Talk:Dietary Supplement Health and Education Act of 1994

Copy of a US Federal work

The draft I made of this page is a copy of a work by the United States Federal government.

• Janet Rehnquist (2003), Department of Health and Human Services - Office of the Inspector General - Dietary Supplement Labels: Key Elements (PDF), United States Department of Health and Human Services, OEI-01-01-00120, retrieved 2 April 2013 {{citation}}: Unknown parameter |month= ignored (help)

This document is noncopyright because of the special copyright status of work by the U.S. government, and this eligible for copying into this article. Blue Rasberry (talk) 14:37, 2 April 2013 (UTC)

Bluerasberry, great job.Sthubbar (talk) 14:34, 9 April 2013 (UTC)

first ref

I am taking out the first reference and content based on it. First ref is an article written by the former president of the trade industry for dietary supplements. This is not a neutral reliable source for content on the history of the DSHEA. Here is the bio of the author http://www.crnusa.org/safetypdfs/AnnetteDickinson.pdf

am looking for a reliable, NPOV source on the history of DSHEA and will create content based on it when i find it.Jytdog (talk) 15:25, 2 April 2013 (UTC)

Try the New England Journal of Medicine. https://www.google.com/webhp?rls=ig#psj=1&q=site:nejm.org+Dietary+Supplement+Health+And+Education+Act+of+1994 --Nbauman (talk) 17:53, 4 November 2013 (UTC)

I think that both this and the removed reference should be integrated. The first link is not neutral when presented alone but it is a notable perspective, and when the views of prominent people with strong representative biases are not mentioned in Wikipedia articles, then that makes the article NPOV. Perhaps neutrality would be better achieved if the biases were labeled along with the perspectives. Blue Rasberry (talk) 19:05, 4 November 2013 (UTC)

Criticism of DSHEA

A search of the NEJM turns up the following book review, which is a good explanation of what some of the critics are saying: http://www.nejm.org/doi/full/10.1056/NEJMbkrev57733 Natural Causes: Death, Lies, and Politics in America's Vitamin and Herbal Supplement Industry N Engl J Med 2007; 356:2659June 21, 2007 DOI: 10.1056/NEJMbkrev57733

The NEJM may be paywalled, but there is an article in the New York Times by the author of the book that gives the same basic argument. http://www.nytimes.com/2007/01/16/health/16diet.html?pagewanted=all

It is an understatement to say that the DSHEA is controversial. This article contains mostly primary sources, which is discouraged by WP:RS and WP:MEDMOS, which require comments from reliable secondary sources, according to WP:NPOV. --Nbauman (talk) 18:07, 4 November 2013 (UTC)

MEDMOS does not apply here because this is an article about a law and not medicine, but yes, secondary sources are always best. They rarely exist in any field, even in medicine, but thanks for sharing links. Even though I would not call that book a secondary source it is definitely a scholarly perspective worth integrating. I am a bit overextended at this time and unable to process this now but I agree that adding content from the NEJM would be ideal. Blue Rasberry (talk) 19:03, 4 November 2013 (UTC)

Ephedra

Why has all reference to ephedra and the deaths attributed to it been deleted from this article? --Nbauman (talk) 17:38, 10 March 2015 (UTC)

Nbauman I found the deletion by Jytdog in April 2013. I think the problem is that the text does not connect this law with ephedra, and that if the text were re-added then the connection between this law and that substance should be made more clear. What connection exists? Blue Rasberry (talk) 03:44, 11 March 2015 (UTC)

Thanks, Lane. Happy to discuss, NBauman. Jytdog (talk) 11:06, 11 March 2015 (UTC)

User:Bluerasberry, I don't know what you mean when you say that the text does not connect this law with ephedra. Here's one that user:Jytdog deleted:

http://www.nytimes.com/1996/04/19/opinion/natural-doesn-t-mean-safe.html
Natural' Doesn't Mean Safe
By Richard A. Friedman
Published: April 19, 1996
In banning the sale of the herbal stimulant ephedra, which has been linked to 15 deaths nationwide, Nassau County this week not only took on the multimillion-dollar dietary supplement industry but also issued a challenge to Congress.
The question is not whether local governments should protect consumers but why Congress has taken away the Food and Drug Administration's power to regulate potentially toxic products.
Herbal Ecstasy, Cloud 9, Ultimate Xphoria and other products containing ephedra (also called ephedrine and ma huang) have been linked to heart attacks, seizures, severe psychiatric disturbances and strokes, even when used as directed. And ephedra is not the only questionable dietary supplement on the market....

