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 WASHINGTON, Dec. 29 /PRNewswire/ -- The following was released today by Citizens For Health:
 The announcement of the FDA's final rules on the labeling of dietary supplements was greeted with disappointment by the national non-profit consumer health organization, Citizens For Health.
 Commissioner David Kessler was quoted today as saying that "These rules enable the public to make informed choices. They will not restrict access." "Unfortunately, neither statements are true," according to Executive Vice President Joan Priestley, M.D., and Executive Director Alexander Schauss, Ph.D.
 "By establishing a 'significant scientific agreement' standard for health claims on labels of dietary supplements, the FDA actually denies the public access to truthful and scientific evidence of health claims for dietary supplements," contends Dr. Priestley.
 The FDA's excessive and restrictive interpretation of adequate scientific proof has led to their approval of only two health claims for nutrients in the 87 years of the agency's existence. "'Significant scientific agreement' is the same thing as consensus," reminded Priestly. "As long as the agency finds a scientist to oppose a health claim, as it did successfully with the claim for folic acid and neural tube defects for 11 years, until relentless pressure by numerous public health agencies forced it to approve the claim, it can deny a claim based on its new standard."
 The public does not realize that the FDA defines a "label" as including such items as package inserts, press releases, journal articles, videos, speeches and even comments made by sales representatives and even health food store employees to potential customers. "Such limitations of free speech are in direct conflict with the First Amendment and effectively denies consumers the right to make informed choices," contended Dr. Schauss. "It's simply defacto censorship of information that should be freely available to consumers in a democratic society."
 Kessler deliberately obscured the issue of access by neglecting to mention that today's notice of final rules has nothing to do with the issue of access to dietary supplements. Today's rules do not terminate the intent of the FDA to classify all amino acids as "drugs," classify hundreds, possibly thousands of other nutritional supplements and herbs as "unapproved food additives," or limit the potency of vitamins and minerals, as the agency stated it intended to do in the June 18, 1993 "Federal Register" Advanced Notice of Proposed Rules for dietary supplements.
 The Dietary Supplement Health and Education Act of 1993 (S. 784/H.R. 1709) would protect consumers' access to dietary supplements while insuring the dissemination of truthful and non- misleading health claims. The bill currently has 63 Senate and 215 House co-sponsors.
 "In 1968 the FDA attempted to remove 300 supplements as 'drugs,'" reminded Schauss. "This battle has been going on for more than 30 years. It needs to be resolved by duly-elected representatives in Congress," added Priestly.
 -0- 12/29/93
 /CONTACT: Alexander G. Schauss, Ph.D. of Citizens For Health, 800-357-2211/

CO: Citizens For Health; Food and Drug Administration ST: IN: HEA SU:

JH-IC -- SE005 -- 7923 12/29/93 20:33 EST
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Publication:PR Newswire
Date:Dec 29, 1993

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