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redsamurai
Banned
indubitably
Congress - HGH - & Professional Athletics
- Thread starter Captain FT
- Start date
indubitably
redsamurai
Banned
how many people have died from ecoli having been in their supplement bottles?
Honestly I dunno, it's an honest question and you obviously have the answer so let's hear it.
mrplunkey
New member
how many people have died from ecoli having been in their supplement bottles?
Honestly I dunno, it's an honest question and you obviously have the answer so let's hear it.
Yeah, synthol, bathtub tren and DNP has never hurt anyone.
redsamurai
Banned
Yeah, synthol, bathtub tren and DNP has never hurt anyone.
How is that answering my question "at all"?
First off you're not getting that shit at GNC so it has no business in this discussion. Second, how many people have contracted E coli from supplement bottles they get from GNC? You know, not shit that's made in someones basement.
mrplunkey
New member
Have you still not figured out that I was making fun of you when I suggested e. coli in supplement bottles?
Do you even know what I'm talking about when I referred to "All-natural pot smoke V2.0"?
redsamurai
Banned
This was a sarcastic comment, you are saying that infact if we regulate the meat industry certainly the supplement industry needs the same manner of regs. I'm not playing your little games tonight, what is your answer?
mrplunkey
New member
If the meat industry deserves regulation, the supplement industry should get a similar degree of regulation.
Are you still not getting it?
redsamurai
Banned
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.
Next Section
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.
Previous Section
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.
Texture
mrplunkey
New member
The advocacy arm I the AMA couldn't give a damn less about supplements. They lobby for one issue -- physician reimbursement (and all of its derivatives).
redsamurai
Banned
As with most topics here at EF that don't revolve around finance or some form of business mechanics....you are again woefully underinformed. The AMA is at the forefront to getting supplements regulated to the point where you ahve to get a prescription for them.
AMA? American Motorcycle Association? LOL @ squidly talking about AMA!!!!
mrplunkey
New member
Pssst!
They publish their lobbying agenda here: Current Topics in Advocacy
Please provide a single link to the AMA lobbying against supplements, particularly your narrowly defined "vitamins".
mrplunkey
New member
Yes, the discussion is regarding the American Motorcycle Association's lobbying efforts against supplements.
You sure are a clever guy!
mrplunkey
New member
Here's another great article on supplements and regulation. Did you know L-tryptophan killed 38 people and injured over 1,500 more back in 1989?
Dietary Supplements—Regulatory Issues and Implications for Public Health
Bryan E. Denham, PhD
[+] Author Affiliations
Author Affiliation: Department of Communication Studies, Clemson University, Clemson, South Carolina.
Corresponding Author: Bryan E. Denham, PhD, Department of Communication Studies, 412 Strode Tower, Clemson University, Clemson, SC 29634 ([email protected]).
More author information
KEYWORDS:
CONSUMER PRODUCT SAFETY,
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT,
DIETARY SUPPLEMENTS,
GOVERNMENT REGULATION,
LEGISLATION, DRUG,
LEGISLATION, FOOD,
PUBLIC HEALTH,
UNITED STATES FOOD AND DRUG ADMINISTRATION.
In October 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA), and 17 years later, health experts, policy makers, and industry lobbyists continue to spar over the legislation. Classifying dietary supplements as a subcategory of food, DSHEA allowed supplement manufacturers to market products without submitting proof of safety or efficacy to the US Food and Drug Administration (FDA).1 Currently, for a tainted or otherwise hazardous product to be removed from the supplement marketplace, an agency such as the FDA or the Drug Enforcement Administration must offer evidence that the product is unsafe, contains a controlled substance, or is absent ingredients listed on the product label after the product has appeared in retail outlets.2 For US health professionals, the fact that more than 150 million US residents use dietary supplements should be a point of concern as many users will almost certainly forgo conventional medical treatment in favor of using products that may offer no medicinal value and taking health advice from medically untrained sales representatives.3
Counterintuitively, DSHEA became law 5 years after the L-tryptophan amino acid disaster of 1989, in which 38 individuals died and 1500 sustained adverse reactions.1 When the FDA appeared heavy-handed in its response to the supplement catastrophe, industry lobbyists began applying pressure to lawmakers, especially those with a vested political interest in the economic success of supplement companies. US Senator Orrin Hatch, representing Utah, a major producer of dietary supplements, responded to industry appeals by coauthoring DSHEA and shepherding it through Congress. In doing so, Hatch sought to help manufacturers enjoy the freedom they had profited from during the 1980s after the Proxmire Amendment of 1976 barred the FDA from using potency levels to classify dietary supplements as drugs.4 To date, no public official has defended the interests of the supplement industry to a similar extent.
