Guest guest Posted May 2, 2004 Report Share Posted May 2, 2004 http://www.dadamo.com/columns/nap/ask2.pl On the The NAP Perspective For 1 May 2004 A WAKE UP CALL! Proposed Legislation to Weaken DSHEA, and Codex Alimentarius Looms. I find, as I’m sure many of you do, that it is difficult enough to find all the hours in a day to accomplish the job, much less the responsibilities that many have with family and parenting, church, and other obligations. For most people, the thought of actually taking the time to become involved in weighing-in on certain congressional legislation is perhaps the straw that would break the camel’s back. But I believe it is a straw that must be risked, if we are to maintain our freedoms in many areas. The area I’m most focused on at the moment is an attempt by the sponsor and cosponsors of certain proposed legislation in Congress to seriously erode our future freedom to have access to dietary supplements, as we have been able to do since unanimous passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. The language of this act is voluminous. The original DSHEA document can be viewed online here and the amendments to the original document can be viewed online here. What follows is the essence of DSHEA, succinctly put (thanks to the summary below from Tracy A. Taylor, Director of Pubic Affairs and Communications for NNFA at the Washington, DC office). Essentially, DSHEA was passed to balance the American consumer’s growing interest in health maintenance with the preservation of public safety. This legislation improved consumer access to dietary supplements and information about these products. It also increased consumer protection against unsafe products and false and misleading claims. In addition, it required supplement manufacturers to submit evidence of the safety of their products and the scientific basis for claims. DSHEA is often mischaracterized as lessening the Food and Drug Administration’s ability to regulate supplements. In fact, the enactment of DSHEA provided the FDA, the primary agency that regulates supplements, with increased enforcement powers by establishing new labeling and potency standards. Briefly, under DSHEA, the FDA has the power to: Seize dietary supplements that pose an “unreasonable or significant risk of illness or injury” [section 402 (f)]. Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard [section 402 (f)]. Require dietary supplements to meet strict manufacturing guidelines (Good Manufacturing Practices), including potency, cleanliness, and stability [section 402 (g)] Stop a new dietary ingredient from being marketed if the FDA does not receive enough safety data in advance [section 413]. Refer to criminal action any company that sells a dietary supplement that is toxic or unsanitary [section 402 (a)]. Obtain an injunction against the sale of a dietary supplement that has false or unsubstantiated claims [section 403 (a), (r6)]. So, DSHEA, in effect, is what allows dietary supplements to be manufactured and allows us to purchase dietary supplements from sources such as health food stores, online sources, and so forth. In other words, it created a favorable regulatory climate for dietary supplements, and also addressed the issue of consumer safety. Since 1994, there have been regulations published and defined that have had a favorable impact on DSHEA, such as those in 1997 that amended and strengthened it to require, among other things, structure/function claims on labels, and the requirement to list all ingredients (including “other ingredients”) on the labels of each product as well. These amendments became effective in 1999. However, there are current attempts to restrict the favorable climate for DSHEA, and these attempts are disturbing to say the least. My purpose in writing this particular column is to alert you to current, proposed Congressional legislation regarding dietary supplements, give you websites you can access to keep you informed of the progress of this proposed legislation (as well as my opinion on how you ought to perceive it), tell you what you can do to express your concern and have an impact on the outcome, and relate what is happening in this country to what is happening in the European Union in this area – a disturbing prospect for the US as well. To begin, the strongest and most well-organized lobbying group in this country for the continued existence of DSHEA as the writers intended it to be is the National Nutritional Foods Association (NNFA). This is a professional organization, of which NAP is a member. NNFA represents nearly 5,000 members including retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. It is through this organization that we at NAP, as well as other members, are kept apprised of current legislation that would seek to limit one’s access to dietary supplements. Interestingly, this March 23rd marked the date for the 7th Annual Natural Foods Day lobbying event in Washington, DC, sponsored by NNFA. This day long activity is an annual lobbying