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This article was originally published in The Tan Sheet

Executive Summary

FOOD SOURCE ONE PETITION FOR FOOD STATUS DENIED BY FDA in an April 27 letter that upholds a 1990 FDA regulatory letter that found the product misbranded and an unapproved drug. The April 27 letter from FDA is in response to a petition filed by Food Source One manufacturer National Dietary Research, Inc. in February 1992 that maintained that the diet product is a "food" and not a "drug." The FDA letter also responds to a Jan. 14 request by Iowa Attorney General Campbell urging FDA to issue a ruling on Food Source One before a lawsuit filed by the state of Iowa against the manufacturer went to trial ("The Tan Sheet" March 1, p. 8). "We have examined the relevant sources including the petition, label and advertising, that establish that FS-1's intended use is to affect the structure or function of the body by suppressing the appetite and causing weight loss. This intended use makes FS-1 a drug," FDA stated in the letter. The Iowa attorney general's case against Tampa-based National Dietary Research (NDR) is being heard in Iowa District Court for Polk County in Des Moines. The trial, which began on April 27, is expected to run through late May. A ruling on whether the diet product is being marketed illegally as a drug is expected to be handed down later this summer. The February 1992 citizen petition filed by NDR maintains that Food Source One is a "meal supplement or replacement" that has been reformulated since FDA issued the reg letter to reduce the amount of guar gum in the product. The company argued that Food Source One is now a food by virtue of its flavoring, natural ingredients, and vitamin and mineral content (33% RDA per three- tablet serving). While FDA acknowledged that "a manufacturer's intent is critical to the definition of [a] drug," the agency cited a 1983 federal appellate court ruling on Nutrilab, Inc. v. Schweiker that found that "intent is not part of the definition of food." FDA further stated that "a manufacturer's subjective claims that a product is a food are not sufficient to make that product a food, where it is not used for its taste, aroma or nutritive value." The FDA ruling explained that the agency "cannot accept" the company's argument that because the product has been reformulated, it is no longer a "drug." The FDA letter states that "the fact that a product is flavored does not make it a food; many drug products are flavored to make them more palatable. Similarly, adding vitamins and minerals to a product does not make it a food." The agency concluded that "to the extent that FS-1 may encourage weight loss, it is not claimed to do so through its provision of vitamins and minerals; rather, these nutrients are subordinate to its intended use, causing weight loss." Food Source One labeling specifies that the consumer "chew three tablets daily followed by a full (eight ounce) glass of water, three times daily, thirty minutes before meals," according to NDR's petition. Again citing the Nutrilab opinion, FDA asserted that the instructions for use of Food Source One "distinguish it from 'the way most people use food' . . . and [belie] the assertion that FS-1 is a meal replacement." The agency added that "consumption of a particular dosage of tablets, with water, at specific times is a typical direction for use of a drug." The NDR petition notes that Food Source One contains: "apple pectin, guar gum (as a thickening agent in amounts less than 0.5% by weight), cellulose gum, microcrystalline cellulose, vegetable fiber, psyllium and xanthum gum." In its petition, NDR characterizes the product as a "low-calorie, vitamin fortified food supplement." In denying the petition, FDA said that "an article derived from food is not necessarily a food . . . FS-1's ingredients do not make it a food." FDA also dismissed the NDR argument that Food Source One is a food for a special dietary use. In its letter, FDA stated that "a food for special dietary use . . . must first be a food. . . . There is no reason to declare that as such it is exempt from FDA's final rule regarding weight control products." The agency also cited two recent ads for the product that appeared in the Washington Post on Jan. 27 and March 24. The Jan. 24 ad, entitled "Weight Loss Surprises Researcher," claims that the "nutritionally complete 'high tech' food tablet" marketed by NDR is a "windfall for overweight people." The ad refers to Food Source One as a "natural plant colloid [that] actually caused people to lose weight, even though specifically instructed not to alter normal eating patterns. . . . Researchers in an earlier study had speculated that the weight loss was due to a decrease in the intestinal absorption of calories." The ad also included a testimonial from an unidentified woman who claimed that her cholesterol dropped while taking the product. FDA stated that "a product that is offered to reduce cholesterol levels is a drug, because it is offered for the treatment or prevention of heart disease." FDA concluded that "FS-1's intended use to lower cholesterol makes the product a drug, regardless of the validity of the petitioner's assertion that FS-1 is a food." In its petition, NDR suggested that FDA's 1990 reg letter "may have been politically motivated" due to "political pressure" from the Iowa AG. FDA said April 27 that "the petitioners did not offer, and FDA did not find, any evidence to support these highly speculative allegations." FDA said it issued the 1990 regulatory letter "because of the hazards associated with guar gum-containing weight control drugs." FDA added that the "primary conclusion" of the reg letter "was not . . . that FS-1 is not safe" but that FS-1 "is an unapproved new drug and is misbranded." Iowa first brought action against Food Source One in 1988.

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