Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction
Has FDA flagged "erectile dysfunction"?
Yes. FDA has quoted wording matching "erectile dysfunction" in 17 warning letters in our database. The most recent is FDA's August 24, 2026 letter to Royal Peptides LLC.
Checked against published FDA warning letters, updated November 15, 2026.
Letters that quote it
Each quote is copied from the company's marketing as FDA printed it in the letter.
FOR ERECTILE DYSFUNCTION
Indications:... Spermatorrhoea [sic] Erectile dysfunction
MACA may helps [sic] to reduce erectile dysfunction.
Hard Steel wins against erectile dysfunction
Moderate Conditions Lyme Disease, COPD, Localized Injury, Back Pain, Alzheimer’s/Dementia, Epilepsy/Seizure Disorders, Erectile Dysfunction, Infertility (male & female), etc.
Our Moor Herbs ‘High Science’ Resurrection formulae, is a 100% all-natural herbal-based formula for men experiencing difficulty with attaining and maintaining an erection (penile erectile dysfunction) with the root cause being poor circulation due to poor diet (and lifestyle) – a diet too high in animal protein (meat, flesh, cadavaer, carion, etc.) and animal fat which clogs the veins and arteries and thus impairing circulation which is vital for a healthy, solid, firm, and stiff erection.
Tags: Erectile Dysfunction
Its main use applies to erectile dysfunction and low sexual desire, but it is also used against general weakness, painfulness, spontaneous sweat.
Boost nitric oxide levels with Redwood... Increasing your nitric oxide levels can benefit almost every aspect of your circulatory health from your blood pressure, symptoms of erectile dysfunction, and symptoms of varicose veins.
Ashwagandha Arishtam... heal sexual disorders, relieve depression... This arishtam and remedies premature ejaculation and erectile dysfunction
Category: SINGLE DRUG CAPSULE... Anxiety[,] Depression[,] Muscle fatigue and neck/back stiffness[,] Insomnia[,] Diabetic neuropathy[,] Erectile dysfunction and low sperm count, premature ejaculation... Benefits: Reduces bodyweight, decreases cholesterol levels
Asian ginseng is prescribed for those with low energy, tendency to feel cold, and a lack of sex drive. Studies have shown ginseng improves erectile dysfunction in men
Tongkat Ali ( Eurycoma longifolia )... has long been traditionally used as a medicinal plant in a variety of folk medicine preparations for ailments which range from malaria to erectile dysfunction.
It is focused on increasing testosterone secretions from the glands related to this function. This... should assist in erectile dysfunction problems.
Sexual debility is an ever-increasing issue in modern life. One need only watch television to note the many drug ads for pills to elevate sexual performance. In the U.S. it is estimated that 5% of 40 year-old men and 15-25% of 65 year old men have erectile dysfunction. This is another area, along with its role on the training table of athletes, where demand is driving the overharvesting. The sex drive is so central to one’s sense of well-being that people will pay a king’s ransom for a product that holds out hope for remedying the loss of sexual vitality. And Chinese studies do seem to indicate there is some hope for help with Cordyceps, even when consumed in a modest dose.
Alpha Male Plus is a male enhancement supplement that improves sexual performance as a truly unique natural solution for erectile dysfunction...
Why FDA quotes wording like this
Warning letters quote a company's own marketing as evidence of how a product is being sold. Under the Federal Food, Drug, and Cosmetic Act, a product promoted to cure, treat, mitigate or prevent disease is a drug, so disease claims on a supplement, CBD or wellness product can make it an unapproved drug. Some letters quote wording like "FDA approved" or "clinically proven" for other reasons. Each letter states its own charges, so read the source before deciding anything.
This page is informational and is not legal advice.
Is "erectile dysfunction" anywhere on your website?
FDA letters quote blog posts, FAQ answers and social captions, not just product pages. Our $39.99 report checks every page of your site against every letter in our database, with a link to each match.