event designed to build the Industry’s base of support through personal meetings with members of Congress. It is an opportunity to put a face to public policy issues and to tell legislators how to stand on important legislation, such as bills that would restrict your right to buy and sell safe, affordable and effective dietary supplements. In the morning, attendees are coached on strategies to make the most of one-on-one meetings with members of Congress. In the afternoon, attendees have scheduled appointments with legislators that have been pre-arranged with representatives from each attendee’s home state. The evening features a Congressional Champions Awards Reception, which offers an opportunity to relax and recount the day’s successes with fellow activists and to mingle with members of Congress. Now let’s segue to the issues at hand. The current proposed legislations, regarding dietary supplements that you need to be aware of, fall into four bills (three in the Senate and one in the House): S.1780 Anabolic Steroid Control Act of 2003, S.1538 DSHEA Full Implementation and Enforcement Act of 2003, S.722 Dietary Supplement Safety Act of 2003, and H.R.3377 Dietary Supplement Access and Awareness Act. S.1780 Anabolic Steroid Control Act of 2003 is a bill to amend the Controlled Substances Act to clarify the definition of anabolic steroids and to provide for research and education relating to steroids and steroid precursors. It has bipartisan support and is cosponsored by Senators Ted Stevens ® Alaska, John McCain ® Arizona, Dianne Feinstein (D) California, Joseph Biden (Sponsor, D) Delaware, Bill Nelson (D) Florida, Tom Harken (D) Iowa, Charles Grassley ® Iowa, Orrin hatch ® Utah, and George Allen ® Virginia. NNFA supports the cosponsors’ positions on this bill, and I agree. The current status on this bill is that it was read twice and referred to the Committee on the Judiciary on October 23, 2003. S.1538 DSHEA Full Implementation and Enforcement Act of 2003 is a bill that will eliminate the Food and Drug Administration’s (FDA) favorite excuses that it doesn’t have enough staff, money or power to regulate supplements. The FDA has fallen short when it comes to enforcing the law. Because dietary supplements come from natural ingredients, they can’t be patented. While this insures that these products are readily – and affordably – available, it takes away the ability of manufactures to recoup research costs. The bill doubles the funding given to the Office of Dietary Supplements to expand research and consumer information about these products. Finally, this bill will require the FDA to file annual reports to Congress about how they’re regulating dietary supplements. If they fail in their responsibility to fully implement the law, they’ll be held accountable. This bill has bipartisan support and is cosponsored by Senators Tom Harkin (Sponsor, D) Iowa, Hillary Clinton (D) New York, Lindsey Graham ® South Carolina, and Orrin Hatch ® Utah. NNFA supports the cosponsors’ positions on this bill, and I agree. The current status on the bill is that it was read twice and referred to the Committee on Health, Education, Labor, and Pensions on July 31, 2003. S.722 Dietary Supplement Safety Act of 2003 is a RED FLAG for all of us. Stay with me on this because what follows is a lengthier definition of the bill. It was introduced on March 26, 2003. It amends the Federal Food, Drug, and Cosmetic Act to require each manufacturer of a dietary supplement (supplement), and each packer or distributor of a supplement the name of which appears on the labeling, to report serious adverse experiences to the Secretary of Health and Human Services and to investigate such occurrences. Defines a serious adverse experience and adverse event associated with the use of a supplement in a human that involves death or one of other serious calamities. Directs The Secretary to conduct a clinical evaluation of each such reported experience. Requires the manufacturer of a dietary supplement to report periodically on other adverse experiences and to review such occurrences. Allows the Secretary to grant a waiver from the above reporting, reviewing, and investigating requirements with respect to a dietary supplement upon determination that compliance is not necessary to protect the public health. Authorizes the Secretary to require a manufacturer to conduct postmarket surveillance for a supplement under specific circumstances. Permits the Secretary to require a manufacturer of a supplement or of an ingredient in a supplement to demonstrate that its product is safe under specified circumstances, and directs the Secretary to approve the continued marketing of such a supplement or ingredient or to disapprove it. Prohibits any introduction into interstate commerce of a supplement containing a stimulant unless it is approved by the Secretary under this Act. Amends the Act to exclude a product that bears or contains an anabolic steroid from the definition of a dietary supplement for a specified chapter