Among the products cited in the letter are Gym Candy brand products Life Candy and Pump Candy; BioTech Underground products Purify and Tudca; and DTF brand products CLA FUEL, JOINT FUEL, DHEA FUEL and PUMP FUEL. They are considered adulterated because of the lack of quality control measures, FDA says.
Federal inspectors visited the company’s Hembree Parkway facility after last summer’s recall of Tri-ton. The company recalled the product after FDA testing found that it contained what are called selective androgen receptor modulators, or SARMs.
SARMS, which are intended to have effects like anabolic steroids, have not been approved for human consumption as prescription drugs. They are also banned by the World Anti-Doping Agency because of their potential for misuse.
by the NBA after testing positive for SARMs.
The company responded to the FDA's inspection in July, saying that it was implementing corrective actions. But the FDA said the company did not provide documentation to show that that it had implemented the changes. "We will verify the sufficiency of your corrective action during our next inspection," the letter says.
FDA has issued warning letters to other companies marketing products with SARMS. "We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients," an FDA official said in an October advisory. "We will continue to take action against companies marketing these products to protect public health."