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redsamurai
Banned
explain, I'm all ears.
Congress - HGH - & Professional Athletics
- Thread starter Captain FT
- Start date
explain, I'm all ears.
mrplunkey
New member
Which word did you not understand?
PICK3
New member
meat
redsamurai
Banned
you did not give a concise and educated explanation for your reasoning. We know why the meat industry needs regulated, why do supplements need that same sort of regulation? Sell it to me.
mrplunkey
New member
How about I let the Journal of the American Medical Association do it for me?
The Need for Regulation of Dietary Supplements—Lessons From Ephedra
Phil B. Fontanarosa, MD;
Drummond Rennie, MD;
Catherine D. DeAngelis, MD, MPH
[+] Author Affiliations
Author Affiliations: Dr Fontanarosa is Executive Deputy Editor, Dr Rennie is Deputy Editor, and Dr DeAngelis is Editor, JAMA.
Corresponding Author: Phil B. Fontanarosa, MD, JAMA, 515 N State St, Chicago, IL 60610 (e-mail: [email protected]).
More author information
KEYWORDS:
complementary the, rapies,
dietary, supplements,
drug reaction, adverse,
ephedrine,
ephedra, ,
sports medicine,
weight loss.
Dietary supplements encompass a wide spectrum of products, including vitamins and minerals, such as folate and calcium; herbal therapies and botanical agents, such as ephedra and ginkgo biloba; and enzymes or extracts from organs or glands, such as some "hormone" preparations.1 Dietary supplements are readily available in pharmacies, grocery stores, and health food stores, as well as by mail and via the Internet. These products are widely promoted, often with unsubstantiated claims of benefit and rarely with any mention of potential hazards. In the United States, dietary supplements are used by millions of people every day and account for billions of dollars in sales annually.
Dietary supplements are regulated by the US Food and Drug Administration (FDA), although under different regulations than those governing prescription medications and over-the-counter drugs.1 The Dietary Supplement Health and Education Act (DSHEA) of 1994 established that substances classified as dietary supplements are not "drugs" and substantially changed the role of the FDA in regulating these products.2 The DSHEA amended the existing federal Food, Drug, and Cosmetic Act with provisions that created a new regulatory framework governing the safety and labeling of dietary supplements.1
Under the provisions of DSHEA, manufacturers of dietary supplements are not required to provide evidence of efficacy or safety prior to marketing the product. Moreover, except for a supplement that contains a "new dietary ingredient," dietary supplements are not required to have FDA approval or to be registered with the FDA before they are produced and marketed. Manufacturers are responsible for establishing their own manufacturing practice guidelines, because there are no FDA regulations to ensure the identity, purity, quality, composition, or strength of dietary supplements.1 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, essentially amounting to a "postmarketing" regulatory framework.1, 3 As for advertising of dietary supplements, the Federal Trade Commission (FTC) is primarily responsible for ensuring that claims in print and broadcast ads, infomercials, catalogs, and direct marketing materials ". . . must be truthful, not misleading, and substantiated."4
Despite the widespread use as well as the pervasive and persuasive marketing of these agents, it is increasingly clear that for at least some dietary supplements, lack of sufficient oversight and inadequate regulation may pose a risk to the health and safety of the public. In this issue of THE JOURNAL, Shekelle and colleagues5 provide an evidence-based summary of the efficacy and safety of ephedra and ephedrine, which are among the most controversial dietary supplements. Based on their review of 52 controlled trials, the authors concluded that supplements containing these agents promote modest short-term weight loss (approximately 0.9 kg/mo more than placebo). However, the evidence was insufficient to support ephedra use for long-term weight loss or for enhancing athletic performance. Analysis of safety data from 50 trials revealed that ephedra and ephedrine are associated with 2- to 3-fold increases in the odds of psychiatric symptoms, autonomic symptoms, upper gastrointestinal symptoms, and heart palpitations. An additional evaluation of adverse event reports revealed 5 deaths, 5 myocardial infarctions, 11 cerebrovascular accidents, 4 seizures, and 8 psychiatric cases as "sentinel events" associated with prior consumption of ephedra or ephedrine.