of the Act. Eliminates a provision of the Act requiring the United States to bear the burden of proof to show a supplement or an ingredient in a supplement is adulterated due to a safety violation. This bill has lopsided bipartisan support and is cosponsored by Senators John McCain ® Arizona, Dianne Feinstein (D) California, Richard Durbin (Sponsor, D) Illinois, Charles Shumer (D) New York, and Hillary Clinton (D) New York. NNFA does not support the cosponsors’ positions on this bill, and I strongly agree with NNFA. The current status on this bill is that it was read twice and referred to the Committee on Health, Education, Labor, and Pensions on March 26, 2003. The last of the four bills is the H.R.3377 Dietary Supplement and Awareness Act, which is another RED FLAG for all of us. This is a House bill similar in its intent to S.722, so I won’t list its entire text here, but will give you a source for this information before I finish this column. This bill has entirely partisan support to include George Miller (D 7th) California, Fortney Stark (D 13th) California, Henry Waxman (D 30th) California, Lucille Royball-Allard (D 34th) California, Grace Napolitano (D 38th) California, Susan Davis (Sponsor, D 53rd) California, Eleanor Holmes Norton (D At-Large) District of Columbia, John Dingell (D 15th) Michigan, Edolphus Towns (D 10th) New York, Major Owens (D 11th) New York, and Donna Christensen (D At-Large) Virgin Islands. NNFA does not support the cosponsors’ positions on this bill, and I strongly agree with NNFA. The current status on this bill is that it was referred to the House Committee on Energy and Commerce on October 28, 2003, and then to the Subcommittee on Health on December 4, 2003. Although NNFA is a membership organization, there is a wealth of information that can be accessed by nonmembers at www.nnfa.org. For instance, you can look at virtually all the headings on the home page without having to enter the site through the Member Log In. Of particular interest might be for you to put your cursor on “Products and Services”, move down the drop-down-window to “Government Relations”, then move your cursor to the right and click on each of the five subject categories under “Rules, Regulations, and Reports”, which include “Federal”, “State”, “International”, “NNFA Comments, Positions and Guidelines”, and “Advocacy and PAC”. Also, you can email prepared letters or easily write your own email letters if you click on the “Write Congress” square on the home page. Or you can take a little more time if you put your cursor on “Products and Services”, move it down the drop-down-window to “Government Relations”, move it right to “Advocacy and PAC”, and click. At the new page, click on the “Advocacy Action Center” link, and choose the “Congress and President” link on the next page to contact your legislators. Fill in the appropriate information, and you’re on your way. Take some time to review the other informational links on this page as well. You can, for example, get informed about legislators, congressional schedules, and even register to vote. In addition, there are two more things you can do while at the NNFA website. First, there is another prepared letter under the subject “Don’t Dismantle DSHEA” found by clicking on the link that says “Don’t Let Congress Limit Your Access to Dietary Supplements”, found at the “Advocacy Action Center link”. Complete the information and send this to your representatives. And second, there is a “Grassroots Action Team Manual” link at the “Advocacy Action Center” that will allow you to download the Manual in PDF format, which will tell you how to optimize your activism. If you don’t have Adobe Acrobat Reader (which you will need to have to download the Manual), you can get it for free by logging onto www.adobe.com, clicking on the link that says “Get Adobe Reader”, and following the directions. And before I forget, make sure to look at the “State” category under “Rules, Regulations, and Reports” at the NNFA website. You will find legislation that has been passed and other items of interest regarding dietary supplements in California, New York, Illinois, Florida, Missouri, South Dakota, and Texas. If you live in one of these states, you should be aware of what’s going on. Another valuable website to jot down is www.citizens.org, which will take you to the Citizens for Health organization. You can log onto this website and view S.722, and H.R.3377 as well as additional legislation on health that you should be aware of. This site is set up so that you can also email a prepared letter to your Senator or Congressperson, by filling in the appropriate information. It’s as easy as that. By perusing these sites, you will also understand the FDA’s recent ban on ephedra (the culprit was actually ephedrine, a concentrated alkaloid, often synthesized, of ephedra) in a better light than perhaps just thinking that one more supplement “bit the dust” at the hands of the FDA. As I mentioned earlier, DSHEA has a consumer safety provision