Michael Floren and his companies, EonNutra LLC, CDSM LLC and HABW LLC, have been ordered to stop producing and selling their dietary supplements until Floren can prove that his companies are working within FDA guidelines. The order is effective immediately.
“Companies that market their products with unproven health claims and also continue to violate manufacturing regulations put consumers’ health in jeopardy,” said FDA spokesperson Melinda Plaisier. Plaisier is an FDA associate commissioner for regulatory affairs.
Floren’s 3 “herbal” supplements businesses (and their many websites) share the same address and have been visited by FDA inspectors multiple times in the past 5 years. The agency alleges that it documented numerous violations–mostly involving unallowed marketing claims and shoddy recordkeeping.
A 2012 inspection of EonNutra, for example found violations including:
- EonNutra did not test their raw ingredients for purity, strength or even identity.
- EonNutra did not test finished products for quality.
- EonNutra did not retain samples of distributed products.
Floren was also warned about some of the medical claims he allegedly made about his products. Some of those claims included statements about the supplements’ efficacy for conditions like:
- High cholesterol
- High blood pressure
- Muscle pain
As of my visit to one of Floren’s websites (DeerAntlerMax.com) this morning, I found such claims like those of lowering blood pressure and cholesterol, still plainly visible. On another site, PrimalRageNutrition.com, I found promises of “awesome muscle gains” and “significant fat loss” attached to the 1-Andro-Stane supplement.
Under the terms of the consent decree, Floren cannot go back into business until he does the following:
- Recalls the “adulterated” and “mislabeled” supplements
- Hire experts in FDA-compliant labeling
- Hire a Good Manufacturing Practices expert
- Receives formal permission from the FDA