In April, the Food and Drug Administration announced a recall of two dietary supplements manufactured by Organic Herbal Supply, Zrect for Women and LabidaMAX, that were marketed to boost women’s sex drive.
Both supplements were found to have traces of flibanserin, which had been approved by the FDA back in 2015 to treat hypoactive sexual desire disorder, referring to a woman’s a chronic lack of interest in sex to the point where it causes issues in her relationships. While this will mark the first time that FDA officials have recalled a product laced with this particular drug, it is not uncommon for male sexual enhancement supplements to be contaminated by Viagra. According to FDA lab tests, Viagra has turned up in dozens of over-the counter pills that never disclosed that they contained the drug.
Spokesperson for the FDA, Lyndsay Meyer told STATNews, “FDA lab tests have found that hundreds of these products contain undisclosed drug ingredients.”
The dietary supplement market is huge and largely unregulated as these products can be sold prescription-free in supermarkets, specialty supplement stores and even online. While supplement makers are prohibited from making false claims that their products can cure a particular condition, they are able to make general claims that their products promote sexual desire.
Dr. Pieter Cohen, a physician at Harvard Medical School who studies dietary supplements told STATNews, “There’s nothing that you can actually put in the pill that lives up to the advertised claims, so there is this temptation to introduce a pharmaceutical drug that attempts to meet these claims.”
The consumption of flibanserin puts consumers at a high risk of serious harm. The prescription drug Addyi, approved by the FDA in August 2015 with flibanserin as it main ingredient, carries a black-box warning, the strongest warning required by the FDA, on its packaging. The warning states that the drug can cause severe drops in blood pressure and fainting, which can lead irreversible or even life-threatening injuries.The labeling goes on to caution that patients taking flibanserin must never combine the drug with alcohol and that women with liver disease or who are taking other drugs that may interfere with the body’s breakdown of flibanserin are at the greatest risk.
The FDA has yet to receive any reports of adverse effects directly tied to either of the supplements but researchers and experts still insist that they are far from safe due to the severe lack of regulation.
In regards to the message of the recall, Cohen says: “Consumers should just completely avoid sexual enhancement supplements. They either might be safe and don’t work, or they might work but are likely to be dangerous.”