to allow the FDA to step in to control a supplement under certain circumstances. Androstenedione (a steroid hormone precursor that can be converted to testosterone and estrogens in the body, readily available in health food stores) appears to be the next target. The take home message from this is that manufactures and distributors must be ever more vigilant in what they produce, what they produce it for, and in whom it’s going to be used. Two thousand years ago for example, proponents of Traditional (TCM) would never have used the alkaloid ephedrine for what some greedy manufactures have primarily produced it for today – weight loss. The herb ephedra (also called Ma Huang) had more primary uses for upper respiratory issues, and still does, and quite effective at that. But now we’ve lost easy access to even liquid extracts of ephedra or capsules of the herb, in my opinion, because of industry greed in trying to capture the weight loss market. And yes, you can ask, what about deaths from products like Tylenol and from pharmaceuticals, because there are far more deaths from these (I’ll save this for another discussion) than ever occurred from ephedrine? But the question will fall on deaf ears, because for a quick buck, some in the dietary supplement industry have not policed themselves, and that is where the real fault lies. Fortunately, if I’m not mistaken, I believe the tea of ephedra will still be available, because it falls under the category of “food”. Interesting though, isn’t it, that the tea takes us back to probably the oldest form of administration of herbs – the infusion. It’s also a lot safer, and the Chinese knew this. Moving ahead now, the attempt to limit access to dietary supplements is also in full force in Europe. Our good friend and European distributor of NAP products Nick Bowler (for those of you in Europe, Nick heads up Stacktheme, Ltd. in Scotland, which can be reached at www.stacktheme.com), recently visited and brought us up to date on the dietary supplement issues within the European Union (EU) -- legislation perhaps far more serious at present than what is being proposed in the US, although S.722 and H.R.3377 if ever enacted would certainly be the beginning of a very slippery slope. But that slope could turn out to be of relatively minor concern when contrasted with what you’ll read in the very well researched article by Paul Anthony Taylor that follows, which I’ve included in its entirety. This article appeared at the website, and posits very disturbing, potential implications of a finalized Codex text, not only for the EU, but for the US as well. You may want to paste this URL into your browser, so you can access the actual web page and bring to life the numerous links the author has included in his article to allow you to access more information. I just finished talking with Paul by phone, and he very kindly gave me permission to include his article in my column. So, without delay, and with much gratitude to Paul Anthony Taylor, please read his article below and become informed and enlightened. There is a short lead-in to the article. Codex Alimentarius – A threat to your vitamin supplements? Legislation Codex Alimentarius is an international standard-setting body dealing with how to safely process and store food products, avoiding hazards to our health. For about ten years, the Codex Committee on Nutrition and Foods for Special Dietary Uses has been mulling over a guideline for vitamin and mineral supplements, originally proposed by the German delegation to this committee, presumably to eliminate dangers from these additions of vital nutrients to our nutrition. So far so good, but what dangers exactly are we talking about? When statistical evidence indicates that food supplements are by far the safest category of products in existence, why do we need regulations? Could it be that pharmaceutical drugs, recently shown to be a leading cause of death in the Western world, are losing ground, that the pharmaceutical business is on its way out? If so, might it just be that the proponents of pharmaceutical drug " treatment " of disease could be leaning on legislators to eliminate what they perceive to be the cause of their woes - the natural way to health by proper nutrition? How ever that may be, Paul Taylor has examined the question of Codex Alimentarius and the threat this international legislative body's deliberations may pose to our health by " regulating " supplements of vital nutrients in a most restrictive way. Codex Alimentarius – A threat to your vitamin supplements? By Paul Anthony Taylor Have you ever wondered what would happen if a group of legislators from 48 different countries got together to talk about nutrition and food? Probably not, as most of us have more important things to think about. Presumably though, they would sit down and discuss the importance of diet, nutrition and the prevention of chronic diseases, and then try to figure out ways to help us all to live longer, healthier lives. Right? Wrong, unfortunately. Welcome