What Does FDA Approval Mean for Hair Loss Treatments?


Can a hair loss treatment work if it's not FDA approved? In this article we review what FDA Approval means, when it is required, and how to use that information to determine which hair loss treatments can effectively stop hair loss.

In my last article we reviewed the effectiveness of various hair loss treatments available. This time I’m taking a closer look at what FDA approval or not means for hair loss treatments. There are a LOT of shampoos out there making claims to cure hair loss with more seemingly popping up every day, so this is something you should be aware of to avoid spending your money on something which won’t work.

Let’s start by looking at the facts and then think about this logically:

  1. DHT is the cause of androgenetic alopecia (hereditary hair loss).
  2. DHT binds to the hair follicle and causes the hair to miniaturize and eventually die.
  3. Unless we prevent the DHT from forming and reduce the amount of circulating DHT in our system we cannot stop hair loss.
  4. DHT is a chemical. Molecularly it is very similar to Testosterone, but it has 2 extra hydrogen molecules attached. I call it the Bad testosterone. As opposed to the good one which gives us vitality, strength, ability to build muscle, etc. Don’t be afraid of chemicals though, remember water and air are also chemicals, just know which ones are bad and which are good checmicals.

Now let’s take a look at the FDA regulations to see how those work. According to the Federal Food, Drug, and Cosmetic Act, it mandates FDA approval is required of any product or active ingredient which meets the following criteria:

  • It is intended to cure, treat, mitigate or prevent disease in humans
  • It affects the structure or function of the human body – ie: it works on the inside of our body
  • It achieves its primary intended purpose through chemical action
  • The product is metabolized by the human body – it penetrates the skin to work inside and is then broken down by the human body


So going back to our known facts about hair loss, we know that unless we reduce the amount of DHT in our system, we cannot stop hair loss. In order to reduce DHT we need to remove the extra hydrogen molecules off the DHT plus ideally also prevent the DHT from forming in the first place.  These are both chemical actions. In order to reduce DHT, the ingredients must penetrate through the skin to be able to make changes to us internally or be digested and absorbed through our digestion process to be able to take a chemical action or make chemical changes to the DHT or prevent it from forming which is also a function of the human body.

The law says, that if a product actually does any of these things it is REQUIRED to go through FDA review and approval.

This is your first red flag. What it means is that any product which makes claims to do any of these things but is not FDA approved, cannot ACTUALLY do as they claim or legally they could not be sold.

But that doesn’t make sense you say. How is it that they are allowed to lie and get away with it?

Well only products which are regulated by the FDA are required to tell the truth in their claims. Any product which is not FDA regulated can make whatever claims they like about what they do and don’t do and there is no legislation which governs that.

So what does this mean to you? Basically it gives you an easy mechanism for determining whether a product is effective or not because only a product or active ingredients that are FDA approved can be effective at stopping hair loss.

I keep seeing more new miracle hair loss products pop up with ingredients that claim to prevent or reduce DHT like: Maxelder, Grathaw, Patlarnay head jungle shampoo and the many others out there. So now you know based on the legislation that unless these ingredients are FDA approved then they cannot possibly do as they claim and therefore will not be effective at stopping hair loss.

All the active ingredients utilized in the Stop and reGrow program are FDA Approved either to reduce DHT or to stimulate hair growth and Stop and reGrow is clinically proven to stop hair loss and regrow thin hair.

Article by
Beverly Hills Physician