IOM critique of DSHEA

[Guest guest]

Since all ready-made Chinese medicines are legally sold in the U.S.

under DSHEA, I thought I would share the most recent communication to

member U.S. herb companies from AHPA (American Herbal Producers

Assoc.). You might consider asking your herbal suppliers A) if they

are members, and B) why not.

 

The message from APHA:

 

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,

AHPA president. " 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 prepublication 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 premarketing 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 states 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? "

 

IOM's press release can be read at

http://www4.nationalacademies.org/news.nsf/isbn/0309092701?OpenDocument.

 

The full IOM report is available online:

http://www.nap.edu/catalog/11182.html, and the chapter on dietary

supplements (Chapter 9) can be purchased there for $3.00 by following

the prompts to " purchase PDF chapters. "