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DIETARY SUPPLEMENT NLEA EXEMPTION WILL EXPIRE DEC. 15

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT NLEA EXEMPTION WILL EXPIRE DEC. 15 after eleventh-hour negotiations in the House failed to come up with a bill to extend the supplement moratorium. While the Senate passed a four-month moratorium (S 1762) by unanimous consent on Nov. 20, the House was unable to reach a consensus by the close of 1993 business. In the absence of legislation to extend Sen. Orrin Hatch's (R-Utah) 1992 proviso exempting supplements from regulation under the Nutrition Labeling & Education Act, FDA is free to finalize regulations that would include supplements under the NLEA labeling framework for foods. In the waning hours of the first session of the 103rd Congress, House Energy & Commerce/health subcommittee Chairman Henry Waxman (D-Calif.) proposed a 12-month extension to the moratorium and sought to pass it on Nov. 22 by unanimous consent. However, the author of HR 1709, Rep. Bill Richardson (D-N.M.), led cosponsors of the bill in objecting to the one-year moratorium extension and, instead, pushed for a House version of S 1762, which would have prohibited FDA from issuing final regulations on dietary supplements prior to April 15, 1994, and from finalizing the regulations prior to April 30. Waxman reportedly withdrew his initial proposal and, in its place, submitted the "Dietary Supplement Access and Claims Moratorium Act of 1993" (HR 3650), which stipulated a six-month moratorium ending June 30, 1994 and redefined the term "dietary supplement" to the chagrin of industry negotiators and HR 1709 supporters in the House. HR 3650's definition of a dietary supplement apparently would not allow liquid supplements consumed by the glass. According to the bill, a dietary supplement is "a product which contains one or more dietary [ingredients] marketed to supplement the diet" in either "tablet, capsule, powder, softgel, or liquid form and if in liquid form is formulated in a fluid carrier and is intended for ingestion in daily quantities measured in drops or similar small units of measure." The bill's definition of "dietary ingredient" includes vitamins, minerals, herbs, amino acids, and "other [ingredients] contained in a product marketed in the U.S. as a dietary supplement on or before Nov. 15." However, the industry was reportedly concerned that this definition would not include plant extracts or oils. Under HR 3650, a dietary supplement could not be "represented for use as a conventional food or as a sole item of a meal or of the diet," and could not "include any ingredient other than a vitamin or mineral which has been approved as the active ingredient of a drug." Waxman also inserted language in HR 3650 that would deem a dietary supplement "misbranded" or an "adulterated food" under the FD&C Act at FDA's discretion if the product contains "a dietary ingredient at a level that may be injurious to health or is a dietary supplement which, when used in accordance with the conditions of use, may be injurious to health." In addition, HR 3650 would amend Section 503(b), the prescription drug marketing section of the FD&C Act, with a provision that "for a dietary supplement marketed on or before Nov. 15, [FDA] may not, after Nov. 15, require a prescription. For a dietary supplement first marketed after Nov. 15, this subsection as it was in effect on the date of the enactment of the Dietary Supplement Access and Claims Moratorium Act of 1993 shall apply." Reportedly, sections of HR 3650 are similar to provisions included in an earlier draft of a Waxman dietary supplement compromise bill that was circulated in autumn. At a July hearing on FDA regulation of dietary supplements, Waxman suggested that any legislative approach to supplement regulation should try to retain FDA authority ("The Tan Sheet" Aug. 2, pp. 6-11). Waxman reportedly floated at least two drafts of alternative legislation to Richardson's HR 1709 during the last session of Congress but never formally introduced legislation until HR 3650. The Senate counterpart to HR 1709, Hatch's S 784, was slated for a mark-up in Sen. Edward Kennedy's (D-Mass.) Labor & Human Resources Committee on Nov. 17 but was postponed due to an impasse between Kennedy and Hatch. S 784 cosponsor Nancy Kassebaum (R- Kan.) joined Hatch and Kennedy in proposing the Nov. 20 Senate moratorium. In a Nov. 20 speech on the Senate floor, Kassebaum stated that although "in the past week, we have made some encouraging progress toward resolving the many controversial issues surrounding FDA's interpretation of NLEA as it applies to dietary supplements . . . several major issues remain to be resolved." Kennedy, in a speech to the Senate, declared that "ending the uncertainty around dietary supplements must be our priority." He promised that Congress "will focus on this issue immediately upon its return in January." To date, HR 1709 has 209 cosponsors and S 784 has 63 cosponsors. Concern that FDA may promulgate a final rule on dietary supplement labeling before Congress can pass comprehensive supplement legislation prompted Hatch, Richardson, and HR 1709 cosponsor Elton Gallegly (R-Calif.) to send a letter to HHS Secretary Donna Shalala requesting that the agency postpone publishing a final rule. Hatch's 1992 legislation establishing the original moratorium mandated that FDA issue the final rule by Dec. 31. The Nutritional Health Alliance voiced strong opposition to HR 3650, saying that "the winter congressional recess will be a time of intense efforts by the grassroots to communicate with Congress" and to reiterate its support for HR 1709 and S 784. According to NHA, HR 3650 would "damage industry and lead to eventual removal of many products" by subjecting dietary supplements "to new safety standards that could be abused in the future by FDA." The National Nutritional Foods Association also complained that the Waxman bill "did not allow truthful and non-misleading health claims and did not protect industry products . . . from FDA-established potency limits."
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