FDA Warns Against Healthy Life Chemistry Supplement
July 29, 2013
SILVER SPRING, Md.U.S. Food and Drug Administration (FDA) warned consumers against using Healthy Life Chemistry by Purity First B-50, a product marketed as a vitamin B dietary supplement.
A preliminary FDA laboratory analysis indicated the product contains two potentially harmful anabolic steroidsmethasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.
Products marketed as a vitamin but which contain undisclosed steroids pose a real danger to consumers and are illegal," said Howard Sklamberg, director of the Office of Compliance in FDAs Center for Drug Evaluation and Research. The FDA is committed to ensuring that products marketed as vitamins and dietary supplements do not pose harm to consumers."
FDA received reports of 29 adverse incidents associated with the use of Healthy Life Chemistry. These reports include fatigue, muscle cramping and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function and cholesterol levels.
Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone. Consumers using Healthy Life Chemistry who experience any of these symptoms should consult a health care professional and report their experience to FDA.
Using anabolic steroid-containing products may cause acute liver injury. Some of the cases reported have resulted in hospitalization, but there were no reports of death or acute liver failure.
In addition, anabolic steroids may cause other serious long-term consequences in women, men and children. These include adverse effects on blood lipid levels, increased risk of heart attack and stroke, masculinization of women, shrinkage of the testicles, breast enlargement, infertility in males and short stature in children.
Healthy Life Chemistry is manufactured by Mira Health Products Ltd. and is sold on various websites and in retail stores. While Mira Health products recalled the product in its production facility, Purity First B-50 declined to voluntarily recall the product or to warn consumers about the potential for injury. Failure to promptly correct violations of the Federal Food, Drug and Cosmetic Act may result in legal action including, without limitation, seizure, injunction and criminal prosecution.
Mira declined to comment further on the product.
For more information on FDA compliance and marketing supplements legally, visit the Regulatory topic in the INSIDER content library.
You May Also Like