Our freedom of choice under DSHEA is being threatened

The USA is widely regarded as the research and development center for the natural products industry worldwide.  Dietary supplement sales in the US currently comprise around 8.5% the volume of pharmaceutical sales in the US, in contrast with only around 1.5% of total pharmaceutical sales in Europe.

The Dietary Supplement Health & Education Act of 1994 (DSHEA) has provided the environment to catapult the natural products industry in the US to its present state.  But DSHEA, which was only won after a massive campaign targeting Congress, is now seriously under attack.

Two key reports from the Natural Academies of Science Institute of Medicine (IOM) provide the writing on the wall:

1. The CAM report, released on January 12, 2005, and
2. The other is the proposed dietary supplement evaluation framework, released on April 1, 2004.

See the Alliance for Natural Health news item for our take on the CAM report.

Burden of proof: a pharmaceutical model

The proposed dietary supplement evaluation scheme switches the burden of proof and puts it squarely on the industry — as it does for pharmaceutical products.  To many, this might seem fair and reasonable; however, supplements are not anything like drugs.  They are made up, for the most part, of naturally-occurring substances, in the form they are found in foods.  Length of use, as well as their natural state, have long demonstrated their safety.  This is vastly different than pharmaceuticals which, while sometimes derived from natural sources, have been so isolated and altered.  They pose serious risks to anyone's health.  (They are, afterall, one of the leading causes of death in America.)

The framework of the IOM report places considerable onus on the supplement industry to supply data on safety which will be prohibitively expensive for all but the largest manufacturers.  Since there is no patent available for any of these substances, there simply is no way to recoup the costs.  It's a model designed for the pharmaceutical industry, and makes no sense for natural health substances.

All forms and regardless of benefits

Further, the IOM report urges that safety issues for these substances be considered in isolation (i.e.: without concomitant consideration of safety and beneficial effects; the FDA arguing, like the European Commission, that this comparison is valid only for drugs).  What makes this really insidious is that the FDA has also recently enabled itself to remove any product from the market that contains anything similar to any substance that has been suggested to cause harm in laboratory animals.  That means, if someone in a lab somewhere creates some ill effect in a rat using a synthetic forms of vitamin E, the FDA has reserved the right to remove all vitamin E from the market, even though natural forms of vitamin E have strikingly different effects on the human organism.

The IOM framework, as per the EU equivalent, comes into effect gradually, the "compliance period" supposedly giving industry sufficient time to adjust — or expire.

These reports should be the ultimate wake up call for all Americans and other citizens of the world who value their freedom to choose natural products.

Perhaps it's easier now to see how global harmonization works.  The IOM proposals are very similar in effect to the EU Directives, which provide such a major threat to the leading-edge of the natural health sector in Europe.  It's just that the EU Directives are further down the road, and the first of several directives, the Food Supplements Directive, is set to ban some 75% of vitamin and mineral forms as of August 1, 2005 — unless the ANH legal challenge in the European Court of Justice (Luxembourg) succeeds on 25 January. 

[Update: There was some success in this legal challenge to the Directive; however, further legal challenges are in the works, and a reasonable guideline for supplement doses is being developed.]

Get more information on the threats to your health

For more information on this threat to your health freedom, listen to the audio file of the emergency teleconference, and watch the Emergency Health Freedom DVD.  As goes the EU, so will go the world via Codex — unless we can stop this assault on our health freedom.

See also the review of the IOM report, and the really bad science that's behind it.  This news article from the American Herbal Products Association, trashes the recent IOM Report, citing numerous gross and misleading inaccuracies in it, showing just how low these Pharma-dominated groups will go in their zeal to scuttle the Dietary Supplement Health and Education Act of 1994 (DSHEA).

You need to fully grasp the danger this report presents: Members of Congress will accept what IOM is saying, taking it at face value, unless you take the trouble to educate them by calling them to tell them about AHPAs numerous, quite valid criticisms of the IOM report.  (You might also remind them of how many people rely on these supplements, and the consequences that amending DSHEA could have in the next election.)

If you are an American, to defend your health freedom, it is imperative that you take action immediately.

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Here is the news article from the American Herbal Products Association.

