Under which clause is the FDA required to ban food additives found to cause cancer in humans or animals as indicated by testing?

• A. Delaney Clause
• B. Federal Food Additives Amendment
• C. Pure Food and Drug Act
• D. National Environmental Policy Act

Answer: (A)

The key idea is a strict zero-tolerance rule for cancer-causing substances in food. The Delaney Clause states that if testing shows a food additive can cause cancer in either humans or animals, it must be banned by the FDA, regardless of the dose or the perceived level of risk. This makes carcinogenicity the sole determinant for prohibition under this clause, rather than weighing costs and benefits or exposure levels.

This clause is part of the Food Additives Amendments of 1958 to the Federal Food, Drug, and Cosmetic Act. The broader amendment established how additives are evaluated, but it’s the Delaney Clause itself that imposes the immediate ban on any carcinogenic additive found in testing. The Pure Food and Drug Act predates these developments and did not include this cancer-specific ban. The National Environmental Policy Act is about environmental impact assessments and not about regulating food additives.