Regulatory and Legislative Battles of the 1980s

The long-running effort by CTFA to permanently list color additives provisionally listed under the 1960 Color Additive Amendments continued into the 1980s.

After completing two rounds of tests in the 1960s and 1970s, the industry was ordered by FDA to run a third round of tests in 1977. These tests were financed through voluntary contributions of member companies.

In March 1983, CTFA President Ed Kavanaugh met with FDA Commissioner Hayes and convinced the agency not to delist three very important color additives. CTFA then set out to establish the safety of several provisionally listed color additives. It also urged FDA to adopt a "de minimis" standard, whereby FDA could approve color additives that had a minimal cancer risk.

Consumer groups filed two major lawsuits against FDA and the Department of Health and Human Services (HHS), urging the ban of provisionally listed color additives. Afterward, HHS Secretary Margaret Heckler stated that she favored a de minimis standard, leaving it up to the Secretary's discretion to permit products to remain on the market or to be approved for use if the risk was insignificant.

Subsequently, the U.S. Court of Appeals ruled in 1987 "with some reluctance" that FDA did not have the authority to apply the de minimis policy, thereby mandating a strict interpretation of the Delaney anti-cancer clause.

CTFA worked to develop additional data to support petitions for the use of new colors as well as for additional uses of previously listed colors.