The Eyes of Texas (and FDA) Were upon Them
Farley, Dixie, FDA Consumer
The Eyes of Texas (and FDA) Were Upon Them
King of the Texas cowboys, Pecos Bill, was just a toddlin' babe when he whupped his first panther. At age 2, Bill joined a pack of coyotes, giving each a good lickin' to establish he was boss. Claims grow far beyond fact in tall tales about Texans, but the exaggerations are fun and harmless.
When it comes to real-life foods, drugs, and the public health, however, Texas doesn't take kindly to exaggerated claims. Neither does the Food and Drug Administration. United Sciences of America, Inc., of Carrollton, Texas, found that out while promoting its dietary supplements with far-fetched health claims about dozens of conditions as diverse as colds, cancer, colitis, and kidney stones. Last December, FDA ordered the firm to stop. And in January, the attorneys general for not only Texas but California and New York as well followed with simultaneous lawsuits. Eventually, USA., Inc., exaggerated itself right out of business.
FDA's initial encounter with USA, Inc., in December 1985, was at a temporary location in California where the company had been operating for about four months. The founder of the firm was Dallas businessman Robert Adler II, whose wealth came from a computer invention. An FDA investigator inspecting the operation pointed out that two of the dietary supplements had hypoallergenic claims. Company officials said future labels would be printed without those claims.
At that time, the product line consisted of a protein and fiber powder, a vitamin-mineral tablet, and a fish-oil capsule. A fiber "energy' bar was to be added soon.
Then, early in 1986, as USA, Inc., got its promotional program into full swing, FDA's Dallas district office began getting calls from people nationwide: consumers, reporters, distributors of other products, and potential USA, Inc., investors. They wanted to know whether the claims being made were true and whether FDA had approved the supplements. So, the Dallas office sent an investigator to the firm for another look-- actually, several looks between May 20 and June 23.
At first, USA, Inc., cooperated with FDA. The investigator freely obtained samples of the products, newsletters, labeling, sales-training materials, and promotional videotapes (all but one narrated by actor William Shatner, Captain Kirk of Star Trek). Cooperation dwindled, though, as the investigator asked more and more questions about claims the company was making for its products and about complaint files, product specifications, manufacturing records, and so-called clinical tests. Finally, the firm's management refused to answer, stating that questions must thereafter be submitted in writing, in advance. The investigator wasn't authorized to do that, so the inspection ended.
FDA tested the product samples for nutritional content and sent the analysis to the agency's Center for Food Safety and Applied Nutrition for evaluation. That center and the FDA Center for Drugs and Biologics began reviewing product labeling and promotional materials for medical claims. More questions arose. To find answers, FDA officials met on Aug. 12 with Jerris Leonard, the USA, Inc., president and lawyer (and a former U.S. assistant attorney general), and Jeffrey Fisher, M.D., the firm's medical director.
Leonard and Fisher contended the videotapes were meant to provide correct information about the products so that salespeople wouldn't make medical claims for them. Indeed, they said, anyone making such claims would be fired. But the FDA representatives said the tapes and literature depicted USA, Inc., products as having drug benefits, that FDA's centers were reviewing the materials, and that written comments would be sent to the firm. Leonard said FDA needed more information about his company and vowed cooperation to help FDA better understand the operation.
What FDA soon did understand about USA, Inc. …