Have You Been Injured? We're Ready to Fight for You.

Warning Letters Sent to Five Supplement Makers Regarding the Synthetic Drug Picamilon

Published on Jan 4, 2016 at 10:35 pm in Supplements.

The U.S. Food and Drug Administration has sent letters to five nutritional supplement manufacturers warning them to remove products labeled with the synthetic ingredient picamilon.  Letters were sent to DBM Nutrition, ICF International LLC, Top Secret Nutrition LLC, Applied Nutriceuticals Inc., and SDC Nutrition Inc., giving each company fifteen business days to respond to requests to take away products labeled with picamilon as an ingredient or be subject to further enforcement by the FDA.  Picamilon is a synthetic chemical developed in the former Soviet Union and still used in Russia as a drug to treat neurological conditions.  According to the FDA, the substance does not meet its definition of a dietary ingredient, therefore any supplements sold listing picamilon as a dietary ingredient are misbranded.

The letters are an action following a lawsuit filed in October by the Oregon Attorney General against the large supplement retailer GNC Holdings Inc., accusing the company of selling drug-spiked dietary supplements.  GNC is one of the world’s largest retailers of dietary supplements.  According to internal company records, the retailer has knowingly sold products containing the two synthetic drugs, picamilon and beta-methylphenethylamine (BMPEA).  The retailer claims to sell products made only from all-natural ingredients, yet their internal records indicate knowledge of picamilon as a synthetic drug as far back as 2007.  GNC stopped selling products with BMPEA in April and products with picamilon in September.

GNC has released a short statement regarding the pending litigation, stating “The claims made by the Oregon Attorney General are without merit and GNC intends to vigorously defend against these allegations.  In response to FDA statements regarding the regulatory status of BMPEA and picamilon, GNC promptly took action to remove from sale all products containing those ingredients.”  The Oregon lawsuit raises questions about the effectiveness of the FDA in regulating the dietary supplement industry, who’s supplements have increasingly been found to contain hidden and risky pharmaceuticals.

Under existing law, the FDA says it must show a product is unsafe, that its labeling is false or misleading, or that it was not made using good manufacturing practices before it can take any action to remove it from the market.  GNC argues that any issue involving use of the ingredients picamilon and BMPEA should have been addressed by a warning letter from the FDA, not a lawsuit at the state level.  Oregon’s Assistant Attorney General said in a statement, “Regardless of whether regulation of dietary supplements requires reform, more aggressive enforcement of existing laws will better protect consumers.”

 

If you wish to learn more about the FDA and the regulation of dietary supplements, contact Thomas Law Offices for more information.

Free Case Evaluation

At Thomas Law Offices, our personal injury attorneys recognize that our potential clients are likely going through some of the most difficult times of their lives. We don't want you to have to worry about paying out of pocket for legal advice when you're just starting to learn your legal rights and options. That's why we provide free case evaluations. We'll offer our expert advice about your potential case and walk you through how we can help you.

Call us or fill out the form below to tell us about your potential case and a personal injury lawyer will get back to you as quickly as possible.

Meet Our Founder

Tad Thomas - Trial Lawyer

Tad Thomas

Managing Partner

Tad Thomas has dedicated his practice to representing plaintiffs in various types of civil litigation, including personal injury, business litigation, class actions, and multi-district litigation.

After graduating with his law degree in 2000 from Salmon P. Chase College of Law at Northern Kentucky University, Mr. Thomas immediately opened his own private practice and began representing injury victims.

In 2011, Thomas Law Offices was established in Louisville, Kentucky. Over the past decade, Mr. Thomas has expanded his firm and now has offices in three additional locations: Cincinnati, Ohio, Columbia, Missouri, and Chicago, Illinois. He is also a frequent lecturer on topics like trial skills and ethics and technology.

Legal & Firm News

Two Nurses Arrested in Ohio for Nursing Home Resident Neglect

In April 2022, Sunrise Manor nursing home’s director of nursing and assistant nursing director were arrested for allegations of patient neglect. Christina Drake and Jennie Elliott are being investigated following a criminal complaint filed in regard to an incident that occurred in April 2020. The two nursing staff members are facing multiple first-degree misdemeanor charges, […]

Read More

What Injuries Do Unattended Children Most Commonly Suffer?

It is a tragedy when a child is killed or injured in an accident that could have been prevented. Most of the time, it only takes one attentive adult to stop these tragic incidents from happening. The personal injury lawyers at Thomas Law Offices look at what injuries unattended children most commonly suffer and⁠—more importantly—how […]

Read More

What Injuries Can Result From Slamming on the Brakes?

No matter how safely you may drive, you will undoubtedly encounter situations in which you will have to take significant evasive maneuvers to avoid a car accident. While avoiding a motor vehicle crash is virtually always preferable to a collision, there are times when the evasive action can also cause harm.

Read More
Tad Thomas on The National Crime Victim Bar Association
Tad Thomas on AVVO
Tad Thomas on Lawyer Minds
Tad Thomas on American Association for Justice
Southern Trial Lawyers Association
Illinois Trial Lawyers Association
Ohio Association for Justice
Kentucky Justice Association
Tad Thomas on Attorney at Law Magazine
Tad Thomas on Attorney at Law Magazine
2021 Public Justice Member
AAJ Masters of Trial Law: Champion