I think that's a clear connection. The New York Times had about 100 stories specificially associating the DSHEA with ephedra deaths, which you can find with the Google search "site:nytimes.com ephedra dietary supplement health and education act" or by searching in the NYT's own search.

At the time of the DSHEA/ephedra controversy, I was writing for medical magazines read by doctors, and I wrote a few stories about complementary and alternative medicine, so I read the medical literature carefully at the time and I remember what I read. Ephedra is literally the classic, textbook case of the inadequacies of the DHEA leading to deaths. The only stronger evidence you could have is randomized, controlled trials with humans. The best way to find it is with a PubMed search:

http://www.nejm.org/doi/full/10.1056/NEJM200006083422309
Editorial
Cancer and Herbs
David A. Kessler, M.D.
N Engl J Med 2000; 342:1742-1743
June 8, 2000
DOI: 10.1056/NEJM200006083422309
Among the other well-documented examples of adverse reactions are the association of germander with acute hepatitis, of comfrey with hepatic veno-occlusive disease, of yohimbe with seizures and renal failure, and of ephedra with death from cardiovascular causes.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2803%2915315-9/fulltext
363(9403):135, 10 January 2004
News
FDA issues alert on ephedra supplements in the USA
Roxanne Nelson
DOI: http://dx.doi.org/10.1016/S0140-6736(03)15315-9
“Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law”, said FDA Commissioner Mark McClellan.

http://jama.jamanetwork.com/article.aspx?articleid=196217
The need for regulation of dietary supplements--lessons from ephedra.
Fontanarosa PB, Rennie D, DeAngelis CD.
JAMA. 2003 Mar 26;289(12):1568-70. Epub 2003 Mar 10.
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.
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.

http://jama.jamanetwork.com/article.aspx?articleid=196247
Review
Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance: A Meta-analysis
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(12):1537-1545.
doi:10.1001/jama.289.12.1470.
[Free]

If you can't use PubMed you can do a Google search, which gives for example the following WP:RS:

http://illinoislawreview.org/wp-content/ilr-content/articles/2010/3/Nowak.pdf
DHEA's Failure: Why a Proactive Approach to Dietary Supplement Regulation is Needed to Effectively Protect Consumers
Richard E. Nowak
University of Illinois Law Review 2010:1046
--Nbauman (talk) 18:08, 11 March 2015 (UTC)

Nbauman I wrote the wrong thing and I regret that you did more work and explaining than is necessary as a result. I am not disputing any of the facts. Again, here is the deleted text. I do not see the text which you added above in the article anywhere. Can you please look in the history and find the deleted WP:DIFF so that I will know what you are referencing? In the deleted text that I found, there is no connection made between ephedra and the DSHE. To make this more clear, I will repeat the deleted text here: "Since 2004, ephedra-containing products have been prohibited for sale in the United States due to probable health concerns and side effects. After this restriction, other supplements took its place in the market, and research has shown that these products may also have safety problems." Can you say more about how this 1994 legislation was the cause of a 2004 prohibition? Is there something more that I could do to explain how those two sentences do not mention the law that is the subject of this article? Are you perhaps looking for a Wikipedia article which is discussing the history of regulation of ephedra in the United States? I am not sure how to continue this conversation - please say more. Blue Rasberry (talk) 18:18, 11 March 2015 (UTC)

User:Bluerasberry, forget about the edit history. My concern is that:

(1) There is an extensive WP:MEDRS literature, which I sampled above, which says consistently and repeatedly that: the DSHEA does not regulate "dietary supplements" well enough to protect the public, injuries and deaths have in fact occurred as they predicted, and one of the best-documented examples is ephedra.