In 2009, a US Government Accountability Office (GAO) report found that “consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting the labels on these products.”2 In fact, one of the most significant problems with DSHEA is that it allows structure and function claims to appear on product labels; as long as products do not claim to treat, prevent, or cure specific diseases, they can enter and remain in the marketplace.1 The concern is that consumers may not differentiate between technical descriptions and marketing language and may attempt to use dietary supplements in place of medicines that have been tested in rigorous trials. To that end, a 2010 GAO investigation found that sellers of dietary supplements may actually encourage consumers to substitute supplements for physician-prescribed medications.3
In preparing its 2010 report, the GAO investigated 22 retailers of herbal dietary supplements, hiring an accredited laboratory to examine 40 single-ingredient supplements for the presence of lead, arsenic, mercury, cadmium, and assorted pesticides.3 Although none of the supplements qualified as having an acute toxicity hazard, trace amounts of at least 1 contaminant were found in 37 of 40 products.3 According to the GAO, more troubling than the contaminants was the dubious and potentially hazardous advice offered to investigators who had posed as elderly customers. The GAO gathered written materials from online retailers, observing claims of treating, preventing, and curing conditions such as diabetes, cancer, and cardiovascular disease. Among the more egregious marketing efforts were claims that garlic could be taken in place of high blood pressure medication and that ginkgo biloba could be used to treat Alzheimer disease, depression, and impotence.3 Studies conducted by the National Center for Complementary and Alternative Medicine have shown that ginkgo biloba, in particular, does not reduce the risk of cancer nor does it prove effective in reducing high blood pressure among older adults.5 Careful review of National Center for Complementary and Alternative Medicine studies reveals a similar lack of efficacy for garlic, chromium picolinate, and St John's wort.5
On occasion, policy makers have attempted to address at least some of the problems associated with dietary supplements. For example, citing the 2009 GAO report,6 Senators John McCain and Byron Dorgan introduced the Dietary Supplement Safety Act (S 3002) in February 2010.7 Although this act did not propose significant changes in efficacy assessment, it would have required supplement manufacturers to register with the FDA and disclose all product ingredients. The legislation also would have given the FDA mandatory recall authority, the lack of which had resulted in the agency taking 10 years to remove ephedra from the marketplace.6 But S 3002 never became law. With the support of industry lobbies, Hatch and Senator Tom Harkin persuaded McCain and Dorgan to drop S 3002, introducing in its place the Dietary Supplement Full Implementation and Enforcement Act (S 3414).8 Announced on May 25, 2010, S 3414, which also did not become law, proposed allocating additional monies to the FDA such that the agency could enforce DSHEA more effectively. Hatch has long argued that funding is the key to enforcement success, perhaps because the argument cannot be falsified; that is, whenever problems with DSHEA arise, proponents can simply request additional funding for enforcement efforts. However, such bills have amounted to little more than the perpetual tabling of legislative reform, leaving the FDA in the untenable position of having no premarket screening authority while simultaneously facing critics who blame the agency for not enforcing DSHEA.
Few industries enjoy the level of protection DSHEA provides supplement manufacturers. Legislators, with the support of industry lobbies, continue to find ways to relax regulations. For example, on April 5, 2011, US Representatives Jason Chaffetz and Jared Polis introduced the Free Speech About Science Act (HR 1364),9 which would allow supplement manufacturers to cite research showing health benefits without the FDA classifying corresponding supplements as unapproved drugs. Given that products touted as scientifically formulated already may be marketed by companies that gather and analyze data on a proprietary basis and then cite DSHEA as a means of keeping results private and shielded from robust peer review, the intent of this legislation might be questioned. The basic tenets of science are frequently ignored by companies that use the term to lend credence to their industry, and it is safe to assume that supplement manufacturers will not make an announcement each time a study finds no relationship between a dietary supplement and a health condition. For cases in which the null hypothesis is actually rejected, HR 1364 would allow industry leaders to promote their findings—a practice with which they appear comfortable.