to the world of the ‘Codex Committee on Nutrition and Foods for Special Dietary Uses’, where the committee chairman talks about pharmaceutical drugs preventing diseases and the EU representative states that food and the prevention of diseases do not go together. If you’re the type of person who prefers processed food and who wouldn’t be seen dead in a health food shop, then you can relax and stop reading now, because Codex is definitely not a threat to your life style. But if you’re the sort who prefers natural healthcare to pharmaceutical drugs, and who supplements his or her diet with high doses of multi-vitamins and minerals then you could soon have a great deal to worry about, because Codex is a direct threat to your way of life. So what is Codex? The Codex Alimentarius Commission is the international body charged with setting global food standards, and is jointly sponsored by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex Alimentarius literally means " food code " , and the Commission was set up in 1963 to protect the health of consumers, ensure fair practices in international food trade and to co-ordinate all international food standards work. (1). The legal basis for the enforcement of the guidelines and standards created by Codex dates back to the mid-1990s, when Codex Alimentarius signed agreements with the World Trade Organisation (WTO) by which Codex creates trade standards that the WTO uses to resolve international trade disputes. (2), (3), (4). That all sounds fine, you are probably thinking. But how on earth could Codex possibly affect me when I want to buy vitamins, minerals and other nutrients? Good question. In fact, with the exception of co-ordinating international food standards work Codex doesn’t do any of the things that it was set up to do. The health of consumers is not being protected by the work of Codex, and the international trade in food is anything but fair. Nowhere is this more apparent than in what Codex is trying to do to the international availability of vitamins and minerals (which come under the definition of food at Codex), where it is attempting to pass a variation on the extraordinarily restrictive EU Food Supplements Directive (5) as the blueprint for the global regulation of food supplements. The EU Food Supplements Directive, for those who are unaware of it, was passed by the EU Parliament in March 2002, and will be fully implemented on 1st August 2005. An extremely controversial piece of legislation, it will ban, on grounds of safety, almost 300 forms of vitamins and minerals from being sold within the EU - many of which have been sold for decades and are the same forms of nutrients that are found in food itself. So contentious, in fact, is this legislation that two cases challenging the legality of the ban have recently been referred to the European Court of Justice in Luxembourg by the UK High Court. Nevertheless, the EU is the single most important influence upon the Codex discussions, and Basil Mathioudakis, who was responsible for drafting the text of the EU Food Supplements Directive, is the head of the European Commission delegation at meetings of the ‘Codex Committee on Nutrition and Foods for Special Dietary Uses’. Once the 10 new candidate countries join the EU in May 2004 Mr Mathioudakis will be representing a total of 25 EU Member States at Codex, and whenever he exercises his right to vote the 25 Member States will not be entitled to exercise theirs. (6). As such it is very likely that the EU will be able to wield a block vote at the next Codex meeting consisting of almost one half of all of the countries attending. (7). Worse still, of the 48 countries who attended the previous meeting of the ‘Codex Committee on Nutrition and Foods for Special Dietary Uses’ in November 2003 (8), only one of them, South Africa, is actively opposing these restrictive proposals for the world-wide availability of vitamins and mineral supplements. Democratically of course, since the EU, with its soon-to-be population of 450 million people (9), is allowed 25 votes at Codex, then large countries such as the United States, with its population of over 280 million people (10), should proportionately be given at least 15 votes. Under the Codex voting system however the United States is only allowed one vote, which means that the EU is now in an extremely powerful position. As a result, the Codex vitamin and mineral restrictions could possibly be finalised this coming November in Bonn, Germany. If this happens the effect upon the aforementioned legal challenges to the EU Food Supplements Directive could be grave to say the least, because if the Codex restrictions were agreed before the legal challenge was completed the UK lawyers would in essence be arguing for the European Court of Justice to overturn legislation that was fully in line with a newly agreed global standard. Moreover, even if the legal challenges to the EU Food Supplements Directive are successful the Codex proposals could still