FDA issues consumer advisory for Total Body dietary supplement products
ROCKVILLE, Md. The Food and Drug Administration on Friday advised consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue, the agency stated.
The Total Body Formula products are sold in eight-ounce and 32-ounce plastic bottles. The Total Body Mega Formula is sold in 32-ounce plastic bottles. Both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.
The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.
FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.
The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.
The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.
Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional.
The FDA is working with the Florida Department of Health in its investigation.
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.
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.