Flawed Report from IOM Calls for Amending DSHEA

1-13 -2005 — American Herbal Products Association (AHPA)

(Silver Spring, MD) — In a report based on erroneous assumptions and discredited references, the Institutes of Medicine (IOM) has called for amendments to the Dietary Supplement Health and Education Act (DSHEA) that, while largely redundant to the current law, will almost certainly be waved about and cited by critics of the dietary supplement industry for years to come.

"It is unfortunate that such an imminently qualified group of experts was presented with such flawed assumptions about the current regulatory scheme for dietary supplements," said Michael McGuffin, president of the American Herbal Products Association (AHPA)."  The recommendations that resulted from all of the effort that went into this federally funded project have been wasted, and the very credibility of the IOM has been damaged."

The pre-publication version of the report, Use of Complementary and Alternative Medicine (CAM) by the American Public, was made available on IOM's website today, and a press conference was held in Washington, DC to announce its publication.  The report was purportedly prepared "to explore scientific, policy, and practice questions that arise from the significant and increasing use of CAM therapies by the American public."  One chapter of the report was dedicated to dietary supplements, as was a significant portion of the press conference.

Errors in the report

Examples of errors included in the report include:

• In discussing safety of dietary supplements, the report states, "Instead of pre-marketing testing, FDA must prove that a supplement is unsafe to remove it from the market."  As all AHPA members who are familiar with the requirements for new dietary ingredients know, this is not true.  The apparent reference in support of this misleading statement is a 1995 FDA document accessed on FDA's website — which AHPA has requested be removed!
• In a table that summarized and compares FDA regulation of foods, drugs and dietary supplements, the burden on manufacturers to provide conclusive evidence of safety prior to marketing new ingredients is ignored, and the table states that FDA bears the burden of proof for "demonstrating safety or lack thereof" for all dietary supplements.  And what was the reference for that oversight, which again ignores the law on new ingredients?  IOM's own publication from 2004 — which AHPA requested be corrected, prior to its final publication.
• In discussing the ongoing process of awaiting FDA's final rule on good manufacturing practice specific to dietary supplements, the report states that GMP "will require standards … to reduce the risk of contamination with pesticides, heavy metals, and other impurities."  It is apparent that IOM was not aware that all supplement manufacturers are currently required to meet the same high standard of manufacturing practice that is required for all U.S. food producers — and so are already required to address all of the cited contamination issues.
• The document cites a survey of public attitudes about dietary supplements: "Slightly more than half (53 percent) were aware that supplements are not regulated by the government."

"What is sad about this citation is that it makes it apparent that 100 percent of the panel was misinformed about the regulatory status of dietary supplements," commented McGuffin.  "How can anyone propose amendments to a law that they do not understand?"

Recommended amendments to DSHEA

The report's chapter on dietary supplements concludes by stating that " … the committee recommends that the U.S. Congress and federal agencies, in consultation with industry, research scientists, consumers, and other stakeholders, amend the Dietary Supplement Health and Education Act of 1994 and the current regulatory scheme for dietary supplements, with emphasis on strengthening:

Seed-to-shelf quality control,
Accuracy and comprehensiveness in labeling and other disclosure,
Enforcement efforts against inaccurate and misleading claims,
Research into how consumers use supplements,
Incentives for privately funded research into the efficacies of products and brands, and
Consumer protection against all potential hazards."

"DSHEA is a good law that already forbids misleading claims, and requires accurate labeling, including label information that protects consumers," added McGuffin.  "If FDA does a good job with the imminent GMP rules, the quality control issue will be addressed.  Incentivizing research is a worthy conversation, but 'public domain' knowledge about herbs must be considered in any new scheme.  So we are left with research on consumer use of supplements.  Is IOM proposing that the U.S. Congress pass a law to establish a statutory requirement that somebody conduct surveys?"

Read the IOM's press release.

The full IOM report is available online, and the chapter on dietary supplements (Chapter 9) can be purchased there for $3.00 by following the prompts to "purchase PDF chapters."

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The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues.  AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. 

AHPA's mission is to promote the responsible commerce of herbal products.  AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. 

Website: www.ahpa.org

Contact: Karen Robin, Director of Communications American Herbal Products Association
Telephone: (301) 588-1171, x-107
Email: KRobin@ahpa.org www.ahpa.org