(2) The Wikipedia article doesn't say that. Instead, under "Criticism," it gives vague, unsupported claims, including arguments that date back to the time of the passage of the act, and don't reflect the much stronger criticism that were made when "supplement" users finally started dying from ephedra and other drugs as predicted.

I've read drafts of articles and reports in which someone deleted all the strong arguments and supporting facts on one side, to make the evidence seem weaker and to avoid giving offense to someone. That's what this "Criticism" section looks like. Just compare what Kessler says in this WP entry to his complete article in the NEJM.

Why don't you write a draft summary of the above literature in Talk? I would write it myself but I don't know what you would accept. --Nbauman (talk) 18:47, 11 March 2015 (UTC)

How rude. Lane was just being helpful and answering your question. you are the one who seems quite passionate about it, so perhaps you would like to do it. No one has asked, but my reason for removing that bit of content was that it was a strange one-off and without context. I think that the article could benefit from some encyclopedic content about problems that have arisen under DSHEA with things like ephedra, steroids, etc. I don't think opinions like "the DSHEA does not regulate "dietary supplements" well enough to protect the public" can be said in WP's voice (and i doubt any MEDRS says that this is a Fact so flatly stated, based on the huge volume of snake oil dietary supplements that are consumed by americans and the small small percentage of actual problems they cause. But neither a one-off without context, nor a laundry list, are encyclopdic. Jytdog (talk) 19:06, 11 March 2015 (UTC)

Nbauman Nothing rude happened, we are just talking. I apologize but I do not have time to take on this project at this time. If you have time to draft something, then I can help you, just as I would help others who come here. I do not dispute that there is literature which says this; the only thing that I said was that the deleted text did not seem to connect to the subject of the article. It would be great if someone wrote "As a result of the DSHE, the following things happened..." then cited sources for each statement made.

Typically what I accept is what students write, as I do a lot of outreach to schools. My personal standards are that if someone writes a coherent sentence which matches the source cited and seems relevant to the subject of the article then it is probably good enough. If you want to talk this through, then feel free to email me and perhaps we could talk by phone if you are new to editing Wikipedia and have questions about how this works.

In the longer term, I meet regularly with health students and want better coverage of alternative medicine in Wikipedia, so if you are not interested, then perhaps someday I will find someone else here. I care about the topic but am unable to write and research this at this time. Blue Rasberry (talk) 19:21, 11 March 2015 (UTC)

User:Jytdog, if you see something you don't like on Wikipedia, we would be better served if you followed WP:PRESERVE and improved it rather than merely deleting it.

I read the peer-reviewed journals on dietary supplements, and that's what they said. We should say in Wikipedia's voice that that's what the peer-reviewed journals said. You are free to read the peer-reviewed journals yourself and show us what you think they said.--Nbauman (talk) 00:21, 12 March 2015 (UTC)

Nbauman It sounds like we have consensus here. I hope that the information you shared here on the talk page is someday added to the article by someone. Blue Rasberry (talk) 01:39, 12 March 2015 (UTC)

"FDA and DSHEA" section

Threw up an NPOV tag due to some pretty heavy-duty editorializing. Not nearly enough time has passed for me between "woke up" and "logged into my computer" to do much about that section beyond tagging it, though, at least for right now. -Technogeek (talk) 15:49, 16 October 2015 (UTC)

Enforcement section needed

Either as a separate section or under FDA and DSHEA there is need for an explanation for the FDA's enforcement of DSHEA. This should cover when Good Manufacturing Practices became incorporated into law for dietary supplements, the black-box FDA disclaimer statement, why Warning Letters are issued and how enforced, the line drawn between supplements and foods so that supplement ingredients are not added to foods, etc. For international perspective, could include a paragraph on FOSHU (Japan) and EFSA (European Common Market). There should be a way to craft this so it does not deteriorate into dueling examples of the trespassing by industry and over-reaction by government. David notMD (talk) 08:42, 31 March 2017 (UTC)

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How the DSHEA of 1994 gave conspiracy mongers the means

[1] The Truth vs. Alex Jones: How the DSHEA of 1994 gave conspiracy mongers the means to fund their empires

I don't know how and if this WP:SBM piece by David Gorski can be integrated into the article. --Hob Gadling (talk) 06:59, 2 April 2024 (UTC)