Since October 1994, when DSHEA became law, industry statements about life in a free society and the rights of consumers have frequently overridden practical arguments about the safety and efficacy of dietary supplements, resulting in a conversation that has privileged demagoguery over informed debate. The conversation needs a more sophisticated tone and the FDA took a positive step in 2007, issuing a rule on good manufacturing practices.10 Ideally, good manufacturing practices will help reduce availability of products containing contaminants such as pesticide residue or oxidation by-products; however, as the GAO investigations revealed, there is still room for improvement. Physicians should support future efforts to improve or reform DSHEA because individuals with serious medical conditions may be relying on products with no medicinal value. Like dietary supplements, the regulations should be efficacious and formulated for legitimate ends.
Next Section
Author Information
Author Affiliation: Department of Communication Studies, Clemson University, Clemson, South Carolina.
Corresponding Author: Bryan E. Denham, PhD, Department of Communication Studies, 412 Strode Tower, Clemson University, Clemson, SC 29634 ([email protected]).
Published Online: July 5, 2011. doi:10.1001/jama.2011.982
Conflict of Interest Disclosures: Dr Denham has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Previous Section
REFERENCES
1.
Hill JA
. Creating balance: problems within DSHEA and suggestions for reform. J Food Law Policy. 2006;2:361-396. http://www.nationalaglawcenter.org/assets/bibarticles/hill_balance.pdf. Accessed April 7, 2011.
2.
US Government Accountability Office
. Dietary supplements: FDA should take further actions to improve oversight and consumer understanding. January 2009. Publication No. GAO-09-250. http://www.gao.gov/new.items/d09250.pdf. Accessed April 8, 2011.
3.
US Government Accountability Office
. Herbal dietary supplements: examples of deceptive or questionable marketing practices and potentially dangerous advice. May 2010. Publication No. GAO-10-662T. http://www.gao.gov/new.items/d10662t.pdf. Accessed April 7, 2011.
4.
US General Accounting Office
. FDA regulation of dietary supplements. July 1993. Publication No. HRD-93-28R. http://archive.gao.gov/d43t14/149513.pdf. Accessed June 3, 2011.
5.
National Center for Complementary and Alternative Medicine
. Research results for dietary herbal supplements: selected results of NCCAM-funded research on dietary and herbal supplements. NCCAM Web site. http://nccam.nih.gov/research/results/topicds/index.php?title=Dietary_and_Herbal_Supplements. Accessed June 4, 2011.
6.
Senator John McCain introduces the Dietary Supplement Safety Act of 2010 [press release]. February 3, 2010. US Senator John McCain Web site. http://mccain.senate.gov/public/ind...ecord_id=952dda07-b71c-4034-4f34-c38974978f7d. Accessed June 3, 2011.
7.
Dietary Supplement Safety Act of 2010, S 3002 , 111th Cong, 2nd Sess (2010).
8.
Dietary Supplement Full Implementation and Enforcement Act of 2010, S 3414 , 111th Cong, 2nd Sess (2010).
9.
Free Speech About Science Act of 2011, HR 1364 , 112th Cong, 1st Sess (2011).
10.
US Food and Drug Administration
. Current good manufacturing practices (CGMPs): dietary supplements. FDA Web site. Current Good Manufacturing Practices (CGMPs). Accessed June 3, 2011.
Dietary Supplements—Regulatory Issues and Implications for Public Health
Bryan E. Denham, PhD
[+] Author Affiliations
Author Affiliation: Department of Communication Studies, Clemson University, Clemson, South Carolina.
Corresponding Author: Bryan E. Denham, PhD, Department of Communication Studies, 412 Strode Tower, Clemson University, Clemson, SC 29634 ([email protected]).
More author information
KEYWORDS:
CONSUMER PRODUCT SAFETY,
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT,
DIETARY SUPPLEMENTS,
GOVERNMENT REGULATION,
LEGISLATION, DRUG,
LEGISLATION, FOOD,
PUBLIC HEALTH,
UNITED STATES FOOD AND DRUG ADMINISTRATION.
