Product Liability

FDA cracks down on hormone-enhancing ‘dietary supplements’

IFN REV 001 100x100 FDA cracks down on hormone enhancing dietary supplementsThe Food and Drug Administration (FDA) is cracking down on a group of products marketed as “dietary supplements” and sold over-the-counter at retail outlets and online because they contain aromatase inhibitors, a class of drugs commonly known as ADTs and used in the treatment of breast cancer and ovarian cancer in postmenopausal women. Not only do ADTs carry a host of adverse events – such as decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure and liver dysfunction – use in these “dietary supplements” means the supplements do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.

Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. Because of this, the FDA concludes that the products containing aromatase inhibitors have a reasonable probability of resulting in permanent impairment of a body structure or function in at-risk consumers.

The recalled dietary supplements include:

  • Reversitol by Tribrarus/iForce Nutrition, marketed to promote hormonal regulation. The product was reportedly discontinued about a year ago but may still be available at some stores
  • Off Cycle II Hardcore by Fizogen Precision Technology, marketed to grow and sustain muscle mass. The product was reportedly discontinued about a year ago but may still be available at some stores
  • Arom-X, Arom-X UTT, Arom-XL, 4 AD, Decarol by Advanced Muscles Science, marketed as natural testosterone boosters and libido enhancers.
  • ArimaDex by Genetic Edge Technologies, marketed to increase and maintain testosterone levels.
  • Clomed by Kilosports Inc., marketed as a hormone to elevate testosterone.

Consumers with these products in their possession should stop using them immediately and contact their healthcare professional if they experience any adverse side effects. Any adverse events with these or any other products should be reported to the FDA MedWatch Adverse Events Reporting Program at www.FDA.gov/MedWatch.