The FDA’s mission is clear: “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” How well does it carry out this mission? Sadly, the agency often moves at a speed that would shame any self-respecting snail. One need dig no deeper than Red Dye No. 3 or the decongestant phenylephrine (PE) to question the FDA’s ability to take action in a timely manner.
PE’s Long Con: A Decades-Long Decongestant Debacle:
The Food and Drug Administration works in slow and mysterious ways. One of its most critical missions is to ensure the effectiveness of America’s drugs. It completely dropped the ball with regard to the oral decongestant phenylephrine (PE).
PE is found in hundreds of cough and cold products and is supposed to ease symptoms of nasal congestion. Over the last decade, Americans have spent billions on products containing this ingredient.
We were aware of questions about the effectiveness of phenylephrine more than 50 years ago. That’s because a 1974 report in Consumer Reports noted that PE was ineffective in the doses found in oral doses being used in popular products. At a 2007 FDA meeting, the agency was informed that “PE is not more effective than placebo.”
It took the agency until recently to propose the elimination of PE from oral cough, cold and allergy products, though. The FDA is accepting comments about the proposed ban until May 7, 2025. Eventually we may see the elimination of PE and the reformulation of hundreds of products that still contain this ingredient.
As I write this analysis, here are just a few of the products that contain phenylephrine:
- Advil Multi-Symptoms Cold & Flu Tablets
- Advil Sinus Congestion & Pain Relief
- Benadryl Allergy Plus Congestion
- Benadryl PE Dry Cough and Nasal Congestion
- Dayquil Severe Cold and Flu
- Mucinex Fast-Max Severe Congestion & Cough
- Nyquil Severe Cold & Flu
- Theraflu Nighttime Severe Cold & Cough Hot Liquid
- Tylenol Sinus Congestion & Pain Caplets
Red Dye No. 3: Controversial for Decades!
Let’s go back a bit further in time. In 1958 Congress passed legislation containing the Delaney Clause. That’s when the clause became part of the Food, Drug and Cosmetic Act. According to the Government Accountability Office, this law requires the Food and Drug Administration to:
“ban food additives which are found to cause or induce cancer in humans or animals as indicated by testing.”
One might think that such clear language would have allowed the FDA to take action against any food additive that was tested and found to cause cancer. The first red flag on Red Dye No. 3 went up in the early 1980s. That was when an animal study revealed that rats fed high doses of this coloring agent developed tumors.
In 1990 the FDA banned Red Dye No. 3 from topical drugs such as arthritis ointments and cosmetics like lipstick. But it allowed Red No. 3 in foods. That all changed on January 15, 2025.
No More Red Dye No. 3…in Two Years:
On January 15, 2027, after more than 40 years, the FDA says that Red No. 3 needs to be removed from foods and drinks. Most people have no clue how many products will be affected. Red Dye No. 3 is found in some gummies, cupcake icing, frozen popsicles, beef jerky, jelly beans, fruit rolls, candy, cookies, ice cream, soda, fruit-flavored drinks and strawberry-flavored milk. And that’s just for starters. We encourage anyone who seems candy or food with a red color to look at the ingredient list!
According to Consumer Reports: and the Environmental Working Groups food database:
“…there are over 2,900 food products that contain it [Red Dye No. 3]
You might think that after all these years the feds would be moving a bit more quickly. But the agency is giving manufacturers a lot of time to prepare:
“Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products.”
Many pharmaceuticals contain Red No. 3. That includes cough medicines, vitamins and a surprisingly large number of pills and capsules. If your medication has a reddish color, why not call your pharmacy and ask the pharmacist if he or she could check the ingredient list for Red Dye No. 3. Here is just a partial list of some generic meds that might contain this coloring agent. Please keep in mind that each generic drug manufacturer has the discretion to use an approved coloring agent, so just because your med might be on this list does not mean that it contains Red No. 3. Only the pharmacist can tell you for sure:
Some Generic Drugs that Might Contain Red Dye No. 3:
- Celecoxib
- Diltiazem
- Fluoxetine
- Gabapentin
- Esomeprazole
- Omeprazole
- Oseltamivir
- Phentermine
- Propranolol
We are not entirely surprised that it has taken the Food and Drug administration decades to act. We have been monitoring the agency for nearly 50 years. It is much more likely to approve a new drug than to remove a problematic drug from the marketplace.
We have spent decades warning alerting readers about pharmaceutical advances and warning about drug dangers. Here are just a few examples of FDA delays:
FDA Slow to Recognize Asbestos Danger in Powder
Although the FDA has known for decades that some talcum powder might be contaminated with asbestos, for most of that time it overlooked the risk
What Took the FDA So Long to Warn About Z-Drug Dangers?
The FDA crows about its new drug approvals. It is less enthusiastic about black box warnings. Z-drug dangers now include sleep walking and sleep driving
Why Was the FDA So Slow to Warn About FQ Disasters?
Fluoroquinolone (FQ) antibiotics like Cipro and Levaquin have been around for decades. There’s a dark side to these drugs. What are the latest FQ disasters?
Aviation Disasters Highlight Fundamental Flaws at the FDA
What do airplane accidents, the FAA and the FDA have in common? Plane crashes and drug disasters have similarities. Are there fundamental flaws at the FDA?
Final Words:
We suspect, but we cannot prove, that the FDA hates to admit it might have made a mistake. Many bureaucracies find it easier to defend difficult decisions than to acknowledge a problem.
That is why we encourage our readers to avoid artificial flavors and colors whenever they can. If the FDA won’t adopt the European “precautionary principle” which requires proof of safety before marketing, then individuals need to protect themselves by reading labels carefully.
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