FDA COMPLETED 904 IMPORT DETENTIONS OF DIETARY SUPPLEMENTS IN FY 1992

FDA COMPLETED 904 IMPORT DETENTIONS OF DIETARY SUPPLEMENTS IN FY 1992 under the food additive safety provision of the FD&C Act (Section 409), the agency told Congress in a dietary supplement enforcement report sent to the Hill on May 19. In the report mandated by the Dietary Supplement Act of 1992, FDA noted that 872 of the import detentions were for the diet aid ingredient, Ultra Bios; the remaining 32 import detentions were for L-carnitine (18), L-tryptophan (7) and evening primrose oil (7). In fiscal 1992, FDA completed a total of 41,155 import detentions.

The agency reported that of the 2,028 warning letters issued since May 1991, five targeted dietary supplement manufacturers for unproven supplement ingredients under the food additive provisions of the FD&C Act. "The level of enforcement resources devoted to dietary supplements is relatively small given the size of the industry nationally," FDA maintained.

In the report, FDA estimated that approximately 15 to 20 "person years" were devoted to compliance activities involving dietary supplements out of its total field force of "over 3,000 employees" and most of that activity was conducted through FDA's "health fraud" program. According to the agency, 11 of the 669 judicial enforcement actions brought by FDA between 1989 and 1992 pertained to violations under Section 409; in four of these 11 cases, the charges were combined with charges brought under the drug provision statutes.

"It is current agency policy to reply on this section only when the product has been targeted for regulatory action under the [1987 FDA compliance policy guides] and the agency's Center for Food Safety and Applied Nutrition finds that (1) the product contains an ingredient that is an unlisted (unapproved) food additive in clear violation of the act and (2) there is a basis for concern regarding the safety of the food additive that needs to be addressed to protect public health," FDA said in the report.

"Even though the numbers are modest, actions relying on Section 409 have played a significant role in protecting public health," the agency asserted. FDA mentioned its 1990 action against supplements comprised of the amino acid L-tryptophan, which was linked to eosinophilia-myaglia syndrome, as well as its seizures of "evening primrose oil and related products, black currant oil and borage oil," all of which contain gamma linoleic acid. "This component poses serious health concerns related to convulsions, potential changes in blood clotting, and other tissue changes," FDA said.

While a major focus of the report is FDA's enforcement activities under Sec. 409, the report does not address two recent federal appellate court rulings that single-ingredient dietary supplements cannot be considered food additives under the FD&C Act. In a footnote, FDA notes only that it "has appealed" two earlier district court rulings.

Recently, an FDA petition for a rehearing of its case against Traco's black currant oil was denied by an Illinois federal appeals court ("The Tan Sheet" April 12, In Brief). The petition followed a Jan. 27 ruling by the appellate court that the single- ingredient capsule was a "food" and not a "food additive," and, therefore, the burden of proof to show the product was unsafe rested with the agency. A similar petition for a rehearing of case involving Oakmont's BCO was denied by a Massachusetts federal appeals court in April. FDA Commissioner David Kessler told an April 15 press conference that the agency was considering appealing the Traco BCO case to the Supreme Court ("The Tan Sheet" April 19, p. 1).

In a related case, FDA sent a March 23 warning letter to Traco claiming that the company had not yet received a "May Proceed or Release Notice" for its detained evening primrose oil capsules. Traco contested the warning in an April 6 letter to the agency ("The Tan Sheet" April 12, In Brief). The Scottish importer Callanish was also involved in a January FDA import action against its evening primrose oil capsules in a Boston federal appeals court ("The Tan Sheet" March 1, p. 7). However, the judge in that case told federal attorneys that because of the Traco ruling, they could not take action against imported evening primrose oil based on Sec. 409.

FDA also said in the report that it "has concerns about dietary supplements that contain complex mixtures of substances, including substances not normally found in the food supply." FDA pointed out that for some of these substances, "there is no evidence in the scientific literature or otherwise available to the agency from manufacturers or other sources to support safety." The agency added that it "cannot be certain of the chemical identity of some of the substances used in these products." In addition, the report explains that FDA also takes action against dietary supplement products that make health claims "without any known scientific support or without scientific support meeting the standards established in the [FD&C] Act."

The report notes that much of FDA's enforcement activity involving dietary supplements comes under the agency's "health fraud" program, which was initiated in 1987 and targets "articles of unproven effectiveness that are promoted to improve health, well being, or appearance." Although the agency's fraud program does not specifically target supplements, FDA said it "applies to them if they fit the criteria for health fraud products."

The report also points out that the agency issued a compliance policy guide in 1986 directed at herbal products under which FDA "will consider action against botanical products as food on a case-by-case basis under Sec. 402(a)(1) (poisonous or deleterious substance) and the food additive provisions. Products that make therapeutic claims, however, are regulated under the drug provisions of the FD&C Act," FDA noted. The report does not provide the number of dietary supplement or herbal product enforcement actions under the drug provisions of the law.