In October 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA), and 17 years later, health experts, policy makers, and industry lobbyists continue to spar over the legislation. Classifying dietary supplements as a subcategory of food, DSHEA allowed supplement manufacturers to market products without submitting proof of safety or efficacy to the US Food and Drug Administration (FDA).1 Currently, for a tainted or otherwise hazardous product to be removed from the supplement marketplace, an agency such as the FDA or the Drug Enforcement Administration must offer evidence that the product is unsafe, contains a controlled substance, or is absent ingredients listed on the product label after the product has appeared in retail outlets.2 For US health professionals, the fact that more than 150 million US residents use dietary supplements should be a point of concern as many users will almost certainly forgo conventional medical treatment in favor of using products that may offer no medicinal value and taking health advice from medically untrained sales representatives.3
Counterintuitively, DSHEA became law 5 years after the L-tryptophan amino acid disaster of 1989, in which 38 individuals died and 1500 sustained adverse reactions.1 When the FDA appeared heavy-handed in its response to the supplement catastrophe, industry lobbyists began applying pressure to lawmakers, especially those with a vested political interest in the economic success of supplement companies. US Senator Orrin Hatch, representing Utah, a major producer of dietary supplements, responded to industry appeals by coauthoring DSHEA and shepherding it through Congress. In doing so, Hatch sought to help manufacturers enjoy the freedom they had profited from during the 1980s after the Proxmire Amendment of 1976 barred the FDA from using potency levels to classify dietary supplements as drugs.4 To date, no public official has defended the interests of the supplement industry to a similar extent.
In 2009, a US Government Accountability Office (GAO) report found that “consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting the labels on these products.”2 In fact, one of the most significant problems with DSHEA is that it allows structure and function claims to appear on product labels; as long as products do not claim to treat, prevent, or cure specific diseases, they can enter and remain in the marketplace.1 The concern is that consumers may not differentiate between technical descriptions and marketing language and may attempt to use dietary supplements in place of medicines that have been tested in rigorous trials. To that end, a 2010 GAO investigation found that sellers of dietary supplements may actually encourage consumers to substitute supplements for physician-prescribed medications.3
In preparing its 2010 report, the GAO investigated 22 retailers of herbal dietary supplements, hiring an accredited laboratory to examine 40 single-ingredient supplements for the presence of lead, arsenic, mercury, cadmium, and assorted pesticides.3 Although none of the supplements qualified as having an acute toxicity hazard, trace amounts of at least 1 contaminant were found in 37 of 40 products.3 According to the GAO, more troubling than the contaminants was the dubious and potentially hazardous advice offered to investigators who had posed as elderly customers. The GAO gathered written materials from online retailers, observing claims of treating, preventing, and curing conditions such as diabetes, cancer, and cardiovascular disease. Among the more egregious marketing efforts were claims that garlic could be taken in place of high blood pressure medication and that ginkgo biloba could be used to treat Alzheimer disease, depression, and impotence.3 Studies conducted by the National Center for Complementary and Alternative Medicine have shown that ginkgo biloba, in particular, does not reduce the risk of cancer nor does it prove effective in reducing high blood pressure among older adults.5 Careful review of National Center for Complementary and Alternative Medicine studies reveals a similar lack of efficacy for garlic, chromium picolinate, and St John's wort.5
On occasion, policy makers have attempted to address at least some of the problems associated with dietary supplements. For example, citing the 2009 GAO report,6 Senators John McCain and Byron Dorgan introduced the Dietary Supplement Safety Act (S 3002) in February 2010.7 Although this act did not propose significant changes in efficacy assessment, it would have required supplement manufacturers to register with the FDA and disclose all product ingredients. The legislation also would have given the FDA mandatory recall authority, the lack of which had resulted in the agency taking 10 years to remove ephedra from the marketplace.6 But S 3002 never became law. With the support of industry lobbies, Hatch and Senator Tom Harkin persuaded McCain and Dorgan to drop S 3002, introducing in its place the Dietary Supplement Full Implementation and Enforcement Act (S 3414).8 Announced on May 25, 2010, S 3414, which also did not become law, proposed allocating additional monies to the FDA such that the agency could enforce DSHEA more effectively. Hatch has long argued that funding is the key to enforcement success, perhaps because the argument cannot be falsified; that is, whenever problems with DSHEA arise, proponents can simply request additional funding for enforcement efforts. However, such bills have amounted to little more than the perpetual tabling of legislative reform, leaving the FDA in the untenable position of having no premarket screening authority while simultaneously facing critics who blame the agency for not enforcing DSHEA.
Few industries enjoy the level of protection DSHEA provides supplement manufacturers. Legislators, with the support of industry lobbies, continue to find ways to relax regulations. For example, on April 5, 2011, US Representatives Jason Chaffetz and Jared Polis introduced the Free Speech About Science Act (HR 1364),9 which would allow supplement manufacturers to cite research showing health benefits without the FDA classifying corresponding supplements as unapproved drugs. Given that products touted as scientifically formulated already may be marketed by companies that gather and analyze data on a proprietary basis and then cite DSHEA as a means of keeping results private and shielded from robust peer review, the intent of this legislation might be questioned. The basic tenets of science are frequently ignored by companies that use the term to lend credence to their industry, and it is safe to assume that supplement manufacturers will not make an announcement each time a study finds no relationship between a dietary supplement and a health condition. For cases in which the null hypothesis is actually rejected, HR 1364 would allow industry leaders to promote their findings—a practice with which they appear comfortable.
