FDA arouses concerns on colorants.

The Food and Drug Administration's Preamble to its final rule on "Colorants for Polymers," published August 30, states that "under normal conditions, colorants (1) have been shown to migrate to food from polymers, (2) are food additives, and (3) are subject to...the Federal Food, Drug and Cosmetic Act. SPI's lawyer, Jerome H. Heckman, met recently with Michael R. Taylor, FDA Deputy Commissioner for Policy, to express SPI's vehement objections to this new language, which seems to assume migration by all colorants.

The main problem, according to SPI, is that the Pramble seems to dismiss 30 years of indirect food-additives law. Taylor says FDA does not intend to change the way it regulates packaging materials, and does not dispute an individual company's right to determine what is appropriate--"Subject to the risk that FDA may disagree with the conclusion and bring action against the company." Phillip Derfler, FDA General Counsel, who also attended the meeting, said FDA just wanted to reiterate that only FDA's determination of whether a material migrates has "the force and effect of law."

Heckman says, "We explicitly asked that FDA clarify the language in the Preamble to reflect the fact that a company may continue to determine on its own whether a package or packaging component may reasonably be expected to migrate to food." Regardless of FDA's intention, Heckman says, if the agency does not clarify the Preamble, it could cause "a significant change in how the marketplace reacts to colorants and perhaps all packaging components." This is because an erroneous perception by packaging users might lead them to request only materials approved in Title 21 of the Code of Federal Regulations.

Such requests would ultimately require a colorant or packaging manufacturer to petition FDA for clearance of all colorants used in their products, Heckman said. This would be a "disaster," according to Heckman. "No one would object if FDA's reply period on petitions was 30-60 days, but sometimes their reply period can be three, five or even 10 years. In the easiest of cases, a year or more is routinely required by the FDA staff to process even a simple food-additive petition."