The U.S. Food and Drug Administration, or FDA, has made public its official warning letter to Michael Leger and his company, Homeodynamics. From it, we learn that investigators inspected Leger’s manufacturing plant in Madison, Wisconsin back in August. While there, says the letter, agents documented “serious violations” of regulations covering the making, labeling and storing of dietary supplements.
The letter did not say what, if anything, prompted FDA to visit Homeodynamics but we do know that Leger has responded to alleged problems found during that inspection at least twice.
Homeodynamics’ “New Drugs” Violations
One thing we’ve seeing more of in recent years is a crackdown on non-allowed product names. Giving your dietary supplement a name that invokes the name of a disease or medical issue is definitely a no-no, says the agency. In Homeodynamics’ case, the problematic supplements included product names like:
- Zika Virosinum
- Carcinoma Mammae
- Multiple Sclerosis Nosode
- Dengue Fever
Homeodynamics’ “Adulterated” Dietary Supplements
Shoddy recordkeeping is also a problem, says FDA. Leger is accused of, among other things, failing to collect and hold samples of his finished products and failing to develop formal, written guidelines for employees to follow.
Alleged Labeling Issues
Another problem FDA says it found concerns Leger’s apparent unwillingness to use (or ignorance of) standardized serving sizes. Dosage guidelines measured in “drops” or “sprays”, as Leger’s supplements carry, are simply not allowed.
As is typical in warning letters like these, the letter to Homeodynamics was not intended to cover every single potential violation. It is up to Michael Leger and his team to discover and address those, says FDA. But he was given the normal 15 working days to address the noted problems.
Categories: FDA Warning Letters