FDA Issues Warning Letter to Regeneca
6/8/2011
Adam Gilmer, President and Co-Founder of Regeneca International ( Ethos Environmental Inc ) received a new warning letter from the FDA concerning the company's marketing and distribution of "Regenerect". On the heels of the FDA testing that revealed an analogue of the prescription ingredient in Viagra ( sildenafil ), and a recall on their product, the new warning advises Regeneca that their marketing and distribution of Regenerect violates the Federal Food, Drug and Cosmetic Act.
The FDA warning letter details the fact that Regenerect is labeled as a dietary supplement, but that the labeling statement makes it clear that Regenerect is a drug because it is used to prevent, treat, or curse a condition of the body.
Citing several significant violations, the letter warns Regeneca and Adam Gilmer to take "prompt actions to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice."