Congress is considering FDA reform bills

Published: June 01, 1996, By MacArthur, Malcolm D.

The approval process for food packaging may be changing as the House and Senate debate a number of measures.

Packaging that directly contacts food must, of course, be cleared for use under the Food, Drug, and Cosmetic Act and regulations. Thus, changes in the laws that deal with how food packaging is cleared are of enormous interest to converters and suppliers of food packaging materials.

Both the Senate and the House are currently considering Food and Drug Administration (FDA) reform bills that would change the way food packaging is approved. In the Senate the Labor and Human Resources Committee recently approved the Food and Drug Administration Performance and Accountability Act of 1996. While the measure would alter certain approval procedures, it does not contain the Delaney Clause reform provision that would have replaced the Federal Food, Drug, and Cosmetic Act's "zero risk" standard for cancer-causing compounds with a negligible risk standard. That clause prohibits approval of any food additive that is found to cause cancer in man or animals, regardless of the risk presented by the substance. It was removed by Sen. Judd Gregg (R-NH) after Sen. Nancy Kassebaum (R-KS) objected that the presence of the amendment would jeopardize the bill's future.

Among other provisions, the bill requires that the Agency, by July 1, 1998, meet all existing statutory requirements that new petitions and applications be reviewed within 180 days. Were the Agency to fail in this undertaking, the measure mandates that FDA hire private contractors to complete any pending reviews.

One provision of the bill would permit food and dietary supplement manufacturers to make health claims based on the statements or recommendations of public health government agencies, e.g., the Centers for Disease Control and Prevention, the National Cancer Inst., etc. The legislation would also permit FDA to contract with expert organizations and individuals to review all or parts of a food additive petition whenever contracts would improve "efficiency, timeliness, and the quality of the review."

Further, beginning July 1, 1998, if the Agency fails to meet a statutory time limit for action on a direct food additive petition that potentially could make foods "more wholesome and contribute to a healthier diet" and the product is cleared in either the European Union or the United Kingdom, the petitioners would be permitted to ask the Agency to either approve or deny the petition within 30 days.

On March 27 the House Commerce Committee announced its plan to reform FDA's approval processes in three separate bills: the Drugs and Biological Products Reform Act of 1996 (H.R. 3199); the Medical Device Reform Act of 1996 (H.R. 3201); and the Food Amendments of 1996 (H.R. 3200), the last of which was introduced by Rep. Scott Klug (R-WI).

All three bills contain provisions for third-party review of petitions/applications; the food measure also would replace the Delaney Clause's zero risk standard with a negligible risk standard. Also, similar to the Senate bill, the measure would allow information prepared by a federal agency or the National Academy of Sciences to be considered in support of health claims.

Finally, with respect to genetically engineered foods, the food bill (H.R. 3200) would prohibit FDA from mandating labeling that discloses the method of production of the substance, thus codifying FDA's 1992 policy on labeling of genetically engineered foods. That policy mandates that genetically engineered foods only be labeled as such if they transfer genes from the ten most commonly allergenic foods.

H.R. 3200 seeks to provide national uniformity in food, drug, and cosmetic regulation by barring states from establishing or continuing any notification requirement for a food, drug, or cosmetic that provides for disclosure of the constituents, source, or method of production or processing of the food, drug, or cosmetic, or for a warning concerning the safety of the food, drug, or cosmetic.

This provision would cover such issues as California's Proposition 65 warnings on the covered product, as well as the requirements or threatened requirements of various states on such things as milk from BST-treated cows.