The results of this analysis cast doubt on any claims that use of dietary supplements containing ephedra or ephedrine can help achieve long-term weight loss or weight maintenance or can enhance athletic performance. The findings also strongly suggest increased risk of serious adverse effects associated with these products. Moreover, reviewing the accumulated reports of toxicity linked to these compounds, it is hard not to be impressed by the number of serious cardiovascular complications in young adults. The public, aware of recent reports of deaths in young athletes reportedly taking ephedra or ephedrine, is right to be alarmed that the regulation Congress has in place does so little to protect them from the hazards posed by these potentially dangerous compounds.
The article by Shekelle et al5 is based on a comprehensive 300-plus page Evidence Report/Technology Assessment on ephedra and ephedrine commissioned by the National Institutes of Health and the Agency for Healthcare Research and Quality (AHRQ) and conducted by the RAND Corporation.6 Department of Health and Human Services Secretary Tommy Thompson and FDA Commissioner Mark McClellan, MD, PhD, released the results of the RAND report at a news conference on February 28, 2003,7 and also expressed concerns about the safety of ephedra and announced several regulatory actions.
According to a recent White Paper on ephedra,3 the FDA has sent warning letters to manufacturers of ephedra instructing them to remove unproven claims for their products or substantiate those claims, especially those related to athletic performance. The FDA also has proposed "black box" warning labels on all products containing ephedra, indicating that serious adverse events and deaths have been reported after ephedra use.3 In addition, the FDA announced that it was seeking public comment to determine whether in light of current scientific evidence, dietary supplements containing ephedra represent "a significant or unreasonable risk of illness or injury"7 and whether "evidence of significant safety concerns, short of a definitive demonstration of a risk profile, is sufficient for new restrictions on products regulated under DSHEA."3
These actions are important and necessary steps in response to the new information on safety and effectiveness of ephedra provided by Shekelle and colleagues.5-6 However, the current system for regulation of dietary supplements is inadequate for ensuring the protection of the health and safety of the public who choose to use ephedra or other dietary supplements. Major changes in the system used to regulate these products are required.
Labeling for dietary supplements is not permitted to include "disease claims" (eg, prevents Alzheimer disease), but these products nearly always include at least one "structure/function" claim (eg, improves mild memory loss associated with aging). Yet the only way such claims can be valid is if the dietary supplement actually promotes or has inherent biological activity. For example, ephedra alkaloids have biological actions, as evidenced by sympathomimetic pharmacological properties and adverse cardiovascular events.8 Another dietary supplement, saw palmetto, has been shown to suppress tissue levels of dihydrotestosterone in men with symptomatic benign prostatic hyperplasia and to alter the DNA chromatin structure and organization in prostate epithelial cells.9 Likewise, yohimbine, which is promoted as a remedy for male sexual dysfunction, selectively blocks the presynaptic α2 receptor and readily enters the central nervous system, where it acts to increase heart rate and blood pressure, enhance motor activity, and produce tremors.10-11
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. Manufacturers of dietary supplements are trying to have it both ways. They claim their products are powerfully beneficial, on the one hand, but harmless on the other. To claim both makes no sense, and to claim either without trials demonstrating efficacy and safety is deceptive. The public should wonder why dietary supplements have effectively been given a free ride.
New legislation is needed for defining and regulating dietary supplements. Dietary supplements that have biological activity should be evaluated and regulated with at least the same degree of oversight as is used for over-the-counter medications, and for some, with regulation similar to prescription drugs. Currently, this is not the case, as dietary supplements are subject to less regulation than virtually any other products available for public consumption (Table 1).12
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Table. Comparison of FDA's Regulatory Mechanisms to Help Ensure the Safety of Products*
The first step is to address the scope of categories of products included under the definition of dietary supplements, which is too broad. The number of products marketed as dietary supplements has increased considerably in the nearly 10 years since DSHEA was passed into law. Each class of products within dietary supplements should be re-examined, and the types of products within each class should be reviewed and classified according to possible biological action, purported benefit, and potential risks.
