Pharmaceutical

Supplement maker gets hit with FDA warning

dietary supplements pills probiotics Supplement maker gets hit with FDA warning Dietary supplement manufacturer MS Bionic was hit by a Food and Drug Administration (FDA) warning letter for peddling Megajex, a product promoted for sexual enhancement, loaded with hidden prescription drugs sildenafil and tadalafil, the active ingredients in the erectile dysfunction drugs Viagra and Cialis. The warning letter was issued May 3, but posted this week to the FDA’s website.

Following an inspection of the company’s manufacturing plant, the  FDA confirmed the presence of the ED drugs in Megajex with a laboratory analysis. This ingredient poses health risks to some individuals. Viagra and Cialis can interact with nitroglycerin and cause blood pressure to drop dangerously low. People with heart disease, diabetes, high cholesterol and high blood pressure often take nitrates.

Furthermore, the FDA took issue with the promotion of Megajex, saying claims such as “increase stamina” violate federal law because it claims to “prevent, treat or cure disease conditions or affect structure or function of the body.” The agency also said the company’s Casanova Plus supplement is just as unlawful for claiming to “free” men from “premature ejaculation.”

“These products are not generally recognized as safe and effective under the conditions prescribed, recommended or suggested in their labeling,” the FDA’s letter stated.

The FDA’s lengthy warning letter called out several of the company’s other products for being misbranded because the product labels do not comply with the agency’s labeling requirements.

In November 2016, the company issued a nationwide recall of all lots Megajex, which the FDA acknowledged in the letter. As for the other violations identified during inspection, the agency has given MS Bionic 15 working days to respond with its actions to clear up the violations and ensure they are not repeated or else face potential legal consequences.

Source: FDA Warning Letter