your local representatives.References:1. Phil B. Fontanarosa, MD;

Drummond Rennie, MD; Catherine D. DeAngelis, MD, MPH. " The Need for Regulation

of Dietary Supplements—Lessons From Ephedra " JAMA, 2003;289:1568-1570.2.

Department of Health and Human Services, Food & Drug Administration. " Current

Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary

Ingredients and Dietary Supplements, " Docket No. 96N-0417.

http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.html3. Tejal K. Gandhi, M.D.,

M.P.H., et. al. " Adverse Drug Events in Ambulatory Care. " The New England

Journal of Medicine, Volume 348:1556-1564 April 17, 2003 Number 16.

 

 

Gettingwell- / Vitamins, Herbs, Aminos, etc.

 

To , e-mail to: Gettingwell-

Or, go to our group site: Gettingwell

 

 

 

 

The New Search - Faster. Easier. Bingo.