- Chief Compliance Officer and VP of Legal Affairs, Arrow Electronics
By 
Oscar Gonzalez2025-01-15T19:05:00
The U.S. Food and Drug Administration (FDA) announced Wednesday it has revoked authorization for color additive Red No. 3 from food, beverages, and drugs. Health concerns over dye have existed since it was banned from cosmetics in 1990 after it was found that large doses led to the development of cancer in lab rats.
The FDA says it amended its color additive regulation based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the authorization of food additives if it’s been found to cause cancer in animals or humans. Although the studies from the 1990s showed high levels of the dye caused cancer to develop in male rats, the administration did specify that the reaction was a ”rat-specific hormonal mechanism” and exposure to humans was much lower than that of rats.
Red No. 3’s ban comes two years after a petition to revoke the color additive was submitted by 23 organizations, including the Center for Science in the Public Interest, Breast Cancer Prevention Partners, the Center for Environmental Health, and the Center for Food Safety. The organizations said in the petition that children in the U.S. had the highest exposure to the color additive.
THIS IS MEMBERS-ONLY CONTENT. To continue reading, choose one of the options below.
News and analysis for the well-informed compliance or audit exec. Select an option and click continue.
Annual Membership $499 Value offer
Full price one year membership with auto-renewal.
Membership $599
One-year only, no auto-renewal.
The U.S. Food and Drug Administration’s “intended use” final rule reaffirms the agency’s wide latitude of discretion in establishing an off-label use case against pharmaceutical and medical device companies.
The Federal Trade Commission and Food and Drug Administration have signaled they will be increasing their oversight of any potential antitrust behavior in the biologics market.
The FDA is escalating a “forceful” crackdown on retailers and manufacturers that sell nicotine-based products to minors. Among the companies in its crosshairs: Walgreens.
The Consumer Financial Protection Bureau has issued a proposed rule aimed at protecting the privacy of the public when using novel digital payment systems, such as those offered by large technology platforms and video gaming companies.
Banks and other lenders will be prohibited from using medical debt information in credit reports, under a new rule finalized by the Consumer Financial Protection Bureau, the agency said.
New rules on cyber risk management across the EU put execs firmly in the crosshairs for noncompliance and are likely to apply to a wider range of organizations than many business leaders may initially think. However, there are also concerns that the rules may become muddled across the wide bloc. ...
