More Truthful Information on Supplements is Coming
FDA Loses Again
Following the United States Court of Appeals' (Pearson v. Shalala) unanimous 3-0 decision, on January 15, 1999, favoring the First Amendment and commercial free speech, another important court decision supporting the dissemination of truthful information by supplement manufacturers has rolled in. (See Momentous First Amendment Victory - March 1999 for more details.) The Appeals case was initiated and financed largely by Life Enhancement formulators Durk Pearson & Sandy Shaw®, although several organizations, companies and individuals, including Life Enhancement, joined in support of the effort.
Just a little over one month later, on February 17, 1999, a Federal District Court in Utah ordered the FDA to lift its ban on the importation of red yeast rice that is used in the manufacturing of Cholestin, a dietary supplement used to manage cholesterol levels.1
Since red yeast rice (Cholestin) is not a drug, Judge Dale Kimball ordered that the product could be sold by its manufacturer as a dietary supplement and ordered that the FDA could not prevent its sales. Cholestin contains a small percentage of a chemical ingredient that is identical to lovastatin, the active ingredient in Merck's Mevacor®. Mevacor is marketed as a prescription drug to help lower cholesterol.
In Judge Kimball's decision to lift the FDA's ban, which has been in place since last June, he favored the will of Congress, which had enacted the Dietary Supplement Health and Education Act (DSHEA) in 1994. The DSHEA is supposed to support the dissemination of truthful information.
A comment by the president of the company who manufactures Cholestin, "This decision reflects that good science, while contributing [just because it contributes, editor comment] to the health of Americans, does not transform a natural health supplement into a drug." Incidentally, the FDA had not questioned the safety of the supplement during the course of litigation.
This new ruling on Cholestin is very important for health seekers because it should result in limiting the ability of the FDA to contend that factual statements about nutritional supplements are "unapproved health claims."
About the Pearson decision, Jonathan Emord, attorney for the winning plaintiffs, called the ruling "... perhaps the most significant labeling law handed down by a court in over 20 years. This decision invalidates the FDA's entire review regime for labeling claims on the basis that it is unconstitutional, arbitrary and capricious."2
Also chiming in was Dr Ralph Miranda, president of the American Preventive Medical Association, who said, "For years, dietary supplement companies have been afraid to challenge this agency for fear of retaliation. ... Now, the FDA will no longer be able to get away with continually raising the bar for supplement manufacturers in an effort to prohibit the dissemination of truthful, scientific information."
According to Emord, "What was a high, impenetrable wall is now porous." He said that the two court decisions will likely result in a flood of health information that the FDA has previously prevented from reaching consumers.3
[See Congress Tells FDA - April 1999.]
- Winnick E. Court rules against FDA in dietary supplement case. Reuters Health News. Date: 02/19/99.
- FDA loses supplement health claims labeling case. Reuters Health News. Date: 01/20/99.
- Winnnick E. Ibid.
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