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This article was originally published in The Tan Sheet

Executive Summary

NUTRICOLOGY's INTENT TO PROMOTE SUPPLEMENTS AS "DRUGS" FOUND "AMBIGUOUS" by San Francisco federal court Judge Lowell Jensen in denying FDA's request for a summary judgment on Sept. 23. "In light of the ambiguous" promotional material identified by the government, Jensen declared, "there is a genuine issue of fact as to whether defendants' products are intended to cure or treat diseases." San Leandro, Calif.-based NutriCology, which also conducts business as the Allergy Research Group, distributes approximately 100 nutritional products nationwide via direct mail and through health professionals and retail distributors. "Certain factual issues remain which render summary judgment inappropriate," Jensen explained in handing down his decision, "including whether [NutriCology's] advertising can be said to reflect an "intent" to cure or treat diseases, whether the disclaimers are instructive in considering intent, and whether [the company's] own intent is persuasive." FDA's lawsuit objects to the company's use of various promotional materials that claim that the products are useful for preventing and/or treating various conditions including AIDS, cancer, multiple sclerosis, arteriosclerosis, leukemia, diabetes and cystic fibrosis. FDA also alleged that NutriCology fraudulently represented that the products have been proven safe and effective for such uses. FDA filed the suit against NutriCology in May 1991 charging that 14 of the company's products are drugs based on health claims made in promotional materials. The suit alleges that NutriCology's products violate the FD&C Act because: (1) they are unapproved "new drugs"; (2) they are misbranded drugs; and (3) they contain unsafe food additives. Jensen denied FDA's motion for summary judgment on the three charges. In addition, the federal judge granted NutriCology's motion to throw out FDA's charge that the company had committed mail and wire fraud in marketing its products. Jensen also denied FDA's request for restitution and for a temporary restraining order and rejected NutriCology's motion that a permanent injunction is not an appropriate remedy in this case. However, the judge acknowledged that a "permanent injunction in this case does not, on this record, appear warranted." Jensen has scheduled a status conference on the case for Oct. 27. Of the 14 products cited by FDA in the suit, only eight remain on the market, including germanium, OxyNutrients, flax seed oil, borage oil, Coenzyme 010, ParaMycocidin, ParaOing and N-Acetyl Cysteine. Since 1982, FDA has monitored NutriCology's activities and products. The court document notes that three times in 1982, twice in 1985 and twice in 1988, FDA's San Francisco district office notified the company that the agency considered the firm's products to be "drugs" or "new drugs" and that the products were misbranded and mislabeled. The company was not contacted by FDA again until 1991 when the agency filed its lawsuit. FDA was granted a temporary restraining order (TRO) against the company on May 8, 1991 but the court revoked it 15 days later, ruling that injunctive relief was unwarranted since FDA had failed to demonstrate "any harm to consumers despite over nine years of investigation." FDA appealed the ruling to the federal circuit court, which affirmed the district court's denial of a preliminary injunction and TRO. In denying FDA's request, Jensen noted that the agency "relies solely upon defendants" promotional literature . . . for its position that the products at issue are drugs." Jensen added: "whether NutriCology's claims are permissible nutritional claims or impermissible drug claims cannot be determined from their words alone." The judge also suggested that the question of NutriCology's intent is further obscured by disclaimers the company includes on product packaging: "No such statements shall be construed as claims or representations that any NutriCology or Allergy Research Group products, which are foods and foods for special dietary use, are offered for the diagnosis, cure, mitigation, treatment or prevention of any disease." Jensen ruled that "'Intent' is a question of fact and, in light of the ambiguous literature identified by the government, there is a genuine issue of fact as to whether defendants' products are intended to cure or treat disease." The court denied FDA's request to consider promotional material the company had used in the past but discontinued prior to the trial. In his ruling, Jensen said the "defendants correctly claim that the literature discontinued prior to the hearing date is irrelevant as to current intent" unless the agency can provide evidence that customers relied on the former promotional material when purchasing the product. FDA argued that the court's position "simply encourages defendants to withdraw literature once the FDA files a lawsuit," Jensen noted. However, he stated that FDA "made no showing as to why defendants should be forever chained to its former promotional literature." In addition, Jensen found that NutriCology's promotional language did not necessarily constitute drug claims. For example, in promotions for germanium, NutriCology had stated that the product "may contribute to maintaining a variety of physiological functions within their normal ranges," specifically citing apparent benefits on hypertension shown by a study of 30 subjects. The promotional materials also mentioned the positive effects on immune responses seen in animal studies. Jensen stated in his ruling that the "language itself suggests some beneficial uses of germanium, but does not explicitly reveal whether the product is intended to fight disease." Moreover, Jensen explained, the "promotional language is not dispositive on the factual issue of intent and the disclaimer adds to the uncertainty." In the case of OxyNutrients claims, Jensen said that "claiming a product improves the immune function is not identical to claiming that a product should be used to cure, prevent, mitigate or treat a disease." FDA's "position on the definition of drug appears, to say the least, to raise significant issues of overreaching," Jensen stated, adding: "it is apparently the FDA's view that if a company makes a claim that milk helps prevent rickets, milk suddenly becomes a drug." However, Jensen acknowledged that FDA has "made a showing that NutriCology has made many exceedingly broad and artfully couched claims, particularly in the past, about its products." Jensen also did not rule out that FDA may be able to prove that the statements or purported testing are false and misleading and that the products are not generally recognized as safe or effective for their intended uses. In response to the other charges, the court concluded that since it could not determine that the products were drugs, it could therefore not deem them "new drugs." Similarly, "misbranding" also applies to products that are determined to be drugs. Regarding FDA's claim that germanium and borage oil are unapproved food additives, Jensen cited a case involving encapsulated black currant oil in U.S. v. Two Plastic Drums that found that a food ingredient put into an inert capsule does not make it a food additive ("The Tan Sheet" April 12, In Brief).





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