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Biotech / Medical : Paracelsian Inc (PRLN)

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To: Jonathan Schonsheck who wrote (3665)6/5/1998 10:08:00 PM
From: John H. Farro  Read Replies (1) of 4342
 
Jonathan, I found the following response to the article you posted at PRLN's web site under PRLN IN THE NEWS.

The following article appeared as an NNFA press release on June 3,
1998

NNFA Calls Good Housekeeping Test Results of St.
John's Wort "Misleading"

Newport Beach, CA (June 3, 1998) - Recent results of laboratory
analyses by the National Nutritional Foods Association (NNFA) of St.
John's wort products stand in sharp contrast to those released by Good
Housekeeping magazine earlier this year. At a symposium in March
attacking the dietary supplement industry, Good Housekeeping
announced test results that found a "startling lack of consistency" in the hypericin levels of the nine St. John's wort products it tested.

"The Good Housekeeping symposium was clearly designed to cast doubt
on the safety and efficacy of dietary supplements," said Michael Q. Ford, NNFA's executive director. "The release of their test results on St. John's wort was calculated to bolster the magazine's contention that this industry needs more regulation."

Jill Ellis, Ph.D., NNFA's director of science and quality assurance,
explained why Good Housekeeping's results were misleading and how
the association was able to determine there was no lack of quality or
consistency in the supplier member products it tested.

"Accounting for the variations in capsule weight, non-active ingredients and dosage, we found that all five member products tested achieved label integrity," Ellis said. "We also performed a functionality test, which measures serotonin and dopamine re-uptake inhibition in the brain, on three of the products. The results indicated that all three would be effective in generating positive mood enhancement."

NNFA member products tested included Futurebiotics, Herb Pharm,
Enzymatic Therapy, Nature's Herbs and Nature's Way.

"What we need to remember is that herbal and botanical products are
complex mixtures of naturally occurring compounds that can act
synergistically," Ellis said. "They require analyses by a laboratory well versed in the methodology and idiosyncrasies associated with specific testing of plants for biological activity." NNFA used Paracelsian, Inc., of Ithaca, New York, to perform the analyses which included HPLC (the same method used by Good Housekeeping), the industry standard DAC 86, and the cutting-edge in vitro functionality test.

In addition to denouncing the integrity of St. John's wort products, Good Housekeeping impugned the integrity of the entire dietary supplement industry by wrongly referring to it as "wholly unregulated" and "out of control."

"In fact, the exact opposite is true," said Ford. "The passage of the
Dietary Supplement Health and Education Act (DSHEA) in 1994
actually increased FDA's enforcement powers and set new labeling and
potency standards."

Under DSHEA, FDA has the power to: Require dietary supplements to
meet strict manufacturing requirements (Good Manufacturing Practices),
including potency, cleanliness and stability [Section 402(g)]; seize dietary supplements that pose an "unreasonable or significant risk of illness or injury" [Section 402(f)]; and obtain an injunction against the sale of a dietary supplement that has false or unsubstantiated claims [Section
403(a),(r6)].

"The fact that FDA frequently chooses not to exercise its enforcement
ability when appropriate should be the real focus of Good Housekeeping's ire," Ford said.

Robin
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