The U.S. Food and Drug Administration (FDA) described a tainted herbal dietary supplement as a “serious threat” after hidden drugs were found to be included in the pills.
A nationwide recall has been issued over the possible side effects that could happen. The agency notes that the situation could be potentially life threatening and urge consumers to check their medicine cabinets for the supplement.
The Company
The company is a Georgia based supplement creator called GURU INC.
Specializing in Eastern and Tibetan medicine, the company claims to be on the mission to save the lives of those suffering to regain happiness while using natural herbs, teas, and alcohol essences.
The Recall
The company voluntarily recalled a batch of the “Infla-650” herbal supplements on July 16.
They pills were found to contain acetaminophen, diclofenac and phenylbutazone, although the compounds were not listed on the packaging. The product is marketed as an all natural herbal supplement to relieve pain and reduce inflammation.
FDA Finds the Hidden Drugs
The FDA has noted that including unknown substances in products “poses a serious threat to consumers.”
Unlabelled allergens is one of the biggest causes for recalls in the country. The hidden drugs were first identified by the FDA on June 20 following routine tests.
The Threat
Although active ingredients like acetaminophen are commonly used as a pain killer, taking them unknowingly, even in small quantities, could post a serious threat to the consumer.
The tainted supplement could cause an unintentional overdose and could cause severe liver damage and serious skin reactions to those who are allergic or taking other drugs that might not mix well.
Serious Complications Are Possible
The other active ingredient that the FDA found was diclofenac, it’s an anti-inflammatory prescription drug that may increase the risk of cardiovascular events and gastrointestinal damage when taken in high concentrations.
Diclofenac can easily interact negatively with other medications.
The Most Concerning Hidden Drug
The most serious drug that was hidden in the supplement was phenylbutazone, which has previously been discontinued for human use in the U.S. because of health risks.
According to the FDA, “The most serious and life-threatening injury associated with phenylbutazone treatment is bone marrow toxicity, which occurs when the body does not produce enough red blood cells, white blood cells, and/or platelets.”
Who Is at Risk?
The FDA also recorded that Patients with anemia, low white or red blood cell count, or decreased blood platelets may be at a greater risk of death or serious injury” if they unknowingly ingest the drug.
This issue highlights the importance of labelling items correctly and what outcomes might occur if a consumer ingests something they shouldn’t.
No Injuries Reported Yet
Thankfully, no injuries have been reported to GURU INC. yet.
The company has done its due diligence to notify customers and distributers of the recall by email and has urged all customers to stop using the product.
Are Dietary Supplements Safe?
Although tested and approved by the FDA, there has been some dubious reports about the effectiveness of dietary supplements in the past.
One report shows that a supplements can actually reduce life span as the unregulated industry overpromises and underdelivers.
The Herbs in the Supplement
Intra-650 is said to contain a blend of herbs based on the ancient Indian medicine system known as Ayurveda.
The other ingredients listed on the packaging include ashwagandha, fenugreek seed, and shilajit.
Supplements are Unproved Drugs
The FDA also made a note that dietary supplements are classified as “unapproved” drugs and have not undergone the same testing and scrutiny as pharmaceutical products sold in pharmacies.
“FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients,” and works as a stark reminder that items bought and sold in the internet might be deceiving consumers in some way.
