FDA Warning Letters

Amerigo Formally Warned For Claims About PowerUp, PowerDown

Amerigo Laboratories’ owners Ralph Maser and Carol Maser have found themselves in hot water with health officials for hawking supplements the U.S. Food and Drug Administration, or FDA, says are unproven and shoddily labeled.

The supplements, PowerUp and PowerDown, are nootropics, or brain enhancers. PowerUp, for example, is peddled as an all-natural way to enhance memory, sharpen focus and improve attention. Its companion product, PowerDown, promises to lower anxiety, deepen concentration and improve sleep. Together, the two products offer “full brain support” for “maximizing your brain potential”.

But it’s the Masers’ claims about narcolepsy, cataplexy, ADHD an other serious medical issues that got the FDA’s hackles up.

PowerUp by Americo is marketed with non-allowed claims for blood thinning, Alzheimer's and schizophrenia.

Screengrab with FDA-warned claims for Amerigo’s PowerUp supplement still visible as of this morning.

FDA says that neither product has been formally greenlit for claims about Alzheimer’s disease, attention deficit hyperactivity disorder, heart disease prevention or a host of other serious medical issues mentioned in the products’ marketing. And both products are further misbranded because they’re marketed for conditions that cannot be accurately self-diagnosed or effectively self-treated at home with over-the-counter supplements.

The agency also takes issue with the way Amerigo is labeling its products. The products lack contact information a customer could use to report an adverse event, for example, and do not disclose their nutrition facts, among other things.

Ralph Maser and Carol Maser were given the normal 15 working days to respond. The letter was dated April 04, 2018; as you can see from the screengrab above, it appears they have not yet removed the allegedly bogus health claims.

It does not appear that either owner has publicly addressed the release of the FDA’s letter.