A Roswell company illegally sold an unapproved new drug, marketing it as a dietary supplement that could be used as a “physique enhancing agent,” federal regulators say. That product, recalled last year, can cause life-threatening reactions including liver toxicity, and increase the risk of heart attack and stroke.
In a warning letter sent in December to William T. Wotiz, owner of Dynamic Technical Formulations, the Food and Drug Administration notes that violation and says that federal inspectors discovered a number of other serious problems at the company's Roswell facility.
Among them, it says the company cannot ensure the purity, strength or composition of supplements because neither Wotiz nor any employees had the education, training or experience required. And if any consumers had a bad reaction to any product, the bottles didn’t provide any way for reporting them to the company. Instead, the warning letter says, the labels had an old address for the company and a phone number that went to a voice recording about the FDA‘s program.
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.
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."
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