By Karen L. Kier, Pharmacist

On October 15, 2010, the movie Red was released to theaters with only average reviews from critics.  The movie was loosely based on a DC Comics’ series of the same name. The movie has some significant star power including Bruce Willis, Morgan Freeman, John Malkovich, Helen Mirren, Richard Dreyfuss and Ernest Borgnine. While the comic strip was fairly violent, the movie infused comedy into the action drama. The movie grossed over $90 million in the United States.  

Bruce Willis has retired from acting after his diagnosis in 2022 of frontotemporal dementia (FTD). His first symptoms were related to a condition termed aphasia, which means a difficulty in writing, speaking, reading and understanding. He and his family are being open about the diagnosis to bring more awareness to the condition. Morgan Freeman continues to be active in films at the age of 87 while becoming a beekeeper on his 124-acre ranch in Mississippi.

Why is the color red in the news?

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On January 15, 2025, the Food and Drug Administration (FDA) announced they were amending the color additive regulations to no longer allow FD&C Red No. 3 in food or ingested drugs. FD&C Red No. 3 is known as Red Dye 3, Red Dye No. 3, and erythrosine. This red dye is a synthetically produced coloring for creating a bright cherry-red color to foods and some medications.

The FDA has the authority to revoke the use of FD&C Red No. 3 based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act enacted in 1960.  The Delaney Clause prohibits the FDA authorizing a food additive or color additive if it has been found to induce cancer in humans or animals. 

In 1990, the FDA banned FD&C Red No. 3 from topical drug products and cosmetics due to an increase risk of cancer seen in rat studies. A June 2008 petition submitted by the Center for Science in the Public Interest requested the FDA to remove the Red Dye No. 3 due to the risk of cancer in animals. The FDA at the time concluded a lack of high-quality scientific evidence and did not ban its use.

The FDA acted on more recent data presented in 2022 as part of a color additive petition showing an increase risk of cancer with the dye in male laboratory rats exposed to extremely high doses of erythrosine. There was no evidence submitted that the Red Dye No. 3 produces cancer in humans.

Many manufacturers of drugs and foods had already removed Red Dye No. 3 from their products and had replaced the red color with Red Dye 40. For example, the red candy M&M’s use Red 40 for their color.  Red Dye 40 is also called allura.  

The ban will not go into effect immediately. Food manufacturers have until January 15, 2027 to remove FD&C Red No. 3 from their products. Drug manufacturers have until January 15, 2028 to do the same.  

It is important to read food labels for products having a pink to bright red color. For medications, it can be a little more difficult to know without consulting your healthcare professional or the company.  The ONU HealthWise Drug and Health Information Center subscribes to a database providing information on additives in medications including dyes and gluten.

If you are seeing red, contact ONU HealthWise for medication advice!

If you are interested in more information please contact ONU HealthWise Pharmacy at 419-722-3784. ONU HealthWise offers the shingles vaccine along with flu, COVID-19 and other vaccinations. The pharmacy is open 9:00 a.m.-1:00 p.m. and 2:00-6:00 p.m. on weekdays and 10:00 a.m.-2:00 p.m. on Saturdays.