Since October 1994, when DSHEA became law, industry statements about life in a free society and the rights of consumers have frequently overridden practical arguments about the safety and efficacy of dietary supplements, resulting in a conversation that has privileged demagoguery over informed debate. The conversation needs a more sophisticated tone and the FDA took a positive step in 2007, issuing a rule on good manufacturing practices.10 Ideally, good manufacturing practices will help reduce availability of products containing contaminants such as pesticide residue or oxidation by-products; however, as the GAO investigations revealed, there is still room for improvement. Physicians should support future efforts to improve or reform DSHEA because individuals with serious medical conditions may be relying on products with no medicinal value. Like dietary supplements, the regulations should be efficacious and formulated for legitimate ends.
Next Section
Author Information
Author Affiliation: Department of Communication Studies, Clemson University, Clemson, South Carolina.
Corresponding Author: Bryan E. Denham, PhD, Department of Communication Studies, 412 Strode Tower, Clemson University, Clemson, SC 29634 ([email protected]).
Published Online: July 5, 2011. doi:10.1001/jama.2011.982
Conflict of Interest Disclosures: Dr Denham has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Previous Section
REFERENCES
1.
Hill JA
. Creating balance: problems within DSHEA and suggestions for reform. J Food Law Policy. 2006;2:361-396. http://www.nationalaglawcenter.org/assets/bibarticles/hill_balance.pdf. Accessed April 7, 2011.
2.
US Government Accountability Office
. Dietary supplements: FDA should take further actions to improve oversight and consumer understanding. January 2009. Publication No. GAO-09-250. http://www.gao.gov/new.items/d09250.pdf. Accessed April 8, 2011.
3.
US Government Accountability Office
. Herbal dietary supplements: examples of deceptive or questionable marketing practices and potentially dangerous advice. May 2010. Publication No. GAO-10-662T. http://www.gao.gov/new.items/d10662t.pdf. Accessed April 7, 2011.
4.
US General Accounting Office
. FDA regulation of dietary supplements. July 1993. Publication No. HRD-93-28R. http://archive.gao.gov/d43t14/149513.pdf. Accessed June 3, 2011.
5.
National Center for Complementary and Alternative Medicine
. Research results for dietary herbal supplements: selected results of NCCAM-funded research on dietary and herbal supplements. NCCAM Web site. http://nccam.nih.gov/research/results/topicds/index.php?title=Dietary_and_Herbal_Supplements. Accessed June 4, 2011.
6.
Senator John McCain introduces the Dietary Supplement Safety Act of 2010 [press release]. February 3, 2010. US Senator John McCain Web site. http://mccain.senate.gov/public/ind...ecord_id=952dda07-b71c-4034-4f34-c38974978f7d. Accessed June 3, 2011.
7.
Dietary Supplement Safety Act of 2010, S 3002 , 111th Cong, 2nd Sess (2010).
8.
Dietary Supplement Full Implementation and Enforcement Act of 2010, S 3414 , 111th Cong, 2nd Sess (2010).
9.
Free Speech About Science Act of 2011, HR 1364 , 112th Cong, 1st Sess (2011).
10.
US Food and Drug Administration
. Current good manufacturing practices (CGMPs): dietary supplements. FDA Web site. Current Good Manufacturing Practices (CGMPs). Accessed June 3, 2011.
mrplunkey
New member
Here's more information from the L-Tryptophan disaster of 1989:
In 1989, an outbreak of eosinophilia-myalgia syndrome (EMS) occurred among L-tryptophan users [2]. A hitherto rare disorder, EMS is a debilitating disease characterized by severe muscle and joint pain, weakness, swelling of the arms and legs, fever, skin rash, and an increase of eosinophils (certain white blood cells) in the blood. Over the next year, more than 1,500 cases and twenty-eight deaths were reported to the U.S. Centers for Disease Control and Prevention [3]. The actual toll probably was more than 5,000 people, many of whom suffered for years and are still disabled. Soke of the victims were children. When the link between EMS and L-tryptophan became apparent, the FDA quickly banned its sale [4,5].