be implemented as the global standard, thus effectively overruling any short-term victory for health freedom in the EU. As such, a finalised Codex text would have the ability to override the dietary supplement laws of all countries, including the United States. Long-term, it would not be unreasonable to expect that other EU health-related legislation, such as restrictive regulations on nutrition and health claims, will become the blueprints for still further standards to be enacted by Codex on a globally harmonised basis. Ironic isn’t it, that far from being the protectors of our health, our governments and legislators now appear to be one of the biggest risks to it? REFERENCES (1) United Nations Food and Agriculture Organization (2) SPS Agreement. World Trade Organization. URUGUAY ROUND AGREEMENT: Agreement on the Application of Sanitary and Phytosanitary Measure. (3) TBT Agreement. World Trade Organization. URUGUAY ROUND AGREEMENT: Agreement on Technical Barriers to Trade. (4) Understanding Codex Alimentarius. Food and Agriculture Organisation of the United Nations. World Health Organization. 2000. pp. 24-25. (5) EU Food Supplements Directive (6) Codex Alimentarius Commission. Procedural Manual. Thirteenth Edition. Rules of Procedure of the Codex Alimentarius Commission. Rule II (3) - Member Organizations. p. 6. (7) Forty eight countries attended the Codex Committee on Nutrition and Foods for Special Dietary Uses 25th Session, held at the Bruckenforum, Bonn, Germany, from 3-7 November 2003. ALINORM04/26. See here. These forty eight countries included three of the new EU countries (Hungry, Poland and Slovenia). If the other seven new EU countries attend the next meeting in November 2004 (and assuming that every country that attended last year also attends) there will be fifty five countries attending in total. The EU will have twenty five votes. (8) Codex Committee on Nutrition and Foods for Special Dietary Uses. 25th Session. Bruckenforum, Bonn, Germany 3-7 November 2003. ALINORM04/26. (9) Europe - statistics (10) US - Census If you wish to contact the Author: Paul Anthony Taylor paulandpolly Tel: +44 (0)1325-466361 Cell: +44 (0)7903-738340 A more extensive version of this article with more details of a legal nature, is also available. The title of that article is " Codex Guidelines for Vitamins and Minerals - Optional or Mandatory? " It can be found on this site. Thank you Paul, now back to John Harris. If you copy and paste the URL for Paul’s article into your browser (as I mentioned above), you can activate the link above to take you to a more extensive version of this article with more details of a legal nature. Here's the link. The title of the article is Codex Guidelines for Vitamins and Minerals – Optional or Mandatory?, also written by Paul. It’s well worth reading. You can actually have some influence on the Codex Alimentarius by logging onto http://www.laleva.cc/, and following the links to get to and sign the petition opposing the Codex, as I did three years ago. This will not take much time, and you can alert others to do so as well. You can even download a form for people to sign if they do not have a computer, and you can forward it to the appropriate authority. To keep track of the progress of the Codex Alimentarius and the legal efforts to fight it, you can log onto www.alliance-natural-health.org, which will take you to the alliance for natural health, a great website for understanding the natural health issues in Europe – not uncommon from what we are dealing with in the US. You can also log onto www.nnfa.org, and scroll to the “International” link (see directions earlier in my column) and keep current with the Codex and international rules, regulations, and other notices that are of significance to the natural products industry. Countries included are Canada, UK, Kenya, Finland, Denmark, China, and Mexico. To sum up, I’ve alerted you to what is a serious Wake Up Call to what is being proposed regarding dietary supplements in this country and abroad. You can decide not to participate in the legislation and have no influence on the outcome. Or you can take a few minutes out of a busy schedule, and let your legislators know how you feel about it – very possibly influencing the outcome. I’ve shown you how you can easily do this. I’ve given you the sponsor and cosponsors for each current Senate and House bill, their party affiliation, and their states. Even if your state does not have a cosponsor for one of these bills, you can still make your voice heard by calling or writing the offices of your own representatives and letting them know how you want them to vote, should these bills ever make it to the floor of the Senate or House. It only takes one vote to make the difference on the success or failure of a bill. And that bill could have a far reaching effect on your freedoms. I choose participation, and I strongly urge you to do so too. John Win a $20,000 Career Makeover at HotJobs Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.