Hello Cake: What the FDA Letter Means for What You Pay

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://hellocake.com in August 2025 and has observed that your website offers various compounded drug products, including products containing sildenafil and tadalafil.

1. 1

   “"While the little blue pill costs $90/dose at some pharmacies, we offer Cake Meds, which has the exact same active ingredients as the branded variety for less."”

2. 2

   “"Cake ED Meds are compounded medication with high concentrations of Sildenafil (commonly known as 'Viagra') and Tadalafil (commonly known as 'Cialis'). The two ingredients are combined into one unique compounded medication...."”

3. 3

   “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”

1. 1

   Letter issued

   September 2025

2. 2

   15-working-day response window

   FDA gives the company 15 working days to respond in writing.

3. 3

   Close-out, if issued

   FDA may post one once it is satisfied the cited issues have been corrected.

hellocake.com returned a live retail storefront when we checked in August 2026, with an Rx Care category alongside its lubricants and supplements lines and an active first-order discount offer.

This is the letter to read if you have ever compared a telehealth ED price against a pharmacy price and taken the comparison at face value. Hello Cake's $90-a-dose reference point is not what FDA challenged — the agency said nothing about whether that figure is accurate. What it challenged was the second half of the sentence, the claim that the cheaper product has the exact same active ingredients as the branded one, because a compounded combination of sildenafil and tadalafil has not been through FDA approval the way Viagra and Cialis have. A savings claim and an equivalence claim are two different claims, and a letter like this one is FDA objecting only to the second.

As of August 2026, FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Hello Cake failed to respond.