Fake Opioid Treatment Distributors Targeted by FDA

Last Updated: Sep 20th 2019

Reviewed by Brittany Polansky

One of the unfortunate side effects of a market driven economy is the incentive of money that can motivate some people and their companies to put profits and exploitation above the customer satisfaction and even safety. With the opioid epidemic catching a large portion of the news cycle, morally ambiguous businesses are popping up claiming to have solutions to opioid addiction while completely avoiding the approval process of the FDA, which was established by congress passing the Food and Drug Act in 1906 to protect consumers from negligent business practices. The FDA approval process for drugs involves rigorous testing and proving the effectiveness of the drug, reviewing and documenting possible side effects and general safety when used by the consumer.

Recently, numerous reports to the FDA drew attention to the marketing of tianeptine by at least two specific companies who are being investigated for violating the regulatory laws resulting from marketing the drug under the supplement category. In some countries, the drug is approved for sale as an antidepressant, but has been rejected by the FDA for any use due to the risks of use which include neurological, gastrointestinal and cardiovascular problems in addition to mimicking opioid withdrawal and toxicity. The U.S. Centers for Disease Control and Prevention reported in August the number of tianeptine exposure calls to U.S. poison control centers rose during 2014 to 2017, suggesting a possible emerging public health risk.

 

Tianeptine as a “Dietary Supplement”

Tianeptine itself, being distributed as a ‘dietary supplement’ in order to avoid FDA approval as a safe consumer-grade drug, was found to be in Tianaa Red, Tianaa Green and Tianaa White distributed by Jack B Goods Outlet Store and Vicaine, distributed by MA Labs. The FDA issued warnings to cease distribution of these products in an effort to ensure consumer safety. With the opioid crisis showing very little signs of slowing down overall, the FDA has it’s work cut out for them in maintaining a safe consumer environment that prevents exploitation of businesses in this way to cash in on the addiction epidemic.

While these two specific companies were the only ones named in the warning letters sent out, which does not demand any monetary compensation related to the customers whose health was adversely affected already, there’s no authoritative information available at this time about how many different ‘supplements’ are currently sold under different names and outlets.

Opioid addiction is serious and requires professional treatment and rehab to be successful within an addict. The biggest risk to an addict is overdose which can lead to death. The longer the addiction goes on, the risk to overdose increases as well. If you or someone you know is addicted to opioids such as oxycodone or hydrocodone, 1st Step Behavioral Health can help. Please call (866) 319-6126 to speak to a qualified counselor about treatment options and residential in the southern Florida area.

Reviewed for Medical & Clinical Accuracy by Brittany Polansky

Brittany PolanskyBrittany has been working in behavioral health since 2012 and is a Primary Clinician at our facility. She is an LCSW and holds a master’s degree in social work. She has great experience with chemical dependency and co-occurring mental health diagnoses as well as various therapeutic techniques. Brittany is passionate about treating all clients with dignity and respect, and providing a safe environment where clients can begin their healing journey in recovery.