Even with a GMP clean bill of health, overblown claims can spark warning letter

By Hank Schultz

- Last updated on GMT

Even with a GMP clean bill of health, overblown claims can spark warning letter
Operating a fully compliant manufacturing facility is no bulwark against trouble caused by noncompliant disease claims, as a recent warning letter illustrates.

FDA sent a warning letter in early April to Amerigo Labs ​of Lenexa, KS.  The letter is unusual in a couple of respects, one being that it hinges on noncompliant disease claims that the agency said if found embedded in informational copy on the company’s website.  But that review came after the company apparently received a clean bill of GMP health from the agency after an inspection.

“I can’t recall a warning letter based on a subsequent website review following a clean inspection,” ​said attorney Ivan Wasserman, manager of the Washington DC office of Amin Talati Upadhye LLC. “Clearly this company had its ducks in a row with respect to manufacturing.”

Amerigo Labs’ business is based on an ingredients-in-the-cap delivery system. The company introduced the system to the US market in 2015​ after licensing the technology from an Italian company.

The technology was envisioned as a way to deliver probiotics and other ingredients that might be potentially unstable in solution.  The company is still advertising the delivery mode as available to brand holders, but in the meantime has started to manufacture its own dietary supplements using the system.

The products, called PowerUp and PowerDown, are liquid dietary supplements that feature a variety of ingredients, included branded ingredient offerings. PowerUp, which is position as a cognitive support supplement, includes AlphaSize branded alpha glycerol phosphoryl choline from Chemi Nutra, Cognizin citicoline from Kyowa Hakko and Optiberry, a blend of berry extracts from Lonza’s Interhealth division.

PowerDown features Relora, also from Lonza (originally developed by Next Pharmaceuticals), which is a mixture of extracts of two TCM botanicals, Magnolia officials​, known for supporting normal adrenal function, and Pheillodendron amurense​, known for supporting a calm state of mind.

Descriptions of products and ingredients crossed the line

Judging from the lack of any observations from the inspection, Amerigo Labs apparently had no issues in manufacturing these multi ingredient products in a compliant manner.  Where they fell down was in what they said about them on their website.

For example, in a section of the website titled “Help and Hope for People with Narcolepsy and  Catalepsy,”​ the copy read: “Both medications and supplements have proven to be effective for some people with narcolepsy and cataplexy. The PowerUP | PowerDOWN system has been shown to help regulate the symptoms that come with EDS (Excessive Daytime Sleepiness . . .”

Another disease claim cited by FDA was: “PowerUp | PowerDown has been shown     to be effective in adults with ADHD.”

Wasserman said the warning letter was also noteworthy in that is builds on a trend he has seen in recent warning letters in which FDA makes observations in the form of suggestions of things the company might consider changing or improving. He has seen a list like the one in the Amerigo Labs letter tacked onto the end of more than one communication.

“These are observations that the agency is not necessarily saying are violations of the act,” ​Wasserman said. “It’s a list of things that the agency is saying they hope the company would put right.”  ​Among these are labeling discrepancies such as calling out ‘vitamin B1’ without using the name ‘thiamine’ in parenthesis afterwords.





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