FDA warns consumers about unapproved E.D. products
ROCKVILLE, Md. The Food and Drug Administration on Tuesday advised consumers not to purchase or use “Blue Steel” or “Hero” products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. Both products are distributed by Active Nutraceuticals or the Marion Group.
The Blue Steel and Hero products are promoted and sold over the Internet for the treatment of erectile dysfunction and for sexual enhancement, the FDA stated. They’re touted as “all natural” and labeled as dietary supplements. However, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for E.D.
“Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” stated Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking.”
Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two blue capsules. Hero is sold in blister packs containing two blue capsules.
Pharmavite introduces new SoyJoy flavors
NORTHRIDGE, Calif. Pharmavite on Tuesday announced the introduction of two new SoyJoy flavors—strawberry and peanut chocolate chip.
“With 8 grams of whole soy per bar, SoyJoy contains the nutritious fiber, isoflavones and complete protein naturally found in soy,” stated Allegra Burton, Pharmavite spokeswoman. “While many soy products on the market today use highly processed soy protein concentrate and isolate, SoyJoy is always made from high-quality, non-genetically modified whole soybeans.”
The two new soy bars will be on shelves in April in the nutrition bar aisle of most grocery, drug, mass and health food stores nationwide, Pharmavite stated. Suggested retail price is $1.29.
Everidis introduces probiotic drops for kids
ST. LOUIS Everidis Health Sciences announced last week that it would begin distribution of BioGaia Probiotic Drops, a probiotic formulated for children. According to the company, the drop-form delivery system is the first in probiotics.
BioGala Drops contains L. reuteri—a double-blind, placebo-controlled study published online in the January edition of the Journal of Pediatrics found that L. reuteri improved gut function and feeding tolerance in formula-fed pre-term newborns.
Everidis already has distribution for its B-natal product via AmerisourceBergen; Cardinal; Dakota Drug; Harvard Drug; HD Smith; Kinray; McKesson; McQueary; Morris & Dickson; N.C. Mutual Drug; Smith Drug and Value Drug.