Second, dietary supplements should be subject to more rigorous regulation by the FDA. Lewis and Strom13 have proposed that manufacturers of any product with a health claim should be held to the same standards as the pharmaceutical industry and have suggested several features for a system to regulate nutritional supplements. Health claims for dietary supplements should meet the same rigorous criteria as claims by drugs used to prevent or treat disease.13 Data from acceptable studies must be approved by the FDA before the product can be marketed. Data on efficacy and toxicity should be submitted and carefully evaluated, and recommendations for dosages of supplements must be appropriate and evidence based. Manufacturing practices and quality control processes must be sufficient to ensure product content integrity and purity. Standards to document the content of products should be established and enforced.13
Third, formal systems for mandatory postmarketing surveillance and mandatory adverse event reporting should be established to replace the current system of haphazard, voluntary reporting of anecdotal reports. According to a report from the Office of Inspector General,12 the potential of the current FDA dietary supplement adverse event reporting system to serve as a consumer safeguard is "inherently limited." The Office of Inspector General report noted that the FDA reportedly receives reports of less than 1% of all adverse events associated with dietary supplements; that data on these events are characterized by limited medical information, limited product information, limited manufacturer information, limited information on the affected consumer, and limited ability to analyze trends of adverse event reports; and that "FDA rarely takes safety actions related to the adverse event reporting system."12
Fourth, the Federal Trade Commission in cooperation with the FDA should ensure that advertising for dietary supplements is accurate and not misleading. As with advertisements for therapeutic drugs, advertisements for dietary supplements must not make claims without substantiation by scientific evidence and must include appropriate information about adverse effects.
The reports by Shekelle et al,5-6 along with other studies documenting the increased risk of adverse reactions associated with ephedra,14 are sufficient evidence to restrict the use of this agent. However, the most important lessons from the new information on ephedra are demonstration of the inadequate nature of the current system of regulation of dietary supplements and recognition that much more rigorous oversight of these biologically active agents is necessary to protect the health and safety of the public.
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Author Information
Author Affiliations: Dr Fontanarosa is Executive Deputy Editor, Dr Rennie is Deputy Editor, and Dr DeAngelis is Editor, JAMA.
Corresponding Author: Phil B. Fontanarosa, MD, JAMA, 515 N State St, Chicago, IL 60610 (e-mail: [email protected]).
Editorials represent the opinions of the authors and THE JOURNAL and not those of the American Medical Association.
Editor's Note: While the policies of THE JOURNAL generally preclude publication of original articles based on reports that are already published or in the public domain, the decision to publish the article by Shekelle et al was based on consideration of several factors. The information in the JAMA article has undergone peer review and editorial evaluation, is timely and relevant for readers, and is more accessible and focused than the Evidence Report/Technology Assessment from RAND. In addition, the authors had informed the editors about their full evidence report and its relation to the article they had submitted to JAMA. After the paper submitted to JAMA had been reviewed, revised, and accepted for publication, the authors and editors, along with staff members at AHRQ, had planned to coordinate release of the RAND report and publication of the JAMA article, and had agreed on the date for release of the materials. However, the decision to release the results of the RAND report at the news conference was beyond the control of the authors. In this specific case, it would be unfair to penalize the authors, who have acted in good faith, by not publishing their article in JAMA because of prior release of the full evidence report.
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References
1.
US Food and Drug Administration. Overview of dietary supplements. Available at: Overview of Dietary Supplements. Accessibility verified March 5, 2003.
2.
Dietary Supplement Health and Education Act of 1994, Pub L No. 103.417.
3.
US Food and Drug Administration White Paper on Ephedra. Evidence on the safety and effectiveness of ephedra: implications for regulation. Available at: http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html. Accessibility verified March 5, 2003.
4.
Federal Trade Commission. Dietary supplements: an advertising guide for industry. Available at: http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm. Accessibility verified March 5, 2003.
5.
