The owner of Gentech Pharmaceuticals has accepted a plea deal following a federal grand jury investigation into his company’s manufacturing, marketing and sales of dietary supplements containing unlabeled DMAA (1, 3-dimethylamylamine), a controversial stimulant FDA has been working to remove from the market since 2012 and that is the subject of a recent court ruling. Derek Vest now faces up to three years in prison, a US$250,000 fine and forfeiture of $2.5 million in assets. Sentencing is scheduled for July 3, 2017.

Vest’s attorney, David M. Goldberg, declined a request for comment.

Intent to Defraud and Mislead

Vest founded the Ft. Myers, Florida-based company in 2010 as a provider of "non-prescription pharmaceuticals" for weight loss, cognitive function and sleep management.

In 2012, FDA started sending warning letters to companies selling DMAA, advising DMAA is not a "dietary ingredient."

In 2013, Gentech sold DMAA in several supplements: the weight-loss products PhenTabz and PhenTabz-Teen, as well as AddTabz, a mental performance product advertised as an alternative to Adderall, an amphetamine drug for Attention Deficit hyperactivity disorder (ADHD).

According to the plea agreement, filed and approved in U.S. District Court in the Middle District of Florida, Vest knowingly authorized the use of DMAA in the manufacturing of these products, but he did not disclose the presence of the controversial ingredient on the products’ labeling or marketing.

From the period of at least April 2013 to November 2014, Gentech introduced more than 2 million of these misbranded products into interstate commerce at about $1.25 per tablet, according to court documents. Thus, the amount of his asset penalty is roughly equal to the amount of revenue from the sale of the misbranded products.

 The Gentech, ADDTabz Metamorphosis

Starting in 2014, Gentech began morphing into Lexium International. Vest was a sole shareholder in Lexium International LLC, but he sold his interest in 2015. Lexium is currently run by Vest’s sister, Tara Vest.

After selling to Lexium, Derek Vest founded a new company, Cellmark Biopharma, which focuses on the same health condition areas as Gentech did, weightloss and cognitive health. In a 2015 article in the News-Press, a South Florida publication in the USA TODAY Network, Vest said his new products are designed to "give the patient everything they need nutritionally to fuel their fight against cancer," and part of the goal is to prevent patients from getting cancer cachexia—weight-loss and atrophy.

Lexium continues to sell PhenTabz and ADDTabz, but it has removed the DMAA from the formulation.

Lexium and Cellmark occupy the same building in Ft. Myers.

Continued Enforcement Against DMAA

The mislabeling of the supplements is in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), a law enforced by FDA, which has been taking action against dietary supplements containing DMAA.

Hi-Tech Pharmaceuticals Inc., a sports nutrition manufacturer, has argued in court documents that the compound can be found in geranium plants and is a legitimate dietary ingredient. FDA has countered there is no metabolic pathway for geranium to make DMAA, and that the substance is an unapproved food additive that doesn’t belong in supplements.

On April 3, a judge in Atlanta ruled DMAA is not a dietary ingredient and that Hi-Tech’s products containing the substance are adulterated.

Responding to the ruling, FDA told INSIDER it is actively overseeing the market and will take action against DMAA when appropriate.