Sleep Aid Controversy

 

There’s been a bit of a controversy over at the FDA regarding a certain ingredient in some dietary supplements. It’s Phenibut, an ingredient in sleep aids. Apparently, it no longer fits in with all the other ingredients that are allowed to go into dietary supplements. It’s a good old fashioned case of “one of these things is not like the others.”

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines a dietary ingredient as “a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.”

In short, it means that Phenibut doesn’t fit squarely into any of those categories, and because it’s not playing by the FDA’s rules they have decided that any dietary supplements that declare Phenibut as a dietary ingredient are “misbranded.”

That’s worth repeating: misbranded, not dangerous.

Here’s where it gets a little muddy.

There’s also been an FDA warning about the dangers of certain prescription insomnia medications. there are some shocking stories coming from people who have suffered from unusual side effects… But, we’ll talk more about that next week.

For now, let’s unpack this whole Phenibut misunderstanding.

Because it’s not dangerous, but merely found in the wrong category, the FDA is wanting everyone who sells any supplements with Phenibut in it to be reformulated and rebranded. They are NOT saying is that you should trash what you have.  Moreover, they are allowing what has been manufactured to be sold because — it’s important to state again — Phenibut is not dangerous in dietary supplements. As common sense and medical professionals would all say, as with any supplement, use it ONLY as directed.

So why are we going to such great lengths to clarify all of this?

We don’t want there to be any confusions: our Kavinace & Sleep Essentials are completely safe and very effective. We would never put anyone in danger. If there was any risk, we would take them off the shelf immediately.

Our purpose has always been to help educate and empower our customers to make their own decisions about their health. When information like this surfaces, you can always trust that we will bring it to you immediately.

Thank you for trusting us. It’s an honor we will never take for granted.

 

Sources:

https://www.fda.gov/food/dietary-supplement-products-ingredients/phenibut-dietary-supplements?fbclid=IwAR1hjy-yNCWN1yllGyHibCEefRy8zOwLexgTSt1sP_J8bjgtEwbuVk0Kr4Q

https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warnings-about-rare-serious-incidents-related-certain-prescription-insomnia

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