FDA Warning Letters

FDA Warns BrainAlert – Bogus Claims, “Adulterated”, “Misbranded”

BrainAlert and its distributor, Jared Lykken, have been formally warned by the U.S. Food and Drug Administration, or FDA, for the way Lykken was marketing his BrainAlert supplement.

From the letter, which was dated December 14, 2017, we learn that Lykken was the target of a 2-day inspection back in June and a 1-day visit in July. During those inspections–and after a peek at Lykken’s website, BrainAlert.com–agents found what they characterized as “serious violations” of FDA regulations.

Under current FDA rules, dietary supplements like BrainAlert are limited in the promises they can make. And Lykken when too far when, for example, he listed a variety of medical conditions, including depression, and declared, “Then BrainAlert is the solution for you!”

Archived webpage showing FDA-cited claim about BrainAlert.

BrainAlert’s promise to aid in the struggle against depression is an example of a non-allowed claim that got the FDA’s hackles up.

Comments made about BrainAlert’s ingredients were also cited as unallowed. The supplement’s DMAE, Huperzine A, Gotu kola and nicotinamide were cited in particular. Such claims, and Lykken’s citing of scientific studies on certain ingredients used in BrainAlert, show, according to FDA, that BrainAlert is being touted not as a dietary supplement but as a new (and unapproved) drug. And a “new drug” cannot be sold without FDA approval.

BrainAlert is further “misbranded”, adds the agency, because it is peddled for serious medical conditions the average person cannot accurately self-diagnose or successfully treat without a doctor’s input.

The company was also warned about its lack of documentation regarding its supplier and the way it handled some of its labeling.

BrainAlert was given the standard 15 working days to respond. As of my last check at the company’s website this morning, it appeared Lykken had already pulled down the website. There was no notice I could find of when (or even if) the site would be back up. The company’s Facebook page appears not to have been updated for months.