Shekelle PG, Hardy ML, Morton SC, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA. 2003;289:1537-1545.
Free Full Text
6.
Shekelle PG, Morton S, Maglione M, et al. Ephedra and ephedrine for weight loss and athletic performance enhancement: clinical efficacy and side effects. Evidence Report/Technology Assessment No. 76 (Prepared by Southern California Evidence-based Practice Center, RAND, under Contract No. 290-97-0001, Task Order No. 9). AHRQ Publication 03-E022. Rockville, Md: Agency for Healthcare Research and Quality; February 2003.
7.
US Food and Drug Administration. HHS acts reduce potential risks of dietary supplements containing ephedra. February 28, 2003. Available at: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html. Accessibility verified March 5, 2003.
8.
Haller CA, Benowitz NL. Adverse cardiovascular events and central nervous system events associated with dietary supplements containing ephedra alkaloids. N Engl J Med. 2000;343:1833-1838.
CrossRefMedline
9.
Veltri RW, Marks LS, Miller MC, et al. Saw palmetto alters nuclear measurements reflecting DNA content in men with symptomatic BPH: evidence for a possible molecular mechanism. Urology. 2002;60:617-622.
CrossRefMedline
10.
Favreau JT, Ryu ML, Braunstein G, et al. Severe hepatotoxicity associated with the dietary supplement LipoKinetix. Ann Intern Med. 2002;136:590-595.
Free Full Text
11.
Hoffman B. Catecholamines, sympathomimetic drugs, and adrenergic receptor antagonists. In: Hardman JG, Limbird LE, Gilman AG, eds. Goodman and Gilman's the Pharmacologic Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001.
12.
Office of Inspector General, Department of Health and Human Services. Adverse event reporting for dietary supplements: an inadequate safety valve. April 2001. Available at: http://oig.hhs.gov/oei/reports/oei-01-00-00180.pdf. Accessibility verified March 5, 2003.
13.
Lewis JD, Strom BL. Balancing safety of dietary supplements with the free market. Ann Intern Med. 2002;136:616-618.
Free Full Text
14.
Bent S, Tiedt TN, Odden MC, et al. The relative safety of ephedra compared with other herbal products. Ann Intern Med. 2003. Available at: http://www.acponline.org/journals/annals/ephedra.htm?hp. Accessibility verified March 5, 2003.
redsamurai
Banned
I will read the whole thing but right off the bat it's not a valid source since they've got skin in the game. MM has made many posts about these people lobbying congress. Kind of a prime example of the type of corruption we've been discussing lately.
But I will read what they have to say....
But I will read what they have to say....
redsamurai
Banned
ok, first off I'm talking vitamins and minerals. I do somewhat agree with them on compounds that have been shown to effect the human body to the level of say the autonomic nervous system. The comparison I'm discussing with you is the packaging of supplements vs meat. A factory making bottles of Vitamin C should not have to adhere to the same regulations as meat except in the case where they may be running other more powerful drugs through the same conveyor systems that could contaminate the vitamn C. If they make straight up vitamins than no they shouldn't have to undergo the same regs as a meat packing plant. This is how spinach gets contaminated because some of these food plants run meat or eggs through the same belts they then later run vegetables through.
As to regulating what is constituted a "supplement" vs a drug.....they do have a point. I think they are absolutely true when it came to ephedra. And we know that ephedra got pulled so the system did work in that instance.
As to regulating what is constituted a "supplement" vs a drug.....they do have a point. I think they are absolutely true when it came to ephedra. And we know that ephedra got pulled so the system did work in that instance.
mrplunkey
New member
Yeah, the JAMA is just a rag full of holes.
Perhaps we'll luck-out and you can find us something more rigorous and intellectually honest from Cybercollege.
redsamurai
Banned
on this issue they have skin in the game plunkey, they're spending untold sums of money in washington to get supplements regulated. We've been over this before. YOu should be intelligent enough to at the very least acknowledge this source "might" be tainted. But like I said, some of the things they say makes sense....but when you put it next to their lobbying efforts it takes on a different shine. Think things through sometime.
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