Taking the Gloves Off
Then there is the flip side of the FDA — products which have been kept or taken off the shelves due to agency action. What emerged was a pattern of misguided priorities and even retaliatory tactics.
Case in point: At the direction of then-Commissioner Kessler, the FDA seized 24,000 gallons of Citrus Hill Fresh Choice orange juice because the label bore the word “fresh” in the brand name, when it was made from concentrate — a fact the label also stated.
This bizarre incident wasn’t in isolation. In 1995, the agency sent out more than 1,600 letters — mostly to mom and pop health food stores and alternative medicine establishments — warning the recipients they were in violation of one or more regulations, some highly obscure. Under Kessler’s reign, the agency also staged numerous raids on vitamin stores and health food suppliers, some with drawn guns, seizing primrose oil, black currant oil and vitamin products.
Only about 10 percent of its warning letters went to pharmaceutical manufacturers — chiding them for violations of advertising regulations. In September 1996, Public Citizen’s Health Research Group condemned these violations as “the tip of a very dangerous iceberg” and exhorted the FDA “to use criminal prosecution to send the message that such violations are not acceptable.” No such action appears to be forthcoming from the halls of the Food and Drug Administration.
While treating drug companies with kid gloves, the FDA crushes non-addictive remedies, such as L-tryptophan and other amino acids.
Amino acids are essential building blocks, manufactured by the body and obtained from certain foods. In 1989, the amino acid L-tryptophan was linked to adverse effects, including deaths. This became the agency’s primary argument for moving against amino acids.
Studies published in The Journal of the American Medical Association and The New England Journal of Medicine demonstrated that the deaths were due to a contaminant in a single batch of L-tryptophan from a single foreign manufacturer and thus were not due to L-tryptophan at all. The FDA recalled L-tryptophan from the market in 1989 and, despite evidence that it is safe, has refused to allow it back on.
Continued...
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