The EMS outbreak was traced to the presence of an impurities in the L-tryptophan produced by Showa Denko K.K., a Japanese wholesaler that was the major supplier to American manufacturers [6-8]. Showa Denko realized that it would not only be liable for damages to L-tryptophan victims but would probably be forced to reimburse American manufacturers for the costs of legal actions against them. Rather than working at cross-purposes with the manufacturers, Showa Denko agreed to shoulder all the expenses involved.
Minneapolis attorney Roger P. Brosnahan, who chaired the steering committee for all plaintiffs who brought cases in federal court, estimates that about 2,000 L-tryptophan victims (or their survivors) filed lawsuits or entered negotiations without suing. Most cases have generated little publicity because they were settled out of court with an agreement not to disclose the settlement terms. Even though the total amount paid by Showa Denko approximated one billion dollars, the general news media have not considered the outcome of the lawsuits newsworthy.
The full text can be found here: Notes on the Tryptophan Disaster
In 1989, an outbreak of eosinophilia-myalgia syndrome (EMS) occurred among L-tryptophan users [2]. A hitherto rare disorder, EMS is a debilitating disease characterized by severe muscle and joint pain, weakness, swelling of the arms and legs, fever, skin rash, and an increase of eosinophils (certain white blood cells) in the blood. Over the next year, more than 1,500 cases and twenty-eight deaths were reported to the U.S. Centers for Disease Control and Prevention [3]. The actual toll probably was more than 5,000 people, many of whom suffered for years and are still disabled. Soke of the victims were children. When the link between EMS and L-tryptophan became apparent, the FDA quickly banned its sale [4,5].
The EMS outbreak was traced to the presence of an impurities in the L-tryptophan produced by Showa Denko K.K., a Japanese wholesaler that was the major supplier to American manufacturers [6-8]. Showa Denko realized that it would not only be liable for damages to L-tryptophan victims but would probably be forced to reimburse American manufacturers for the costs of legal actions against them. Rather than working at cross-purposes with the manufacturers, Showa Denko agreed to shoulder all the expenses involved.
Minneapolis attorney Roger P. Brosnahan, who chaired the steering committee for all plaintiffs who brought cases in federal court, estimates that about 2,000 L-tryptophan victims (or their survivors) filed lawsuits or entered negotiations without suing. Most cases have generated little publicity because they were settled out of court with an agreement not to disclose the settlement terms. Even though the total amount paid by Showa Denko approximated one billion dollars, the general news media have not considered the outcome of the lawsuits newsworthy.
The full text can be found here: Notes on the Tryptophan Disaster
redsamurai
Banned
pssssttt, pretty sure he was engaging in situational irony, you being a poser and all. Laugh, my, fucking, ass off....holy geez u are dense.
redsamurai
Banned
aaah, so it was a purity problem...not the actual supplement itself. And how do the impurities get introduced? By cross contamination with other compounds being compounded by the same equipment.....lean cost cutting operations basically. Yeah and that happens with name brand pharmaceuticals as well. On this I agree that supplement makers should be held to the same standard as big pharmaceutical makers. And it must have been a quite severe impurity problem because L-tryptophan is nothing, it's in turkey for godsake....it's whats gonna make you pass the fuck out tommorrow after you're done stuffing your pudgy little pie hole.
mrplunkey
New member
So is salmonella. Do you always type in circles or just here on EF?
redsamurai
Banned
redsamurai
Banned
and do you always talk out your ass or just here at EF?
wait, completely rhetorical...my bad, don't answer that.
wait, completely rhetorical...my bad, don't answer that.
mrplunkey
New member
and do you always talk out your ass or just here at EF?
wait, completely rhetorical...my bad, don't answer that.
You better jump in this thread and set your BF straight:
Is an EF breakup imminent?
redsamurai
Banned
mrplunkey
New member
RS wants "unresistable" to be the next "irregardless", but its knot gonna happen
PICK3
New member
fyp
redsamurai
Banned
it already has happened and it's gonna happen....I'm going to bring it up every post or every other post to him for, well, the rest of my time here at EF. It's the exact same word jumble that happened to me and so now I'm going to poop in my hand and throw it back, at all you quite frankly.
PICK3
New member
indubitably
mrplunkey
New member
it already has happened and it's gonna happen....I'm going to bring it up every post or every other post to him for, well, the rest of my time here at EF. It's the exact same word jumble that happened to me and so now I'm going to poop in my hand and throw it back, at all you quite frankly.
Irregardless of the context?
redsamurai
Banned
i cannot unresist the temptation.
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